NOAEL Studies
Cosmetic Ingredient
Butoxyethanol NOAEL Studies
INCI: BUTOXYETHANOL
CAS: 111-76-2
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
ATSDR_toxval_ATSDR_MRLs.xlsx 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ATSDR_toxval_ATSDR_MRLs.xlsx | LOAEL | =32 | mg/kg/day | Rat (F344; M) | oral | short-term; 2 days | short-term | ATSDR MRLs; row_hash=f0534935b37f75dc; source_hash=ToxValhc_bd1459974a919cc8e307fdce32268645; raw_endpoint_type=LOAEL; raw_endpoint_subtype=; raw_value=32; raw_unit=mg/kg/day; method=gavage; effect=hematological; effect_category=hematology; file=toxval_ATSDR_MRLs.xlsx; long_ref=Ghanayem BI, Blair PC, Thompson MB, et al. 1987a. Effect of age on the toxicity and metabolism of ethylene glycol monobutyl ether (2-butoxyethanol) in rats. Toxicol Appl Pharmacol91(2):222-234.; stored_source_record=https://clowder.edap-cluster.com/files/6568f404e4b063812d584bf1 |
| ATSDR_toxval_ATSDR_MRLs.xlsx | LOAEL | =69 | mg/kg/day | Rat (F344/N; M/F) | oral | subchronic; 13 weeks | subchronic | ATSDR MRLs; row_hash=8f23aeb70d9b5320; source_hash=ToxValhc_eac2eb0b36287edac2a2a131e61b0b18; raw_endpoint_type=LOAEL; raw_endpoint_subtype=; raw_value=69; raw_unit=mg/kg/day; method=drinking water; effect=hepatic; effect_category=other; file=toxval_ATSDR_MRLs.xlsx; long_ref=NTP. 1993. Ethylene glycol ethers, 2-ethoxyethanoI, 2-butoxyethanol administered in drinking water to F344/N rats and B6C3Fl mice. NTP toxicity report series no. 26. National Toxicology Program, National Institutes of Health, Public Health Services, U.S. Department of Health and Human Services. NIH publication 93-3349.; stored_source_record=https://clowder.edap-cluster.com/files/6568f404e4b063812d584bf1 |
| ATSDR_toxval_ATSDR_MRLs.xlsx | NOAEL | =241.67 | mg/m3 | Rat (Fischer 344; F) | inhalation | short-term (developmental); 10 days | reproduction developmental | ATSDR MRLs; row_hash=a85b08822ff1270b; source_hash=ToxValhc_8af693f227f72aff2a70b90332453526; raw_endpoint_type=NOAEL (HEC); raw_endpoint_subtype=; raw_value=50; raw_unit=ppm; effect=hematological; effect_category=hematology; file=toxval_ATSDR_MRLs.xlsx; long_ref=Tyl RW, Millicovsky G, Dodd DE, et al. 1984. Teratologic evaluation of ethylene glycol monobutyl ether in Fischer 344 rats and New Zealand white rabbits following inhalation exposure. Environ Health Perspect 57:47-68.; stored_source_record=https://clowder.edap-cluster.com/files/6568f404e4b063812d584bf1 |
| ATSDR_toxval_ATSDR_MRLs.xlsx | NOAEL | =120.835 | mg/m3 | Rat (Fischer 344; M/F) | inhalation | subchronic; 90 days | subchronic | ATSDR MRLs; row_hash=bce2112d7f01f597; source_hash=ToxValhc_5176e7c5c0e3796b8000f4eb43eb8e05; raw_endpoint_type=NOAEL (HEC); raw_endpoint_subtype=; raw_value=25; raw_unit=ppm; effect=hematological; effect_category=hematology; file=toxval_ATSDR_MRLs.xlsx; long_ref=Dodd DE, Snellings WM, Maronpot RR, et al. 1983. Ethylene glycol monobutyl ether: Acute, 9-day, and 90-day vapor inhalation studies in Fischer 344 rats. Toxicol Appl Pharmacol68(3):405-414.; stored_source_record=https://clowder.edap-cluster.com/files/6568f404e4b063812d584bf1 |
| ATSDR_toxval_ATSDR_MRLs.xlsx | NOAEL | =2.90004 | mg/m3 | Human (M) | inhalation | chronic; 6 years | occupational | ATSDR MRLs; row_hash=0f89730048748bd2; source_hash=ToxValhc_5f2f0308b3b7d9259306ccfc6f36849f; raw_endpoint_type=NOAEL; raw_endpoint_subtype=; raw_value=0.6; raw_unit=ppm; effect=hematological; effect_category=hematology; file=toxval_ATSDR_MRLs.xlsx; long_ref=Haufroid V, Thirion F, Mertens P, et al. 1997. Biological monitoring of workers exposed to low levels of 2- butoxyethanol. Int Arch Occup Environ Health 70:232-236.; stored_source_record=https://clowder.edap-cluster.com/files/6568f404e4b063812d584bf1 |
COSMOS_DB 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 46 | mg/kg bw/day | rat | oral | 91 day | Subchronic | REACH; NTP TR 26 |
| COSMOS_DB | LOAEL | 615 | mg/kg bw/day | mouse | oral | 90 day | Subchronic | REACH; NTP TR 26 |
| COSMOS_DB | NOAEL | 1000 | mg/kg bw/day | mouse | oral | 35 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 222 | mg/kg bw/day | mouse | oral | 42 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 500 | mg/kg bw/day | mouse | oral | 36 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1180 | mg/kg bw/day | mouse | oral | NA | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 100 | mg/kg bw/day | rat | oral | 3 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 150 | mg/kg bw/day | rat | oral | 3 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 700 | mg/kg bw/day | mouse | oral | NA | Multigeneration Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1379 | mg/kg bw/day | mouse | oral | 105 day | Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1223 | mg/kg bw/day | mouse | oral | 96 day | Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 125 | mg/kg bw/day | rat | oral | 12 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 250 | mg/kg bw/day | rat | oral | 1 day | Special Toxicology Study | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 591 | mg/kg bw/day | rat | oral | 1 day | Special Toxicology Study | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 265 | mg/kg bw/day | rat | oral | 14 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 82 | mg/kg bw/day | rat | oral | 91 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 627 | mg/kg bw/day | mouse | oral | 14 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 676 | mg/kg bw/day | mouse | oral | 91 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 443 | mg/kg bw/day | rat | oral | 60 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 246 | mg/kg bw/day | rat | oral | 63 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 159 | mg/kg bw/day | rat | oral | 42 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 225 | mg/kg bw/day | rat | oral | 90 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 400 | mg/kg bw/day | mouse | oral | 5 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 297 | mg/kg bw/day | mouse | oral | 90 day | Subchronic | REACH; NTP TR 26 |
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | LOAEL | =69 | mg/kg bw/day | Rat | - | - | subchronic | EFSA AFC - 2009 - OutputID 2306 - haematology - hemopoietic - Flavouring Group Evaluation 10, Revision 1 (FGE10 Rev1) Aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical groups 9, 13 and 30 - doi:10.2903/j.efsa.2009.934 |
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | LOAEL | =9.5 | mg/kg bw/day | Unspecified | - | - | - | EFSA CEF - 2011 - OutputID 2100 - hemopoietic - Scientific Opinion on Flavouring Group Evaluation 10, Revision 2 (FGE.10Rev2): Aliphatic primary and secondary saturated and unsaturated alcohols, aldehydes, acetals, carboxylic acids and esters containing an additional oxygenated functional group and lactones from chemical groups 9, 13 and 30 - doi:10.2903/j.efsa.2011.2164 |
EPA_IRIS_iris_rfc_systems.csv 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EPA_IRIS_iris_rfc_systems.csv | BMCL (HEC) | =16 | mg/m^3 | - | inhalation | chronic | IRIS chronic inhalation RfC system PoD | row_hash=583ee71a48100827; file=iris_rfc_systems.csv; kind=point_of_departure; raw_column=point_of_departure; raw_value=BMCL (HEC): 16 mg/m^3; system=Hematologic; basis=Hemosiderin deposition in the liver; point_of_departure=BMCL (HEC): 16 mg/m^3; composite_uf=10; confidence=Medium/High; dtxsid=DTXSID1024097; detail_url=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=500; rfc_last_updated=03/31/2010; rfc_pdf_url=https://iris.epa.gov/static/pdfs/0500_summary.pdf |
| EPA_IRIS_iris_rfc_systems.csv | RfC | =1.6 | mg/m^3 | - | inhalation | chronic | IRIS chronic inhalation RfC system | row_hash=17af1fe99d0400fc; file=iris_rfc_systems.csv; kind=reference_value; raw_column=rfc_mg_per_m3; raw_value=1.6; system=Hematologic; basis=Hemosiderin deposition in the liver; point_of_departure=BMCL (HEC): 16 mg/m^3; composite_uf=10; confidence=Medium/High; dtxsid=DTXSID1024097; detail_url=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=500; rfc_last_updated=03/31/2010; rfc_pdf_url=https://iris.epa.gov/static/pdfs/0500_summary.pdf |
EPA_IRIS_iris_rfd_systems.csv 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EPA_IRIS_iris_rfd_systems.csv | BMDL (HED) | =1.4 | mg/kg/day | - | oral | chronic | IRIS chronic oral RfD system PoD | row_hash=1f6a0e4533d656d6; file=iris_rfd_systems.csv; kind=point_of_departure; raw_column=point_of_departure; raw_value=BMDL (HED): 1.4 mg/kg-day; system=Hematologic; basis=Hemosiderin deposition in the liver; point_of_departure=BMDL (HED): 1.4 mg/kg-day; composite_uf=10; confidence=Medium/High; dtxsid=DTXSID1024097; detail_url=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=500; rfd_last_updated=03/31/2010; rfd_pdf_url=https://iris.epa.gov/static/pdfs/0500_summary.pdf |
| EPA_IRIS_iris_rfd_systems.csv | RfD | =0.1 | mg/kg/day | - | oral | chronic | IRIS chronic oral RfD system | row_hash=2fdd615ae8d644e1; file=iris_rfd_systems.csv; kind=reference_value; raw_column=rfd_mg_per_kg_day; raw_value=1e-1; system=Hematologic; basis=Hemosiderin deposition in the liver; point_of_departure=BMDL (HED): 1.4 mg/kg-day; composite_uf=10; confidence=Medium/High; dtxsid=DTXSID1024097; detail_url=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=500; rfd_last_updated=03/31/2010; rfd_pdf_url=https://iris.epa.gov/static/pdfs/0500_summary.pdf |
IARC Monographs 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| IARC Monographs | IARC carcinogenicity classification | 3 | IARC group | - | - | 2004 | IARC Monographs | {"additional_info":"volume_publication_year=2006","evaluation_year":2004,"source_table":"iarc_classifications","volume":"88"} |
| IARC Monographs | IARC carcinogenicity classification | 3 | IARC group | - | - | 2004 | IARC Monographs | {"additional_info":"volume_publication_year=2006","evaluation_year":2004,"source_table":"iarc_classifications","volume":"88"} |
| IARC Monographs | IARC carcinogenicity classification | 3 | IARC group | - | - | 2004 | IARC Monographs | {"additional_info":"volume_publication_year=2006","evaluation_year":2004,"source_table":"iarc_classifications","volume":"88"} |
INCHEM_WHO_cicads_cicads_cicad10 7 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| INCHEM_WHO_cicads_cicads_cicad10 | LOAEL | =77 | ppm | - | - | - | Chronic toxicity | document_id=cicads_cicads_cicad10; title=Butoxyethanol, 2- (CICADS); path=mirror/documents/cicads/cicads/cicad10.htm; row_hash=5642aa24c76d5d24; raw_unit=ppm; context=LOAEL = 77 ppm [372 mg/m 3 ]) in animals exposed subchronically (Dodd et al., 1983); and decreased red blood cells and increased mean cell volume (NOAEL = 50 ppm [242 mg/m 3 ]; |
| INCHEM_WHO_cicads_cicads_cicad10 | LOAEL | =100 | ppm | - | - | - | Toxicology study | document_id=cicads_cicads_cicad10; title=Butoxyethanol, 2- (CICADS); path=mirror/documents/cicads/cicads/cicad10.htm; row_hash=c267ed97fb705254; raw_unit=ppm; context=LOAEL = 100 ppm [483 mg/m 3 ]) in pregnant animals exposed on days 6-15 of gestation (Tyl et al., 1984). |
| INCHEM_WHO_cicads_cicads_cicad10 | LOAEL | =50 | ppm | - | - | - | Developmental toxicity | document_id=cicads_cicads_cicad10; title=Butoxyethanol, 2- (CICADS); path=mirror/documents/cicads/cicads/cicad10.htm; row_hash=1d76439ea0fe127d; raw_unit=ppm; context=In the developmental study, the NOAEL and LOAEL in the dams were 50 ppm (242 mg/m 3 ) and 100 ppm (483 mg/m 3 ), respectively (Tyl et al., 1984). |
| INCHEM_WHO_cicads_cicads_cicad10 | LOAEL | =25 | ppm | - | inhalation | subchronic | Chronic toxicity | document_id=cicads_cicads_cicad10; title=Butoxyethanol, 2- (CICADS); path=mirror/documents/cicads/cicads/cicad10.htm; row_hash=7f4da8a9f4499344; raw_unit=ppm; context=In the subchronic inhalation study, the NOAEL and LOAEL were 25 ppm (121 mg/m 3 ) and 77 ppm (372 mg/m 3 ), respectively (Dodd et al., 1983). |
| INCHEM_WHO_cicads_cicads_cicad10 | NOAEL | =20 | ppm | - | - | - | Toxicology study | document_id=cicads_cicads_cicad10; title=Butoxyethanol, 2- (CICADS); path=mirror/documents/cicads/cicads/cicad10.htm; row_hash=be14728ef1fa82a4; raw_unit=ppm; context=The no-observed-adverse- effect level (NOAEL) in this study is 20 ppm (97 mg/m 3 ). |
| INCHEM_WHO_cicads_cicads_cicad10 | NOAEL | =50 | ppm | - | - | - | Toxicology study | document_id=cicads_cicads_cicad10; title=Butoxyethanol, 2- (CICADS); path=mirror/documents/cicads/cicads/cicad10.htm; row_hash=ae18d7c6be2af39f; raw_unit=ppm; context=The NOAEL in this study is 50 ppm (242 mg/m 3 ) 2-butoxyethanol. |
| INCHEM_WHO_cicads_cicads_cicad10 | NOAEL | =25 | ppm | - | - | - | Toxicology study | document_id=cicads_cicads_cicad10; title=Butoxyethanol, 2- (CICADS); path=mirror/documents/cicads/cicads/cicad10.htm; row_hash=795d7ed3109b538f; raw_unit=ppm; context=The NOAEL in this study is 25 ppm (121 mg/m 3 ). |
NTP_ICE_acute_inhalation 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | LC50 | 4.3473 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=936; Record_ID=acute_inhalation_2474; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=4.3473; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/3/3/?documentUUID=175889e8-9a39-4c77-b6c6-bcd3fb1876ed; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_acute_inhalation | LC50 | range1 | mg/L | - | Inhalation | Duration=3 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=937; Record_ID=acute_inhalation_2920; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=range; Response=>1 and 4<; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/3/3/?documentUUID=32b82222-1aaa-4c34-98a7-bd7d66a96c4e; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_acute_inhalation | LC50 | 3.8643 | mg/L | - | Inhalation | Duration=8 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=939; Record_ID=acute_inhalation_2480; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=3.8643; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/3/3/?documentUUID=d09bf766-8c2c-48f0-9caa-60c423f512ff; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_acute_inhalation | LC50 | 2.9 | mg/L | - | Inhalation | Duration=7 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=940; Record_ID=acute_inhalation_1635; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=2.9; Response_Unit=mg/L; Reference=NIOSH; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_acute_inhalation | LC50 | 2.1737 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=942; Record_ID=acute_inhalation_1117; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=2.1737; Response_Unit=mg/L; Reference=ChemIDplus; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_acute_inhalation | LC50 | >4.26 | mg/L | - | Inhalation | Duration=7 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=943; Record_ID=acute_inhalation_2481; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=4.26; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/3/3/?documentUUID=1eeb89a5-a642-4434-ad2e-723c5afaf971; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_acute_inhalation | LC50 | 2.5263 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=944; Record_ID=acute_inhalation_2471; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=2.5263; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/3/3/?documentUUID=6f3d6ee2-17a8-4932-a3a3-6e83f7082fb0; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_acute_inhalation | LC50 | 2.6326 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=945; Record_ID=acute_inhalation_2473; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=2.6326; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/3/3/?documentUUID=6f3d6ee2-17a8-4932-a3a3-6e83f7082fb0; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
NTP_ICE_acute_oral 7 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | <3000 | mg/kg bw | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | record_id=acute_oral_1068; row=2458; data_type=In Vivo; mixture=Chemical; chemical_name=2-Butoxyethanol; preferred_name=2-Butoxyethanol; dtxsid=DTXSID1024097; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1024097; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1746 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | OECD eChemPortal (undated); record_id=acute_oral_1067; row=2459; data_type=In Vivo; mixture=Chemical; chemical_name=2-Butoxyethanol; preferred_name=2-Butoxyethanol; dtxsid=DTXSID1024097; url=https://www.echemportal.org/echemportal/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1024097; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =880 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | ECHA ChemProp (undated); record_id=acute_oral_1065; row=2460; data_type=In Vivo; mixture=Chemical; chemical_name=2-Butoxyethanol; preferred_name=2-Butoxyethanol; dtxsid=DTXSID1024097; url=https://echa.europa.eu/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1024097; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1480 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | ECHA ChemProp (undated); record_id=acute_oral_1066; row=2461; data_type=In Vivo; mixture=Chemical; chemical_name=2-Butoxyethanol; preferred_name=2-Butoxyethanol; dtxsid=DTXSID1024097; url=https://echa.europa.eu/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1024097; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =615 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | ECHA ChemProp (undated); record_id=acute_oral_1064; row=2462; data_type=In Vivo; mixture=Chemical; chemical_name=2-Butoxyethanol; preferred_name=2-Butoxyethanol; dtxsid=DTXSID1024097; url=https://echa.europa.eu/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1024097; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | >560 | mg/kg bw | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | record_id=acute_oral_1063; row=2463; data_type=In Vivo; mixture=Chemical; chemical_name=2-Butoxyethanol; preferred_name=2-Butoxyethanol; dtxsid=DTXSID1024097; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1024097; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =470 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_1062; row=2464; data_type=In Vivo; mixture=Chemical; chemical_name=2-Butoxyethanol; preferred_name=2-Butoxyethanol; dtxsid=DTXSID1024097; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1024097; source_file=acute_oral.xlsx |
NTP_ICE_adme_parameters 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_adme_parameters | Clint | 4.299 | uL/min/10^6 cells | Human | - | - | Measured; httk, Human Hepatic Intrinsic Clearance | sheet=Data; excel_row=557; Record_ID=adme_parameters_1134; Data_Type=Measured; DTXSID=DTXSID1024097; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=4.299; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Linakis 2020; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_adme_parameters | Clint | 6.691 | uL/min/10^6 cells | Rat | - | - | Measured; httk, Rat Hepatic Intrinsic Clearance | sheet=Data; excel_row=560; Record_ID=adme_parameters_1134; Data_Type=Measured; DTXSID=DTXSID1024097; Assay=httk, Rat Hepatic Intrinsic Clearance; Endpoint=Clint; Response=6.691; Response_Unit=ul/min/10^6 cells; Species=Rat; Reference=httk2.3.1, Linakis 2020; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_adme_parameters | Fu | 0.8332 | fraction | Human | - | - | Measured; httk, Human Plasma Fraction Unbound | sheet=Data; excel_row=558; Record_ID=adme_parameters_1134; Data_Type=Measured; DTXSID=DTXSID1024097; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.8332; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Linakis 2020; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_adme_parameters | Fu | 0.5544 | fraction | Rat | - | - | Measured; httk, Rat Plasma Fraction Unbound | sheet=Data; excel_row=559; Record_ID=adme_parameters_1134; Data_Type=Measured; DTXSID=DTXSID1024097; Assay=httk, Rat Plasma Fraction Unbound; Endpoint=Fu; Response=0.5544; Response_Unit=Unitless Fraction; Species=Rat; Reference=httk2.3.1, Linakis 2020; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
NTP_ICE_cancer 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_cancer | IARC group | 3 | unitless | - | - | - | WOE; IARC Carcinogenicity | sheet=Data; excel_row=1826; Record_ID=cancer_5726; Data_Type=WOE; Formulation_Name=2-Butoxyethanol; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/106; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_cancer | POLY-3 lowest dose | 1208.34355828221 | mg/m3/day | Mouse | Inhalation | - | In Vivo; Two year cancer bioassay | sheet=Data; excel_row=1814; Record_ID=cancer_5724; Data_Type=In Vivo; Formulation_Name=2-Butoxyethanol (ethylene glycol monobutyl ether); Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Two year cancer bioassay; Endpoint=POLY-3 lowest dose; Response=1208.3435582822087; Response_Unit=mg/m3/day; Species=Mouse; Strain=B6C3F1; Sex=Female; Route=Inhalation; Level_of_Evidence=Some evidence; Tissue=Forestomach; Lesion=Squamous cell carcinoma or papilloma squamous; Reference=TR-484; URL=https://ntp.niehs.nih.gov/publications/reports/tr/400s/tr484/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_cancer | Top dose | 250 | ppm | Mouse | Inhalation | - | In Vivo; NTP Carcinogenicity | sheet=Data; excel_row=1816; Record_ID=cancer_5723; Data_Type=In Vivo; Formulation_Name=2-Butoxyethanol (Ethylene Glycol Monobutyl Ether); Mixture=Chemical; DTXSID=DTXSID1024097; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=250; Response_Unit=ppm; Species=Mouse; Strain=B6C3F1; Sex=Male; Route=Inhalation; Reference=TR-484; URL=https://ntp.niehs.nih.gov/publications/reports/tr/400s/tr484/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_cancer | Top dose | 125 | ppm | Rat | Inhalation | - | In Vivo; NTP Carcinogenicity | sheet=Data; excel_row=1819; Record_ID=cancer_5730; Data_Type=In Vivo; Formulation_Name=2-Butoxyethanol (Ethylene Glycol Monobutyl Ether); Mixture=Chemical; DTXSID=DTXSID1024097; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=125; Response_Unit=ppm; Species=Rat; Strain=F344/N; Sex=Male; Route=Inhalation; Reference=TR-484; URL=https://ntp.niehs.nih.gov/publications/reports/tr/400s/tr484/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
NTP_ICE_endocrine 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=2200; RecordID=ARPathway2016_577; DatasetName=ARPathway2016; DTXSID=DTXSID1024097; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
NTP_ICE_eye_irritation 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_eye_irritation | Draize rabbit irritation score | 68.7 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=500; Record_ID=eye_irritation_162; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=68.7; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_eye_irritation | EPA Classification | 2 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=505; Record_ID=eye_irritation_41; Data_Type=In Vivo; Concentration=100.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=2; Response_Unit=Unitless; Species=Rabbit; Reference=ICCVAM 2006; URL=https://ntp.niehs.nih.gov/sites/default/files/iccvam/docs/ocutox_docs/oteval/otevalrpt.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_eye_irritation | GHS Classification | 1 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=507; Record_ID=eye_irritation_41; Data_Type=In Vivo; Concentration=100.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=GHS Classification; Response=1; Response_Unit=Unitless; Species=Rabbit; Reference=ICCVAM 2006; URL=https://ntp.niehs.nih.gov/sites/default/files/iccvam/docs/ocutox_docs/oteval/otevalrpt.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_eye_irritation | Intensity | 0.48 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=502; Record_ID=eye_irritation_1299; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Vitrigel; Endpoint=Intensity; Response=0.48; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_eye_irritation | Lag time | 0 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=501; Record_ID=eye_irritation_1299; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Vitrigel; Endpoint=Lag time; Response=0; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
| NTP_ICE_eye_irritation | Plateau level | 58 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=503; Record_ID=eye_irritation_1299; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1024097; Assay=Vitrigel; Endpoint=Plateau level; Response=58; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024097; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024097 |
SCCS_vision_codex 152 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =150 | mg/kg | - | - | - | NOAEL study | {"dose":"Based on a NOAEL 150 mg/kg and a skin penetration rate of 113µg/cm2 the member state concluded, that the substance could be considered safe for the consumers, when used in a concentration up to 4% in permanent hair dyes and up to 2% in non-oxidative hair dyes.","effect":"____________________________ 5 1. BACKGROUND A risk assessment of EGBE with the chemical name 2-butoxyethanol or ethylene glycol monobutyl ether was done by a member state (France). The risk assessment is based mainly on open scientific literature and on skin absorptions studies done by Industry. The risk assessment led the member state to put some restrictions on the use this substance. According to the notification to the Commission EGBE is used in cosmetic products only as a solvent in hair dyes. Based on a NOAEL 150 mg/kg and a skin penetration rate of 113µg/cm2 the member state concluded, that the substance could be considered safe for the consumers, when used in a concentration up to 4% in permanent hair dyes and up to 2% in non-oxidative hair dyes. 2. TERMS OF REFERENCE 1. Does the SCCP consider the use of EGBE as solvent in hair dyes in a concentration up to 4% in oxidative hair dyes and up to 2% in non-oxidative hair dyes safe for the consumer taken into consideration the scientific data provided? 2. If not, does","page":5,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_001"} |
| SCCS_vision_codex | NOAEL | >50 | ppm | guinea pig | dermal | - | irritation | {"citation":"Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation","dose":"From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm.","effect":"ogical changes in the volunteers under the different conditions, physiological monitoring equipment was used). The published study paper does not mention if these signs were checked except the recording of the physiological changes. However, the author did indicate in a written communication that the volunteers were asked to report any adverse effects and none were reported. Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation. From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm. 3.3.3. Skin sensitisation Guinea pigs The study was performed according to OECD guideline 406. EGBE was tested in Guinea pigs for sensitisation potential. Induction was made with a dermal injection of 0.5% EGBE in 0.9% saline and a topical application of a 25% EGBE in 0.9% saline. Challenge was made with a topical application of 10% EGBE in saline. All topical applications were made occlusively. Concentrations tested were based on res","page":14,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_002"} |
| SCCS_vision_codex | NOAEL | =222 | mg/kg | rat | oral | 90 days | NOAEL study | {"citation":"Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0","dose":"helium in all treated animals.","effect":"helium in all treated animals. Hepatomegaly was also seen in 4 out of 10 animals of the high dose group. Haemosiderin deposition was seen in some animals (7/10 and 6/10 in the high and mid dose group respectively). Thymus atrophy was seen in one animal of the high dose group. Congestion of the spleen was seen in all treated animals. Extramedullary haematopoiesis was reported for one animal in the high dose group and haemosiderin deposit in the majority of animals of the high and mid dose group. For this study, the NOAEL can be considered to be lower than 222 mg/kg (which is the Low Observable Adverse Effect Level: LOAEL) based on effects seen on spleens and RBC parameters. Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0.03, 0.125, 0.5 and 2% Butyl cellosolve (EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days. No deaths were seen attributable to the direct action of EGBE. Appetite was not affected and no pertinent micropathology was discovered. Tests f","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | rat | - | 90 days | NOAEL study | {"citation":"Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0","dose":"EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days.","effect":"EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days. No deaths were seen attributable to the direct action of EGBE. Appetite was not affected and no pertinent micropathology was discovered. Tests for blood in pooled urine sample from the 2%, 0.5% and controls groups after 3 and 6 days were negative. The mean weight gain was lower than controls for the 2% group. Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose. The NOAEL can be considered to be 0.125% (76 mg/kg bw/d) but considering that the test conditions were poorly reported (no control of the administered substance, evaporation?) this NOAEL will not be taken into account for the risk characterisation. The LOAEL was 310 mg/kg bw/d. Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0.01, 0.05, 0.25, and 1.25% (corresponding to 0, 7, 38, 188, and 919 mg/kg bw in males and 0, 9, 41, 222, and 976 mg/kg","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_005"} |
| SCCS_vision_codex | NOAEL | =310 | mg/kg bw/d | rat | - | 6 days | NOAEL study | {"citation":"Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0","dose":"Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose.","effect":"ted and no pertinent micropathology was discovered. Tests for blood in pooled urine sample from the 2%, 0.5% and controls groups after 3 and 6 days were negative. The mean weight gain was lower than controls for the 2% group. Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose. The NOAEL can be considered to be 0.125% (76 mg/kg bw/d) but considering that the test conditions were poorly reported (no control of the administered substance, evaporation?) this NOAEL will not be taken into account for the risk characterisation. The LOAEL was 310 mg/kg bw/d. Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0.01, 0.05, 0.25, and 1.25% (corresponding to 0, 7, 38, 188, and 919 mg/kg bw in males and 0, 9, 41, 222, and 976 mg/kg bw in females respectively) during 3 months. Animals were weighted 4 times during the first week and once a week thereafter. After euthanasia liver and kidneys were weighed. Or","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.25 | % | - | oral | - | NOAEL study | {"citation":"Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E","dose":"One animal died at day 73 after the beginning of the study in the high dose group.","effect":"es. One animal died at day 73 after the beginning of the study in the high dose group. Food consumption was decreased in both males and females at 1.25%. In males a significant decrease of food consumption was also observed at 0.25% dose. A significant decrease of body weight gain was seen in animals dosed with 1.25% EGBE. It was also seen in males at doses of 0.25%. The mean liver and kidney weight of males and females were definitely increased at the 1.25% dose. At both 1.25% and 0.25% testes were atrophied. The NOAEL for this study can be considered to be 0.05%. The purity of the EGBE used in this study is not given, nor does there appear to be analytical verification of EGBE doses, homogeneity and stability. Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE. Given the availability of numerous other more recent and robust studies, this one cannot be considered reliable to derive the criti","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_007"} |
| SCCS_vision_codex | NOAEL | =99 | % | rat | oral | - | NOAEL study | {"citation":"Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E","dose":"54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE.","effect":"this study can be considered to be 0.05%. The purity of the EGBE used in this study is not given, nor does there appear to be analytical verification of EGBE doses, homogeneity and stability. Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE. Given the availability of numerous other more recent and robust studies, this one cannot be considered reliable to derive the critical NOAEL. Guideline: / Species/strain: F344/N rats Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 ppm","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_008"} |
| SCCS_vision_codex | NOAEL | =129 | mg/kg bw/d | rat | - | - | NOAEL study | {"citation":"Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co","dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used.","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 pp","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_009"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/d | rat | oral | 13 weeks | NOAEL study | {"citation":"Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co","dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used.","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 ppm Route: Oral, drinking water Exposures: 13 weeks GLP: In compliance EGBE was administered in drinking water at concentrations of 0, 750, 1500, 3000, 4500 or 6000 ppm to grou","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_010"} |
| SCCS_vision_codex | NOAEL | =370 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments","dose":"rol group and treated mice.","effect":"rol group and treated mice. No mice treated with EGBE died or were killed before the scheduled end of the study and there were no significant clinical signs of toxicity. Body weight gains were slightly reduced in both male and female mice of the 3000 and 6000 ppm treatment groups. No particular pattern was evident in drinking water consumption. Organ weight changes that were found were secondary to body weight gain reduction. No treatment related gross or microscopic lesions in male or female mice were found. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LO","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.05 | % | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments","dose":"The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study.","effect":"ght changes that were found were secondary to body weight gain reduction. No treatment related gross or microscopic lesions in male or female mice were found. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LOAEL = 310 Poorly reported 53 90 days in food NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) Decrease in food consumption and body weight gain in males. Testes atrophy. 54 13 weeks in drinking water LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild Slight cytoplasmic alterations in hepatoc","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_012"} |
| SCCS_vision_codex | NOAEL | =370 | mg/kg bw/d | rat | oral | 13 weeks | irritation | {"dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (female...","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (females) may be used) Mice 13 weeks in drinking water NOAEL = 223 and 370 mg/kg bw/d for males and females respectively LOAEL = 553 and 676 mg/kg bw/d for males and females respectively Slight decrease in body weight gain 55 General comments Effects seen by oral route were body weight reduction, haemolysis, hepatic effects and local irritation effects. Irritation to the forestomach was seen after gavage dosing. A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and","page":24,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_016"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | rabbit | dermal | 9 days | irritation | {"citation":"Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mix","dose":"ative responses significant only at doses of 500 and 1000 mg/kg (a decrease was also seen for the 1500 mg/kg bw dose but not statistically significant, this weakens the relevance of this finding).","effect":"ative responses significant only at doses of 500 and 1000 mg/kg (a decrease was also seen for the 1500 mg/kg bw dose but not statistically significant, this weakens the relevance of this finding). The same results were seen in the MLR assay (decreased responses at the high doses, significant only at 500 and 1000 mg/kg bw). NK, CTL activity and T-dependent PFC response was unchanged after treatment. The lack of a dose-related response in these observations throws doubt on their significance for EGBE toxicology. The NOAEL for immunological effects was 1000 mg/kg bw, based on spleen weight reduction at 1500 mg/kg bw/d. Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mixture corresponding to 45, 225, 450, and 900 mg/kg bw) during 6 hr/day for 9 days (dosed 5 days, no dosed 2 days and dosed 4 days). Control group was treated with vehicle only. Dermal irritation score were determined after each test","page":25,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_019"} |
| SCCS_vision_codex | NOAEL | =450 | mg/kg | rabbit | - | 14-day | NOAEL study | {"citation":"Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2","dose":"Gross findings included some thickening of the skin in male rabbits given undiluted substance and possibly dose related patchy colour change of the kidneys of the three females.","effect":"d no indication of biologically significant haematological effects. The increased mean red blood cell counts on day 9 of treatment in the 5% dilution group and on day 14 after exposure in the 25% dilution group are considered to be statistical artefacts. No changes were noted in any organ weight measured in all animals. Gross findings included some thickening of the skin in male rabbits given undiluted substance and possibly dose related patchy colour change of the kidneys of the three females. For this study, the NOAEL of 450 mg/kg can be taken into account mainly based on gross findings observed in animals dosed with pure substance. Haematological effects seen during the study were transient and recovery was complete after the 14-day observation period. Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2.8% - 14.3% and 42.8% in distilled water (corresponding to dose levels of 0, 10, 50, and 150 mg/kg) for a 6 hr period/day 5 d/","page":26,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_020"} |
| SCCS_vision_codex | NOAEL | =1500 | mg/kg bw/day | mouse | dermal | subchronic | repeated dose toxicity | {"dose":"Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolys","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_023"} |
| SCCS_vision_codex | NOAEL | =900 | mg/kg bw/d | mouse | dermal | subchronic | repeated dose toxicity | {"dose":"Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.","effect":"butyl ether ___________________________________________________________________________________________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_024"} |
| SCCS_vision_codex | NOAEL | =450 | mg/kg bw/d | rat | inhalation | 4 days | repeated dose toxicity | {"dose":"0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500.","effect":"f. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whol","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_026"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg | rat | inhalation | 9 days | repeated dose toxicity | {"dose":"This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d.","effect":"ministered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whole body) to various concentrations of EGBE and for different periods of time. Rats were maintained in the exposure chamber for periods of up to 6 hours, and between repeated daily exposures they were returned to their cages where food and water were freely available. In the initial experiments the concentrations were selected to produce, if possible, acute effects after short","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_029"} |
| SCCS_vision_codex | NOAEL | =720 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | {"citation":"Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, i","dose":"66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death.","effect":"of reproductive organs, sperm motility, morphology and the oestrous cycle length and frequency were noted. However, a significant increase in relative kidney weight in the females and a significant increase in relative liver weight in both the males and females were observed. Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death. Under the conditions of the study, the NOAEL for reproductive toxicity of EGBE (fertility) can be set as 720 mg/kg bw/day. For developmental toxicity, no NOAEL can be derived. A conservative LOAEL of 720 mg/kg bw/day can be taken as only a slight decrease in pup weight (p<0.05) was observed at this dose. 3.3.8.2. Teratogenicity Oral route Rats Guideline: / Species/strain: Fisher 344 rats Group size: See below Test substance: EGBE Batch: / Purity: >99% Dose levels: 0 (control), 30, 100, and 200 mg/kg bw/day (GD 9-11); 0 (control), 30, 100, and 300 mg/kg bw","page":47,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_030"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/day | - | - | - | NOAEL study | {"dose":"The maternal NOAEL is 30 mg/kg bw/day based on the effects describes before.","effect":"SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 48 particular, dramatic reductions in circulating red blood cells, haematocrit and haemoglobin resulted by 24 hours after treatment. By GD20 the haematotoxic effects were nearly reversed. The changes observed in haematological parameters and organ weights in this study are typical of haemolytic anaemia and the compensatory haematopoietic response associated with recovery. The maternal NOAEL is 30 mg/kg bw/day based on the effects describes before. Embryo/foetal effects were: increased resorptions, nonlive implants, and adversely affected implants per litter in the 200 mg/kg bw/day group dosed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_032"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg | mouse | oral | developmental | developmental toxicity | {"citation":"Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per","dose":"osed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13.","effect":"osed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effec","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_033"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | {"citation":"Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per","dose":"When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted.","effect":"incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numer","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_035"} |
| SCCS_vision_codex | NOAEL | =350 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | {"citation":"Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant m","dose":"00 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18).","effect":"00 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numerically reduced number of viable foetuses were observed at 1000 and 1500 mg/kg bw/day. 4/43 foetus (in one litter) at 1000 mg/kg bw/day and 1/25 at 1500 mg/kg bw/day had cleft palates. For this study, the NOAEL for maternal toxicity is 350 mg/kg bw/day and the NOAEL for developmental toxicity is 650 mg/kg bw/day. Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant mice, days 7 through 14 of gestation GLP: In compliance In a subsequent reproduction study (following a Chernoff modification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between G","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_036"} |
| SCCS_vision_codex | NOAEL | =650 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | {"dose":"odification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22).","effect":"odification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22). No significant effects on pup growth or survival resulted. No adverse developmental effects were reported. Signs of haemolytic effects and bw gain reduction were seen at 1000 mg/kg in dams. The NOAEL for maternal toxicity is 650 mg/kg bw/day in this study, and as no effects were seen in pups, the NOAEL for developmental toxicity can be considered to be greater than 1000 mg/kg bw/day. In another Chernoff assay, fifty mated CD1 mice were orally administered EGBE (99 % purity) by gavage at 1180 mg/kg bw/day (calculated LD10 based on a non-pregnant mouse","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_039"} |
| SCCS_vision_codex | NOAEL | =97 | % | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","effect":"SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 49 pilot study) in corn oil from GD7-14 (GD1=vaginal sperm plug), then allowed to litter and to rear pups to PND3. 20 % of the dams died, maternal weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day","page":49,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_040"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","effect":"pups to PND3. 20 % of the dams died, maternal weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand","page":49,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_041"} |
| SCCS_vision_codex | NOAEL | =200 | ppm | rat | - | developmental | reproductive toxicity | {"citation":"Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99","dose":"A statistically significant decrease in foetal weights was observed in the 150 ppm exposure group.","effect":"oup. A statistically significant decrease in foetal weights was observed in the 150 ppm exposure group. Since differences in foetal weights between experimental and control groups were slight, and, also, that significant differences were not observed in the 200 ppm exposure group, these differences were not thought to have been of biological significance. For this study a very conservative LOAEL of 150 ppm can be determined for dams for haematuria seen in the first day of treatment. For developmental toxicity, the NOAEL is 200 ppm. Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99.6 %) for 6hr/day on GD 6-15 (GD0 = sperm plug positive). No adverse reproductive or developmental effects were observed in animals exposed to 25 ppm or 50 ppm. Maternal toxicity was observed in a dose-related incidence during the exposure period, included evidence of haematuria from 100 ppm and pale, cold extremities with necrosis of the","page":49,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_046"} |
| SCCS_vision_codex | NOAEL | =1 | - | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 1 3","effect":"ube defect). For EGBE, these studies did not allow to draw any conclusion about its potential effects on humans because no studies are able to define clearly an unique source of glycol ether; Usually studies described co- exposure to various glycol ethers, including known developmental toxins such as EGME and other chemicals as well. Ref.: 1 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) Since all key effects are induced by haemolysis in rodents, a NOAEL based on haemotoxicity will be used in the risk characterisation. The selection of an appropriate interspecies chemical safety assessment factor (CSAF) must take into account the lower sensitivity of humans than rats (or mice) to the metabolite BAA. WHO (1994) has proposed splitting the CSAF in two components representing the toxicokinetic and toxicodynamic adjustment factors (Inter-species kinetics (4.0) and Inter-species dynamics (2.5) (see also The SCCP Notes of guidance for the testing of cosmetic ingredients","page":53,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_047"} |
| SCCS_vision_codex | NOAEL | =95 | µg/cm | rat | dermal | - | dermal absorption | {"citation":"Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure","dose":"Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","effect":". However, a more cautious and conservative initial approach would be to propose a value of 0.1. This implies that a factor of 0.4 (4.0 x 0.1) is justified for species differences and gives a minimal MOS of 4 taking intra species variation into consideration. Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL","page":54,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_048"} |
| SCCS_vision_codex | NOAEL | =1.11 | mg/kg bw | rat | dermal | - | dermal absorption | {"dose":"Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","effect":"g dermal exposure. Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not","page":54,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_049"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | rat | dermal | - | dermal absorption | {"dose":"l absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","effect":"l absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not report","page":54,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_050"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/d | rabbit | - | 3 day | reproductive toxicity | {"dose":"The lowest NOAEL was 30 mg/kg bw/d obtained a reproductive toxicity study and represent maternal toxicity after 3 day exposure.","effect":"K model. The toxicodynamics factor needs to be set to an appropriate value to reflect the lower sensitivity of humans to haemolysis. The data available on the most sensitive measure (pre-haemolytic changes) suggests that a value of 0.01 would be realistic. However, a more cautious and conservative initial approach would be to propose a value of 0.1. This imply that a factor of (4.0 x 0.1) 0.4 is just for species differences and gives a minimal MOS of 4 taking intra species variation into consideration. The lowest NOAEL was 30 mg/kg bw/d obtained a reproductive toxicity study and represent maternal toxicity after 3 day exposure. The effect was due to haematological effects and probably secondary reaction to this at a dose of 100 mg/kg bw/d. Irritation / sensitisation Studies performed on rabbits and guinea pigs have shown that EGBE have caused moderate irritation (erythema and oedema) when applied occlusively on the skin for a period of 4 hours. If the substance was applied on scarified skin or for a longer period of time, sign","page":56,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_061"} |
| SCCS_vision_codex | NOAEL | =23 | - | - | - | - | NOAEL study | {"dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","effect":"Unlabeled table on page 23: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_063"} |
| SCCS_vision_codex | NOAEL | =222 | - | - | oral | 6 weeks | irritation | {"effect":"Unlabeled table on page 23: 6 weeks gavage | LOAEL = 222 | Haematological effects at all doses and irritant effects on the stomach | 52","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_066"} |
| SCCS_vision_codex | NOAEL | =76 | - | - | - | 90 days | NOAEL study | {"effect":"Unlabeled table on page 23: 90 days in food | NOAEL = 76 LOAEL = 310 | Poorly reported | 53","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_067"} |
| SCCS_vision_codex | NOAEL | =82 | mg/kg bw/day | rat | oral | 13 weeks | NOAEL study | {"dose":"13 weeks in drinking water | LOAEL of 69 and 82 mg/kg bw/day for males and females respectively.","effect":"Unlabeled table on page 23: 13 weeks in drinking water | LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild | Slight cytoplasmic alterations in hepatocytes of both male and female rats | 55","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_068"} |
| SCCS_vision_codex | NOAEL | =24 | - | - | - | - | NOAEL study | {"dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","effect":"Unlabeled table on page 24: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":24,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_069"} |
| SCCS_vision_codex | NOAEL | =27 | - | - | - | - | NOAEL study | {"dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","effect":"Unlabeled table on page 27: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_072"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg | - | - | - | NOAEL study | {"dose":"Based on a NOAEL 150 mg/kg and a skin penetration rate of 113µg/cm2 the member state concluded, that the substance could be considered safe for the consumers, when used in a concentration up to 4% in permanent hair dyes and up to 2% in non-oxidative hair dyes.","effect":"____________________________ 5 1. BACKGROUND A risk assessment of EGBE with the chemical name 2-butoxyethanol or ethylene glycol monobutyl ether was done by a member state (France). The risk assessment is based mainly on open scientific literature and on skin absorptions studies done by Industry. The risk assessment led the member state to put some restrictions on the use this substance. According to the notification to the Commission EGBE is used in cosmetic products only as a solvent in hair dyes. Based on a NOAEL 150 mg/kg and a skin penetration rate of 113µg/cm2 the member state concluded, that the substance could be considered safe for the consumers, when used in a concentration up to 4% in permanent hair dyes and up to 2% in non-oxidative hair dyes. 2. TERMS OF REFERENCE 1. Does the SCCP consider the use of EGBE as solvent in hair dyes in a concentration up to 4% in oxidative hair dyes and up to 2% in non-oxidative hair dyes safe for the consumer taken into consideration the scientific data provided? 2. If not, does","page":5,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_001"} |
| SCCS_vision_codex | NOAEL | >50 | ppm | guinea pig | dermal | - | irritation | {"citation":"Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation","dose":"From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm.","effect":"ogical changes in the volunteers under the different conditions, physiological monitoring equipment was used). The published study paper does not mention if these signs were checked except the recording of the physiological changes. However, the author did indicate in a written communication that the volunteers were asked to report any adverse effects and none were reported. Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation. From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm. 3.3.3. Skin sensitisation Guinea pigs The study was performed according to OECD guideline 406. EGBE was tested in Guinea pigs for sensitisation potential. Induction was made with a dermal injection of 0.5% EGBE in 0.9% saline and a topical application of a 25% EGBE in 0.9% saline. Challenge was made with a topical application of 10% EGBE in saline. All topical applications were made occlusively. Concentrations tested were based on res","page":14,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_002"} |
| SCCS_vision_codex | NOAEL | =222 | mg/kg | rat | oral | 90 days | NOAEL study | {"citation":"Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0","dose":"helium in all treated animals.","effect":"helium in all treated animals. Hepatomegaly was also seen in 4 out of 10 animals of the high dose group. Haemosiderin deposition was seen in some animals (7/10 and 6/10 in the high and mid dose group respectively). Thymus atrophy was seen in one animal of the high dose group. Congestion of the spleen was seen in all treated animals. Extramedullary haematopoiesis was reported for one animal in the high dose group and haemosiderin deposit in the majority of animals of the high and mid dose group. For this study, the NOAEL can be considered to be lower than 222 mg/kg (which is the Low Observable Adverse Effect Level: LOAEL) based on effects seen on spleens and RBC parameters. Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0.03, 0.125, 0.5 and 2% Butyl cellosolve (EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days. No deaths were seen attributable to the direct action of EGBE. Appetite was not affected and no pertinent micropathology was discovered. Tests f","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | rat | - | 90 days | NOAEL study | {"citation":"Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0","dose":"EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days.","effect":"EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days. No deaths were seen attributable to the direct action of EGBE. Appetite was not affected and no pertinent micropathology was discovered. Tests for blood in pooled urine sample from the 2%, 0.5% and controls groups after 3 and 6 days were negative. The mean weight gain was lower than controls for the 2% group. Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose. The NOAEL can be considered to be 0.125% (76 mg/kg bw/d) but considering that the test conditions were poorly reported (no control of the administered substance, evaporation?) this NOAEL will not be taken into account for the risk characterisation. The LOAEL was 310 mg/kg bw/d. Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0.01, 0.05, 0.25, and 1.25% (corresponding to 0, 7, 38, 188, and 919 mg/kg bw in males and 0, 9, 41, 222, and 976 mg/kg","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_005"} |
| SCCS_vision_codex | NOAEL | =310 | mg/kg bw/d | rat | - | 6 days | NOAEL study | {"citation":"Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0","dose":"Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose.","effect":"ted and no pertinent micropathology was discovered. Tests for blood in pooled urine sample from the 2%, 0.5% and controls groups after 3 and 6 days were negative. The mean weight gain was lower than controls for the 2% group. Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose. The NOAEL can be considered to be 0.125% (76 mg/kg bw/d) but considering that the test conditions were poorly reported (no control of the administered substance, evaporation?) this NOAEL will not be taken into account for the risk characterisation. The LOAEL was 310 mg/kg bw/d. Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0.01, 0.05, 0.25, and 1.25% (corresponding to 0, 7, 38, 188, and 919 mg/kg bw in males and 0, 9, 41, 222, and 976 mg/kg bw in females respectively) during 3 months. Animals were weighted 4 times during the first week and once a week thereafter. After euthanasia liver and kidneys were weighed. Or","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.25 | % | - | oral | - | NOAEL study | {"citation":"Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E","dose":"One animal died at day 73 after the beginning of the study in the high dose group.","effect":"es. One animal died at day 73 after the beginning of the study in the high dose group. Food consumption was decreased in both males and females at 1.25%. In males a significant decrease of food consumption was also observed at 0.25% dose. A significant decrease of body weight gain was seen in animals dosed with 1.25% EGBE. It was also seen in males at doses of 0.25%. The mean liver and kidney weight of males and females were definitely increased at the 1.25% dose. At both 1.25% and 0.25% testes were atrophied. The NOAEL for this study can be considered to be 0.05%. The purity of the EGBE used in this study is not given, nor does there appear to be analytical verification of EGBE doses, homogeneity and stability. Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE. Given the availability of numerous other more recent and robust studies, this one cannot be considered reliable to derive the criti","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_007"} |
| SCCS_vision_codex | NOAEL | =99 | % | rat | oral | - | NOAEL study | {"citation":"Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E","dose":"54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE.","effect":"this study can be considered to be 0.05%. The purity of the EGBE used in this study is not given, nor does there appear to be analytical verification of EGBE doses, homogeneity and stability. Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE. Given the availability of numerous other more recent and robust studies, this one cannot be considered reliable to derive the critical NOAEL. Guideline: / Species/strain: F344/N rats Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 ppm","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_008"} |
| SCCS_vision_codex | NOAEL | =129 | mg/kg bw/d | rat | - | - | NOAEL study | {"citation":"Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co","dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used.","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 pp","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_009"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/d | rat | oral | 13 weeks | NOAEL study | {"citation":"Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co","dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used.","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 ppm Route: Oral, drinking water Exposures: 13 weeks GLP: In compliance EGBE was administered in drinking water at concentrations of 0, 750, 1500, 3000, 4500 or 6000 ppm to grou","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_010"} |
| SCCS_vision_codex | NOAEL | =370 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments","dose":"rol group and treated mice.","effect":"rol group and treated mice. No mice treated with EGBE died or were killed before the scheduled end of the study and there were no significant clinical signs of toxicity. Body weight gains were slightly reduced in both male and female mice of the 3000 and 6000 ppm treatment groups. No particular pattern was evident in drinking water consumption. Organ weight changes that were found were secondary to body weight gain reduction. No treatment related gross or microscopic lesions in male or female mice were found. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LO","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.05 | % | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments","dose":"The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study.","effect":"ght changes that were found were secondary to body weight gain reduction. No treatment related gross or microscopic lesions in male or female mice were found. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LOAEL = 310 Poorly reported 53 90 days in food NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) Decrease in food consumption and body weight gain in males. Testes atrophy. 54 13 weeks in drinking water LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild Slight cytoplasmic alterations in hepatoc","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_012"} |
| SCCS_vision_codex | NOAEL | =370 | mg/kg bw/d | rat | oral | 13 weeks | irritation | {"dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (female...","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (females) may be used) Mice 13 weeks in drinking water NOAEL = 223 and 370 mg/kg bw/d for males and females respectively LOAEL = 553 and 676 mg/kg bw/d for males and females respectively Slight decrease in body weight gain 55 General comments Effects seen by oral route were body weight reduction, haemolysis, hepatic effects and local irritation effects. Irritation to the forestomach was seen after gavage dosing. A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and","page":24,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_016"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | rabbit | dermal | 9 days | irritation | {"citation":"Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mix","dose":"ative responses significant only at doses of 500 and 1000 mg/kg (a decrease was also seen for the 1500 mg/kg bw dose but not statistically significant, this weakens the relevance of this finding).","effect":"ative responses significant only at doses of 500 and 1000 mg/kg (a decrease was also seen for the 1500 mg/kg bw dose but not statistically significant, this weakens the relevance of this finding). The same results were seen in the MLR assay (decreased responses at the high doses, significant only at 500 and 1000 mg/kg bw). NK, CTL activity and T-dependent PFC response was unchanged after treatment. The lack of a dose-related response in these observations throws doubt on their significance for EGBE toxicology. The NOAEL for immunological effects was 1000 mg/kg bw, based on spleen weight reduction at 1500 mg/kg bw/d. Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mixture corresponding to 45, 225, 450, and 900 mg/kg bw) during 6 hr/day for 9 days (dosed 5 days, no dosed 2 days and dosed 4 days). Control group was treated with vehicle only. Dermal irritation score were determined after each test","page":25,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_019"} |
| SCCS_vision_codex | NOAEL | =450 | mg/kg | rabbit | - | 14-day | NOAEL study | {"citation":"Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2","dose":"Gross findings included some thickening of the skin in male rabbits given undiluted substance and possibly dose related patchy colour change of the kidneys of the three females.","effect":"d no indication of biologically significant haematological effects. The increased mean red blood cell counts on day 9 of treatment in the 5% dilution group and on day 14 after exposure in the 25% dilution group are considered to be statistical artefacts. No changes were noted in any organ weight measured in all animals. Gross findings included some thickening of the skin in male rabbits given undiluted substance and possibly dose related patchy colour change of the kidneys of the three females. For this study, the NOAEL of 450 mg/kg can be taken into account mainly based on gross findings observed in animals dosed with pure substance. Haematological effects seen during the study were transient and recovery was complete after the 14-day observation period. Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2.8% - 14.3% and 42.8% in distilled water (corresponding to dose levels of 0, 10, 50, and 150 mg/kg) for a 6 hr period/day 5 d/","page":26,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_020"} |
| SCCS_vision_codex | NOAEL | =1500 | mg/kg bw/day | mouse | dermal | subchronic | repeated dose toxicity | {"dose":"Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolys","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_023"} |
| SCCS_vision_codex | NOAEL | =900 | mg/kg bw/d | mouse | dermal | subchronic | repeated dose toxicity | {"dose":"Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.","effect":"butyl ether ___________________________________________________________________________________________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_024"} |
| SCCS_vision_codex | NOAEL | =450 | mg/kg bw/d | rat | inhalation | 4 days | repeated dose toxicity | {"dose":"0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500.","effect":"f. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whol","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_026"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg | rat | inhalation | 9 days | repeated dose toxicity | {"dose":"This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d.","effect":"ministered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whole body) to various concentrations of EGBE and for different periods of time. Rats were maintained in the exposure chamber for periods of up to 6 hours, and between repeated daily exposures they were returned to their cages where food and water were freely available. In the initial experiments the concentrations were selected to produce, if possible, acute effects after short","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_029"} |
| SCCS_vision_codex | NOAEL | =720 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | {"citation":"Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, i","dose":"66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death.","effect":"of reproductive organs, sperm motility, morphology and the oestrous cycle length and frequency were noted. However, a significant increase in relative kidney weight in the females and a significant increase in relative liver weight in both the males and females were observed. Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death. Under the conditions of the study, the NOAEL for reproductive toxicity of EGBE (fertility) can be set as 720 mg/kg bw/day. For developmental toxicity, no NOAEL can be derived. A conservative LOAEL of 720 mg/kg bw/day can be taken as only a slight decrease in pup weight (p<0.05) was observed at this dose. 3.3.8.2. Teratogenicity Oral route Rats Guideline: / Species/strain: Fisher 344 rats Group size: See below Test substance: EGBE Batch: / Purity: >99% Dose levels: 0 (control), 30, 100, and 200 mg/kg bw/day (GD 9-11); 0 (control), 30, 100, and 300 mg/kg bw","page":47,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_030"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/day | - | - | - | NOAEL study | {"dose":"The maternal NOAEL is 30 mg/kg bw/day based on the effects describes before.","effect":"SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 48 particular, dramatic reductions in circulating red blood cells, haematocrit and haemoglobin resulted by 24 hours after treatment. By GD20 the haematotoxic effects were nearly reversed. The changes observed in haematological parameters and organ weights in this study are typical of haemolytic anaemia and the compensatory haematopoietic response associated with recovery. The maternal NOAEL is 30 mg/kg bw/day based on the effects describes before. Embryo/foetal effects were: increased resorptions, nonlive implants, and adversely affected implants per litter in the 200 mg/kg bw/day group dosed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_032"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg | mouse | oral | developmental | developmental toxicity | {"citation":"Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per","dose":"osed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13.","effect":"osed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effec","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_033"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | {"citation":"Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per","dose":"When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted.","effect":"incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numer","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_035"} |
| SCCS_vision_codex | NOAEL | =350 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | {"citation":"Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant m","dose":"00 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18).","effect":"00 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numerically reduced number of viable foetuses were observed at 1000 and 1500 mg/kg bw/day. 4/43 foetus (in one litter) at 1000 mg/kg bw/day and 1/25 at 1500 mg/kg bw/day had cleft palates. For this study, the NOAEL for maternal toxicity is 350 mg/kg bw/day and the NOAEL for developmental toxicity is 650 mg/kg bw/day. Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant mice, days 7 through 14 of gestation GLP: In compliance In a subsequent reproduction study (following a Chernoff modification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between G","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_036"} |
| SCCS_vision_codex | NOAEL | =650 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | {"dose":"odification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22).","effect":"odification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22). No significant effects on pup growth or survival resulted. No adverse developmental effects were reported. Signs of haemolytic effects and bw gain reduction were seen at 1000 mg/kg in dams. The NOAEL for maternal toxicity is 650 mg/kg bw/day in this study, and as no effects were seen in pups, the NOAEL for developmental toxicity can be considered to be greater than 1000 mg/kg bw/day. In another Chernoff assay, fifty mated CD1 mice were orally administered EGBE (99 % purity) by gavage at 1180 mg/kg bw/day (calculated LD10 based on a non-pregnant mouse","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_039"} |
| SCCS_vision_codex | NOAEL | =97 | % | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","effect":"SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 49 pilot study) in corn oil from GD7-14 (GD1=vaginal sperm plug), then allowed to litter and to rear pups to PND3. 20 % of the dams died, maternal weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day","page":49,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_040"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","effect":"pups to PND3. 20 % of the dams died, maternal weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand","page":49,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_041"} |
| SCCS_vision_codex | NOAEL | =200 | ppm | rat | - | developmental | reproductive toxicity | {"citation":"Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99","dose":"A statistically significant decrease in foetal weights was observed in the 150 ppm exposure group.","effect":"oup. A statistically significant decrease in foetal weights was observed in the 150 ppm exposure group. Since differences in foetal weights between experimental and control groups were slight, and, also, that significant differences were not observed in the 200 ppm exposure group, these differences were not thought to have been of biological significance. For this study a very conservative LOAEL of 150 ppm can be determined for dams for haematuria seen in the first day of treatment. For developmental toxicity, the NOAEL is 200 ppm. Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99.6 %) for 6hr/day on GD 6-15 (GD0 = sperm plug positive). No adverse reproductive or developmental effects were observed in animals exposed to 25 ppm or 50 ppm. Maternal toxicity was observed in a dose-related incidence during the exposure period, included evidence of haematuria from 100 ppm and pale, cold extremities with necrosis of the","page":49,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_046"} |
| SCCS_vision_codex | NOAEL | =1 | - | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 1 3","effect":"ube defect). For EGBE, these studies did not allow to draw any conclusion about its potential effects on humans because no studies are able to define clearly an unique source of glycol ether; Usually studies described co- exposure to various glycol ethers, including known developmental toxins such as EGME and other chemicals as well. Ref.: 1 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) Since all key effects are induced by haemolysis in rodents, a NOAEL based on haemotoxicity will be used in the risk characterisation. The selection of an appropriate interspecies chemical safety assessment factor (CSAF) must take into account the lower sensitivity of humans than rats (or mice) to the metabolite BAA. WHO (1994) has proposed splitting the CSAF in two components representing the toxicokinetic and toxicodynamic adjustment factors (Inter-species kinetics (4.0) and Inter-species dynamics (2.5) (see also The SCCP Notes of guidance for the testing of cosmetic ingredients","page":53,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_047"} |
| SCCS_vision_codex | NOAEL | =95 | µg/cm | rat | dermal | - | dermal absorption | {"citation":"Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure","dose":"Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","effect":". However, a more cautious and conservative initial approach would be to propose a value of 0.1. This implies that a factor of 0.4 (4.0 x 0.1) is justified for species differences and gives a minimal MOS of 4 taking intra species variation into consideration. Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL","page":54,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_048"} |
| SCCS_vision_codex | NOAEL | =1.11 | mg/kg bw | rat | dermal | - | dermal absorption | {"dose":"Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","effect":"g dermal exposure. Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not","page":54,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_049"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | rat | dermal | - | dermal absorption | {"dose":"l absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","effect":"l absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not report","page":54,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_050"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/d | rabbit | - | 3 day | reproductive toxicity | {"dose":"The lowest NOAEL was 30 mg/kg bw/d obtained a reproductive toxicity study and represent maternal toxicity after 3 day exposure.","effect":"K model. The toxicodynamics factor needs to be set to an appropriate value to reflect the lower sensitivity of humans to haemolysis. The data available on the most sensitive measure (pre-haemolytic changes) suggests that a value of 0.01 would be realistic. However, a more cautious and conservative initial approach would be to propose a value of 0.1. This imply that a factor of (4.0 x 0.1) 0.4 is just for species differences and gives a minimal MOS of 4 taking intra species variation into consideration. The lowest NOAEL was 30 mg/kg bw/d obtained a reproductive toxicity study and represent maternal toxicity after 3 day exposure. The effect was due to haematological effects and probably secondary reaction to this at a dose of 100 mg/kg bw/d. Irritation / sensitisation Studies performed on rabbits and guinea pigs have shown that EGBE have caused moderate irritation (erythema and oedema) when applied occlusively on the skin for a period of 4 hours. If the substance was applied on scarified skin or for a longer period of time, sign","page":56,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_061"} |
| SCCS_vision_codex | NOAEL | =23 | - | - | - | - | NOAEL study | {"dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","effect":"Unlabeled table on page 23: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_063"} |
| SCCS_vision_codex | NOAEL | =222 | - | - | oral | 6 weeks | irritation | {"effect":"Unlabeled table on page 23: 6 weeks gavage | LOAEL = 222 | Haematological effects at all doses and irritant effects on the stomach | 52","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_066"} |
| SCCS_vision_codex | NOAEL | =76 | - | - | - | 90 days | NOAEL study | {"effect":"Unlabeled table on page 23: 90 days in food | NOAEL = 76 LOAEL = 310 | Poorly reported | 53","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_067"} |
| SCCS_vision_codex | NOAEL | =82 | mg/kg bw/day | rat | oral | 13 weeks | NOAEL study | {"dose":"13 weeks in drinking water | LOAEL of 69 and 82 mg/kg bw/day for males and females respectively.","effect":"Unlabeled table on page 23: 13 weeks in drinking water | LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild | Slight cytoplasmic alterations in hepatocytes of both male and female rats | 55","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_068"} |
| SCCS_vision_codex | NOAEL | =24 | - | - | - | - | NOAEL study | {"dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","effect":"Unlabeled table on page 24: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":24,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_069"} |
| SCCS_vision_codex | NOAEL | =27 | - | - | - | - | NOAEL study | {"dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","effect":"Unlabeled table on page 27: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_072"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg | - | - | - | NOAEL study | {"dose":"Based on a NOAEL 150 mg/kg and a skin penetration rate of 113µg/cm2 the member state concluded, that the substance could be considered safe for the consumers, when used in a concentration up to 4% in permanent hair dyes and up to 2% in non-oxidative hair dyes.","effect":"____________________________ 5 1. BACKGROUND A risk assessment of EGBE with the chemical name 2-butoxyethanol or ethylene glycol monobutyl ether was done by a member state (France). The risk assessment is based mainly on open scientific literature and on skin absorptions studies done by Industry. The risk assessment led the member state to put some restrictions on the use this substance. According to the notification to the Commission EGBE is used in cosmetic products only as a solvent in hair dyes. Based on a NOAEL 150 mg/kg and a skin penetration rate of 113µg/cm2 the member state concluded, that the substance could be considered safe for the consumers, when used in a concentration up to 4% in permanent hair dyes and up to 2% in non-oxidative hair dyes. 2. TERMS OF REFERENCE 1. Does the SCCP consider the use of EGBE as solvent in hair dyes in a concentration up to 4% in oxidative hair dyes and up to 2% in non-oxidative hair dyes safe for the consumer taken into consideration the scientific data provided? 2. If not, does","page":5,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_001"} |
| SCCS_vision_codex | NOAEL | >50 | ppm | guinea pig | dermal | - | irritation | {"citation":"Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation","dose":"From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm.","effect":"ogical changes in the volunteers under the different conditions, physiological monitoring equipment was used). The published study paper does not mention if these signs were checked except the recording of the physiological changes. However, the author did indicate in a written communication that the volunteers were asked to report any adverse effects and none were reported. Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation. From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm. 3.3.3. Skin sensitisation Guinea pigs The study was performed according to OECD guideline 406. EGBE was tested in Guinea pigs for sensitisation potential. Induction was made with a dermal injection of 0.5% EGBE in 0.9% saline and a topical application of a 25% EGBE in 0.9% saline. Challenge was made with a topical application of 10% EGBE in saline. All topical applications were made occlusively. Concentrations tested were based on res","page":14,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_002"} |
| SCCS_vision_codex | NOAEL | =222 | mg/kg | rat | oral | 90 days | NOAEL study | {"citation":"Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0","dose":"helium in all treated animals.","effect":"helium in all treated animals. Hepatomegaly was also seen in 4 out of 10 animals of the high dose group. Haemosiderin deposition was seen in some animals (7/10 and 6/10 in the high and mid dose group respectively). Thymus atrophy was seen in one animal of the high dose group. Congestion of the spleen was seen in all treated animals. Extramedullary haematopoiesis was reported for one animal in the high dose group and haemosiderin deposit in the majority of animals of the high and mid dose group. For this study, the NOAEL can be considered to be lower than 222 mg/kg (which is the Low Observable Adverse Effect Level: LOAEL) based on effects seen on spleens and RBC parameters. Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0.03, 0.125, 0.5 and 2% Butyl cellosolve (EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days. No deaths were seen attributable to the direct action of EGBE. Appetite was not affected and no pertinent micropathology was discovered. Tests f","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | rat | - | 90 days | NOAEL study | {"citation":"Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0","dose":"EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days.","effect":"EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days. No deaths were seen attributable to the direct action of EGBE. Appetite was not affected and no pertinent micropathology was discovered. Tests for blood in pooled urine sample from the 2%, 0.5% and controls groups after 3 and 6 days were negative. The mean weight gain was lower than controls for the 2% group. Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose. The NOAEL can be considered to be 0.125% (76 mg/kg bw/d) but considering that the test conditions were poorly reported (no control of the administered substance, evaporation?) this NOAEL will not be taken into account for the risk characterisation. The LOAEL was 310 mg/kg bw/d. Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0.01, 0.05, 0.25, and 1.25% (corresponding to 0, 7, 38, 188, and 919 mg/kg bw in males and 0, 9, 41, 222, and 976 mg/kg","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_005"} |
| SCCS_vision_codex | NOAEL | =310 | mg/kg bw/d | rat | - | 6 days | NOAEL study | {"citation":"Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0","dose":"Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose.","effect":"ted and no pertinent micropathology was discovered. Tests for blood in pooled urine sample from the 2%, 0.5% and controls groups after 3 and 6 days were negative. The mean weight gain was lower than controls for the 2% group. Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose. The NOAEL can be considered to be 0.125% (76 mg/kg bw/d) but considering that the test conditions were poorly reported (no control of the administered substance, evaporation?) this NOAEL will not be taken into account for the risk characterisation. The LOAEL was 310 mg/kg bw/d. Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0.01, 0.05, 0.25, and 1.25% (corresponding to 0, 7, 38, 188, and 919 mg/kg bw in males and 0, 9, 41, 222, and 976 mg/kg bw in females respectively) during 3 months. Animals were weighted 4 times during the first week and once a week thereafter. After euthanasia liver and kidneys were weighed. Or","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.25 | % | - | oral | - | NOAEL study | {"citation":"Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E","dose":"One animal died at day 73 after the beginning of the study in the high dose group.","effect":"es. One animal died at day 73 after the beginning of the study in the high dose group. Food consumption was decreased in both males and females at 1.25%. In males a significant decrease of food consumption was also observed at 0.25% dose. A significant decrease of body weight gain was seen in animals dosed with 1.25% EGBE. It was also seen in males at doses of 0.25%. The mean liver and kidney weight of males and females were definitely increased at the 1.25% dose. At both 1.25% and 0.25% testes were atrophied. The NOAEL for this study can be considered to be 0.05%. The purity of the EGBE used in this study is not given, nor does there appear to be analytical verification of EGBE doses, homogeneity and stability. Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE. Given the availability of numerous other more recent and robust studies, this one cannot be considered reliable to derive the criti","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_007"} |
| SCCS_vision_codex | NOAEL | =99 | % | rat | oral | - | NOAEL study | {"citation":"Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E","dose":"54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE.","effect":"this study can be considered to be 0.05%. The purity of the EGBE used in this study is not given, nor does there appear to be analytical verification of EGBE doses, homogeneity and stability. Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE. Given the availability of numerous other more recent and robust studies, this one cannot be considered reliable to derive the critical NOAEL. Guideline: / Species/strain: F344/N rats Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 ppm","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_008"} |
| SCCS_vision_codex | NOAEL | =129 | mg/kg bw/d | rat | - | - | NOAEL study | {"citation":"Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co","dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used.","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 pp","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_009"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/d | rat | oral | 13 weeks | NOAEL study | {"citation":"Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co","dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used.","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 ppm Route: Oral, drinking water Exposures: 13 weeks GLP: In compliance EGBE was administered in drinking water at concentrations of 0, 750, 1500, 3000, 4500 or 6000 ppm to grou","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_010"} |
| SCCS_vision_codex | NOAEL | =370 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments","dose":"rol group and treated mice.","effect":"rol group and treated mice. No mice treated with EGBE died or were killed before the scheduled end of the study and there were no significant clinical signs of toxicity. Body weight gains were slightly reduced in both male and female mice of the 3000 and 6000 ppm treatment groups. No particular pattern was evident in drinking water consumption. Organ weight changes that were found were secondary to body weight gain reduction. No treatment related gross or microscopic lesions in male or female mice were found. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LO","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.05 | % | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments","dose":"The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study.","effect":"ght changes that were found were secondary to body weight gain reduction. No treatment related gross or microscopic lesions in male or female mice were found. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LOAEL = 310 Poorly reported 53 90 days in food NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) Decrease in food consumption and body weight gain in males. Testes atrophy. 54 13 weeks in drinking water LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild Slight cytoplasmic alterations in hepatoc","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_012"} |
| SCCS_vision_codex | NOAEL | =370 | mg/kg bw/d | rat | oral | 13 weeks | irritation | {"dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (female...","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (females) may be used) Mice 13 weeks in drinking water NOAEL = 223 and 370 mg/kg bw/d for males and females respectively LOAEL = 553 and 676 mg/kg bw/d for males and females respectively Slight decrease in body weight gain 55 General comments Effects seen by oral route were body weight reduction, haemolysis, hepatic effects and local irritation effects. Irritation to the forestomach was seen after gavage dosing. A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and","page":24,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_016"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | rabbit | dermal | 9 days | irritation | {"citation":"Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mix","dose":"ative responses significant only at doses of 500 and 1000 mg/kg (a decrease was also seen for the 1500 mg/kg bw dose but not statistically significant, this weakens the relevance of this finding).","effect":"ative responses significant only at doses of 500 and 1000 mg/kg (a decrease was also seen for the 1500 mg/kg bw dose but not statistically significant, this weakens the relevance of this finding). The same results were seen in the MLR assay (decreased responses at the high doses, significant only at 500 and 1000 mg/kg bw). NK, CTL activity and T-dependent PFC response was unchanged after treatment. The lack of a dose-related response in these observations throws doubt on their significance for EGBE toxicology. The NOAEL for immunological effects was 1000 mg/kg bw, based on spleen weight reduction at 1500 mg/kg bw/d. Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mixture corresponding to 45, 225, 450, and 900 mg/kg bw) during 6 hr/day for 9 days (dosed 5 days, no dosed 2 days and dosed 4 days). Control group was treated with vehicle only. Dermal irritation score were determined after each test","page":25,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_019"} |
| SCCS_vision_codex | NOAEL | =450 | mg/kg | rabbit | - | 14-day | NOAEL study | {"citation":"Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2","dose":"Gross findings included some thickening of the skin in male rabbits given undiluted substance and possibly dose related patchy colour change of the kidneys of the three females.","effect":"d no indication of biologically significant haematological effects. The increased mean red blood cell counts on day 9 of treatment in the 5% dilution group and on day 14 after exposure in the 25% dilution group are considered to be statistical artefacts. No changes were noted in any organ weight measured in all animals. Gross findings included some thickening of the skin in male rabbits given undiluted substance and possibly dose related patchy colour change of the kidneys of the three females. For this study, the NOAEL of 450 mg/kg can be taken into account mainly based on gross findings observed in animals dosed with pure substance. Haematological effects seen during the study were transient and recovery was complete after the 14-day observation period. Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2.8% - 14.3% and 42.8% in distilled water (corresponding to dose levels of 0, 10, 50, and 150 mg/kg) for a 6 hr period/day 5 d/","page":26,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_020"} |
| SCCS_vision_codex | NOAEL | =1500 | mg/kg bw/day | mouse | dermal | subchronic | repeated dose toxicity | {"dose":"Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolys","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_023"} |
| SCCS_vision_codex | NOAEL | =900 | mg/kg bw/d | mouse | dermal | subchronic | repeated dose toxicity | {"dose":"Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.","effect":"butyl ether ___________________________________________________________________________________________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_024"} |
| SCCS_vision_codex | NOAEL | =450 | mg/kg bw/d | rat | inhalation | 4 days | repeated dose toxicity | {"dose":"0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500.","effect":"f. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whol","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_026"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg | rat | inhalation | 9 days | repeated dose toxicity | {"dose":"This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d.","effect":"ministered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whole body) to various concentrations of EGBE and for different periods of time. Rats were maintained in the exposure chamber for periods of up to 6 hours, and between repeated daily exposures they were returned to their cages where food and water were freely available. In the initial experiments the concentrations were selected to produce, if possible, acute effects after short","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_029"} |
| SCCS_vision_codex | NOAEL | =720 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | {"citation":"Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, i","dose":"66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death.","effect":"of reproductive organs, sperm motility, morphology and the oestrous cycle length and frequency were noted. However, a significant increase in relative kidney weight in the females and a significant increase in relative liver weight in both the males and females were observed. Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death. Under the conditions of the study, the NOAEL for reproductive toxicity of EGBE (fertility) can be set as 720 mg/kg bw/day. For developmental toxicity, no NOAEL can be derived. A conservative LOAEL of 720 mg/kg bw/day can be taken as only a slight decrease in pup weight (p<0.05) was observed at this dose. 3.3.8.2. Teratogenicity Oral route Rats Guideline: / Species/strain: Fisher 344 rats Group size: See below Test substance: EGBE Batch: / Purity: >99% Dose levels: 0 (control), 30, 100, and 200 mg/kg bw/day (GD 9-11); 0 (control), 30, 100, and 300 mg/kg bw","page":47,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_030"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/day | - | - | - | NOAEL study | {"dose":"The maternal NOAEL is 30 mg/kg bw/day based on the effects describes before.","effect":"SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 48 particular, dramatic reductions in circulating red blood cells, haematocrit and haemoglobin resulted by 24 hours after treatment. By GD20 the haematotoxic effects were nearly reversed. The changes observed in haematological parameters and organ weights in this study are typical of haemolytic anaemia and the compensatory haematopoietic response associated with recovery. The maternal NOAEL is 30 mg/kg bw/day based on the effects describes before. Embryo/foetal effects were: increased resorptions, nonlive implants, and adversely affected implants per litter in the 200 mg/kg bw/day group dosed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_032"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg | mouse | oral | developmental | developmental toxicity | {"citation":"Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per","dose":"osed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13.","effect":"osed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effec","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_033"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | {"citation":"Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per","dose":"When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted.","effect":"incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numer","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_035"} |
| SCCS_vision_codex | NOAEL | =350 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | {"citation":"Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant m","dose":"00 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18).","effect":"00 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numerically reduced number of viable foetuses were observed at 1000 and 1500 mg/kg bw/day. 4/43 foetus (in one litter) at 1000 mg/kg bw/day and 1/25 at 1500 mg/kg bw/day had cleft palates. For this study, the NOAEL for maternal toxicity is 350 mg/kg bw/day and the NOAEL for developmental toxicity is 650 mg/kg bw/day. Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant mice, days 7 through 14 of gestation GLP: In compliance In a subsequent reproduction study (following a Chernoff modification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between G","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_036"} |
| SCCS_vision_codex | NOAEL | =650 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | {"dose":"odification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22).","effect":"odification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22). No significant effects on pup growth or survival resulted. No adverse developmental effects were reported. Signs of haemolytic effects and bw gain reduction were seen at 1000 mg/kg in dams. The NOAEL for maternal toxicity is 650 mg/kg bw/day in this study, and as no effects were seen in pups, the NOAEL for developmental toxicity can be considered to be greater than 1000 mg/kg bw/day. In another Chernoff assay, fifty mated CD1 mice were orally administered EGBE (99 % purity) by gavage at 1180 mg/kg bw/day (calculated LD10 based on a non-pregnant mouse","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_039"} |
| SCCS_vision_codex | NOAEL | =97 | % | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","effect":"SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 49 pilot study) in corn oil from GD7-14 (GD1=vaginal sperm plug), then allowed to litter and to rear pups to PND3. 20 % of the dams died, maternal weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day","page":49,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_040"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","effect":"pups to PND3. 20 % of the dams died, maternal weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand","page":49,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_041"} |
| SCCS_vision_codex | NOAEL | =200 | ppm | rat | - | developmental | reproductive toxicity | {"citation":"Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99","dose":"A statistically significant decrease in foetal weights was observed in the 150 ppm exposure group.","effect":"oup. A statistically significant decrease in foetal weights was observed in the 150 ppm exposure group. Since differences in foetal weights between experimental and control groups were slight, and, also, that significant differences were not observed in the 200 ppm exposure group, these differences were not thought to have been of biological significance. For this study a very conservative LOAEL of 150 ppm can be determined for dams for haematuria seen in the first day of treatment. For developmental toxicity, the NOAEL is 200 ppm. Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99.6 %) for 6hr/day on GD 6-15 (GD0 = sperm plug positive). No adverse reproductive or developmental effects were observed in animals exposed to 25 ppm or 50 ppm. Maternal toxicity was observed in a dose-related incidence during the exposure period, included evidence of haematuria from 100 ppm and pale, cold extremities with necrosis of the","page":49,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_046"} |
| SCCS_vision_codex | NOAEL | =1 | - | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 1 3","effect":"ube defect). For EGBE, these studies did not allow to draw any conclusion about its potential effects on humans because no studies are able to define clearly an unique source of glycol ether; Usually studies described co- exposure to various glycol ethers, including known developmental toxins such as EGME and other chemicals as well. Ref.: 1 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) Since all key effects are induced by haemolysis in rodents, a NOAEL based on haemotoxicity will be used in the risk characterisation. The selection of an appropriate interspecies chemical safety assessment factor (CSAF) must take into account the lower sensitivity of humans than rats (or mice) to the metabolite BAA. WHO (1994) has proposed splitting the CSAF in two components representing the toxicokinetic and toxicodynamic adjustment factors (Inter-species kinetics (4.0) and Inter-species dynamics (2.5) (see also The SCCP Notes of guidance for the testing of cosmetic ingredients","page":53,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_047"} |
| SCCS_vision_codex | NOAEL | =95 | µg/cm | rat | dermal | - | dermal absorption | {"citation":"Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure","dose":"Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","effect":". However, a more cautious and conservative initial approach would be to propose a value of 0.1. This implies that a factor of 0.4 (4.0 x 0.1) is justified for species differences and gives a minimal MOS of 4 taking intra species variation into consideration. Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL","page":54,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_048"} |
| SCCS_vision_codex | NOAEL | =1.11 | mg/kg bw | rat | dermal | - | dermal absorption | {"dose":"Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","effect":"g dermal exposure. Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not","page":54,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_049"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | rat | dermal | - | dermal absorption | {"dose":"l absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","effect":"l absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not report","page":54,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_050"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/d | rabbit | - | 3 day | reproductive toxicity | {"dose":"The lowest NOAEL was 30 mg/kg bw/d obtained a reproductive toxicity study and represent maternal toxicity after 3 day exposure.","effect":"K model. The toxicodynamics factor needs to be set to an appropriate value to reflect the lower sensitivity of humans to haemolysis. The data available on the most sensitive measure (pre-haemolytic changes) suggests that a value of 0.01 would be realistic. However, a more cautious and conservative initial approach would be to propose a value of 0.1. This imply that a factor of (4.0 x 0.1) 0.4 is just for species differences and gives a minimal MOS of 4 taking intra species variation into consideration. The lowest NOAEL was 30 mg/kg bw/d obtained a reproductive toxicity study and represent maternal toxicity after 3 day exposure. The effect was due to haematological effects and probably secondary reaction to this at a dose of 100 mg/kg bw/d. Irritation / sensitisation Studies performed on rabbits and guinea pigs have shown that EGBE have caused moderate irritation (erythema and oedema) when applied occlusively on the skin for a period of 4 hours. If the substance was applied on scarified skin or for a longer period of time, sign","page":56,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_061"} |
| SCCS_vision_codex | NOAEL | =23 | - | - | - | - | NOAEL study | {"dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","effect":"Unlabeled table on page 23: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_063"} |
| SCCS_vision_codex | NOAEL | =222 | - | - | oral | 6 weeks | irritation | {"effect":"Unlabeled table on page 23: 6 weeks gavage | LOAEL = 222 | Haematological effects at all doses and irritant effects on the stomach | 52","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_066"} |
| SCCS_vision_codex | NOAEL | =76 | - | - | - | 90 days | NOAEL study | {"effect":"Unlabeled table on page 23: 90 days in food | NOAEL = 76 LOAEL = 310 | Poorly reported | 53","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_067"} |
| SCCS_vision_codex | NOAEL | =82 | mg/kg bw/day | rat | oral | 13 weeks | NOAEL study | {"dose":"13 weeks in drinking water | LOAEL of 69 and 82 mg/kg bw/day for males and females respectively.","effect":"Unlabeled table on page 23: 13 weeks in drinking water | LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild | Slight cytoplasmic alterations in hepatocytes of both male and female rats | 55","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_068"} |
| SCCS_vision_codex | NOAEL | =24 | - | - | - | - | NOAEL study | {"dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","effect":"Unlabeled table on page 24: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":24,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_069"} |
| SCCS_vision_codex | NOAEL | =27 | - | - | - | - | NOAEL study | {"dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","effect":"Unlabeled table on page 27: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_072"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg | - | - | - | NOAEL study | {"dose":"Based on a NOAEL 150 mg/kg and a skin penetration rate of 113µg/cm2 the member state concluded, that the substance could be considered safe for the consumers, when used in a concentration up to 4% in permanent hair dyes and up to 2% in non-oxidative hair dyes.","effect":"____________________________ 5 1. BACKGROUND A risk assessment of EGBE with the chemical name 2-butoxyethanol or ethylene glycol monobutyl ether was done by a member state (France). The risk assessment is based mainly on open scientific literature and on skin absorptions studies done by Industry. The risk assessment led the member state to put some restrictions on the use this substance. According to the notification to the Commission EGBE is used in cosmetic products only as a solvent in hair dyes. Based on a NOAEL 150 mg/kg and a skin penetration rate of 113µg/cm2 the member state concluded, that the substance could be considered safe for the consumers, when used in a concentration up to 4% in permanent hair dyes and up to 2% in non-oxidative hair dyes. 2. TERMS OF REFERENCE 1. Does the SCCP consider the use of EGBE as solvent in hair dyes in a concentration up to 4% in oxidative hair dyes and up to 2% in non-oxidative hair dyes safe for the consumer taken into consideration the scientific data provided? 2. If not, does","page":5,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_001"} |
| SCCS_vision_codex | NOAEL | >50 | ppm | guinea pig | dermal | - | irritation | {"citation":"Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation","dose":"From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm.","effect":"ogical changes in the volunteers under the different conditions, physiological monitoring equipment was used). The published study paper does not mention if these signs were checked except the recording of the physiological changes. However, the author did indicate in a written communication that the volunteers were asked to report any adverse effects and none were reported. Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation. From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm. 3.3.3. Skin sensitisation Guinea pigs The study was performed according to OECD guideline 406. EGBE was tested in Guinea pigs for sensitisation potential. Induction was made with a dermal injection of 0.5% EGBE in 0.9% saline and a topical application of a 25% EGBE in 0.9% saline. Challenge was made with a topical application of 10% EGBE in saline. All topical applications were made occlusively. Concentrations tested were based on res","page":14,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_002"} |
| SCCS_vision_codex | NOAEL | =222 | mg/kg | rat | oral | 90 days | NOAEL study | {"citation":"Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0","dose":"helium in all treated animals.","effect":"helium in all treated animals. Hepatomegaly was also seen in 4 out of 10 animals of the high dose group. Haemosiderin deposition was seen in some animals (7/10 and 6/10 in the high and mid dose group respectively). Thymus atrophy was seen in one animal of the high dose group. Congestion of the spleen was seen in all treated animals. Extramedullary haematopoiesis was reported for one animal in the high dose group and haemosiderin deposit in the majority of animals of the high and mid dose group. For this study, the NOAEL can be considered to be lower than 222 mg/kg (which is the Low Observable Adverse Effect Level: LOAEL) based on effects seen on spleens and RBC parameters. Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0.03, 0.125, 0.5 and 2% Butyl cellosolve (EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days. No deaths were seen attributable to the direct action of EGBE. Appetite was not affected and no pertinent micropathology was discovered. Tests f","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | rat | - | 90 days | NOAEL study | {"citation":"Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0","dose":"EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days.","effect":"EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days. No deaths were seen attributable to the direct action of EGBE. Appetite was not affected and no pertinent micropathology was discovered. Tests for blood in pooled urine sample from the 2%, 0.5% and controls groups after 3 and 6 days were negative. The mean weight gain was lower than controls for the 2% group. Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose. The NOAEL can be considered to be 0.125% (76 mg/kg bw/d) but considering that the test conditions were poorly reported (no control of the administered substance, evaporation?) this NOAEL will not be taken into account for the risk characterisation. The LOAEL was 310 mg/kg bw/d. Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0.01, 0.05, 0.25, and 1.25% (corresponding to 0, 7, 38, 188, and 919 mg/kg bw in males and 0, 9, 41, 222, and 976 mg/kg","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_005"} |
| SCCS_vision_codex | NOAEL | =310 | mg/kg bw/d | rat | - | 6 days | NOAEL study | {"citation":"Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0","dose":"Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose.","effect":"ted and no pertinent micropathology was discovered. Tests for blood in pooled urine sample from the 2%, 0.5% and controls groups after 3 and 6 days were negative. The mean weight gain was lower than controls for the 2% group. Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose. The NOAEL can be considered to be 0.125% (76 mg/kg bw/d) but considering that the test conditions were poorly reported (no control of the administered substance, evaporation?) this NOAEL will not be taken into account for the risk characterisation. The LOAEL was 310 mg/kg bw/d. Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0.01, 0.05, 0.25, and 1.25% (corresponding to 0, 7, 38, 188, and 919 mg/kg bw in males and 0, 9, 41, 222, and 976 mg/kg bw in females respectively) during 3 months. Animals were weighted 4 times during the first week and once a week thereafter. After euthanasia liver and kidneys were weighed. Or","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.25 | % | - | oral | - | NOAEL study | {"citation":"Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E","dose":"One animal died at day 73 after the beginning of the study in the high dose group.","effect":"es. One animal died at day 73 after the beginning of the study in the high dose group. Food consumption was decreased in both males and females at 1.25%. In males a significant decrease of food consumption was also observed at 0.25% dose. A significant decrease of body weight gain was seen in animals dosed with 1.25% EGBE. It was also seen in males at doses of 0.25%. The mean liver and kidney weight of males and females were definitely increased at the 1.25% dose. At both 1.25% and 0.25% testes were atrophied. The NOAEL for this study can be considered to be 0.05%. The purity of the EGBE used in this study is not given, nor does there appear to be analytical verification of EGBE doses, homogeneity and stability. Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE. Given the availability of numerous other more recent and robust studies, this one cannot be considered reliable to derive the criti","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_007"} |
| SCCS_vision_codex | NOAEL | =99 | % | rat | oral | - | NOAEL study | {"citation":"Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E","dose":"54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE.","effect":"this study can be considered to be 0.05%. The purity of the EGBE used in this study is not given, nor does there appear to be analytical verification of EGBE doses, homogeneity and stability. Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE. Given the availability of numerous other more recent and robust studies, this one cannot be considered reliable to derive the critical NOAEL. Guideline: / Species/strain: F344/N rats Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 ppm","page":21,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_008"} |
| SCCS_vision_codex | NOAEL | =129 | mg/kg bw/d | rat | - | - | NOAEL study | {"citation":"Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co","dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used.","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 pp","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_009"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/d | rat | oral | 13 weeks | NOAEL study | {"citation":"Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co","dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used.","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 ppm Route: Oral, drinking water Exposures: 13 weeks GLP: In compliance EGBE was administered in drinking water at concentrations of 0, 750, 1500, 3000, 4500 or 6000 ppm to grou","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_010"} |
| SCCS_vision_codex | NOAEL | =370 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments","dose":"rol group and treated mice.","effect":"rol group and treated mice. No mice treated with EGBE died or were killed before the scheduled end of the study and there were no significant clinical signs of toxicity. Body weight gains were slightly reduced in both male and female mice of the 3000 and 6000 ppm treatment groups. No particular pattern was evident in drinking water consumption. Organ weight changes that were found were secondary to body weight gain reduction. No treatment related gross or microscopic lesions in male or female mice were found. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LO","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.05 | % | rat | oral | subchronic | repeated dose toxicity | {"citation":"Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments","dose":"The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study.","effect":"ght changes that were found were secondary to body weight gain reduction. No treatment related gross or microscopic lesions in male or female mice were found. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LOAEL = 310 Poorly reported 53 90 days in food NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) Decrease in food consumption and body weight gain in males. Testes atrophy. 54 13 weeks in drinking water LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild Slight cytoplasmic alterations in hepatoc","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_012"} |
| SCCS_vision_codex | NOAEL | =370 | mg/kg bw/d | rat | oral | 13 weeks | irritation | {"dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (female...","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (females) may be used) Mice 13 weeks in drinking water NOAEL = 223 and 370 mg/kg bw/d for males and females respectively LOAEL = 553 and 676 mg/kg bw/d for males and females respectively Slight decrease in body weight gain 55 General comments Effects seen by oral route were body weight reduction, haemolysis, hepatic effects and local irritation effects. Irritation to the forestomach was seen after gavage dosing. A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and","page":24,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_016"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | rabbit | dermal | 9 days | irritation | {"citation":"Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mix","dose":"ative responses significant only at doses of 500 and 1000 mg/kg (a decrease was also seen for the 1500 mg/kg bw dose but not statistically significant, this weakens the relevance of this finding).","effect":"ative responses significant only at doses of 500 and 1000 mg/kg (a decrease was also seen for the 1500 mg/kg bw dose but not statistically significant, this weakens the relevance of this finding). The same results were seen in the MLR assay (decreased responses at the high doses, significant only at 500 and 1000 mg/kg bw). NK, CTL activity and T-dependent PFC response was unchanged after treatment. The lack of a dose-related response in these observations throws doubt on their significance for EGBE toxicology. The NOAEL for immunological effects was 1000 mg/kg bw, based on spleen weight reduction at 1500 mg/kg bw/d. Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mixture corresponding to 45, 225, 450, and 900 mg/kg bw) during 6 hr/day for 9 days (dosed 5 days, no dosed 2 days and dosed 4 days). Control group was treated with vehicle only. Dermal irritation score were determined after each test","page":25,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_019"} |
| SCCS_vision_codex | NOAEL | =450 | mg/kg | rabbit | - | 14-day | NOAEL study | {"citation":"Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2","dose":"Gross findings included some thickening of the skin in male rabbits given undiluted substance and possibly dose related patchy colour change of the kidneys of the three females.","effect":"d no indication of biologically significant haematological effects. The increased mean red blood cell counts on day 9 of treatment in the 5% dilution group and on day 14 after exposure in the 25% dilution group are considered to be statistical artefacts. No changes were noted in any organ weight measured in all animals. Gross findings included some thickening of the skin in male rabbits given undiluted substance and possibly dose related patchy colour change of the kidneys of the three females. For this study, the NOAEL of 450 mg/kg can be taken into account mainly based on gross findings observed in animals dosed with pure substance. Haematological effects seen during the study were transient and recovery was complete after the 14-day observation period. Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2.8% - 14.3% and 42.8% in distilled water (corresponding to dose levels of 0, 10, 50, and 150 mg/kg) for a 6 hr period/day 5 d/","page":26,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_020"} |
| SCCS_vision_codex | NOAEL | =1500 | mg/kg bw/day | mouse | dermal | subchronic | repeated dose toxicity | {"dose":"Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolys","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_023"} |
| SCCS_vision_codex | NOAEL | =900 | mg/kg bw/d | mouse | dermal | subchronic | repeated dose toxicity | {"dose":"Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.","effect":"butyl ether ___________________________________________________________________________________________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_024"} |
| SCCS_vision_codex | NOAEL | =450 | mg/kg bw/d | rat | inhalation | 4 days | repeated dose toxicity | {"dose":"0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500.","effect":"f. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whol","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_026"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg | rat | inhalation | 9 days | repeated dose toxicity | {"dose":"This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d.","effect":"ministered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whole body) to various concentrations of EGBE and for different periods of time. Rats were maintained in the exposure chamber for periods of up to 6 hours, and between repeated daily exposures they were returned to their cages where food and water were freely available. In the initial experiments the concentrations were selected to produce, if possible, acute effects after short","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_029"} |
| SCCS_vision_codex | NOAEL | =720 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | {"citation":"Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, i","dose":"66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death.","effect":"of reproductive organs, sperm motility, morphology and the oestrous cycle length and frequency were noted. However, a significant increase in relative kidney weight in the females and a significant increase in relative liver weight in both the males and females were observed. Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death. Under the conditions of the study, the NOAEL for reproductive toxicity of EGBE (fertility) can be set as 720 mg/kg bw/day. For developmental toxicity, no NOAEL can be derived. A conservative LOAEL of 720 mg/kg bw/day can be taken as only a slight decrease in pup weight (p<0.05) was observed at this dose. 3.3.8.2. Teratogenicity Oral route Rats Guideline: / Species/strain: Fisher 344 rats Group size: See below Test substance: EGBE Batch: / Purity: >99% Dose levels: 0 (control), 30, 100, and 200 mg/kg bw/day (GD 9-11); 0 (control), 30, 100, and 300 mg/kg bw","page":47,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_030"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/day | - | - | - | NOAEL study | {"dose":"The maternal NOAEL is 30 mg/kg bw/day based on the effects describes before.","effect":"SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 48 particular, dramatic reductions in circulating red blood cells, haematocrit and haemoglobin resulted by 24 hours after treatment. By GD20 the haematotoxic effects were nearly reversed. The changes observed in haematological parameters and organ weights in this study are typical of haemolytic anaemia and the compensatory haematopoietic response associated with recovery. The maternal NOAEL is 30 mg/kg bw/day based on the effects describes before. Embryo/foetal effects were: increased resorptions, nonlive implants, and adversely affected implants per litter in the 200 mg/kg bw/day group dosed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_032"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg | mouse | oral | developmental | developmental toxicity | {"citation":"Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per","dose":"osed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13.","effect":"osed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effec","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_033"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | {"citation":"Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per","dose":"When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted.","effect":"incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numer","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_035"} |
| SCCS_vision_codex | NOAEL | =350 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | {"citation":"Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant m","dose":"00 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18).","effect":"00 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numerically reduced number of viable foetuses were observed at 1000 and 1500 mg/kg bw/day. 4/43 foetus (in one litter) at 1000 mg/kg bw/day and 1/25 at 1500 mg/kg bw/day had cleft palates. For this study, the NOAEL for maternal toxicity is 350 mg/kg bw/day and the NOAEL for developmental toxicity is 650 mg/kg bw/day. Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant mice, days 7 through 14 of gestation GLP: In compliance In a subsequent reproduction study (following a Chernoff modification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between G","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_036"} |
| SCCS_vision_codex | NOAEL | =650 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | {"dose":"odification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22).","effect":"odification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22). No significant effects on pup growth or survival resulted. No adverse developmental effects were reported. Signs of haemolytic effects and bw gain reduction were seen at 1000 mg/kg in dams. The NOAEL for maternal toxicity is 650 mg/kg bw/day in this study, and as no effects were seen in pups, the NOAEL for developmental toxicity can be considered to be greater than 1000 mg/kg bw/day. In another Chernoff assay, fifty mated CD1 mice were orally administered EGBE (99 % purity) by gavage at 1180 mg/kg bw/day (calculated LD10 based on a non-pregnant mouse","page":48,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_039"} |
| SCCS_vision_codex | NOAEL | =97 | % | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","effect":"SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 49 pilot study) in corn oil from GD7-14 (GD1=vaginal sperm plug), then allowed to litter and to rear pups to PND3. 20 % of the dams died, maternal weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day","page":49,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_040"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","effect":"pups to PND3. 20 % of the dams died, maternal weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand","page":49,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_041"} |
| SCCS_vision_codex | NOAEL | =200 | ppm | rat | - | developmental | reproductive toxicity | {"citation":"Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99","dose":"A statistically significant decrease in foetal weights was observed in the 150 ppm exposure group.","effect":"oup. A statistically significant decrease in foetal weights was observed in the 150 ppm exposure group. Since differences in foetal weights between experimental and control groups were slight, and, also, that significant differences were not observed in the 200 ppm exposure group, these differences were not thought to have been of biological significance. For this study a very conservative LOAEL of 150 ppm can be determined for dams for haematuria seen in the first day of treatment. For developmental toxicity, the NOAEL is 200 ppm. Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99.6 %) for 6hr/day on GD 6-15 (GD0 = sperm plug positive). No adverse reproductive or developmental effects were observed in animals exposed to 25 ppm or 50 ppm. Maternal toxicity was observed in a dose-related incidence during the exposure period, included evidence of haematuria from 100 ppm and pale, cold extremities with necrosis of the","page":49,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_046"} |
| SCCS_vision_codex | NOAEL | =1 | - | rat | - | developmental | developmental toxicity | {"citation":"Ref.: 1 3","effect":"ube defect). For EGBE, these studies did not allow to draw any conclusion about its potential effects on humans because no studies are able to define clearly an unique source of glycol ether; Usually studies described co- exposure to various glycol ethers, including known developmental toxins such as EGME and other chemicals as well. Ref.: 1 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) Since all key effects are induced by haemolysis in rodents, a NOAEL based on haemotoxicity will be used in the risk characterisation. The selection of an appropriate interspecies chemical safety assessment factor (CSAF) must take into account the lower sensitivity of humans than rats (or mice) to the metabolite BAA. WHO (1994) has proposed splitting the CSAF in two components representing the toxicokinetic and toxicodynamic adjustment factors (Inter-species kinetics (4.0) and Inter-species dynamics (2.5) (see also The SCCP Notes of guidance for the testing of cosmetic ingredients","page":53,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_047"} |
| SCCS_vision_codex | NOAEL | =95 | µg/cm | rat | dermal | - | dermal absorption | {"citation":"Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure","dose":"Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","effect":". However, a more cautious and conservative initial approach would be to propose a value of 0.1. This implies that a factor of 0.4 (4.0 x 0.1) is justified for species differences and gives a minimal MOS of 4 taking intra species variation into consideration. Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL","page":54,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_048"} |
| SCCS_vision_codex | NOAEL | =1.11 | mg/kg bw | rat | dermal | - | dermal absorption | {"dose":"Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","effect":"g dermal exposure. Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not","page":54,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_049"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw | rat | dermal | - | dermal absorption | {"dose":"l absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","effect":"l absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not report","page":54,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_050"} |
| SCCS_vision_codex | NOAEL | =30 | mg/kg bw/d | rabbit | - | 3 day | reproductive toxicity | {"dose":"The lowest NOAEL was 30 mg/kg bw/d obtained a reproductive toxicity study and represent maternal toxicity after 3 day exposure.","effect":"K model. The toxicodynamics factor needs to be set to an appropriate value to reflect the lower sensitivity of humans to haemolysis. The data available on the most sensitive measure (pre-haemolytic changes) suggests that a value of 0.01 would be realistic. However, a more cautious and conservative initial approach would be to propose a value of 0.1. This imply that a factor of (4.0 x 0.1) 0.4 is just for species differences and gives a minimal MOS of 4 taking intra species variation into consideration. The lowest NOAEL was 30 mg/kg bw/d obtained a reproductive toxicity study and represent maternal toxicity after 3 day exposure. The effect was due to haematological effects and probably secondary reaction to this at a dose of 100 mg/kg bw/d. Irritation / sensitisation Studies performed on rabbits and guinea pigs have shown that EGBE have caused moderate irritation (erythema and oedema) when applied occlusively on the skin for a period of 4 hours. If the substance was applied on scarified skin or for a longer period of time, sign","page":56,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_061"} |
| SCCS_vision_codex | NOAEL | =23 | - | - | - | - | NOAEL study | {"dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","effect":"Unlabeled table on page 23: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_063"} |
| SCCS_vision_codex | NOAEL | =222 | - | - | oral | 6 weeks | irritation | {"effect":"Unlabeled table on page 23: 6 weeks gavage | LOAEL = 222 | Haematological effects at all doses and irritant effects on the stomach | 52","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_066"} |
| SCCS_vision_codex | NOAEL | =76 | - | - | - | 90 days | NOAEL study | {"effect":"Unlabeled table on page 23: 90 days in food | NOAEL = 76 LOAEL = 310 | Poorly reported | 53","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_067"} |
| SCCS_vision_codex | NOAEL | =82 | mg/kg bw/day | rat | oral | 13 weeks | NOAEL study | {"dose":"13 weeks in drinking water | LOAEL of 69 and 82 mg/kg bw/day for males and females respectively.","effect":"Unlabeled table on page 23: 13 weeks in drinking water | LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild | Slight cytoplasmic alterations in hepatocytes of both male and female rats | 55","page":23,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_068"} |
| SCCS_vision_codex | NOAEL | =24 | - | - | - | - | NOAEL study | {"dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","effect":"Unlabeled table on page 24: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":24,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_069"} |
| SCCS_vision_codex | NOAEL | =27 | - | - | - | - | NOAEL study | {"dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","effect":"Unlabeled table on page 27: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":27,"pdf":"sccp_o_095.pdf","row_type":"noael_study","study_id":"sccp_o_095_noael_072"} |
ToxRefDB_ToxRefDB_v3_pod.csv 27 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =250 | mg/kg bw/day | rat (fischer; Fischer 344) | oral | 0 day to 14 day | SAC | study_id=5088; toxval_study_source_id=studyid5088_Adult_F0_F_systemic; toxval_effect_list=in life observation-water consumption-water consumption|in life observation-body weight-body weight; dose_level=3; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =400 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | oral | 0 day to 14 day | SAC | study_id=5089; toxval_study_source_id=studyid5089_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-dehydration; dose_level=4; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Mice; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =363 | mg/kg bw/day | rat (fischer; Fischer 344) | oral | 0 week to 13 week | SUB | study_id=5090; toxval_study_source_id=studyid5090_Adult Pregnancy_F0_F_reproductive; toxval_effect_list=reproductive performance-estrous cycle-abnormal; dose_level=4; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =82 | mg/kg bw/day | rat (fischer; Fischer 344) | oral | 0 week to 13 week | SUB | study_id=5090; toxval_study_source_id=studyid5090_Adult_F0_F_systemic; toxval_effect_list=hematology-hemoglobin (hgb)-hemoglobin (hgb)|hematology-anemia-anemia - macrocytic|urinalysis-volume-volume|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|in life observation-clinical signs-defecation (diarrhea)|clinical chemistry-protein-protein|clinical chemistry-urea nitrogen-urea nitrogen|urinalysis-specific gravity/osmolality-specific gravity/osmolality|hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|in life observation-water consumption-water consumption|hematology-reticulocyte-reticulocyte|pathology microscopic-liver-pigmentation|pathology microscopic-liver-cytoplasmic alteration|pathology microscopic-spleen-pigmentation|clinical chemistry-creatinine-creatinine|hematology-platelet-platelet|clinical chemistry-albumin-albumin|pathology microscopic-liver-degeneration|clinical chemistry-creatine phosphokinase-creatine phosphokinase|clinical chemistry-alkaline phosphatase (alp/alk)-alkaline phosphatase (alp/alk)|pathology microscopic-spleen-hematopoietic cell proliferation|pathology microscopic-bone marrow-hypercellularity|hematology-mean corpuscular hemoglobin concentration (mchc)-mean corpuscular hemoglobin concentration (mchc)|clinical chemistry-alanine aminotransferase (alt/sgpt)-alanine aminotransferase (alt/sgpt)|pathology microscopic-bone marrow-hyperplasia|in life observation-body weight-body weight gain|in life observation-body weight-body weight|organ weight-thymus-absolute; dose_level=1; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =69 | mg/kg bw/day | rat (fischer; Fischer 344) | oral | 0 week to 13 week | SUB | study_id=5090; toxval_study_source_id=studyid5090_Adult_F0_M_systemic; toxval_effect_list=in life observation-clinical signs-defecation (diarrhea)|pathology microscopic-liver-cytoplasmic alteration|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|clinical chemistry-albumin-albumin|hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|pathology microscopic-spleen-pigmentation|hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|clinical chemistry-urea nitrogen-urea nitrogen|clinical chemistry-protein-protein|pathology gross-sperm measure-sperm count|hematology-anemia-anemia - macrocytic|pathology microscopic-bone marrow-hyperplasia|pathology microscopic-liver-degeneration|pathology microscopic-spleen-hematopoietic cell proliferation|pathology microscopic-bone marrow-cellular alteration|in life observation-body weight-body weight|in life observation-body weight-body weight gain|organ weight-thymus-absolute|pathology microscopic-blood-thrombocytopenia|in life observation-water consumption-water consumption|pathology microscopic-liver-pigmentation|hematology-reticulocyte-reticulocyte; dose_level=1; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =676 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | oral | 0 week to 13 week | SUB | study_id=5091; toxval_study_source_id=studyid5091_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight gain; dose_level=3; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Mice; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =553 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | oral | 0 week to 13 week | SUB | study_id=5091; toxval_study_source_id=studyid5091_Adult_F0_M_systemic; toxval_effect_list=in life observation-body weight-body weight gain; dose_level=3; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Mice; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =1.55 | mg/kg bw/day | rat (fischer; Fischer 344) | inhalation | 0 week to 14 week | SUB | study_id=5092; toxval_study_source_id=studyid5092_Adult_F0_F_systemic; toxval_effect_list=hematology-hemoglobin (hgb)-hemoglobin (hgb)|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|hematology-hematocrit (hct)-hematocrit (hct)|hematology-anemia-anemia - nos|hematology-nucleated red blood cell (nrbc)-nucleated red blood cell (nrbc)|pathology microscopic-spleen-hematopoietic cell proliferation erythrocytic|pathology microscopic-liver-pigmentation|hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|pathology microscopic-bone marrow-hyperplasia|hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|in life observation-clinical signs-lethargy|in life observation-clinical signs-nasal discharge|in life observation-clinical signs-lacrimation|in life observation-clinical signs-ocular discharge|hematology-reticulocyte-reticulocyte|in life observation-clinical signs-labored respiration|in life observation-clinical signs-general pallor|hematology-platelet-platelet|organ weight-kidney-nos|in life observation-clinical signs-salivation|organ weight-liver-nos|in life observation-clinical signs-urogenital staining|in life observation-mortality-mortality|pathology microscopic-stomach-hyperplasia|pathology microscopic-stomach-necrosis|pathology microscopic-liver-thrombosis|pathology microscopic-heart-thrombosis|organ weight-thymus-nos|pathology microscopic-nose-thrombosis|in life observation-clinical signs-tooth-degeneration|pathology microscopic-thymus-atrophy|pathology microscopic-stomach-ulcer|in life observation-clinical signs-scabbing|in life observation-clinical signs-[other]|hematology-microcytosis-microcytosis|pathology microscopic-kidney-degeneration|pathology microscopic-spleen-atrophy|in life observation-body weight-body weight|pathology microscopic-bone-thrombosis|pathology microscopic-bone-infarct|in life observation-clinical signs-tooth-thrombosis|in life observation-body weight-body weight gain|pathology microscopic-stomach-inflammation|hematology-erythroblast-erythroblast|pathology microscopic-liver-degeneration|in life observation-clinical signs-self-mutilation|pathology microscopic-bone marrow-necrosis|pathology microscopic-liver-necrosis|pathology microscopic-lung-thrombosis; dose_level=1; study_year=2000; study_citation=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Whole-Body; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =4.65 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | inhalation | 0 week to 14 week | SUB | study_id=5093; toxval_study_source_id=studyid5093_Adult_F0_F_systemic; toxval_effect_list=hematology-anemia-anemia - nos|hematology-hemoglobin (hgb)-hemoglobin (hgb)|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|hematology-reticulocyte-reticulocyte|hematology-hematocrit (hct)-hematocrit (hct)|pathology microscopic-stomach-hyperplasia|pathology microscopic-spleen-hemosiderosis|pathology microscopic-liver-hemosiderosis|pathology microscopic-stomach-inflammation|hematology-platelet-platelet|in life observation-mortality-mortality|hematology-erythroblast-erythroblast|pathology microscopic-lymph node-atrophy|in life observation-clinical signs-urogenital staining|pathology microscopic-kidney-degeneration|pathology microscopic-stomach-ulcer|pathology microscopic-stomach-necrosis|pathology microscopic-thymus-atrophy|pathology microscopic-pleura-inflammation|organ weight-liver-relative to body weight|in life observation-clinical signs-labored respiration|pathology microscopic-spleen-atrophy|pathology microscopic-kidney-hemosiderosis|pathology microscopic-spleen-hematopoietic cell proliferation|in life observation-clinical signs-lethargy; dose_level=1; study_year=2000; study_citation=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Mice; dsstox_substance_id=DTXSID1024097; admin_method=Whole-Body; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =1.56 | mg/kg bw/day | rat (fischer; Fischer 344) | inhalation | 0 week to 104 week | CHR | study_id=5094; toxval_study_source_id=studyid5094_Adult_F0_F_systemic; toxval_effect_list=hematology-[other]-[other]|hematology-reticulocyte-reticulocyte|hematology-anemia-anemia - nos|hematology-hematocrit (hct)-hematocrit (hct)|hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|hematology-myeloid/erythroid (m:e) ratio-myeloid/erythroid (m:e) ratio|pathology microscopic-nose-degeneration|pathology microscopic-liver-pigmentation|hematology-hemoglobin (hgb)-hemoglobin (hgb)|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|pathology microscopic-bone marrow-hypercellularity|in life observation-body weight-body weight|pathology microscopic-adrenal gland-hyperplasia; dose_level=1; study_year=2000; study_citation=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_2 year study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Whole-Body; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =9.375 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | inhalation | 0 week to 104 week | CHR | study_id=5095; toxval_study_source_id=studyid5095_Adult_F0_F_systemic; toxval_effect_list=hematology-platelet-platelet|pathology microscopic-stomach-hyperplasia|pathology microscopic-liver-hemosiderosis|pathology microscopic-stomach-ulcer|pathology microscopic-nose-degeneration|hematology-anemia-anemia - nos|pathology microscopic-spleen-hemosiderosis|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|in life observation-body weight-body weight|hematology-hematocrit (hct)-hematocrit (hct)|hematology-hemoglobin (hgb)-hemoglobin (hgb)|hematology-neutrophils-neutrophils|hematology-reticulocyte-reticulocyte|hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|pathology microscopic-spleen-hematopoietic cell proliferation|pathology microscopic-stomach-squamous cell papilloma; dose_level=1; study_year=2000; study_citation=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_2 year study_Mice; dsstox_substance_id=DTXSID1024097; admin_method=Whole-Body; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LOAEL | =650 | mg/kg bw/day | rat (fischer; Fischer 344) | oral | 0 day to 14 day | SAC | study_id=5088; toxval_study_source_id=studyid5088_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight; dose_level=5; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LOAEL | =281 | mg/kg bw/day | rat (fischer; Fischer 344) | oral | 0 week to 13 week | SUB | study_id=5090; toxval_study_source_id=studyid5090_Adult_F0_M_systemic; toxval_effect_list=pathology microscopic-liver-degeneration|hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|clinical chemistry-albumin-albumin|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|pathology microscopic-spleen-hematopoietic cell proliferation|pathology microscopic-bone marrow-cellular alteration|in life observation-body weight-body weight|in life observation-body weight-body weight gain|clinical chemistry-urea nitrogen-urea nitrogen|hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|pathology microscopic-spleen-pigmentation|clinical chemistry-protein-protein|pathology microscopic-bone marrow-hyperplasia|hematology-anemia-anemia - macrocytic|pathology microscopic-blood-thrombocytopenia; dose_level=3; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LOAEL | =6.25 | mg/kg bw/day | rat (fischer; Fischer 344) | inhalation | 0 week to 14 week | SUB | study_id=5092; toxval_study_source_id=studyid5092_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-lethargy|in life observation-clinical signs-nasal discharge|in life observation-clinical signs-lacrimation|hematology-anemia-anemia - nos|in life observation-clinical signs-ocular discharge|hematology-nucleated red blood cell (nrbc)-nucleated red blood cell (nrbc)|hematology-reticulocyte-reticulocyte|hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|in life observation-clinical signs-labored respiration|in life observation-clinical signs-general pallor|hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|hematology-hemoglobin (hgb)-hemoglobin (hgb)|pathology microscopic-bone marrow-hyperplasia|hematology-platelet-platelet|pathology microscopic-spleen-hematopoietic cell proliferation erythrocytic|organ weight-kidney-nos|hematology-hematocrit (hct)-hematocrit (hct)|in life observation-clinical signs-salivation|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|pathology microscopic-liver-pigmentation|organ weight-liver-nos|in life observation-clinical signs-urogenital staining; dose_level=3; study_year=2000; study_citation=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Whole-Body; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LOAEL | =18.75 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | inhalation | 0 week to 14 week | SUB | study_id=5093; toxval_study_source_id=studyid5093_Adult_F0_F_systemic; toxval_effect_list=hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|hematology-reticulocyte-reticulocyte|hematology-hematocrit (hct)-hematocrit (hct)|hematology-hemoglobin (hgb)-hemoglobin (hgb)|pathology microscopic-stomach-hyperplasia|hematology-anemia-anemia - nos; dose_level=3; study_year=2000; study_citation=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Mice; dsstox_substance_id=DTXSID1024097; admin_method=Whole-Body; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LOAEL | =3.125 | mg/kg bw/day | rat (fischer; Fischer 344) | inhalation | 0 week to 104 week | CHR | study_id=5094; toxval_study_source_id=studyid5094_Adult_F0_F_systemic; toxval_effect_list=hematology-reticulocyte-reticulocyte|hematology-anemia-anemia - nos|hematology-hematocrit (hct)-hematocrit (hct)|hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|hematology-myeloid/erythroid (m:e) ratio-myeloid/erythroid (m:e) ratio|hematology-[other]-[other]|pathology microscopic-liver-pigmentation|hematology-hemoglobin (hgb)-hemoglobin (hgb)|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc); dose_level=2; study_year=2000; study_citation=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_2 year study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Whole-Body; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | =150 | mg/kg bw/day | rat (fischer; Fischer 344) | oral | 0 day to 14 day | SAC | study_id=5088; toxval_study_source_id=studyid5088_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight|in life observation-water consumption-water consumption; dose_level=2; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | =250 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | oral | 0 day to 14 day | SAC | study_id=5089; toxval_study_source_id=studyid5089_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-dehydration; dose_level=3; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Mice; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | =304 | mg/kg bw/day | rat (fischer; Fischer 344) | oral | 0 week to 13 week | SUB | study_id=5090; toxval_study_source_id=studyid5090_Adult Pregnancy_F0_F_reproductive; toxval_effect_list=reproductive performance-estrous cycle-abnormal; dose_level=3; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | >0 | mg/kg bw/day | rat (fischer; Fischer 344) | oral | 0 week to 13 week | SUB | study_id=5090; toxval_study_source_id=studyid5090_Adult_F0_F_systemic; toxval_effect_list=pathology gross-uterus-reduced size|clinical chemistry-creatine phosphokinase-creatine phosphokinase|organ weight-thymus-absolute|in life observation-clinical signs-defecation (diarrhea)|urinalysis-specific gravity/osmolality-specific gravity/osmolality|hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|in life observation-body weight-body weight gain|in life observation-body weight-body weight|clinical chemistry-creatinine-creatinine|clinical chemistry-alanine aminotransferase (alt/sgpt)-alanine aminotransferase (alt/sgpt)|in life observation-water consumption-water consumption|hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|pathology microscopic-liver-degeneration|pathology microscopic-bone marrow-hyperplasia|clinical chemistry-albumin-albumin|hematology-platelet-platelet|hematology-anemia-anemia - macrocytic|pathology microscopic-liver-cytoplasmic alteration|urinalysis-volume-volume|pathology microscopic-spleen-pigmentation|hematology-mean corpuscular hemoglobin concentration (mchc)-mean corpuscular hemoglobin concentration (mchc)|clinical chemistry-protein-protein|pathology microscopic-spleen-hematopoietic cell proliferation|pathology microscopic-bone marrow-hypercellularity|clinical chemistry-alkaline phosphatase (alp/alk)-alkaline phosphatase (alp/alk)|hematology-hemoglobin (hgb)-hemoglobin (hgb)|hematology-reticulocyte-reticulocyte|pathology microscopic-liver-pigmentation|clinical chemistry-urea nitrogen-urea nitrogen; dose_level=0; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | =370 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | oral | 0 week to 13 week | SUB | study_id=5091; toxval_study_source_id=studyid5091_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight|in life observation-body weight-body weight gain; dose_level=2; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Mice; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | =223 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | oral | 0 week to 13 week | SUB | study_id=5091; toxval_study_source_id=studyid5091_Adult_F0_M_systemic; toxval_effect_list=in life observation-body weight-body weight|in life observation-body weight-body weight gain; dose_level=2; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Mice; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NOAEL | =400 | mg/kg bw/day | rat (fischer; Fischer 344) | oral | 0 day to 14 day | SAC | study_id=5088; toxval_study_source_id=studyid5088_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight|in life observation-water consumption-water consumption; dose_level=4; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NOAEL | =151 | mg/kg bw/day | rat (fischer; Fischer 344) | oral | 0 week to 13 week | SUB | study_id=5090; toxval_study_source_id=studyid5090_Adult_F0_F_systemic; toxval_effect_list=hematology-anemia-anemia - macrocytic|urinalysis-volume-volume|pathology microscopic-liver-cytoplasmic alteration|pathology microscopic-spleen-pigmentation|hematology-mean corpuscular hemoglobin concentration (mchc)-mean corpuscular hemoglobin concentration (mchc)|clinical chemistry-alkaline phosphatase (alp/alk)-alkaline phosphatase (alp/alk)|clinical chemistry-protein-protein|pathology microscopic-spleen-hematopoietic cell proliferation|pathology microscopic-bone marrow-hypercellularity|hematology-reticulocyte-reticulocyte|hematology-hemoglobin (hgb)-hemoglobin (hgb)|clinical chemistry-urea nitrogen-urea nitrogen|pathology microscopic-liver-pigmentation|pathology gross-uterus-reduced size|clinical chemistry-creatine phosphokinase-creatine phosphokinase|organ weight-thymus-absolute|in life observation-clinical signs-defecation (diarrhea)|in life observation-body weight-body weight gain|in life observation-body weight-body weight|urinalysis-specific gravity/osmolality-specific gravity/osmolality|hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|in life observation-water consumption-water consumption|hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|clinical chemistry-creatinine-creatinine|clinical chemistry-alanine aminotransferase (alt/sgpt)-alanine aminotransferase (alt/sgpt)|clinical chemistry-albumin-albumin|hematology-platelet-platelet|pathology microscopic-liver-degeneration|pathology microscopic-bone marrow-hyperplasia; dose_level=2; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NOAEL | =129 | mg/kg bw/day | rat (fischer; Fischer 344) | oral | 0 week to 13 week | SUB | study_id=5090; toxval_study_source_id=studyid5090_Adult_F0_M_systemic; toxval_effect_list=hematology-reticulocyte-reticulocyte|pathology microscopic-liver-pigmentation|pathology microscopic-bone marrow-hyperplasia|hematology-anemia-anemia - macrocytic|in life observation-water consumption-water consumption|in life observation-clinical signs-defecation (diarrhea)|pathology microscopic-liver-degeneration|pathology microscopic-blood-thrombocytopenia|organ weight-thymus-absolute|pathology gross-sperm measure-sperm count|clinical chemistry-protein-protein|in life observation-body weight-body weight gain|in life observation-body weight-body weight|pathology microscopic-spleen-pigmentation|hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|clinical chemistry-urea nitrogen-urea nitrogen|hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|clinical chemistry-albumin-albumin|pathology microscopic-spleen-hematopoietic cell proliferation|hematology-mean corpuscular hemoglobin concentration (mchc)-mean corpuscular hemoglobin concentration (mchc)|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|pathology microscopic-liver-cytoplasmic alteration|pathology microscopic-bone marrow-cellular alteration; dose_level=2; study_year=1993; study_citation=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Water; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NOAEL | =3.125 | mg/kg bw/day | rat (fischer; Fischer 344) | inhalation | 0 week to 14 week | SUB | study_id=5092; toxval_study_source_id=studyid5092_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-nose-thrombosis|in life observation-clinical signs-ocular discharge|hematology-nucleated red blood cell (nrbc)-nucleated red blood cell (nrbc)|hematology-anemia-anemia - nos|pathology microscopic-thymus-atrophy|pathology microscopic-stomach-ulcer|in life observation-clinical signs-tooth-degeneration|hematology-reticulocyte-reticulocyte|in life observation-clinical signs-scabbing|hematology-microcytosis-microcytosis|in life observation-clinical signs-[other]|pathology microscopic-stomach-necrosis|pathology microscopic-liver-thrombosis|in life observation-clinical signs-lethargy|in life observation-clinical signs-lacrimation|in life observation-clinical signs-nasal discharge|pathology microscopic-heart-thrombosis|organ weight-thymus-nos|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|organ weight-kidney-nos|in life observation-clinical signs-salivation|hematology-hematocrit (hct)-hematocrit (hct)|pathology microscopic-bone marrow-necrosis|hematology-erythroblast-erythroblast|pathology microscopic-liver-degeneration|in life observation-clinical signs-self-mutilation|pathology microscopic-spleen-hematopoietic cell proliferation erythrocytic|organ weight-liver-nos|in life observation-clinical signs-urogenital staining|pathology microscopic-liver-necrosis|pathology microscopic-lung-thrombosis|pathology microscopic-liver-pigmentation|in life observation-clinical signs-labored respiration|in life observation-clinical signs-general pallor|pathology microscopic-spleen-atrophy|hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|pathology microscopic-kidney-degeneration|in life observation-mortality-mortality|pathology microscopic-bone-thrombosis|pathology microscopic-bone-infarct|in life observation-body weight-body weight|pathology microscopic-stomach-hyperplasia|hematology-hemoglobin (hgb)-hemoglobin (hgb)|pathology microscopic-bone marrow-hyperplasia|in life observation-clinical signs-tooth-thrombosis|hematology-platelet-platelet|pathology microscopic-stomach-inflammation|hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|in life observation-body weight-body weight gain; dose_level=2; study_year=2000; study_citation=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Rats; dsstox_substance_id=DTXSID1024097; admin_method=Whole-Body; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NOAEL | =9.375 | mg/kg bw/day | mouse (b6c3f1; B6C3F1) | inhalation | 0 week to 14 week | SUB | study_id=5093; toxval_study_source_id=studyid5093_Adult_F0_F_systemic; toxval_effect_list=in life observation-mortality-mortality|pathology microscopic-spleen-hemosiderosis|hematology-erythroblast-erythroblast|pathology microscopic-lymph node-atrophy|pathology microscopic-liver-hemosiderosis|pathology microscopic-stomach-inflammation|hematology-platelet-platelet|pathology microscopic-stomach-hyperplasia|hematology-anemia-anemia - nos|hematology-hematocrit (hct)-hematocrit (hct)|pathology microscopic-kidney-hemosiderosis|pathology microscopic-spleen-hematopoietic cell proliferation|in life observation-clinical signs-lethargy|hematology-hemoglobin (hgb)-hemoglobin (hgb)|pathology microscopic-thymus-atrophy|hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|in life observation-clinical signs-urogenital staining|pathology microscopic-kidney-degeneration|pathology microscopic-stomach-ulcer|pathology microscopic-stomach-necrosis|hematology-reticulocyte-reticulocyte|pathology microscopic-pleura-inflammation|organ weight-liver-relative to body weight|in life observation-clinical signs-labored respiration|pathology microscopic-spleen-atrophy; dose_level=2; study_year=2000; study_citation=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Mice; dsstox_substance_id=DTXSID1024097; admin_method=Whole-Body; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
ToxValDB_ATSDR_MRLs 15 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ATSDR_MRLs | LOAEL | =32 | mg/kg bw/day | Rat | oral | short-term; 2 days | short-term | LONG_REF=Ghanayem BI, Blair PC, Thompson MB, et al. 1987a. Effect of age on the toxicity and metabolism of ethylene glycol monobutyl ether (2-butoxyethanol) in rats. Toxicol Appl Pharmacol91(2):222-234.; TITLE=Effect of age on the toxicity and metabolism of ethylene glycol monobutyl ether (2-butoxyethanol) in rats; AUTHOR=Ghanayem BI; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6568f404e4b063812d584bf1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.atsdr.cdc.gov/ToxProfiles/tp118.pdf; TOXICOLOGICAL_EFFECT=hematological; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=ATSDR MRLs:15447393:M:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_bd1459974a919cc8e307fdce32268645 |
| ToxValDB_ATSDR_MRLs | LOAEL | =69 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=NTP. 1993. Ethylene glycol ethers, 2-ethoxyethanoI, 2-butoxyethanol administered in drinking water to F344/N rats and B6C3Fl mice. NTP toxicity report series no. 26. National Toxicology Program, National Institutes of Health, Public Health Services, U.S. Department of Health and Human Services. NIH publication 93-3349.; TITLE=Ethylene glycol ethers, 2-ethoxyethanoI, 2-butoxyethanol administered in drinking water to F344/N rats and B6C3Fl mice; AUTHOR=NTP; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6568f404e4b063812d584bf1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.atsdr.cdc.gov/ToxProfiles/tp118.pdf; TOXICOLOGICAL_EFFECT=hepatic; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ATSDR MRLs:15447394:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_eac2eb0b36287edac2a2a131e61b0b18 |
| ToxValDB_ATSDR_MRLs | MRL | =29.0004 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/674e166be4b0a7c65d36ea5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://wwwn.cdc.gov/TSP/MRLS/mrlsListing.aspx; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=hematological in female rats; STUDY_GROUP=ATSDR MRLs_dup_-_15446898_15446899_15446900:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_70e677739a8c390f79fbe608f0fff94c |
| ToxValDB_ATSDR_MRLs | MRL | =14.5002 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/674e166be4b0a7c65d36ea5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://wwwn.cdc.gov/TSP/MRLS/mrlsListing.aspx; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=hematological in male/female rats; STUDY_GROUP=ATSDR MRLs_dup_-_15446898_15446899_15446900:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_41031068779124e85b8054ee31580f46 |
| ToxValDB_ATSDR_MRLs | MRL | =0.96668 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/674e166be4b0a7c65d36ea5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://wwwn.cdc.gov/TSP/MRLS/mrlsListing.aspx; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=hematological; STUDY_GROUP=ATSDR MRLs_dup_-_15446898_15446899_15446900:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_1d109e770ce3f01f62cc2b8a639e471a |
| ToxValDB_ATSDR_MRLs | MRL | =0.4 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/674e166be4b0a7c65d36ea5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://wwwn.cdc.gov/TSP/MRLS/mrlsListing.aspx; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=hematological in male rats; STUDY_GROUP=ATSDR MRLs_dup_-_15446901_15446902:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6c22eb5088ee9708b459307ecae4fec7 |
| ToxValDB_ATSDR_MRLs | MRL | =0.07 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/674e166be4b0a7c65d36ea5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://wwwn.cdc.gov/TSP/MRLS/mrlsListing.aspx; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=hepatic in male/female rats; STUDY_GROUP=ATSDR MRLs_dup_-_15446901_15446902:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7d1b3e9e1d7a504153633d9dee146257 |
| ToxValDB_ATSDR_MRLs | MRL | =29.0004 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/674e166be4b0a7c65d36ea5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://wwwn.cdc.gov/TSP/MRLS/mrlsListing.aspx; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=hematological in female rats; STUDY_GROUP=ATSDR MRLs_dup_-_15446898_15446899_15446900:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_70e677739a8c390f79fbe608f0fff94c |
| ToxValDB_ATSDR_MRLs | MRL | =14.5002 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/674e166be4b0a7c65d36ea5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://wwwn.cdc.gov/TSP/MRLS/mrlsListing.aspx; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=hematological in male/female rats; STUDY_GROUP=ATSDR MRLs_dup_-_15446898_15446899_15446900:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_41031068779124e85b8054ee31580f46 |
| ToxValDB_ATSDR_MRLs | MRL | =0.96668 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/674e166be4b0a7c65d36ea5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://wwwn.cdc.gov/TSP/MRLS/mrlsListing.aspx; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=hematological; STUDY_GROUP=ATSDR MRLs_dup_-_15446898_15446899_15446900:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_1d109e770ce3f01f62cc2b8a639e471a |
| ToxValDB_ATSDR_MRLs | MRL | =0.4 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/674e166be4b0a7c65d36ea5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://wwwn.cdc.gov/TSP/MRLS/mrlsListing.aspx; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=hematological in male rats; STUDY_GROUP=ATSDR MRLs_dup_-_15446901_15446902:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6c22eb5088ee9708b459307ecae4fec7 |
| ToxValDB_ATSDR_MRLs | MRL | =0.07 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/674e166be4b0a7c65d36ea5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://wwwn.cdc.gov/TSP/MRLS/mrlsListing.aspx; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=hepatic in male/female rats; STUDY_GROUP=ATSDR MRLs_dup_-_15446901_15446902:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7d1b3e9e1d7a504153633d9dee146257 |
| ToxValDB_ATSDR_MRLs | NOAEL | =2.90004 | mg/m3 | Human | inhalation | chronic; 6 years | occupational | LONG_REF=Haufroid V, Thirion F, Mertens P, et al. 1997. Biological monitoring of workers exposed to low levels of 2- butoxyethanol. Int Arch Occup Environ Health 70:232-236.; TITLE=Biological monitoring of workers exposed to low levels of 2- butoxyethanol; AUTHOR=Haufroid V; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6568f404e4b063812d584bf1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.atsdr.cdc.gov/ToxProfiles/tp118.pdf; TOXICOLOGICAL_EFFECT=hematological; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=ATSDR MRLs:15447392:M:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_5f2f0308b3b7d9259306ccfc6f36849f |
| ToxValDB_ATSDR_MRLs | NOAEL (HEC) | =241.67 | mg/m3 | Rat | inhalation | short-term (developmental); 10 days | reproduction developmental | LONG_REF=Tyl RW, Millicovsky G, Dodd DE, et al. 1984. Teratologic evaluation of ethylene glycol monobutyl ether in Fischer 344 rats and New Zealand white rabbits following inhalation exposure. Environ Health Perspect 57:47-68.; TITLE=Teratologic evaluation of ethylene glycol monobutyl ether in Fischer 344 rats and New Zealand white rabbits following inhalation exposure; AUTHOR=Tyl RW; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6568f404e4b063812d584bf1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.atsdr.cdc.gov/ToxProfiles/tp118.pdf; TOXICOLOGICAL_EFFECT=hematological; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=ATSDR MRLs_dup_-_15447388_15447389:F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_8af693f227f72aff2a70b90332453526 |
| ToxValDB_ATSDR_MRLs | NOAEL (HEC) | =120.835 | mg/m3 | Rat | inhalation | subchronic; 90 days | subchronic | LONG_REF=Dodd DE, Snellings WM, Maronpot RR, et al. 1983. Ethylene glycol monobutyl ether: Acute, 9-day, and 90-day vapor inhalation studies in Fischer 344 rats. Toxicol Appl Pharmacol68(3):405-414.; TITLE=Ethylene glycol monobutyl ether: Acute, 9-day, and 90-day vapor inhalation studies in Fischer 344 rats; AUTHOR=Dodd DE; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6568f404e4b063812d584bf1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.atsdr.cdc.gov/ToxProfiles/tp118.pdf; TOXICOLOGICAL_EFFECT=hematological; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=ATSDR MRLs_dup_-_15447390_15447391:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_5176e7c5c0e3796b8000f4eb43eb8e05 |
ToxValDB_Cal_OEHHA_REL_derivations 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_Cal_OEHHA_REL_derivations | BMCL (05) | =39.4 | mg/m3 | Rat | inhalation | chronic; 2 years | chronic | LONG_REF=NTP (2000). Toxicology and carcinogenesis studies 2-butoxyethanol (CAS NO. 111-76- 2) in F344/N rats and B6C3F1 mice (inhalation studies).; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c9c006e4b02565fc7d970f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://oehha.ca.gov/; SUBSOURCE_URL=https://oehha.ca.gov/air/crnr/notice-adoption-reference-exposure-levels-ethylene-glycol-mono-n-butyl-ether; YEAR=2018; ORIGINAL_YEAR=2018; TOXICOLOGICAL_EFFECT=Hyaline degeneration of nasal olfactory epithelium; STUDY_GROUP=Cal OEHHA REL derivations:15951806:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_96a9638cb2e880e910ebf32a15aee7f6 |
| ToxValDB_Cal_OEHHA_REL_derivations | LOAEL | =473 | mg/m3 | Human | inhalation | acute; 8 hours | clinical | LONG_REF=Carpenter CP, Keck GA, Nair JH, 3rd, Pozzani UC, Smyth HF, Jr. and Weil CS (1956). The toxicity of butyl cellosolve solvent. AMA Arch Ind Health 14(2): 114-31.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c9c006e4b02565fc7d970f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://oehha.ca.gov/; SUBSOURCE_URL=https://oehha.ca.gov/air/crnr/notice-adoption-reference-exposure-levels-ethylene-glycol-mono-n-butyl-ether; YEAR=2018; ORIGINAL_YEAR=2018; TOXICOLOGICAL_EFFECT=Subjective ocular and respiratory irritation; STUDY_GROUP=Cal OEHHA REL derivations:15951804:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ebf2debad681a0aa7133e763223a8c9d |
| ToxValDB_Cal_OEHHA_REL_derivations | NOAEL | =96.668 | mg/m3 | Human | inhalation | acute; 4 hours | clinical | LONG_REF=Carpenter CP, Pozzani UC, Weil CS, Nair JH, Keck GA, Smyth HF Jr. The toxicity of butyl cellosolve solvent. Arch Ind Health 1956;14:114-131. Johanson G, Kronborg H, Naslund PH, Nordquist MB. Toxicokinetics of inhaled 2-butoxyethanol (ethylene glycol monobutyl ether) in man. Scand J Work Environ Health 1986;12:594-602.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c97043e4b02565fc7d32b8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://oehha.ca.gov/; SUBSOURCE_URL=https://oehha.ca.gov/sites/default/files/media/downloads/crnr/appendixd2final.pdf; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=mucous membrane irritation of the nose and eyes; STUDY_GROUP=Cal OEHHA REL derivations:15951926:-:-volunteers; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a53fbbac5178056d46b9d0788a5560e6 |
ToxValDB_DOE_Protective_Action_Criteria 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_DOE_Protective_Action_Criteria | LEL | =53167.4 | mg/m3 | Human | inhalation | - | acute | LONG_REF=U.S. Department of Energy (DOE) Protective Action Criteria (PAC). 2023. PAC Chemical Database. Updated 11 October 2023. Available: https://edms3.energy.gov/pac/ (Accessed November 16, 2023); TITLE=U.S. Department of Energy (DOE) Protective Action Criteria (PAC) Chemical Database; AUTHOR=U.S. Department of Energy; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65428efee4b045b9ff7cc432; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://edms3.energy.gov/pac/TeelDocs; YEAR=2012; ORIGINAL_YEAR=2012; STUDY_GROUP=DOE Protective Action Criteria:15513003:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8369290a6ec6fb03d7943009f2dea305 |
ToxValDB_ECHA_IUCLID 41 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LEL | =6283.42 | mg/m3 | Rat | inhalation | - | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059759e4b063812d6fa6de; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/3/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Inhalation_15796255_15796256_15796257:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c46a43e1b32f4d56590d5ef76b434454 |
| ToxValDB_ECHA_IUCLID | LOAEL | =676 | mg/kg bw/day | Mouse | oral | subchronic; 90 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eace1e4b0a7c65d1c15ae; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/16067/7/6/2?documentUUID=394d78d7-dafb-4a34-81b0-31ac5f525344; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15832288_15832289_15838642_15838643:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_acb414f3bccc0cbfcb8798ba552814bb |
| ToxValDB_ECHA_IUCLID | LOAEL | =720 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa64e4b0a7c65d1b59a0; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=P0: water consumption and compound intake; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855789_15856544_15860743_15862020:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_3750e188a3fcba349c03f933fe435453 |
| ToxValDB_ECHA_IUCLID | LOAEL | <500 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa64e4b0a7c65d1b599e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855186_15856054:M:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_36b5a5a507ac9173531950eef564d352 |
| ToxValDB_ECHA_IUCLID | LOAEL | <82 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa64e4b0a7c65d1b599b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=P0: haematology; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855911_15855973_15856656_15862035:F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_461709da85dd7c060508ee8bf5bbd46c |
| ToxValDB_ECHA_IUCLID | LOAEL | =635 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa57e4b0a7c65d1b562f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/12659/7/9/2?documentUUID=c30d6d33-b87a-4514-b028-d4a51400c115; YEAR=1987; ORIGINAL_YEAR=1987; TOXICOLOGICAL_EFFECT=P1: organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15858213_15861926:M/F:P1-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_709346f2cc34fb5c01a83f8fc23be35e |
| ToxValDB_ECHA_IUCLID | LOEC | ~483.34 | mg/m3 | Monkey | inhalation | short-term; 10 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/6/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15827671:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7fa00be0e29894d4d345aaf16cde2529 |
| ToxValDB_ECHA_IUCLID | NOAEC | =604.175 | mg/m3 | Mouse | inhalation | - | chronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c7fce4b0a7c65d215f44; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/8?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15816773_15819220:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_927918ecad2a9bc63b3c9463af77fc56 |
| ToxValDB_ECHA_IUCLID | NOAEC | =650 | mg/kg bw/day | Mouse | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabc5e4b0a7c65d1bba9a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=fetus: changes in postnatal survival; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15820847:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6e6834271447a72e962d9bc674e19434 |
| ToxValDB_ECHA_IUCLID | NOAEC | =241.67 | mg/m3 | Rat | inhalation | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d18ae4b0a7c65d22f0d5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15820874:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e4655e9b4693c7969b8fdea6a833296e |
| ToxValDB_ECHA_IUCLID | NOAEC | >966.68 | mg/m3 | Rat | inhalation | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d18ae4b0a7c65d22f0e7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15821288:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_b2adf1f3d233a5f3d0f55af3178b0b3d |
| ToxValDB_ECHA_IUCLID | NOAEC | =200 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabc5e4b0a7c65d1bbacc; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/16067/7/9/3?documentUUID=394d78d7-dafb-4a34-81b0-31ac5f525344; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15821846_15821900:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_36e494eef852df868f236e45c3300fec |
| ToxValDB_ECHA_IUCLID | NOAEC | <725.01 | mg/m3 | Rat | inhalation | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d18ae4b0a7c65d22f0e7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=maternal: urinalysis; TOXICOLOGICAL_EFFECT_CATEGORY=urinalysis; STUDY_GROUP=ECHA IUCLID:15822607:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_738770005da183328b5f088bb25869b2 |
| ToxValDB_ECHA_IUCLID | NOAEC | >500 | mg/kg bw/day | Rat | oral | - | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa35e4b0a7c65d1b4d65; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/10/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15825476:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_64fe74b8b4b3007fe46b25bd5189aad0 |
| ToxValDB_ECHA_IUCLID | NOAEC | >444 | mg/kg bw/day | Rat | oral | - | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa35e4b0a7c65d1b4d65; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/10/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15825477:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_bb5c6c52e3131ef4c1b0cf4da32acf12 |
| ToxValDB_ECHA_IUCLID | NOAEC | >400 | mg/kg bw/day | Rat | oral | - | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa35e4b0a7c65d1b4d68; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/10/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15825485:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_b95f494a8ab5b883f854213b6449ea48 |
| ToxValDB_ECHA_IUCLID | NOAEC | <149.835 | mg/m3 | Rat | inhalation | chronic; 14 weeks | chronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61fc4e4b096bca877ebbe; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/12659/7/6/3?documentUUID=c30d6d33-b87a-4514-b028-d4a51400c115; YEAR=1987; ORIGINAL_YEAR=1987; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827038_15828295:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8b7adf5d58b5a91324e35130add909a5 |
| ToxValDB_ECHA_IUCLID | NOAEC | =302.087 | mg/m3 | Rat | inhalation | chronic; 14 weeks | chronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61fc4e4b096bca877ebbe; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/12659/7/6/3?documentUUID=c30d6d33-b87a-4514-b028-d4a51400c115; YEAR=1987; ORIGINAL_YEAR=1987; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827039_15828296:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_3e9ffbb6bcccfc53e7c06e0ac90cc325 |
| ToxValDB_ECHA_IUCLID | NOAEC | >372.172 | mg/m3 | Rat | inhalation | subchronic; 90 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/6/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=blood; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=ECHA IUCLID:15827525:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_f3444bfa8901240e230cfec7ef7703ac |
| ToxValDB_ECHA_IUCLID | NOAEC | >2595.53 | mg/m3 | Guinea Pig | inhalation | short-term; 15 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/6/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15827782:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8db8a95891ec807a5aa9f7637448f3d5 |
| ToxValDB_ECHA_IUCLID | NOAEC | <261.004 | mg/m3 | Rat | inhalation | subchronic; 6 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/6/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=blood; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=ECHA IUCLID:15828431:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0ab07809cb0259f5b732d1053944849d |
| ToxValDB_ECHA_IUCLID | NOAEC | <541.341 | mg/m3 | Mouse | inhalation | subchronic; 90 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/6/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15828816:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ebcb6d5e134d7bc7b9faf97400bb1cf7 |
| ToxValDB_ECHA_IUCLID | NOAEC | <1812.52 | mg/m3 | Guinea Pig | inhalation | short-term; 30 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/6/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15829180:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_baeef18434d28f4ec0fc08c30ac3ae01 |
| ToxValDB_ECHA_IUCLID | NOAEC | <483.34 | mg/m3 | Dog | inhalation | chronic; 91 days | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/6/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15829572:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_de7b641348a674f38f9a6000a23de69f |
| ToxValDB_ECHA_IUCLID | NOAEC | >96.668 | mg/m3 | Rat | inhalation | short-term; 3 weeks | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/6/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=blood; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15829659_15829660:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_164372a067225aea61e24d893ec711e9 |
| ToxValDB_ECHA_IUCLID | NOAEC | =120.835 | mg/m3 | Rat | inhalation | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c892e4b0a7c65d21937b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15856397:F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8d67bfe72509e10d235ea9283b3c14ba |
| ToxValDB_ECHA_IUCLID | NOAEL | =350 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabc5e4b0a7c65d1bba9a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=maternal: clinical signs|maternal: haematology; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|hematology; STUDY_GROUP=ECHA IUCLID:15822185:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_459e11a0c9db9799ffd2bedd62920b59 |
| ToxValDB_ECHA_IUCLID | NOAEL | =241.67 | mg/m3 | Rabbit | inhalation | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d18ae4b0a7c65d22f0f1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/3?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: clinical signs|maternal: mortality|maternal: number of abortions|maternal: pre and post implantation loss; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|mortality/survival|reproduction; STUDY_GROUP=ECHA IUCLID:15822913:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0f12ed5b2b1939a4fce64c6a1b8af2d6 |
| ToxValDB_ECHA_IUCLID | NOAEL | =30 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabc5e4b0a7c65d1bbacc; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/16067/7/9/3?documentUUID=394d78d7-dafb-4a34-81b0-31ac5f525344; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: food consumption and compound intake|maternal: haematology|maternal: organ weights and organ / body weight ratios|maternal: water consumption and compound intake; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|hematology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15823678_15823746:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_b973e39a89d8bc3f46696d87a81cce20 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1000 | mg/kg bw/day | Mouse | dermal | - | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c851e4b0a7c65d217e58; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/10/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15825461:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_9e6b5e2fa16cd376d7a1f565c66a0a8c |
| ToxValDB_ECHA_IUCLID | NOAEL | >150 | mg/kg bw/day | Rabbit | dermal | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61ec4e4b096bca877afa4; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/6/4?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15826635:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_be71a26ebf9a131f00700baa46b3362a |
| ToxValDB_ECHA_IUCLID | NOAEL | >694 | mg/kg bw/day | Mouse | oral | subchronic; 90 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eace1e4b0a7c65d1c15ae; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/16067/7/6/2?documentUUID=394d78d7-dafb-4a34-81b0-31ac5f525344; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15832287_15838641:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_3cd7c21fac683218081c18ceb00efb7b |
| ToxValDB_ECHA_IUCLID | NOAEL | =370 | mg/kg bw/day | Mouse | oral | subchronic; 90 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eace1e4b0a7c65d1c15ae; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/16067/7/6/2?documentUUID=394d78d7-dafb-4a34-81b0-31ac5f525344; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15832288_15832289_15838642_15838643:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_12c7d3126256e87c736b1d5bf865afae |
| ToxValDB_ECHA_IUCLID | NOAEL | <222 | mg/kg bw/day | Rat | oral | subchronic; 6 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eace1e4b0a7c65d1c1504; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/6/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=spleen: haematology|histopathology: non-neoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology|other; STUDY_GROUP=ECHA IUCLID:15842971:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_db3df7841fe73fd36536d572757a83cb |
| ToxValDB_ECHA_IUCLID | NOAEL | >1306 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa64e4b0a7c65d1b5999; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=P0: reproductive function (oestrous cycle); TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ECHA IUCLID:15855882:F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_f42278df4523ce4f1a638e1e2d6533c2 |
| ToxValDB_ECHA_IUCLID | NOAEL | >470 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa7ee4b0a7c65d1b61f2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14826/7/9/2?documentUUID=71ba2e45-fbd7-417d-9132-f7c68b1eee7d; YEAR=1992; ORIGINAL_YEAR=1992; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855911_15855973_15856656_15862035:F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_bdfbaa154e8d4b76e2aab41b9c0535c2 |
| ToxValDB_ECHA_IUCLID | NOAEL | =129 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa64e4b0a7c65d1b599b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=P0: haematology; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15860480_15861639_15861861_15862346:M:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_02beb09bf3472f2d51df22ee2b395e53 |
| ToxValDB_ECHA_IUCLID | NOAEL | =720 | mg/kg bw/day | Mouse | oral | - | developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa57e4b0a7c65d1b562f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/12659/7/9/2?documentUUID=c30d6d33-b87a-4514-b028-d4a51400c115; YEAR=1987; ORIGINAL_YEAR=1987; TOXICOLOGICAL_EFFECT=F1: body weight and weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15861257_15862190:M/F:F1-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_7a42aab7bb00d91474ca81dc1b2407d8 |
| ToxValDB_ECHA_IUCLID | NOAEL | >452 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa64e4b0a7c65d1b599b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; TOXICOLOGICAL_EFFECT=P0: reproductive function (sperm measures); TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15860480_15861639_15861861_15862346:M:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_986999878d112cb9f2e6150d4ada1214 |
| ToxValDB_ECHA_IUCLID | NOEC | >120 | mg/kg bw/day | Mouse | infusion | - | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c7fce4b0a7c65d215f58; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/8?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15817326:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_f35a92fec68acac3a3c76257391a183a |
| ToxValDB_ECHA_IUCLID | NOEC | >362.505 | mg/m3 | Rat | inhalation | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c892e4b0a7c65d21937b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15247/7/9/2?documentUUID=7556a105-201e-4a94-9184-3d171921724f; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=ECHA IUCLID:15855612:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4b8ceb5679d3e855d653cb53f844fb57 |
ToxValDB_ECOTOX 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =1180 | mg/kg bw/day | Mouse | oral | short-term (developmental); 8 days | reproduction developmental | LONG_REF=Teratog. Carcinog. Mutagen.7:29-48 Hardin,B.D., R.L. Schuler, J.R. Burg, G.M. Booth, K.P. Hazelden, K.M. MacKenzie, V.J. Piccirillo, and K.N. Smith Evaluation of 60 Chemicals in a Preliminary Developmental Toxicity Test 1987; TITLE=Evaluation of 60 Chemicals in a Preliminary Developmental Toxicity Test; AUTHOR=Hardin,B.D., R.L. Schuler, J.R. Burg, G.M. Booth, K.P. Hazelden, K.M. MacKenzie, V.J. Piccirillo, and K.N. Smith; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=49969; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1987; ORIGINAL_YEAR=1987; TOXICOLOGICAL_EFFECT=Growth: Weight gain|Reproduction: Viability; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|reproduction; STUDY_GROUP=ECOTOX:15612030:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=2a3c2554516c63d57193b0771d4a5b5a |
| ToxValDB_ECOTOX | NOEL | =55 | mg/kg bw/day | Rat | injection | short-term; 14 days | short-term | LONG_REF=Toxicol. Lett.45(2/3): 271-280 Bernard,A.M., R. De Russis, J.C. Normand, and R.R. Lauwerys Evaluation of the Subacute Nephrotoxicity of Cyclohexane and Other Industrial Solvents in the Female Sprague-Dawley Rat 1989; TITLE=Evaluation of the Subacute Nephrotoxicity of Cyclohexane and Other Industrial Solvents in the Female Sprague-Dawley Rat; AUTHOR=Bernard,A.M., R. De Russis, J.C. Normand, and R.R. Lauwerys; DOI=10.1016/0378-4274(89)90018-0; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=113042; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=Biochemistry: beta2-Microglobulin|Enzyme(s): beta-N-Acetylhexosaminidase; TOXICOLOGICAL_EFFECT_CATEGORY=enzyme activity; STUDY_GROUP=ECOTOX:15603492:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=3bdce32c5af3d517163f6f1b4fce7797 |
ToxValDB_EPA_TSCA_8e 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_EPA_TSCA_8e | LEL | =200 | mg/kg bw/day | Rat | oral | short-term; 28 days | short-term | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c96d15e4b02565fc7d3269; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://chemview.epa.gov; SUBSOURCE_URL=https://chemview.epa.gov/chemview/proxy?filename=8EHQ-16-20496_Combined.pdf; TOXICOLOGICAL_EFFECT=increased relative spleen weight; STUDY_GROUP=EPA TSCA 8e:15957175:M:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_dbe1ee5f399ec21e7bf51c9b34bac174 |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =98 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15630379:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2bc000ac15396d7adf149bbcbccf48e6 |
ToxValDB_HESS 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_HESS | NOEL | <114 | mg/kg bw/day | Rat | oral | - | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/60da0e16e4b0a676289df68a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.nite.go.jp/en/chem/qsar/hess_update-e.html; TOXICOLOGICAL_EFFECT=Clinical Observation: Diarrhea|Body Weight Changes: decrease|Water Consumption: decrease|Urinalysis: Volume decrease, Specific gravity increase|Hematology: Hct decrease, RBC decrease, MCV increase, MCH decrease, Hgb decrease, Ret increase, Nucleated erythrocytes increase, MCHC decrease, Plt decrease, WBC increase, Seg increase, Lymph increase|Blood Chemistry: BUN increase, Crn increase, TP decrease, Alb decrease, Alp increase, ALT(GPT) increase|Absolute Organ Weight: Thymus decrease|Relative Organ Weight: Right kidney increase|Histopathology: Liver-Cytoplasmic alteration Liver-Degeneration Liver-Pigmentation Bone marrow-Hyperplasiaaf>>4500 Spleen-Hematopoietic cell proliferation Spleen-Pigmentation|Reproductive Tissue Evaluation: Weights-Left epididymis decrease, Spermatozoal measurements-Concentration decrease|Bone Marrow Cellularity Counts: increase; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|clinical signs|food and/or water consumption|hematology|multiple|nonneoplastic histopathology|organ weight|urinalysis; STUDY_GROUP=HESS:15638227:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_132e08c7f616eb46412a1f025b5c7a41 |
ToxValDB_IRIS 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_IRIS | BMCL | =133 | umol-hour/L | Rat | inhalation | chronic; 2 years | chronic | LONG_REF=NTP (2000). NTP technical report on the toxicology and carcinogenesis studies of 2 butoxyethanol (CAS No. 111-76-2) in F344/N rats and B6C3F1 mice (inhalation studies). National Toxicology Program. Research Triangle Park, NC. NTP TR 484. http://ntp.niehs.nih.gov/?objectid=070AC403-B110-CA79-3A23AF79DE7B752A. 196296; TITLE=NTP technical report on the toxicology and carcinogenesis studies of 2 butoxyethanol (CAS No. 111-76-2) in F344/N rats and B6C3F1 mice (inhalation studies); AUTHOR=NTP; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a41e4b045b9ff7a5b2d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=500; TOXICOLOGICAL_EFFECT=hemosiderin deposition in the liver; STUDY_GROUP=IRIS:15644836:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_0bc350bb6195ee48d4b2ed28a74f19ca |
| ToxValDB_IRIS | BMCL (HEC) | =16 | mg/m3 | Rat | inhalation | chronic; 2 years | chronic | LONG_REF=NTP (2000). NTP technical report on the toxicology and carcinogenesis studies of 2 butoxyethanol (CAS No. 111-76-2) in F344/N rats and B6C3F1 mice (inhalation studies). National Toxicology Program. Research Triangle Park, NC. NTP TR 484. http://ntp.niehs.nih.gov/?objectid=070AC403-B110-CA79-3A23AF79DE7B752A. 196296; TITLE=NTP technical report on the toxicology and carcinogenesis studies of 2 butoxyethanol (CAS No. 111-76-2) in F344/N rats and B6C3F1 mice (inhalation studies); AUTHOR=NTP; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a41e4b045b9ff7a5b2d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=500; TOXICOLOGICAL_EFFECT=hemosiderin deposition in the liver; STUDY_GROUP=IRIS:15644833:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_89acf2efbd28a270302555a8bc2c405a |
| ToxValDB_IRIS | BMDL | =133 | umol-hour/L | Rat | oral | chronic; 2 years | chronic | LONG_REF=NTP (2000). NTP technical report on the toxicology and carcinogenesis studies of 2 butoxyethanol (CAS No. 111-76-2) in F344/N rats and B6C3F1 mice (inhalation studies). National Toxicology Program. Research Triangle Park, NC. NTP TR 484. http://ntp.niehs.nih.gov/?objectid=070AC403-B110-CA79-3A23AF79DE7B752A. 196294; TITLE=NTP technical report on the toxicology and carcinogenesis studies of 2 butoxyethanol (CAS No. 111-76-2) in F344/N rats and B6C3F1 mice (inhalation studies); AUTHOR=NTP; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a41e4b045b9ff7a5b2d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=500; TOXICOLOGICAL_EFFECT=hemosiderin deposition in the liver; STUDY_GROUP=IRIS:15644539:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_030dc47ad5725d38e65b9e5b90401de3 |
| ToxValDB_IRIS | BMDL (HED) | =1.4 | mg/kg bw/day | Rat | oral | chronic; 2 years | chronic | LONG_REF=NTP (2000). NTP technical report on the toxicology and carcinogenesis studies of 2 butoxyethanol (CAS No. 111-76-2) in F344/N rats and B6C3F1 mice (inhalation studies). National Toxicology Program. Research Triangle Park, NC. NTP TR 484. http://ntp.niehs.nih.gov/?objectid=070AC403-B110-CA79-3A23AF79DE7B752A. 196295; TITLE=NTP technical report on the toxicology and carcinogenesis studies of 2 butoxyethanol (CAS No. 111-76-2) in F344/N rats and B6C3F1 mice (inhalation studies); AUTHOR=NTP; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a41e4b045b9ff7a5b2d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=500; TOXICOLOGICAL_EFFECT=hemosiderin deposition in the liver; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=IRIS:15644538:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_8de9f13d4472224bf07b15958ba356ae |
| ToxValDB_IRIS | RfC | =1.6 | mg/m3 | Human | inhalation | - | Toxicity Value | LONG_REF=NTP (2000); AUTHOR=NTP; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a41e4b045b9ff7a5b2d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=500; TOXICOLOGICAL_EFFECT=Hemosiderin deposition in male/female rats; STUDY_GROUP=IRIS:15644834:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_6f01f79936080b1976dbc0494d2986fd |
| ToxValDB_IRIS | RfD | =0.1 | mg/kg bw/day | Human | oral | - | Toxicity Value | LONG_REF=NTP (2000); AUTHOR=NTP; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a41e4b045b9ff7a5b2d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=500; TOXICOLOGICAL_EFFECT=Hemosiderin deposition in male/female rats; STUDY_GROUP=IRIS:15644832:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_a757652a54fd6b33aacc50be96430189 |
ToxValDB_RSL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_RSL | RfC | =14.5006 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759b87ce4b0a7c65d37b4e2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/risk/regional-screening-levels-rsls-generic-tables; STUDY_GROUP=RSL:15663454:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_588461569d3355dc515e4437b2be27d8 |
ToxValDB_TX_TCEQ 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_TX_TCEQ | LOAEL | =31 | ppm | Rat | - | chronic | chronic | LONG_REF=National Toxicology Program (NTP). 1998: Toxicology and carcinogenesis studies of 2butoxyethanol (CAS No. 111-76-2) in F344/N rats and B6C3F1 mice (Inhalation Studies). Board Draft NTP TR 484. [Peer Review Date: October 30, 1998]. NTP, Research Triangle Park, NC. U.S. Environmental Protection Agency (USEPA). 1999. Toxicological review of ethylene glycol monobutyl ether (EGBE). USEAP, Washington, DC; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c993f9e4b02565fc7d5b33; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.tceq.texas.gov; SUBSOURCE_URL=https://www.tceq.texas.gov/downloads/toxicology/dsd/final/butoxyethanol-2.pdf; YEAR=2007; ORIGINAL_YEAR=2007; TOXICOLOGICAL_EFFECT=hematological effects; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=TX TCEQ:15954267:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_db97b60a3447a0fd962df55ed847fe5f |
| ToxValDB_TX_TCEQ | NOAEL | =20 | ppm | Human | - | acute; 2 hours | clinical | LONG_REF=Johason, G, H Kronborg , PH Naslund, et al. 1986a. Toxicokinetics of inhaled 2-butoxyethanol (ethylene glycol monobutyl ether) in man. Scand J Work Environ Health 12:594-602.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c993f9e4b02565fc7d5b33; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.tceq.texas.gov; SUBSOURCE_URL=https://www.tceq.texas.gov/downloads/toxicology/dsd/final/butoxyethanol-2.pdf; YEAR=2007; ORIGINAL_YEAR=2007; TOXICOLOGICAL_EFFECT=Respiratory effects, sensory irritation; STUDY_GROUP=TX TCEQ:15954269:M:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_e6888e6293c2d2229f0e27d11c898e9f |
ToxValDB_ToxRefDB 21 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ToxRefDB | LEL | =250 | mg/kg bw/day | Rat | oral | short-term; 14 days | short-term | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Rats; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5088; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: in life observation-water consumption-water consumption|systemic: in life observation-body weight-body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15708466_15708467_15708468_15708469:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_d8de71f49127f1d0fceaa3e4c90bb9a5 |
| ToxValDB_ToxRefDB | LEL | =400 | mg/kg bw/day | Mouse | oral | short-term; 14 days | short-term | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Mice; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Mice; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5089; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-dehydration; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ToxRefDB_dup_-_15708472_15708473:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_17751f9c1985a02d1023550eb8bb4fdd |
| ToxValDB_ToxRefDB | LEL | =363 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5090; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=reproductive: reproductive performance-estrous cycle-abnormal; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ToxRefDB_dup_-_15708476_15708477:F:F0adult-pregnancy; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_cbef7444314422811c347c4675bcc773 |
| ToxValDB_ToxRefDB | LEL | =82 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5090; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-defecation (diarrhea)|systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: hematology-anemia-anemia - macrocytic|systemic: hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|systemic: hematology-hemoglobin (hgb)-hemoglobin (hgb)|systemic: urinalysis-volume-volume|systemic: in life observation-water consumption-water consumption|systemic: clinical chemistry-protein-protein|systemic: clinical chemistry-urea nitrogen-urea nitrogen|systemic: urinalysis-specific gravity/osmolality-specific gravity/osmolality|systemic: hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|systemic: clinical chemistry-creatine phosphokinase-creatine phosphokinase|systemic: clinical chemistry-creatinine-creatinine|systemic: hematology-reticulocyte-reticulocyte|systemic: hematology-platelet-platelet|systemic: pathology microscopic-liver-pigmentation|systemic: clinical chemistry-albumin-albumin|systemic: pathology microscopic-liver-cytoplasmic alteration|systemic: pathology microscopic-liver-degeneration|systemic: pathology microscopic-spleen-pigmentation|systemic: clinical chemistry-alkaline phosphatase (alp/alk)-alkaline phosphatase (alp/alk)|systemic: clinical chemistry-alanine aminotransferase (alt/sgpt)-alanine aminotransferase (alt/sgpt)|systemic: pathology microscopic-spleen-hematopoietic cell proliferation|systemic: pathology microscopic-bone marrow-hypercellularity|systemic: in life observation-body weight-body weight gain|systemic: in life observation-body weight-body weight|systemic: pathology microscopic-bone marrow-hyperplasia|systemic: hematology-mean corpuscular hemoglobin concentration (mchc)-mean corpuscular hemoglobin concentration (mchc)|systemic: organ weight-thymus-absolute; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|clinical signs|food and/or water consumption|hematology|nonneoplastic histopathology|organ weight|urinalysis; STUDY_GROUP=ToxRefDB_dup_-_15708478_15708479_15708480:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0ac6ce3315e8c1bf964e27e679a6c098 |
| ToxValDB_ToxRefDB | LEL | =553 | mg/kg bw/day | Mouse | oral | subchronic; 13 weeks | subchronic | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Mice; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Mice; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5091; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ToxRefDB_dup_-_15708488_15708489_15708490_15708491:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_9c72420cee00f27d0f0828b333a43c30 |
| ToxValDB_ToxRefDB | LEL | =1.55 | mg/kg bw/day | Rat | inhalation | chronic; 14 weeks | chronic | LONG_REF=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Rats; TITLE=Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5092; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=systemic: hematology-hemoglobin (hgb)-hemoglobin (hgb)|systemic: hematology-anemia-anemia - nos|systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: hematology-hematocrit (hct)-hematocrit (hct)|systemic: hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|systemic: hematology-nucleated red blood cell (nrbc)-nucleated red blood cell (nrbc)|systemic: pathology microscopic-spleen-hematopoietic cell proliferation erythrocytic|systemic: pathology microscopic-bone marrow-hyperplasia|systemic: pathology microscopic-liver-pigmentation|systemic: hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|systemic: in life observation-clinical signs-lethargy|systemic: organ weight-kidney-nos|systemic: in life observation-clinical signs-salivation|systemic: in life observation-clinical signs-labored respiration|systemic: in life observation-clinical signs-general pallor|systemic: in life observation-clinical signs-ocular discharge|systemic: hematology-reticulocyte-reticulocyte|systemic: in life observation-clinical signs-nasal discharge|systemic: in life observation-clinical signs-lacrimation|systemic: organ weight-liver-nos|systemic: in life observation-clinical signs-urogenital staining|systemic: hematology-platelet-platelet|systemic: in life observation-mortality-mortality|systemic: pathology microscopic-stomach-hyperplasia|systemic: pathology microscopic-kidney-degeneration|systemic: pathology microscopic-spleen-atrophy|systemic: pathology microscopic-nose-thrombosis|systemic: pathology microscopic-stomach-necrosis|systemic: in life observation-clinical signs-tooth-degeneration|systemic: in life observation-body weight-body weight|systemic: pathology microscopic-bone-thrombosis|systemic: pathology microscopic-bone-infarct|systemic: pathology microscopic-thymus-atrophy|systemic: pathology microscopic-stomach-ulcer|systemic: hematology-erythroblast-erythroblast|systemic: pathology microscopic-liver-degeneration|systemic: in life observation-clinical signs-self-mutilation|systemic: pathology microscopic-bone marrow-necrosis|systemic: pathology microscopic-liver-thrombosis|systemic: pathology microscopic-heart-thrombosis|systemic: in life observation-clinical signs-scabbing|systemic: in life observation-clinical signs-tooth-thrombosis|systemic: in life observation-clinical signs-[other]|systemic: organ weight-thymus-nos|systemic: in life observation-body weight-body weight gain|systemic: hematology-microcytosis-microcytosis|systemic: pathology microscopic-stomach-inflammation|systemic: pathology microscopic-liver-necrosis|systemic: pathology microscopic-lung-thrombosis; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|hematology|mortality/survival|nonneoplastic histopathology|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15708492_15708493_15708494:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_97ab22755d015472b42b0007f328988c |
| ToxValDB_ToxRefDB | LEL | =4.65 | mg/kg bw/day | Mouse | inhalation | chronic; 14 weeks | chronic | LONG_REF=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Mice; TITLE=Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Mice; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5093; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=systemic: hematology-hemoglobin (hgb)-hemoglobin (hgb)|systemic: hematology-anemia-anemia - nos|systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: hematology-hematocrit (hct)-hematocrit (hct)|systemic: hematology-reticulocyte-reticulocyte|systemic: pathology microscopic-stomach-hyperplasia|systemic: pathology microscopic-spleen-hemosiderosis|systemic: pathology microscopic-stomach-inflammation|systemic: pathology microscopic-liver-hemosiderosis|systemic: hematology-platelet-platelet|systemic: in life observation-clinical signs-urogenital staining|systemic: pathology microscopic-kidney-hemosiderosis|systemic: pathology microscopic-kidney-degeneration|systemic: pathology microscopic-stomach-ulcer|systemic: pathology microscopic-stomach-necrosis|systemic: pathology microscopic-thymus-atrophy|systemic: in life observation-mortality-mortality|systemic: pathology microscopic-pleura-inflammation|systemic: organ weight-liver-relative to body weight|systemic: in life observation-clinical signs-labored respiration|systemic: pathology microscopic-spleen-atrophy|systemic: pathology microscopic-spleen-hematopoietic cell proliferation|systemic: hematology-erythroblast-erythroblast|systemic: in life observation-clinical signs-lethargy|systemic: pathology microscopic-lymph node-atrophy; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|hematology|mortality/survival|nonneoplastic histopathology|organ weight|other; STUDY_GROUP=ToxRefDB_dup_-_15708499_15708500_15708501:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_973b622a76d689136e39e77010af75c1 |
| ToxValDB_ToxRefDB | LEL | =1.56 | mg/kg bw/day | Rat | inhalation | chronic; 104 weeks | chronic | LONG_REF=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_2 year study_Rats; TITLE=Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_2 year study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5094; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=systemic: hematology-[other]-[other]|systemic: hematology-reticulocyte-reticulocyte|systemic: pathology microscopic-liver-pigmentation|systemic: hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|systemic: hematology-myeloid/erythroid (m:e) ratio-myeloid/erythroid (m:e) ratio|systemic: hematology-anemia-anemia - nos|systemic: hematology-hemoglobin (hgb)-hemoglobin (hgb)|systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: hematology-hematocrit (hct)-hematocrit (hct)|systemic: pathology microscopic-nose-degeneration|systemic: hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|systemic: in life observation-body weight-body weight|systemic: pathology microscopic-adrenal gland-hyperplasia|systemic: pathology microscopic-bone marrow-hypercellularity; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|hematology|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15708506_15708507_15708508:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_9d9ee4c748f17c82145430d4ceb4e0c2 |
| ToxValDB_ToxRefDB | LOAEL | =650 | mg/kg bw/day | Rat | oral | short-term; 14 days | short-term | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Rats; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5088; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ToxRefDB_dup_-_15708466_15708467_15708468_15708469:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8879e649eb771dd06e1d307cf61e7d51 |
| ToxValDB_ToxRefDB | LOAEL | =281 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5090; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-liver-degeneration|systemic: hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|systemic: clinical chemistry-albumin-albumin|systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: pathology microscopic-spleen-hematopoietic cell proliferation|systemic: clinical chemistry-protein-protein|systemic: in life observation-body weight-body weight|systemic: pathology microscopic-bone marrow-hyperplasia|systemic: in life observation-body weight-body weight gain|systemic: hematology-anemia-anemia - macrocytic|systemic: clinical chemistry-urea nitrogen-urea nitrogen|systemic: hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|systemic: pathology microscopic-spleen-pigmentation|systemic: pathology microscopic-bone marrow-cellular alteration|systemic: pathology microscopic-blood-thrombocytopenia; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|hematology|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15708481_15708482_15708483:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_5008b9f742c4bd562abcb25579ce9ecf |
| ToxValDB_ToxRefDB | LOAEL | =6.25 | mg/kg bw/day | Rat | inhalation | chronic; 14 weeks | chronic | LONG_REF=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Rats; TITLE=Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5092; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=systemic: hematology-anemia-anemia - nos|systemic: pathology microscopic-spleen-hematopoietic cell proliferation erythrocytic|systemic: in life observation-clinical signs-lethargy|systemic: organ weight-kidney-nos|systemic: hematology-hematocrit (hct)-hematocrit (hct)|systemic: hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|systemic: in life observation-clinical signs-salivation|systemic: in life observation-clinical signs-labored respiration|systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: in life observation-clinical signs-general pallor|systemic: in life observation-clinical signs-ocular discharge|systemic: hematology-nucleated red blood cell (nrbc)-nucleated red blood cell (nrbc)|systemic: pathology microscopic-liver-pigmentation|systemic: hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|systemic: hematology-reticulocyte-reticulocyte|systemic: in life observation-clinical signs-nasal discharge|systemic: in life observation-clinical signs-lacrimation|systemic: organ weight-liver-nos|systemic: hematology-hemoglobin (hgb)-hemoglobin (hgb)|systemic: pathology microscopic-bone marrow-hyperplasia|systemic: in life observation-clinical signs-urogenital staining|systemic: hematology-platelet-platelet; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|hematology|nonneoplastic histopathology|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15708492_15708493_15708494:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_fb80299fc46c41e8388d8fe4f217e8f0 |
| ToxValDB_ToxRefDB | LOAEL | =18.75 | mg/kg bw/day | Mouse | inhalation | chronic; 14 weeks | chronic | LONG_REF=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Mice; TITLE=Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Mice; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5093; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: hematology-hematocrit (hct)-hematocrit (hct)|systemic: hematology-reticulocyte-reticulocyte|systemic: hematology-hemoglobin (hgb)-hemoglobin (hgb)|systemic: pathology microscopic-stomach-hyperplasia|systemic: hematology-anemia-anemia - nos; TOXICOLOGICAL_EFFECT_CATEGORY=hematology|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15708499_15708500_15708501:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7366c4ddfd2694183de1a4bb8571232b |
| ToxValDB_ToxRefDB | NEL | =150 | mg/kg bw/day | Rat | oral | short-term; 14 days | short-term | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Rats; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5088; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight|systemic: in life observation-water consumption-water consumption; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15708466_15708467_15708468_15708469:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_d4a3f2cd21a488400c022f059b5e84ff |
| ToxValDB_ToxRefDB | NEL | =250 | mg/kg bw/day | Mouse | oral | short-term; 14 days | short-term | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Mice; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Mice; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5089; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-dehydration; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ToxRefDB_dup_-_15708472_15708473:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_d691fed51c6c8c9c3a856c876a19e085 |
| ToxValDB_ToxRefDB | NEL | =304 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5090; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=reproductive: reproductive performance-estrous cycle-abnormal; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ToxRefDB_dup_-_15708476_15708477:F:F0adult-pregnancy; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_f586ef9f5998caba3a9cb03f1b617102 |
| ToxValDB_ToxRefDB | NEL | =223 | mg/kg bw/day | Mouse | oral | subchronic; 13 weeks | subchronic | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Mice; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Mice; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5091; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight gain|systemic: in life observation-body weight-body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ToxRefDB_dup_-_15708488_15708489_15708490_15708491:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_bc890a3b3e1141265ceba4efb83a92d8 |
| ToxValDB_ToxRefDB | NOAEL | =400 | mg/kg bw/day | Rat | oral | short-term; 14 days | short-term | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Rats; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_2 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5088; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: in life observation-water consumption-water consumption|systemic: in life observation-body weight-body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15708466_15708467_15708468_15708469:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_f5c2614a1c7eeb2ebacd0f8c66d5c36b |
| ToxValDB_ToxRefDB | NOAEL | =151 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5090; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: in life observation-water consumption-water consumption|systemic: pathology gross-uterus-reduced size|systemic: clinical chemistry-alkaline phosphatase (alp/alk)-alkaline phosphatase (alp/alk)|systemic: hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|systemic: clinical chemistry-creatine phosphokinase-creatine phosphokinase|systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: hematology-anemia-anemia - macrocytic|systemic: organ weight-thymus-absolute|systemic: in life observation-clinical signs-defecation (diarrhea)|systemic: clinical chemistry-creatinine-creatinine|systemic: clinical chemistry-protein-protein|systemic: pathology microscopic-spleen-hematopoietic cell proliferation|systemic: clinical chemistry-alanine aminotransferase (alt/sgpt)-alanine aminotransferase (alt/sgpt)|systemic: pathology microscopic-bone marrow-hypercellularity|systemic: in life observation-body weight-body weight gain|systemic: clinical chemistry-albumin-albumin|systemic: in life observation-body weight-body weight|systemic: hematology-platelet-platelet|systemic: hematology-reticulocyte-reticulocyte|systemic: hematology-hemoglobin (hgb)-hemoglobin (hgb)|systemic: clinical chemistry-urea nitrogen-urea nitrogen|systemic: pathology microscopic-liver-pigmentation|systemic: urinalysis-volume-volume|systemic: urinalysis-specific gravity/osmolality-specific gravity/osmolality|systemic: pathology microscopic-liver-cytoplasmic alteration|systemic: pathology microscopic-liver-degeneration|systemic: pathology microscopic-spleen-pigmentation|systemic: pathology microscopic-bone marrow-hyperplasia|systemic: hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|systemic: hematology-mean corpuscular hemoglobin concentration (mchc)-mean corpuscular hemoglobin concentration (mchc); TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|clinical signs|food and/or water consumption|gross pathology|hematology|nonneoplastic histopathology|organ weight|urinalysis; STUDY_GROUP=ToxRefDB_dup_-_15708478_15708479_15708480:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a8996e4a609495bf4a2e73ce60b7da98 |
| ToxValDB_ToxRefDB | NOAEL | =129 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=NTP_1993_Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; TITLE=Technical report on the toxicity studies of Ethylene Glycol Ethers: 2-Methoxyethanol, 2-Ethoxyethanol, 2-Butoxyethanol (CAS No. 109-86-4, 110-80-5, 111-76-2) Administered in Drinking Water_13 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5090; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=systemic: hematology-reticulocyte-reticulocyte|systemic: organ weight-thymus-absolute|systemic: pathology microscopic-liver-pigmentation|systemic: hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|systemic: clinical chemistry-albumin-albumin|systemic: pathology gross-sperm measure-sperm count|systemic: pathology microscopic-bone marrow-hyperplasia|systemic: hematology-anemia-anemia - macrocytic|systemic: in life observation-body weight-body weight gain|systemic: pathology microscopic-spleen-hematopoietic cell proliferation|systemic: hematology-mean corpuscular hemoglobin concentration (mchc)-mean corpuscular hemoglobin concentration (mchc)|systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: in life observation-body weight-body weight|systemic: pathology microscopic-liver-cytoplasmic alteration|systemic: clinical chemistry-protein-protein|systemic: in life observation-water consumption-water consumption|systemic: in life observation-clinical signs-defecation (diarrhea)|systemic: pathology microscopic-liver-degeneration|systemic: pathology microscopic-bone marrow-cellular alteration|systemic: pathology microscopic-spleen-pigmentation|systemic: hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|systemic: clinical chemistry-urea nitrogen-urea nitrogen|systemic: pathology microscopic-blood-thrombocytopenia; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|clinical signs|food and/or water consumption|hematology|nonneoplastic histopathology|organ weight|reproduction; STUDY_GROUP=ToxRefDB_dup_-_15708481_15708482_15708483:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_bd2c13237fc4e10000fb28f0a4e81b0e |
| ToxValDB_ToxRefDB | NOAEL | =3.125 | mg/kg bw/day | Rat | inhalation | chronic; 14 weeks | chronic | LONG_REF=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Rats; TITLE=Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Rats; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5092; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: in life observation-clinical signs-labored respiration|systemic: pathology microscopic-nose-thrombosis|systemic: in life observation-clinical signs-general pallor|systemic: pathology microscopic-stomach-necrosis|systemic: organ weight-kidney-nos|systemic: pathology microscopic-spleen-atrophy|systemic: in life observation-clinical signs-salivation|systemic: hematology-hematocrit (hct)-hematocrit (hct)|systemic: hematology-mean corpuscular hemoglobin (mch)-mean corpuscular hemoglobin (mch)|systemic: in life observation-clinical signs-ocular discharge|systemic: hematology-nucleated red blood cell (nrbc)-nucleated red blood cell (nrbc)|systemic: pathology microscopic-kidney-degeneration|systemic: pathology microscopic-bone marrow-necrosis|systemic: pathology microscopic-liver-thrombosis|systemic: hematology-erythroblast-erythroblast|systemic: hematology-anemia-anemia - nos|systemic: pathology microscopic-liver-degeneration|systemic: in life observation-clinical signs-self-mutilation|systemic: in life observation-mortality-mortality|systemic: pathology microscopic-bone-thrombosis|systemic: pathology microscopic-bone-infarct|systemic: pathology microscopic-thymus-atrophy|systemic: in life observation-clinical signs-lethargy|systemic: pathology microscopic-stomach-ulcer|systemic: pathology microscopic-spleen-hematopoietic cell proliferation erythrocytic|systemic: in life observation-clinical signs-tooth-degeneration|systemic: in life observation-body weight-body weight|systemic: in life observation-clinical signs-lacrimation|systemic: organ weight-liver-nos|systemic: pathology microscopic-stomach-hyperplasia|systemic: hematology-hemoglobin (hgb)-hemoglobin (hgb)|systemic: pathology microscopic-bone marrow-hyperplasia|systemic: hematology-reticulocyte-reticulocyte|systemic: in life observation-clinical signs-scabbing|systemic: in life observation-clinical signs-nasal discharge|systemic: in life observation-clinical signs-tooth-thrombosis|systemic: pathology microscopic-heart-thrombosis|systemic: in life observation-clinical signs-urogenital staining|systemic: hematology-platelet-platelet|systemic: pathology microscopic-liver-necrosis|systemic: pathology microscopic-lung-thrombosis|systemic: pathology microscopic-stomach-inflammation|systemic: pathology microscopic-liver-pigmentation|systemic: hematology-mean corpuscular (cell) volume (mcv)-mean corpuscular (cell) volume (mcv)|systemic: in life observation-body weight-body weight gain|systemic: hematology-microcytosis-microcytosis|systemic: in life observation-clinical signs-[other]|systemic: organ weight-thymus-nos; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|hematology|mortality/survival|nonneoplastic histopathology|organ weight; STUDY_GROUP=ToxRefDB_dup_-_15708492_15708493_15708494:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e336fef31bb4394832edf7b79db5790a |
| ToxValDB_ToxRefDB | NOAEL | =9.375 | mg/kg bw/day | Mouse | inhalation | chronic; 14 weeks | chronic | LONG_REF=NTP_2000_Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Mice; TITLE=Toxicology and Carcinogenesis Studies 2-Butoxyethanol (CAS No. 111-76-2) in F344/N Rats and B6C3F1 Mice (Inhalation Studies)_14 week study_Mice; AUTHOR=NTP; EXTERNAL_SOURCE_ID=5093; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=systemic: hematology-hematocrit (hct)-hematocrit (hct)|systemic: pathology microscopic-thymus-atrophy|systemic: hematology-erythrocyte (rbc) count differential-erythrocyte (rbc)|systemic: in life observation-mortality-mortality|systemic: in life observation-clinical signs-urogenital staining|systemic: pathology microscopic-kidney-hemosiderosis|systemic: pathology microscopic-stomach-inflammation|systemic: pathology microscopic-kidney-degeneration|systemic: pathology microscopic-stomach-ulcer|systemic: pathology microscopic-spleen-hemosiderosis|systemic: pathology microscopic-stomach-necrosis|systemic: pathology microscopic-spleen-hematopoietic cell proliferation|systemic: hematology-platelet-platelet|systemic: hematology-erythroblast-erythroblast|systemic: in life observation-clinical signs-lethargy|systemic: pathology microscopic-lymph node-atrophy|systemic: hematology-hemoglobin (hgb)-hemoglobin (hgb)|systemic: pathology microscopic-stomach-hyperplasia|systemic: hematology-anemia-anemia - nos|systemic: hematology-reticulocyte-reticulocyte|systemic: pathology microscopic-pleura-inflammation|systemic: organ weight-liver-relative to body weight|systemic: pathology microscopic-liver-hemosiderosis|systemic: in life observation-clinical signs-labored respiration|systemic: pathology microscopic-spleen-atrophy; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|hematology|mortality/survival|nonneoplastic histopathology|organ weight|other; STUDY_GROUP=ToxRefDB_dup_-_15708499_15708500_15708501:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_99e0e9efd40caddd0eac6145a0c41b76 |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 75 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 150 | mg/kg | - | - | - | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=150; DOSE=Based on a NOAEL 150 mg/kg and a skin penetration rate of 113µg/cm2 the member state concluded, that the substance could be considered safe for the consumers, when used in a concentration up to 4% in permanent hair dyes and up to 2% in non-oxidative hair dyes.; EFFECT=____________________________ 5 1. BACKGROUND A risk assessment of EGBE with the chemical name 2-butoxyethanol or ethylene glycol monobutyl ether was done by a member state (France). The risk assessment is based mainly on open scientific literature and on skin absorptions studies done by Industry. The risk assessment led the member state to put some restrictions on the use this substance. According to the notification to the Commission EGBE is used in cosmetic products only as a solvent in hair dyes. Based on a NOAEL 150 mg/kg and a skin penetration rate of 113µg/cm2 the member state concluded, that the substance could be considered safe for the consumers, when used in a concentration up to 4% in permanent hair dyes and up to 2% in non-oxidative hair dyes. 2. TERMS OF REFERENCE 1. Does the SCCP consider the use of EGBE as solvent in hair dyes in a concentration up to 4% in oxidative hair dyes and up to 2% in non-oxidative hair dyes safe for the consumer taken into consideration the scientific data provided? 2. If not, does; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"Based on a NOAEL 150 mg/kg and a skin penetration rate of 113µg/cm2 the member state concluded, that the substance could be considered safe for the consumers, when used in a concentration up to 4% in permanent hair dyes and up to 2% in non-oxidative hair dyes.","duration":"","effect":"____________________________ 5 1. BACKGROUND A risk assessment of EGBE with the chemical name 2-butoxyethanol or ethylene glycol monobutyl ether was done by a member state (France). The risk assessment is based mainly on open scientific literature and on skin absorptions studies done by Industry. The risk assessment led the member state to put some restrictions on the use this substance. According to the notification to the Commission EGBE is used in cosmetic products only as a solvent in hair dyes. Based on a NOAEL 150 mg/kg and a skin penetration rate of 113µg/cm2 the member state concluded, that the substance could be considered safe for the consumers, when used in a concentration up to 4% in permanent hair dyes and up to 2% in non-oxidative hair dyes. 2. TERMS OF REFERENCE 1. Does the SCCP consider the use of EGBE as solvent in hair dyes in a concentration up to 4% in oxidative hair dyes and up to 2% in non-oxidative hair dyes safe for the consumer taken into consideration the scientific data provided? 2. If not, does","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"150","page":5,"route":"","species":"","study_id":"sccp_o_095_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 222 | mg/kg | rat | oral | 90 days | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=222; DOSE=helium in all treated animals.; EFFECT=helium in all treated animals. Hepatomegaly was also seen in 4 out of 10 animals of the high dose group. Haemosiderin deposition was seen in some animals (7/10 and 6/10 in the high and mid dose group respectively). Thymus atrophy was seen in one animal of the high dose group. Congestion of the spleen was seen in all treated animals. Extramedullary haematopoiesis was reported for one animal in the high dose group and haemosiderin deposit in the majority of animals of the high and mid dose group. For this study, the NOAEL can be considered to be lower than 222 mg/kg (which is the Low Observable Adverse Effect Level: LOAEL) based on effects seen on spleens and RBC parameters. Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0.03, 0.125, 0.5 and 2% Butyl cellosolve (EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days. No deaths were seen attributable to the direct action of EGBE. Appetite was not affected and no pertinent micropathology was discovered. Tests f; CITATION=Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0; CITATION_NUMBERS=[52,5]; REFERENCE=Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0","dose":"helium in all treated animals.","duration":"90 days","effect":"helium in all treated animals. Hepatomegaly was also seen in 4 out of 10 animals of the high dose group. Haemosiderin deposition was seen in some animals (7/10 and 6/10 in the high and mid dose group respectively). Thymus atrophy was seen in one animal of the high dose group. Congestion of the spleen was seen in all treated animals. Extramedullary haematopoiesis was reported for one animal in the high dose group and haemosiderin deposit in the majority of animals of the high and mid dose group. For this study, the NOAEL can be considered to be lower than 222 mg/kg (which is the Low Observable Adverse Effect Level: LOAEL) based on effects seen on spleens and RBC parameters. Ref.: 52 Five groups of Sherman rats (5/sex/group) were fed with diet containing 0, 0.03, 0.125, 0.5 and 2% Butyl cellosolve (EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days. No deaths were seen attributable to the direct action of EGBE. Appetite was not affected and no pertinent micropathology was discovered. Tests f","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"222","page":21,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.5 | % | rat | - | 90 days | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=0.5; DOSE=EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days.; LOAEL_VALUE=310 mg/kg bw/d; EFFECT=EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days. No deaths were seen attributable to the direct action of EGBE. Appetite was not affected and no pertinent micropathology was discovered. Tests for blood in pooled urine sample from the 2%, 0.5% and controls groups after 3 and 6 days were negative. The mean weight gain was lower than controls for the 2% group. Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose. The NOAEL can be considered to be 0.125% (76 mg/kg bw/d) but considering that the test conditions were poorly reported (no control of the administered substance, evaporation?) this NOAEL will not be taken into account for the risk characterisation. The LOAEL was 310 mg/kg bw/d. Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0.01, 0.05, 0.25, and 1.25% (corresponding to 0, 7, 38, 188, and 919 mg/kg bw in males and 0, 9, 41, 222, and 976 mg/kg; CITATION=Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0; CITATION_NUMBERS=[53,10]; REFERENCE=Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0","dose":"EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days.","duration":"90 days","effect":"EGBE purity unknown) corresponding to doses of 0, 18, 76, 310 and 1540 mg/kg/d for 90 days. No deaths were seen attributable to the direct action of EGBE. Appetite was not affected and no pertinent micropathology was discovered. Tests for blood in pooled urine sample from the 2%, 0.5% and controls groups after 3 and 6 days were negative. The mean weight gain was lower than controls for the 2% group. Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose. The NOAEL can be considered to be 0.125% (76 mg/kg bw/d) but considering that the test conditions were poorly reported (no control of the administered substance, evaporation?) this NOAEL will not be taken into account for the risk characterisation. The LOAEL was 310 mg/kg bw/d. Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0.01, 0.05, 0.25, and 1.25% (corresponding to 0, 7, 38, 188, and 919 mg/kg bw in males and 0, 9, 41, 222, and 976 mg/kg","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"310 mg/kg bw/d","noael_unit":"%","noael_value":"0.5","page":21,"route":"","species":"rat","study_id":"sccp_o_095_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 310 | mg/kg bw/d | rat | - | 6 days | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=310; DOSE=Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose.; LOAEL_VALUE=310 mg/kg bw/d; EFFECT=ted and no pertinent micropathology was discovered. Tests for blood in pooled urine sample from the 2%, 0.5% and controls groups after 3 and 6 days were negative. The mean weight gain was lower than controls for the 2% group. Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose. The NOAEL can be considered to be 0.125% (76 mg/kg bw/d) but considering that the test conditions were poorly reported (no control of the administered substance, evaporation?) this NOAEL will not be taken into account for the risk characterisation. The LOAEL was 310 mg/kg bw/d. Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0.01, 0.05, 0.25, and 1.25% (corresponding to 0, 7, 38, 188, and 919 mg/kg bw in males and 0, 9, 41, 222, and 976 mg/kg bw in females respectively) during 3 months. Animals were weighted 4 times during the first week and once a week thereafter. After euthanasia liver and kidneys were weighed. Or; CITATION=Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0; CITATION_NUMBERS=[53,10]; REFERENCE=Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0","dose":"Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose.","duration":"6 days","effect":"ted and no pertinent micropathology was discovered. Tests for blood in pooled urine sample from the 2%, 0.5% and controls groups after 3 and 6 days were negative. The mean weight gain was lower than controls for the 2% group. Relative kidney and liver weight were increased at 2% dose and relative liver weight was increased at 0.5% dose. The NOAEL can be considered to be 0.125% (76 mg/kg bw/d) but considering that the test conditions were poorly reported (no control of the administered substance, evaporation?) this NOAEL will not be taken into account for the risk characterisation. The LOAEL was 310 mg/kg bw/d. Ref.: 53 Groups of young DW albino rats (10 males and 10 females/group) were given food with EGBE (purity unknown) at doses of 0, 0.01, 0.05, 0.25, and 1.25% (corresponding to 0, 7, 38, 188, and 919 mg/kg bw in males and 0, 9, 41, 222, and 976 mg/kg bw in females respectively) during 3 months. Animals were weighted 4 times during the first week and once a week thereafter. After euthanasia liver and kidneys were weighed. Or","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"310 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"310","page":21,"route":"","species":"rat","study_id":"sccp_o_095_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.25 | % | - | oral | - | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=0.25; DOSE=One animal died at day 73 after the beginning of the study in the high dose group.; EFFECT=es. One animal died at day 73 after the beginning of the study in the high dose group. Food consumption was decreased in both males and females at 1.25%. In males a significant decrease of food consumption was also observed at 0.25% dose. A significant decrease of body weight gain was seen in animals dosed with 1.25% EGBE. It was also seen in males at doses of 0.25%. The mean liver and kidney weight of males and females were definitely increased at the 1.25% dose. At both 1.25% and 0.25% testes were atrophied. The NOAEL for this study can be considered to be 0.05%. The purity of the EGBE used in this study is not given, nor does there appear to be analytical verification of EGBE doses, homogeneity and stability. Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE. Given the availability of numerous other more recent and robust studies, this one cannot be considered reliable to derive the criti; CITATION=Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E; CITATION_NUMBERS=[54]; REFERENCE=Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E","dose":"One animal died at day 73 after the beginning of the study in the high dose group.","duration":"","effect":"es. One animal died at day 73 after the beginning of the study in the high dose group. Food consumption was decreased in both males and females at 1.25%. In males a significant decrease of food consumption was also observed at 0.25% dose. A significant decrease of body weight gain was seen in animals dosed with 1.25% EGBE. It was also seen in males at doses of 0.25%. The mean liver and kidney weight of males and females were definitely increased at the 1.25% dose. At both 1.25% and 0.25% testes were atrophied. The NOAEL for this study can be considered to be 0.05%. The purity of the EGBE used in this study is not given, nor does there appear to be analytical verification of EGBE doses, homogeneity and stability. Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE. Given the availability of numerous other more recent and robust studies, this one cannot be considered reliable to derive the criti","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"%","noael_value":"0.25","page":21,"route":"oral","species":"","study_id":"sccp_o_095_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 99 | % | rat | oral | - | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=99; DOSE=54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE.; EFFECT=this study can be considered to be 0.05%. The purity of the EGBE used in this study is not given, nor does there appear to be analytical verification of EGBE doses, homogeneity and stability. Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE. Given the availability of numerous other more recent and robust studies, this one cannot be considered reliable to derive the critical NOAEL. Guideline: / Species/strain: F344/N rats Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 ppm; CITATION=Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E; CITATION_NUMBERS=[54]; REFERENCE=Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of E","dose":"54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE.","duration":"","effect":"this study can be considered to be 0.05%. The purity of the EGBE used in this study is not given, nor does there appear to be analytical verification of EGBE doses, homogeneity and stability. Ref.: 54 Comment The effects on testis is difficult to interpret given for example that testicular atrophy was not reported in other oral, repeated-dose studies even at higher doses of EGBE. Given the availability of numerous other more recent and robust studies, this one cannot be considered reliable to derive the critical NOAEL. Guideline: / Species/strain: F344/N rats Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 ppm","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"%","noael_value":"99","page":21,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 129 | mg/kg bw/d | rat | - | - | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=129; DOSE=SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used.; EFFECT=SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 pp; CITATION=Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co; CITATION_NUMBERS=[55,6,3,1,10,50,4]; REFERENCE=Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co","dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used.","duration":"","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 pp","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"129","page":23,"route":"","species":"rat","study_id":"sccp_o_095_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 150 | mg/kg bw/d | rat | oral | 13 weeks | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=150; DOSE=SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used.; EFFECT=SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 ppm Route: Oral, drinking water Exposures: 13 weeks GLP: In compliance EGBE was administered in drinking water at concentrations of 0, 750, 1500, 3000, 4500 or 6000 ppm to grou; CITATION=Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co; CITATION_NUMBERS=[55,6,3,1,10,50,4]; REFERENCE=Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co","dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used.","duration":"13 weeks","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 23 NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. Ref.: 55 Mice Guideline: / Species/strain: B6C3F1 mice Group size: 10 males and 10 females Test substance: EGBE Batch: Lot BT00504LP Aldrich Chemical Co., USA Purity: ≈ 99% Dose levels: 0, 750, 1500, 3000, 4500, and 6000 ppm Route: Oral, drinking water Exposures: 13 weeks GLP: In compliance EGBE was administered in drinking water at concentrations of 0, 750, 1500, 3000, 4500 or 6000 ppm to grou","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"150","page":23,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 450 | mg/kg | rabbit | - | 14-day | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=450; DOSE=Gross findings included some thickening of the skin in male rabbits given undiluted substance and possibly dose related patchy colour change of the kidneys of the three females.; EFFECT=d no indication of biologically significant haematological effects. The increased mean red blood cell counts on day 9 of treatment in the 5% dilution group and on day 14 after exposure in the 25% dilution group are considered to be statistical artefacts. No changes were noted in any organ weight measured in all animals. Gross findings included some thickening of the skin in male rabbits given undiluted substance and possibly dose related patchy colour change of the kidneys of the three females. For this study, the NOAEL of 450 mg/kg can be taken into account mainly based on gross findings observed in animals dosed with pure substance. Haematological effects seen during the study were transient and recovery was complete after the 14-day observation period. Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2.8% - 14.3% and 42.8% in distilled water (corresponding to dose levels of 0, 10, 50, and 150 mg/kg) for a 6 hr period/day 5 d/; CITATION=Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2; CITATION_NUMBERS=[57,10,2]; REFERENCE=Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2","dose":"Gross findings included some thickening of the skin in male rabbits given undiluted substance and possibly dose related patchy colour change of the kidneys of the three females.","duration":"14-day","effect":"d no indication of biologically significant haematological effects. The increased mean red blood cell counts on day 9 of treatment in the 5% dilution group and on day 14 after exposure in the 25% dilution group are considered to be statistical artefacts. No changes were noted in any organ weight measured in all animals. Gross findings included some thickening of the skin in male rabbits given undiluted substance and possibly dose related patchy colour change of the kidneys of the three females. For this study, the NOAEL of 450 mg/kg can be taken into account mainly based on gross findings observed in animals dosed with pure substance. Haematological effects seen during the study were transient and recovery was complete after the 14-day observation period. Ref.: 57 Four groups of 10 males and 10 females NZ white rabbits were treated dermally (occlusively) with EGBE (high purity) at concentration of 0% - 2.8% - 14.3% and 42.8% in distilled water (corresponding to dose levels of 0, 10, 50, and 150 mg/kg) for a 6 hr period/day 5 d/","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"450","page":26,"route":"","species":"rabbit","study_id":"sccp_o_095_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 150 | mg/kg bw | - | - | - | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=150; DOSE=in or food consumption in any group treated compared to control animals.; EFFECT=in or food consumption in any group treated compared to control animals. Sporadic changes in haematology parameters and RBC fragility values were noted but values were within normal ranges for this laboratory and probably not related to the test material. Sporadic changes were also noted in WBC counts but were not related to test material administration. No changes in biochemistry were related to treatment. No test material related effects were noted on absolute or relative organ weights or final body weights. The NOAEL for this study was equal to 150 mg/kg bw, the highest tested dose. The actual NOAEL may be of a higher value. It is stated that the study was performed in compliance with GLP. Ref.: 58; CITATION=Ref.: 58; CITATION_NUMBERS=[58]; REFERENCE=Ref.: 58; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 58","dose":"in or food consumption in any group treated compared to control animals.","duration":"","effect":"in or food consumption in any group treated compared to control animals. Sporadic changes in haematology parameters and RBC fragility values were noted but values were within normal ranges for this laboratory and probably not related to the test material. Sporadic changes were also noted in WBC counts but were not related to test material administration. No changes in biochemistry were related to treatment. No test material related effects were noted on absolute or relative organ weights or final body weights. The NOAEL for this study was equal to 150 mg/kg bw, the highest tested dose. The actual NOAEL may be of a higher value. It is stated that the study was performed in compliance with GLP. Ref.: 58","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"150","page":26,"route":"","species":"","study_id":"sccp_o_095_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 150 | mg/kg bw | - | - | - | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=150; DOSE=The NOAEL for this study was equal to 150 mg/kg bw, the highest tested dose.; EFFECT=anges in haematology parameters and RBC fragility values were noted but values were within normal ranges for this laboratory and probably not related to the test material. Sporadic changes were also noted in WBC counts but were not related to test material administration. No changes in biochemistry were related to treatment. No test material related effects were noted on absolute or relative organ weights or final body weights. The NOAEL for this study was equal to 150 mg/kg bw, the highest tested dose. The actual NOAEL may be of a higher value. It is stated that the study was performed in compliance with GLP. Ref.: 58; CITATION=Ref.: 58; CITATION_NUMBERS=[58]; REFERENCE=Ref.: 58; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 58","dose":"The NOAEL for this study was equal to 150 mg/kg bw, the highest tested dose.","duration":"","effect":"anges in haematology parameters and RBC fragility values were noted but values were within normal ranges for this laboratory and probably not related to the test material. Sporadic changes were also noted in WBC counts but were not related to test material administration. No changes in biochemistry were related to treatment. No test material related effects were noted on absolute or relative organ weights or final body weights. The NOAEL for this study was equal to 150 mg/kg bw, the highest tested dose. The actual NOAEL may be of a higher value. It is stated that the study was performed in compliance with GLP. Ref.: 58","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"150","page":26,"route":"","species":"","study_id":"sccp_o_095_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 30 | mg/kg bw/day | - | - | - | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=30; DOSE=The maternal NOAEL is 30 mg/kg bw/day based on the effects describes before.; EFFECT=SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 48 particular, dramatic reductions in circulating red blood cells, haematocrit and haemoglobin resulted by 24 hours after treatment. By GD20 the haematotoxic effects were nearly reversed. The changes observed in haematological parameters and organ weights in this study are typical of haemolytic anaemia and the compensatory haematopoietic response associated with recovery. The maternal NOAEL is 30 mg/kg bw/day based on the effects describes before. Embryo/foetal effects were: increased resorptions, nonlive implants, and adversely affected implants per litter in the 200 mg/kg bw/day group dosed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"The maternal NOAEL is 30 mg/kg bw/day based on the effects describes before.","duration":"","effect":"SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 48 particular, dramatic reductions in circulating red blood cells, haematocrit and haemoglobin resulted by 24 hours after treatment. By GD20 the haematotoxic effects were nearly reversed. The changes observed in haematological parameters and organ weights in this study are typical of haemolytic anaemia and the compensatory haematopoietic response associated with recovery. The maternal NOAEL is 30 mg/kg bw/day based on the effects describes before. Embryo/foetal effects were: increased resorptions, nonlive implants, and adversely affected implants per litter in the 200 mg/kg bw/day group dosed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":48,"route":"","species":"","study_id":"sccp_o_095_noael_032"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 450 | mg/kg bw/d | rat | inhalation | 9 days | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=450; DOSE=que de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation.; EFFECT=que de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. This value is also in agreement with results from the skin painting experiment below. Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects at higher doses. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. A mouse study designed for the assessment of EGBE effects on the immune system, had a NOAEL of 1000 mg/kg. The main effect in rodent after inhalation of EGBE was haemolysis, which was consistently observed and sometimes associated with secondar; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"que de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation.","duration":"9 days","effect":"que de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. This value is also in agreement with results from the skin painting experiment below. Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects at higher doses. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. A mouse study designed for the assessment of EGBE effects on the immune system, had a NOAEL of 1000 mg/kg. The main effect in rodent after inhalation of EGBE was haemolysis, which was consistently observed and sometimes associated with secondar","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"450","page":55,"route":"inhalation","species":"rat","study_id":"sccp_o_095_noael_054"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 450 | mg/kg bw/d | rat | inhalation | 9 days | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=450; DOSE=Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally.; EFFECT=rats were more severe than in the male rats for their MOS calculation. This value is also in agreement with results from the skin painting experiment below. Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects at higher doses. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. A mouse study designed for the assessment of EGBE effects on the immune system, had a NOAEL of 1000 mg/kg. The main effect in rodent after inhalation of EGBE was haemolysis, which was consistently observed and sometimes associated with secondary hepatic effects (Kupffer cells pigmentation and absolute and relative liver weight increases). Other effects were decreases of bo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally.","duration":"9 days","effect":"rats were more severe than in the male rats for their MOS calculation. This value is also in agreement with results from the skin painting experiment below. Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects at higher doses. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. A mouse study designed for the assessment of EGBE effects on the immune system, had a NOAEL of 1000 mg/kg. The main effect in rodent after inhalation of EGBE was haemolysis, which was consistently observed and sometimes associated with secondary hepatic effects (Kupffer cells pigmentation and absolute and relative liver weight increases). Other effects were decreases of bo","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"450","page":55,"route":"inhalation","species":"rat","study_id":"sccp_o_095_noael_055"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 150 | mg/kg bw/d | mouse | inhalation | 9 days | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=150; DOSE=Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally.; EFFECT=e skin painting experiment below. Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects at higher doses. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. A mouse study designed for the assessment of EGBE effects on the immune system, had a NOAEL of 1000 mg/kg. The main effect in rodent after inhalation of EGBE was haemolysis, which was consistently observed and sometimes associated with secondary hepatic effects (Kupffer cells pigmentation and absolute and relative liver weight increases). Other effects were decreases of body weight gain, effects on the forestomach and effects on the WBC sub- populations (T lymphocyte). In these studies, a NOAE; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally.","duration":"9 days","effect":"e skin painting experiment below. Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects at higher doses. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. A mouse study designed for the assessment of EGBE effects on the immune system, had a NOAEL of 1000 mg/kg. The main effect in rodent after inhalation of EGBE was haemolysis, which was consistently observed and sometimes associated with secondary hepatic effects (Kupffer cells pigmentation and absolute and relative liver weight increases). Other effects were decreases of body weight gain, effects on the forestomach and effects on the WBC sub- populations (T lymphocyte). In these studies, a NOAE","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"150","page":55,"route":"inhalation","species":"mouse","study_id":"sccp_o_095_noael_056"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1000 | mg/kg | rat | inhalation | 9 days | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=1000; DOSE=of EGBE administered dermally.; EFFECT=of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects at higher doses. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. A mouse study designed for the assessment of EGBE effects on the immune system, had a NOAEL of 1000 mg/kg. The main effect in rodent after inhalation of EGBE was haemolysis, which was consistently observed and sometimes associated with secondary hepatic effects (Kupffer cells pigmentation and absolute and relative liver weight increases). Other effects were decreases of body weight gain, effects on the forestomach and effects on the WBC sub- populations (T lymphocyte). In these studies, a NOAEC of 25 ppm in rats (about 9 mg/ kg bw/d) and a LOAEC of 31 ppm in mice and rats was established (based on haemo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"of EGBE administered dermally.","duration":"9 days","effect":"of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects at higher doses. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. A mouse study designed for the assessment of EGBE effects on the immune system, had a NOAEL of 1000 mg/kg. The main effect in rodent after inhalation of EGBE was haemolysis, which was consistently observed and sometimes associated with secondary hepatic effects (Kupffer cells pigmentation and absolute and relative liver weight increases). Other effects were decreases of body weight gain, effects on the forestomach and effects on the WBC sub- populations (T lymphocyte). In these studies, a NOAEC of 25 ppm in rats (about 9 mg/ kg bw/d) and a LOAEC of 31 ppm in mice and rats was established (based on haemo","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"1000","page":55,"route":"inhalation","species":"rat","study_id":"sccp_o_095_noael_057"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 23 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 23: Study | NOAEL (mg/kg bw/d) | Effects | Ref.; DOSE=Study | NOAEL (mg/kg bw/d) | Effects | Ref.; EFFECT=Unlabeled table on page 23: Study | NOAEL (mg/kg bw/d) | Effects | Ref.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","duration":"","effect":"Unlabeled table on page 23: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 23: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":23,"route":"","species":"","study_id":"sccp_o_095_noael_063"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 23 | - | - | - | 90 days | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 23: 90 days in food | NOAEL = 76 LOAEL = 310 | Poorly reported | 53; EFFECT=Unlabeled table on page 23: 90 days in food | NOAEL = 76 LOAEL = 310 | Poorly reported | 53; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"","duration":"90 days","effect":"Unlabeled table on page 23: 90 days in food | NOAEL = 76 LOAEL = 310 | Poorly reported | 53","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 23: 90 days in food | NOAEL = 76 LOAEL = 310 | Poorly reported | 53","page":23,"route":"","species":"","study_id":"sccp_o_095_noael_064"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =0.05 | % | - | - | 90 days | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 0.05; DOSE=90 days in food | NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) | Decrease in food consumption and body weight gain in males.; EFFECT=Unlabeled table on page 23: 90 days in food | NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) | Decrease in food consumption and body weight gain in males. Testes atrophy. | 54; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"90 days in food | NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) | Decrease in food consumption and body weight gain in males.","duration":"90 days","effect":"Unlabeled table on page 23: 90 days in food | NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) | Decrease in food consumption and body weight gain in males. Testes atrophy. | 54","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"%","noael_value":"= 0.05","page":23,"route":"","species":"","study_id":"sccp_o_095_noael_065"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =76 | - | - | - | 90 days | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=NOAEL = 76 LOAEL = 310; EFFECT=Unlabeled table on page 23: 90 days in food | NOAEL = 76 LOAEL = 310 | Poorly reported | 53; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"","duration":"90 days","effect":"Unlabeled table on page 23: 90 days in food | NOAEL = 76 LOAEL = 310 | Poorly reported | 53","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"","noael_value":"NOAEL = 76 LOAEL = 310","page":23,"route":"","species":"","study_id":"sccp_o_095_noael_067"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 82 | mg/kg bw/day | rat | oral | 13 weeks | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=82; DOSE=13 weeks in drinking water | LOAEL of 69 and 82 mg/kg bw/day for males and females respectively.; LOAEL_VALUE=82 mg/kg bw/day; EFFECT=Unlabeled table on page 23: 13 weeks in drinking water | LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild | Slight cytoplasmic alterations in hepatocytes of both male and female rats | 55; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"13 weeks in drinking water | LOAEL of 69 and 82 mg/kg bw/day for males and females respectively.","duration":"13 weeks","effect":"Unlabeled table on page 23: 13 weeks in drinking water | LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild | Slight cytoplasmic alterations in hepatocytes of both male and female rats | 55","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"82 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"82","page":23,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_068"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 24 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 24: Study | NOAEL (mg/kg bw/d) | Effects | Ref.; DOSE=Study | NOAEL (mg/kg bw/d) | Effects | Ref.; EFFECT=Unlabeled table on page 24: Study | NOAEL (mg/kg bw/d) | Effects | Ref.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","duration":"","effect":"Unlabeled table on page 24: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 24: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":24,"route":"","species":"","study_id":"sccp_o_095_noael_069"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 129 | mg/kg bw/d | rat | - | - | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=129; DOSE=Unlabeled table on page 24: anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (females) may be used); EFFECT=Unlabeled table on page 24: anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (females) may be used); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"Unlabeled table on page 24: anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (females) may be used)","duration":"","effect":"Unlabeled table on page 24: anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (females) may be used)","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"129","page":24,"route":"","species":"rat","study_id":"sccp_o_095_noael_070"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 370 | mg/kg bw/d | - | oral | 13 weeks | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=370; DOSE=13 weeks in drinking water | NOAEL = 223 and 370 mg/kg bw/d for males and females respectively LOAEL = 553 and 676 mg/kg bw/d for males and females respectively | Slight decrease in body weight gain | 55; LOAEL_VALUE=676 mg/kg bw/d; EFFECT=Unlabeled table on page 24: 13 weeks in drinking water | NOAEL = 223 and 370 mg/kg bw/d for males and females respectively LOAEL = 553 and 676 mg/kg bw/d for males and females respectively | Slight decrease in body weight gain | 55; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"13 weeks in drinking water | NOAEL = 223 and 370 mg/kg bw/d for males and females respectively LOAEL = 553 and 676 mg/kg bw/d for males and females respectively | Slight decrease in body weight gain | 55","duration":"13 weeks","effect":"Unlabeled table on page 24: 13 weeks in drinking water | NOAEL = 223 and 370 mg/kg bw/d for males and females respectively LOAEL = 553 and 676 mg/kg bw/d for males and females respectively | Slight decrease in body weight gain | 55","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"676 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"370","page":24,"route":"oral","species":"","study_id":"sccp_o_095_noael_071"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 27 | - | - | - | - | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:Unlabeled table on page 27: Study | NOAEL (mg/kg bw/d) | Effects | Ref.; DOSE=Study | NOAEL (mg/kg bw/d) | Effects | Ref.; EFFECT=Unlabeled table on page 27: Study | NOAEL (mg/kg bw/d) | Effects | Ref.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"Study | NOAEL (mg/kg bw/d) | Effects | Ref.","duration":"","effect":"Unlabeled table on page 27: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"","noael_value":"unclear:Unlabeled table on page 27: Study | NOAEL (mg/kg bw/d) | Effects | Ref.","page":27,"route":"","species":"","study_id":"sccp_o_095_noael_072"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1500 | mg/kg bw/day | - | - | 4 days | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=1500; DOSE=0, 100, 500, 1000, 1500 mg/kg bw/day | NOAEL=1000 | Effects on splenic cellularity at 1500. | 56; EFFECT=Unlabeled table on page 27: 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day | NOAEL=1000 | Effects on splenic cellularity at 1500. | 56; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"0, 100, 500, 1000, 1500 mg/kg bw/day | NOAEL=1000 | Effects on splenic cellularity at 1500. | 56","duration":"4 days","effect":"Unlabeled table on page 27: 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day | NOAEL=1000 | Effects on splenic cellularity at 1500. | 56","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1500","page":27,"route":"","species":"","study_id":"sccp_o_095_noael_073"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 900 | mg/kg bw/d | - | - | 9 days | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=900; DOSE=45, 225, 450, 900 mg/kg bw/d | NOAEL = 450 | Transient haematological effects | 57; EFFECT=Unlabeled table on page 27: 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d | NOAEL = 450 | Transient haematological effects | 57; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"45, 225, 450, 900 mg/kg bw/d | NOAEL = 450 | Transient haematological effects | 57","duration":"9 days","effect":"Unlabeled table on page 27: 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d | NOAEL = 450 | Transient haematological effects | 57","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"900","page":27,"route":"","species":"","study_id":"sccp_o_095_noael_074"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 150 | mg/kg bw/d | - | - | 13 weeks | - | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=150; DOSE=10, 50, 150 mg/kg bw/d | NOAEL > 150 | No effects | 58; EFFECT=Unlabeled table on page 27: 13 weeks. Doses: 10, 50, 150 mg/kg bw/d | NOAEL > 150 | No effects | 58; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"10, 50, 150 mg/kg bw/d | NOAEL > 150 | No effects | 58","duration":"13 weeks","effect":"Unlabeled table on page 27: 13 weeks. Doses: 10, 50, 150 mg/kg bw/d | NOAEL > 150 | No effects | 58","endpoint":"","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"150","page":27,"route":"","species":"","study_id":"sccp_o_095_noael_075"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 95 | µg/cm | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=95; DOSE=Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.; EFFECT=. However, a more cautious and conservative initial approach would be to propose a value of 0.1. This implies that a factor of 0.4 (4.0 x 0.1) is justified for species differences and gives a minimal MOS of 4 taking intra species variation into consideration. Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL; CITATION=Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure; CITATION_NUMBERS=[1]; REFERENCE=Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure","dose":"Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","duration":"","effect":". However, a more cautious and conservative initial approach would be to propose a value of 0.1. This implies that a factor of 0.4 (4.0 x 0.1) is justified for species differences and gives a minimal MOS of 4 taking intra species variation into consideration. Ref.: 1 CALCULATION OF THE MARGIN OF SAFETY Ethylene glycol monobutyl ether EGBE (Oxidative/non-oxidative hair dyes) The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL","endpoint":"dermal absorption","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"µg/cm","noael_value":"95","page":54,"route":"dermal","species":"rat","study_id":"sccp_o_095_noael_048"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =1.11 | mg/kg bw | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 1.11; DOSE=Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.; EFFECT=g dermal exposure. Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","duration":"","effect":"g dermal exposure. Maximum dermal absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not","endpoint":"dermal absorption","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 1.11","page":54,"route":"dermal","species":"rat","study_id":"sccp_o_095_noael_049"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =30 | mg/kg bw | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 30; DOSE=l absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.; EFFECT=l absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not report; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"l absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","duration":"","effect":"l absorption of test substance reported was 95 µg/cm² Maternal NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not report","endpoint":"dermal absorption","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 30","page":54,"route":"dermal","species":"rat","study_id":"sccp_o_095_noael_050"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =30 | mg/kg bw | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 30; DOSE=NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.; EFFECT=NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not reported. The physico- chemical characterisation and purity of the sub; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d.","duration":"","effect":"NOAEL based on marked reductions in body weight and/or weight gain, increases in organ weights (kidney and spleen) and severe haematotoxicity was 30 mg/kg bw/d. Maximum absorption through the skin DAa (µg/cm²) = 95 µg/cm² Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 66.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 1.11mg/kg bw No observed adverse effect level NOAEL = 30 mg/kg bw (rat, maternal toxicity) Margin of Safety NOAEL / SED = 27 Based on a minimal MOS of 4, the calculated MOS equal to 27 is considered to give sufficient protection in relation to the use of EGBE as solvent in hair dye preparations. 3.3.14. Discussion The safety has only been considered for dermal exposure. The influence of possible evaporation in the various experiments has not been considered. Physico-chemical specification The stability of ethylene glycol monobutyl ether (EGBE) is not reported. The physico- chemical characterisation and purity of the sub","endpoint":"dermal absorption","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 30","page":54,"route":"dermal","species":"rat","study_id":"sccp_o_095_noael_051"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | >50 | ppm | rat | dermal | - | dermal absorption | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=>50; DOSE=In one well performed study EGBE produced irreversible effects on the conjunctivae and on the cornea in at least one treated rabbit.; EFFECT=according to guidelines. But overall, all studies have shown that EGBE is irritant or severely irritant to the eyes of rabbits with effects both on conjunctivae, iris and cornea. In one well performed study EGBE produced irreversible effects on the conjunctivae and on the cornea in at least one treated rabbit. Dilution of EGBE in water or rinsing of the eyes decreased the irritant effects. Studies available did not show any signs of significant respiratory irritation. From the human data, it is apparent that the NOEL is >50 ppm but <100 ppm based on discomfort. No signs of skin sensitisation were seen in two animal studies or in a human patch test. Moreover, considering Structure Activity Relationship (SAR) in the glycol ether family, the wide dispersive use of EGBE and that EGBE has never been associated with cases of skin sensitisation it can be considered that skin sensitisation will not be expected. Dermal absorption Under semi-occlusive conditions, dermal uptake of pure EGBE in rats was between 20 and 30% of the admini; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"In one well performed study EGBE produced irreversible effects on the conjunctivae and on the cornea in at least one treated rabbit.","duration":"","effect":"according to guidelines. But overall, all studies have shown that EGBE is irritant or severely irritant to the eyes of rabbits with effects both on conjunctivae, iris and cornea. In one well performed study EGBE produced irreversible effects on the conjunctivae and on the cornea in at least one treated rabbit. Dilution of EGBE in water or rinsing of the eyes decreased the irritant effects. Studies available did not show any signs of significant respiratory irritation. From the human data, it is apparent that the NOEL is >50 ppm but <100 ppm based on discomfort. No signs of skin sensitisation were seen in two animal studies or in a human patch test. Moreover, considering Structure Activity Relationship (SAR) in the glycol ether family, the wide dispersive use of EGBE and that EGBE has never been associated with cases of skin sensitisation it can be considered that skin sensitisation will not be expected. Dermal absorption Under semi-occlusive conditions, dermal uptake of pure EGBE in rats was between 20 and 30% of the admini","endpoint":"dermal absorption","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"ppm","noael_value":">50","page":56,"route":"dermal","species":"rat","study_id":"sccp_o_095_noael_062"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg | mouse | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=100; DOSE=osed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13.; EFFECT=osed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effec; CITATION=Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per; CITATION_NUMBERS=[69,70,71,97,350,650,1000,1500,2000,6]; REFERENCE=Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per","dose":"osed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13.","duration":"developmental","effect":"osed on GD 9 - 11, and decreased platelet count but no embryolethality in the 300 mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effec","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":48,"route":"oral","species":"mouse","study_id":"sccp_o_095_noael_033"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg | mouse | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=100; DOSE=mg/kg bw/day group dosed on GD 11 - 13.; EFFECT=mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the mate; CITATION=Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per; CITATION_NUMBERS=[69,70,71,97,350,650,1000,1500,2000,6]; REFERENCE=Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per","dose":"mg/kg bw/day group dosed on GD 11 - 13.","duration":"developmental","effect":"mg/kg bw/day group dosed on GD 11 - 13. EGBE exposure during gestation did not increase the incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the mate","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":48,"route":"oral","species":"mouse","study_id":"sccp_o_095_noael_034"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 300 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=300; DOSE=When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted.; EFFECT=incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numer; CITATION=Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per; CITATION_NUMBERS=[69,70,71,97,350,650,1000,1500,2000,6]; REFERENCE=Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per","dose":"When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted.","duration":"developmental","effect":"incidence of foetal malformations; particularly, no cardiovascular malformations were observed. When 200 mg/kg were given from day 9 to 11, an increased foetal lethality without malformations was noted. When 300 mg/kg were given from day 11 to 13, a decrease platelet count was seen in foetuses. It was noted that for developmental toxicity the NOAEL is 100 mg/kg when EGBE is administered from GD 9 - 11 and the conservative NOAEL is 100 mg/kg when EGBE is administered GD11 – 13 (although the NTP conclusion was for a NOAEL of equal to or greater than 300 mg/kg bw/day). Ref.: 69, 70, 71 Mice In a gavage probe study in pregnant CD-mice, EGBE (purity 97 %)was administered in distilled water at 0, 350, 650, 1000, 1500, and 2000 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numer","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":48,"route":"oral","species":"mouse","study_id":"sccp_o_095_noael_035"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 350 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=350; DOSE=00 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18).; EFFECT=00 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numerically reduced number of viable foetuses were observed at 1000 and 1500 mg/kg bw/day. 4/43 foetus (in one litter) at 1000 mg/kg bw/day and 1/25 at 1500 mg/kg bw/day had cleft palates. For this study, the NOAEL for maternal toxicity is 350 mg/kg bw/day and the NOAEL for developmental toxicity is 650 mg/kg bw/day. Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant mice, days 7 through 14 of gestation GLP: In compliance In a subsequent reproduction study (following a Chernoff modification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between G; CITATION=Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant m; CITATION_NUMBERS=[72,73,1,99]; REFERENCE=Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant m; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant m","dose":"00 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18).","duration":"developmental","effect":"00 mg/kg bw/day (6 animals per group) during gestational days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numerically reduced number of viable foetuses were observed at 1000 and 1500 mg/kg bw/day. 4/43 foetus (in one litter) at 1000 mg/kg bw/day and 1/25 at 1500 mg/kg bw/day had cleft palates. For this study, the NOAEL for maternal toxicity is 350 mg/kg bw/day and the NOAEL for developmental toxicity is 650 mg/kg bw/day. Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant mice, days 7 through 14 of gestation GLP: In compliance In a subsequent reproduction study (following a Chernoff modification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between G","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"350","page":48,"route":"oral","species":"mouse","study_id":"sccp_o_095_noael_036"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 350 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=350; DOSE=Haemolytic effects in the dams were observed from 650 mg/kg bw/day.; EFFECT=days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numerically reduced number of viable foetuses were observed at 1000 and 1500 mg/kg bw/day. 4/43 foetus (in one litter) at 1000 mg/kg bw/day and 1/25 at 1500 mg/kg bw/day had cleft palates. For this study, the NOAEL for maternal toxicity is 350 mg/kg bw/day and the NOAEL for developmental toxicity is 650 mg/kg bw/day. Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant mice, days 7 through 14 of gestation GLP: In compliance In a subsequent reproduction study (following a Chernoff modification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the o; CITATION=Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant m; CITATION_NUMBERS=[72,73,1,99]; REFERENCE=Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant m; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant m","dose":"Haemolytic effects in the dams were observed from 650 mg/kg bw/day.","duration":"developmental","effect":"days (GD) 8-14 (Note GD0 = vaginal sperm plug and sacrificed GD18). Haemolytic effects in the dams were observed from 650 mg/kg bw/day. At 1500 mg/kg bw/day the maternal mortality rate was 3/6 and at 2000 mg/kg bw/day 6/6. Increased resorption rates and numerically reduced number of viable foetuses were observed at 1000 and 1500 mg/kg bw/day. 4/43 foetus (in one litter) at 1000 mg/kg bw/day and 1/25 at 1500 mg/kg bw/day had cleft palates. For this study, the NOAEL for maternal toxicity is 350 mg/kg bw/day and the NOAEL for developmental toxicity is 650 mg/kg bw/day. Ref.: 72, 73 Guideline: / Species/strain: Swiss CD-1 mice Group size: See below Test substance: EGBE Batch: / Purity: 99% Dose levels: See below Route: Oral, gavage Exposures: Pregnant mice, days 7 through 14 of gestation GLP: In compliance In a subsequent reproduction study (following a Chernoff modification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the o","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"350","page":48,"route":"oral","species":"mouse","study_id":"sccp_o_095_noael_037"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1000 | mg/kg | mouse | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=1000; DOSE=In compliance In a subsequent reproduction study (following a Chernoff modification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22).; EFFECT=7 through 14 of gestation GLP: In compliance In a subsequent reproduction study (following a Chernoff modification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22). No significant effects on pup growth or survival resulted. No adverse developmental effects were reported. Signs of haemolytic effects and bw gain reduction were seen at 1000 mg/kg in dams. The NOAEL for maternal toxicity is 650 mg/kg bw/day in this study, and as no effects were seen in pups, the NOAEL for developmental toxicity can be considered to be greater than 1000 mg/kg bw/day. In another Chernoff assay, fifty mated CD1 mice were orally administered EGBE (99 % purity) by gavage at 1180 mg/kg bw/day (calculated LD10 based on a non-pregnant mouse; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"In compliance In a subsequent reproduction study (following a Chernoff modification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22).","duration":"developmental","effect":"7 through 14 of gestation GLP: In compliance In a subsequent reproduction study (following a Chernoff modification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22). No significant effects on pup growth or survival resulted. No adverse developmental effects were reported. Signs of haemolytic effects and bw gain reduction were seen at 1000 mg/kg in dams. The NOAEL for maternal toxicity is 650 mg/kg bw/day in this study, and as no effects were seen in pups, the NOAEL for developmental toxicity can be considered to be greater than 1000 mg/kg bw/day. In another Chernoff assay, fifty mated CD1 mice were orally administered EGBE (99 % purity) by gavage at 1180 mg/kg bw/day (calculated LD10 based on a non-pregnant mouse","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"1000","page":48,"route":"oral","species":"mouse","study_id":"sccp_o_095_noael_038"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 650 | mg/kg bw/day | mouse | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=650; DOSE=odification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22).; EFFECT=odification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22). No significant effects on pup growth or survival resulted. No adverse developmental effects were reported. Signs of haemolytic effects and bw gain reduction were seen at 1000 mg/kg in dams. The NOAEL for maternal toxicity is 650 mg/kg bw/day in this study, and as no effects were seen in pups, the NOAEL for developmental toxicity can be considered to be greater than 1000 mg/kg bw/day. In another Chernoff assay, fifty mated CD1 mice were orally administered EGBE (99 % purity) by gavage at 1180 mg/kg bw/day (calculated LD10 based on a non-pregnant mouse; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"odification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22).","duration":"developmental","effect":"odification study design with treatment of the pregnant mice (20 per group) at 650 or 1000 mg/kg bw/day between GD 7-14, the animals were allowed to give birth and the offspring were observed till Post Natal Day (PND)22). No significant effects on pup growth or survival resulted. No adverse developmental effects were reported. Signs of haemolytic effects and bw gain reduction were seen at 1000 mg/kg in dams. The NOAEL for maternal toxicity is 650 mg/kg bw/day in this study, and as no effects were seen in pups, the NOAEL for developmental toxicity can be considered to be greater than 1000 mg/kg bw/day. In another Chernoff assay, fifty mated CD1 mice were orally administered EGBE (99 % purity) by gavage at 1180 mg/kg bw/day (calculated LD10 based on a non-pregnant mouse","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"650","page":48,"route":"oral","species":"mouse","study_id":"sccp_o_095_noael_039"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 97 | % | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=97; DOSE=74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.; EFFECT=SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 49 pilot study) in corn oil from GD7-14 (GD1=vaginal sperm plug), then allowed to litter and to rear pups to PND3. 20 % of the dams died, maternal weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day; CITATION=Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study; CITATION_NUMBERS=[74,100]; REFERENCE=Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","duration":"developmental","effect":"SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 49 pilot study) in corn oil from GD7-14 (GD1=vaginal sperm plug), then allowed to litter and to rear pups to PND3. 20 % of the dams died, maternal weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"%","noael_value":"97","page":49,"route":"","species":"rat","study_id":"sccp_o_095_noael_040"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg bw/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=100; DOSE=74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.; EFFECT=pups to PND3. 20 % of the dams died, maternal weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand; CITATION=Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study; CITATION_NUMBERS=[74,100]; REFERENCE=Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","duration":"developmental","effect":"pups to PND3. 20 % of the dams died, maternal weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":49,"route":"","species":"rat","study_id":"sccp_o_095_noael_041"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg bw/day | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=100; DOSE=74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.; EFFECT=al weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand a similar value was found in a reprotox in; CITATION=Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study; CITATION_NUMBERS=[74,100]; REFERENCE=Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","duration":"developmental","effect":"al weight gain was reduced and, of 31 surviving pregnant females, there were only 24 viable litters (77 %) compared with 97 % control litter viability. No external malformations were seen, pup survival to PND was unaffected and no other indication of specific developmental toxicity was found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand a similar value was found in a reprotox in","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":49,"route":"","species":"rat","study_id":"sccp_o_095_noael_042"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 30 | mg/kg bw/day | rat | inhalation | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=30; DOSE=74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.; EFFECT=found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand a similar value was found in a reprotox inhalation study. Inhalation route Rats The teratogenicity of EGBE (98 to 99.5% purity) was evaluated using female SD rats. The animals were exposed whole body to EGBE vapour on GD 7 – 15 (GD0 = sperm positive vaginal smear) for 7hr/day (GLP status unknown). Sixteen and fifteen rats; CITATION=Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study; CITATION_NUMBERS=[74,100]; REFERENCE=Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","duration":"developmental","effect":"found. A maternal NOAEL could not be calculated and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand a similar value was found in a reprotox inhalation study. Inhalation route Rats The teratogenicity of EGBE (98 to 99.5% purity) was evaluated using female SD rats. The animals were exposed whole body to EGBE vapour on GD 7 – 15 (GD0 = sperm positive vaginal smear) for 7hr/day (GLP status unknown). Sixteen and fifteen rats","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":49,"route":"inhalation","species":"rat","study_id":"sccp_o_095_noael_043"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 30 | mg/kg bw/day | rat | inhalation | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=30; DOSE=74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.; EFFECT=ted and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand a similar value was found in a reprotox inhalation study. Inhalation route Rats The teratogenicity of EGBE (98 to 99.5% purity) was evaluated using female SD rats. The animals were exposed whole body to EGBE vapour on GD 7 – 15 (GD0 = sperm positive vaginal smear) for 7hr/day (GLP status unknown). Sixteen and fifteen rats were exposed to 150 ppm and 200 ppm, respecti; CITATION=Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study; CITATION_NUMBERS=[74,100]; REFERENCE=Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","duration":"developmental","effect":"ted and, although pup development was unaffected, the observation of reduced numbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand a similar value was found in a reprotox inhalation study. Inhalation route Rats The teratogenicity of EGBE (98 to 99.5% purity) was evaluated using female SD rats. The animals were exposed whole body to EGBE vapour on GD 7 – 15 (GD0 = sperm positive vaginal smear) for 7hr/day (GLP status unknown). Sixteen and fifteen rats were exposed to 150 ppm and 200 ppm, respecti","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":49,"route":"inhalation","species":"rat","study_id":"sccp_o_095_noael_044"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg bw/day | rat | inhalation | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=100; DOSE=74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.; EFFECT=umbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand a similar value was found in a reprotox inhalation study. Inhalation route Rats The teratogenicity of EGBE (98 to 99.5% purity) was evaluated using female SD rats. The animals were exposed whole body to EGBE vapour on GD 7 – 15 (GD0 = sperm positive vaginal smear) for 7hr/day (GLP status unknown). Sixteen and fifteen rats were exposed to 150 ppm and 200 ppm, respectively. The untreated control group consisted of 34 dams. Higher dose levels (25; CITATION=Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study; CITATION_NUMBERS=[74,100]; REFERENCE=Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study","dose":"74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study.","duration":"developmental","effect":"umbers of live litters precludes a calculation of the developmental NOAEL. Ref.: 74 Comment The lowest foetal NOAEL is 100 mg/kg bw/day in the rat study. It is based on effects seen at 200 mg/kg bw/day: increase foetal lethality without malformations. These effects were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This NOAEL based on 3 days exposure to 100 mg/kg bw/day is considerably lower than NOAEL based on up to 90 days repeated toxicity studies. On the other hand a similar value was found in a reprotox inhalation study. Inhalation route Rats The teratogenicity of EGBE (98 to 99.5% purity) was evaluated using female SD rats. The animals were exposed whole body to EGBE vapour on GD 7 – 15 (GD0 = sperm positive vaginal smear) for 7hr/day (GLP status unknown). Sixteen and fifteen rats were exposed to 150 ppm and 200 ppm, respectively. The untreated control group consisted of 34 dams. Higher dose levels (25","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":49,"route":"inhalation","species":"rat","study_id":"sccp_o_095_noael_045"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 1 | - | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=unclear:ube defect). For EGBE, these studies did not allow to draw any conclusion about its potential effects on humans because no studies are able to define clearly an unique source of glycol ether; Usually studies described co- exposure to various glycol ethers, including known developmental toxins such as EGME and other chemicals as well. Ref.: 1 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) Since all key effects are induced by haemolysis in rodents, a NOAEL based on haemotoxicity will be used in the risk characterisation. The selection of an appropriate interspecies chemical safety assessment factor (CSAF) must take into account the lower sensitivity of humans than rats (or mice) to the metabolite BAA. WHO (1994) has proposed splitting the CSAF in two components representing the toxicokinetic and toxicodynamic adjustment factors (Inter-species kinetics (4.0) and Inter-species dynamics (2.5) (see also The SCCP Notes of guidance for the testing of cosmetic ingredients; EFFECT=ube defect). For EGBE, these studies did not allow to draw any conclusion about its potential effects on humans because no studies are able to define clearly an unique source of glycol ether; Usually studies described co- exposure to various glycol ethers, including known developmental toxins such as EGME and other chemicals as well. Ref.: 1 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) Since all key effects are induced by haemolysis in rodents, a NOAEL based on haemotoxicity will be used in the risk characterisation. The selection of an appropriate interspecies chemical safety assessment factor (CSAF) must take into account the lower sensitivity of humans than rats (or mice) to the metabolite BAA. WHO (1994) has proposed splitting the CSAF in two components representing the toxicokinetic and toxicodynamic adjustment factors (Inter-species kinetics (4.0) and Inter-species dynamics (2.5) (see also The SCCP Notes of guidance for the testing of cosmetic ingredients; CITATION=Ref.: 1 3; CITATION_NUMBERS=[1,3]; REFERENCE=Ref.: 1 3; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 1 3","dose":"","duration":"developmental","effect":"ube defect). For EGBE, these studies did not allow to draw any conclusion about its potential effects on humans because no studies are able to define clearly an unique source of glycol ether; Usually studies described co- exposure to various glycol ethers, including known developmental toxins such as EGME and other chemicals as well. Ref.: 1 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) Since all key effects are induced by haemolysis in rodents, a NOAEL based on haemotoxicity will be used in the risk characterisation. The selection of an appropriate interspecies chemical safety assessment factor (CSAF) must take into account the lower sensitivity of humans than rats (or mice) to the metabolite BAA. WHO (1994) has proposed splitting the CSAF in two components representing the toxicokinetic and toxicodynamic adjustment factors (Inter-species kinetics (4.0) and Inter-species dynamics (2.5) (see also The SCCP Notes of guidance for the testing of cosmetic ingredients","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"","noael_value":"unclear:ube defect). For EGBE, these studies did not allow to draw any conclusion about its potential effects on humans because no studies are able to define clearly an unique source of glycol ether; Usually studies described co- exposure to various glycol ethers, including known developmental toxins such as EGME and other chemicals as well. Ref.: 1 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) Since all key effects are induced by haemolysis in rodents, a NOAEL based on haemotoxicity will be used in the risk characterisation. The selection of an appropriate interspecies chemical safety assessment factor (CSAF) must take into account the lower sensitivity of humans than rats (or mice) to the metabolite BAA. WHO (1994) has proposed splitting the CSAF in two components representing the toxicokinetic and toxicodynamic adjustment factors (Inter-species kinetics (4.0) and Inter-species dynamics (2.5) (see also The SCCP Notes of guidance for the testing of cosmetic ingredients","page":53,"route":"","species":"rat","study_id":"sccp_o_095_noael_047"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 30 | mg/kg bw/day | rat | inhalation | 3 days | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=30; DOSE=SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 56 were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day.; EFFECT=SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 56 were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This value is based on retarded bodyweight gain and severe haematotoxicity during 3 days of dosing. Based on inhalation studies the developmental NOAEC of 50 ppm can be taken into account for the risk assessment (rats). This value is based on variations seen at 100 ppm. These effects were seen in presence of maternal toxicity (haemolytic anaemia), which was seen at 100 ppm and higher. The maternal NOAEC for this effect was 50 ppm. Calculation of minimal MOS Since all key effect; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 56 were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day.","duration":"3 days","effect":"SCCP/1045/06 Opinion on ethylene glycol monobutylether (EGBE) 56 were seen with maternal toxicity (haemolytic anaemia) and retarded body weight gain evidenced from 100 mg/kg bw/day. The maternal NOAEL is 30 mg/kg bw/day in this study. This value is based on retarded bodyweight gain and severe haematotoxicity during 3 days of dosing. Based on inhalation studies the developmental NOAEC of 50 ppm can be taken into account for the risk assessment (rats). This value is based on variations seen at 100 ppm. These effects were seen in presence of maternal toxicity (haemolytic anaemia), which was seen at 100 ppm and higher. The maternal NOAEC for this effect was 50 ppm. Calculation of minimal MOS Since all key effect","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":56,"route":"inhalation","species":"rat","study_id":"sccp_o_095_noael_059"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 50 | ppm | rat | inhalation | 3 days | developmental toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=50; DOSE=Based on inhalation studies the developmental NOAEC of 50 ppm can be taken into account for the risk assessment (rats).; EFFECT=lue is based on retarded bodyweight gain and severe haematotoxicity during 3 days of dosing. Based on inhalation studies the developmental NOAEC of 50 ppm can be taken into account for the risk assessment (rats). This value is based on variations seen at 100 ppm. These effects were seen in presence of maternal toxicity (haemolytic anaemia), which was seen at 100 ppm and higher. The maternal NOAEC for this effect was 50 ppm. Calculation of minimal MOS Since all key effects are induced by haemolysis in rodents, a NOAEL based on haemotoxicity will be used in the risk characterisation. The selection of an appropriate interspecies chemical safety assessment factor (CSAF) must take into account the lower sensitivity of humans than rats (or mice) to BAA. WHO (1994) has proposed splitting the CSAF two components representing the toxicokinetic and toxicodynamic adjustment factors (Inter- species kinetics (4.0) and Inter-species dynamics (2.5) (see also The SCCP Notes of guidance for the testing of cosmetic ingredients and their safety; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"Based on inhalation studies the developmental NOAEC of 50 ppm can be taken into account for the risk assessment (rats).","duration":"3 days","effect":"lue is based on retarded bodyweight gain and severe haematotoxicity during 3 days of dosing. Based on inhalation studies the developmental NOAEC of 50 ppm can be taken into account for the risk assessment (rats). This value is based on variations seen at 100 ppm. These effects were seen in presence of maternal toxicity (haemolytic anaemia), which was seen at 100 ppm and higher. The maternal NOAEC for this effect was 50 ppm. Calculation of minimal MOS Since all key effects are induced by haemolysis in rodents, a NOAEL based on haemotoxicity will be used in the risk characterisation. The selection of an appropriate interspecies chemical safety assessment factor (CSAF) must take into account the lower sensitivity of humans than rats (or mice) to BAA. WHO (1994) has proposed splitting the CSAF two components representing the toxicokinetic and toxicodynamic adjustment factors (Inter- species kinetics (4.0) and Inter-species dynamics (2.5) (see also The SCCP Notes of guidance for the testing of cosmetic ingredients and their safety","endpoint":"developmental toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"ppm","noael_value":"50","page":56,"route":"inhalation","species":"rat","study_id":"sccp_o_095_noael_060"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | >50 | ppm | guinea pig | dermal | - | irritation | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=>50; DOSE=From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm.; EFFECT=ogical changes in the volunteers under the different conditions, physiological monitoring equipment was used). The published study paper does not mention if these signs were checked except the recording of the physiological changes. However, the author did indicate in a written communication that the volunteers were asked to report any adverse effects and none were reported. Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation. From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm. 3.3.3. Skin sensitisation Guinea pigs The study was performed according to OECD guideline 406. EGBE was tested in Guinea pigs for sensitisation potential. Induction was made with a dermal injection of 0.5% EGBE in 0.9% saline and a topical application of a 25% EGBE in 0.9% saline. Challenge was made with a topical application of 10% EGBE in saline. All topical applications were made occlusively. Concentrations tested were based on res; CITATION=Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation; CITATION_NUMBERS=[40]; REFERENCE=Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation","dose":"From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm.","duration":"","effect":"ogical changes in the volunteers under the different conditions, physiological monitoring equipment was used). The published study paper does not mention if these signs were checked except the recording of the physiological changes. However, the author did indicate in a written communication that the volunteers were asked to report any adverse effects and none were reported. Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation. From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm. 3.3.3. Skin sensitisation Guinea pigs The study was performed according to OECD guideline 406. EGBE was tested in Guinea pigs for sensitisation potential. Induction was made with a dermal injection of 0.5% EGBE in 0.9% saline and a topical application of a 25% EGBE in 0.9% saline. Challenge was made with a topical application of 10% EGBE in saline. All topical applications were made occlusively. Concentrations tested were based on res","endpoint":"irritation","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"ppm","noael_value":">50","page":14,"route":"dermal","species":"guinea pig","study_id":"sccp_o_095_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | >50 | ppm | guinea pig | dermal | - | irritation | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=>50; DOSE=From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm.; EFFECT=teers under the different conditions, physiological monitoring equipment was used). The published study paper does not mention if these signs were checked except the recording of the physiological changes. However, the author did indicate in a written communication that the volunteers were asked to report any adverse effects and none were reported. Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation. From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm. 3.3.3. Skin sensitisation Guinea pigs The study was performed according to OECD guideline 406. EGBE was tested in Guinea pigs for sensitisation potential. Induction was made with a dermal injection of 0.5% EGBE in 0.9% saline and a topical application of a 25% EGBE in 0.9% saline. Challenge was made with a topical application of 10% EGBE in saline. All topical applications were made occlusively. Concentrations tested were based on results found in preliminary s; CITATION=Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation; CITATION_NUMBERS=[40]; REFERENCE=Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation","dose":"From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm.","duration":"","effect":"teers under the different conditions, physiological monitoring equipment was used). The published study paper does not mention if these signs were checked except the recording of the physiological changes. However, the author did indicate in a written communication that the volunteers were asked to report any adverse effects and none were reported. Ref.: 40 Comment Studies available did not show any signs of significant respiratory irritation. From the human data it is apparent that the NOEL is >50 ppm whilst the NOEL (based on effects of discomfort) is 100 – 200 ppm. 3.3.3. Skin sensitisation Guinea pigs The study was performed according to OECD guideline 406. EGBE was tested in Guinea pigs for sensitisation potential. Induction was made with a dermal injection of 0.5% EGBE in 0.9% saline and a topical application of a 25% EGBE in 0.9% saline. Challenge was made with a topical application of 10% EGBE in saline. All topical applications were made occlusively. Concentrations tested were based on results found in preliminary s","endpoint":"irritation","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"ppm","noael_value":">50","page":14,"route":"dermal","species":"guinea pig","study_id":"sccp_o_095_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 129 | mg/kg bw/d | rat | oral | 13 weeks | irritation | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=129; DOSE=SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (female...; LOAEL_VALUE=676 mg/kg bw/d; EFFECT=SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (females) may be used) Mice 13 weeks in drinking water NOAEL = 223 and 370 mg/kg bw/d for males and females respectively LOAEL = 553 and 676 mg/kg bw/d for males and females respectively Slight decrease in body weight gain 55 General comments Effects seen by oral route were body weight reduction, haemolysis, hepatic effects and local irritation ef; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (female...","duration":"13 weeks","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (females) may be used) Mice 13 weeks in drinking water NOAEL = 223 and 370 mg/kg bw/d for males and females respectively LOAEL = 553 and 676 mg/kg bw/d for males and females respectively Slight decrease in body weight gain 55 General comments Effects seen by oral route were body weight reduction, haemolysis, hepatic effects and local irritation ef","endpoint":"irritation","ingredient":"Butoxyethanol (INCI)","loael_value":"676 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"129","page":24,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 370 | mg/kg bw/d | rat | oral | 13 weeks | irritation | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=370; DOSE=SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (female...; LOAEL_VALUE=676 mg/kg bw/d; EFFECT=SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (females) may be used) Mice 13 weeks in drinking water NOAEL = 223 and 370 mg/kg bw/d for males and females respectively LOAEL = 553 and 676 mg/kg bw/d for males and females respectively Slight decrease in body weight gain 55 General comments Effects seen by oral route were body weight reduction, haemolysis, hepatic effects and local irritation effects. Irritation to the forestomach was seen after gavage dosing. A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (female...","duration":"13 weeks","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 24 Study NOAEL (mg/kg bw/d) Effects Ref. anaemia indicated by a decrease in RBC counts in male rats in the three highest dose groups a NOAEL of 129 mg/kg bw/d (males) or 150 mg/kg bw (females) may be used) Mice 13 weeks in drinking water NOAEL = 223 and 370 mg/kg bw/d for males and females respectively LOAEL = 553 and 676 mg/kg bw/d for males and females respectively Slight decrease in body weight gain 55 General comments Effects seen by oral route were body weight reduction, haemolysis, hepatic effects and local irritation effects. Irritation to the forestomach was seen after gavage dosing. A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and","endpoint":"irritation","ingredient":"Butoxyethanol (INCI)","loael_value":"676 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"370","page":24,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 1000 | mg/kg bw | rabbit | dermal | 9 days | irritation | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=1000; DOSE=ative responses significant only at doses of 500 and 1000 mg/kg (a decrease was also seen for the 1500 mg/kg bw dose but not statistically significant, this weakens the relevance of this finding).; EFFECT=ative responses significant only at doses of 500 and 1000 mg/kg (a decrease was also seen for the 1500 mg/kg bw dose but not statistically significant, this weakens the relevance of this finding). The same results were seen in the MLR assay (decreased responses at the high doses, significant only at 500 and 1000 mg/kg bw). NK, CTL activity and T-dependent PFC response was unchanged after treatment. The lack of a dose-related response in these observations throws doubt on their significance for EGBE toxicology. The NOAEL for immunological effects was 1000 mg/kg bw, based on spleen weight reduction at 1500 mg/kg bw/d. Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mixture corresponding to 45, 225, 450, and 900 mg/kg bw) during 6 hr/day for 9 days (dosed 5 days, no dosed 2 days and dosed 4 days). Control group was treated with vehicle only. Dermal irritation score were determined after each test; CITATION=Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mix; CITATION_NUMBERS=[56,4,5,25,50,100,1]; REFERENCE=Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mix; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mix","dose":"ative responses significant only at doses of 500 and 1000 mg/kg (a decrease was also seen for the 1500 mg/kg bw dose but not statistically significant, this weakens the relevance of this finding).","duration":"9 days","effect":"ative responses significant only at doses of 500 and 1000 mg/kg (a decrease was also seen for the 1500 mg/kg bw dose but not statistically significant, this weakens the relevance of this finding). The same results were seen in the MLR assay (decreased responses at the high doses, significant only at 500 and 1000 mg/kg bw). NK, CTL activity and T-dependent PFC response was unchanged after treatment. The lack of a dose-related response in these observations throws doubt on their significance for EGBE toxicology. The NOAEL for immunological effects was 1000 mg/kg bw, based on spleen weight reduction at 1500 mg/kg bw/d. Ref.: 56 Rabbits EGBE was administered occlusively via dermal route to 4 groups of New Zealand (NZ) white rabbits (5 animals/sex) at concentrations of 5, 25, 50, and 100% (1 ml/kg of mixture corresponding to 45, 225, 450, and 900 mg/kg bw) during 6 hr/day for 9 days (dosed 5 days, no dosed 2 days and dosed 4 days). Control group was treated with vehicle only. Dermal irritation score were determined after each test","endpoint":"irritation","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":25,"route":"dermal","species":"rabbit","study_id":"sccp_o_095_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | 150 | mg/kg bw/d | rat | oral | - | irritation | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=150; DOSE=LOAELs of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats.; EFFECT=ts. Irritation to the forestomach was seen after gavage dosing. LOAELs of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats. Alternatively, based on mild anaemia indicated by a decrease in RBC counts and liver damage in male rats a NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. This value is also in agreement with results from the skin painting experiment below. Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects at higher doses. Given that; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"LOAELs of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats.","duration":"","effect":"ts. Irritation to the forestomach was seen after gavage dosing. LOAELs of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats. Alternatively, based on mild anaemia indicated by a decrease in RBC counts and liver damage in male rats a NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. This value is also in agreement with results from the skin painting experiment below. Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects at higher doses. Given that","endpoint":"irritation","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"150","page":55,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_053"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | irritation | =222 | - | - | oral | 6 weeks | irritation | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=LOAEL = 222; EFFECT=Unlabeled table on page 23: 6 weeks gavage | LOAEL = 222 | Haematological effects at all doses and irritant effects on the stomach | 52; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"","duration":"6 weeks","effect":"Unlabeled table on page 23: 6 weeks gavage | LOAEL = 222 | Haematological effects at all doses and irritant effects on the stomach | 52","endpoint":"irritation","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"","noael_value":"LOAEL = 222","page":23,"route":"oral","species":"","study_id":"sccp_o_095_noael_066"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 370 | mg/kg bw | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=370; DOSE=rol group and treated mice.; EFFECT=rol group and treated mice. No mice treated with EGBE died or were killed before the scheduled end of the study and there were no significant clinical signs of toxicity. Body weight gains were slightly reduced in both male and female mice of the 3000 and 6000 ppm treatment groups. No particular pattern was evident in drinking water consumption. Organ weight changes that were found were secondary to body weight gain reduction. No treatment related gross or microscopic lesions in male or female mice were found. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LO; CITATION=Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments; CITATION_NUMBERS=[55]; REFERENCE=Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments","dose":"rol group and treated mice.","duration":"subchronic","effect":"rol group and treated mice. No mice treated with EGBE died or were killed before the scheduled end of the study and there were no significant clinical signs of toxicity. Body weight gains were slightly reduced in both male and female mice of the 3000 and 6000 ppm treatment groups. No particular pattern was evident in drinking water consumption. Organ weight changes that were found were secondary to body weight gain reduction. No treatment related gross or microscopic lesions in male or female mice were found. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LO","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"370","page":23,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =0.05 | % | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 0.05; DOSE=The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study.; LOAEL_VALUE=41 mg/kg; EFFECT=ght changes that were found were secondary to body weight gain reduction. No treatment related gross or microscopic lesions in male or female mice were found. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LOAEL = 310 Poorly reported 53 90 days in food NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) Decrease in food consumption and body weight gain in males. Testes atrophy. 54 13 weeks in drinking water LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild Slight cytoplasmic alterations in hepatoc; CITATION=Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments; CITATION_NUMBERS=[55]; REFERENCE=Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments","dose":"The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study.","duration":"subchronic","effect":"ght changes that were found were secondary to body weight gain reduction. No treatment related gross or microscopic lesions in male or female mice were found. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LOAEL = 310 Poorly reported 53 90 days in food NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) Decrease in food consumption and body weight gain in males. Testes atrophy. 54 13 weeks in drinking water LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild Slight cytoplasmic alterations in hepatoc","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"41 mg/kg","noael_unit":"%","noael_value":"= 0.05","page":23,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =0.05 | % | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 0.05; DOSE=The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study.; LOAEL_VALUE=41 mg/kg; EFFECT=nd. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LOAEL = 310 Poorly reported 53 90 days in food NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) Decrease in food consumption and body weight gain in males. Testes atrophy. 54 13 weeks in drinking water LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild Slight cytoplasmic alterations in hepatocytes of both male and female rats 55; CITATION=Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments; CITATION_NUMBERS=[55]; REFERENCE=Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments","dose":"The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study.","duration":"subchronic","effect":"nd. The NOAEL of 223/370 mg/kg bw is not very reliable because no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LOAEL = 310 Poorly reported 53 90 days in food NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) Decrease in food consumption and body weight gain in males. Testes atrophy. 54 13 weeks in drinking water LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild Slight cytoplasmic alterations in hepatocytes of both male and female rats 55","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"41 mg/kg","noael_unit":"%","noael_value":"= 0.05","page":23,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =0.05 | % | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT== 0.05; DOSE=Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref.; LOAEL_VALUE=41 mg/kg; EFFECT=use no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LOAEL = 310 Poorly reported 53 90 days in food NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) Decrease in food consumption and body weight gain in males. Testes atrophy. 54 13 weeks in drinking water LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild Slight cytoplasmic alterations in hepatocytes of both male and female rats 55; CITATION=Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments; CITATION_NUMBERS=[55]; REFERENCE=Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments","dose":"Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref.","duration":"subchronic","effect":"use no haematological analysis were performed on animals during or after the study. Ref.: 55 The subchronic toxicity after oral administration of EGBE has been determined in several animal experiments. The results are summarized in Table 3.7. Table 3.7. Summary of studies performed by oral route Study NOAEL (mg/kg bw/d) Effects Ref. Rats 6 weeks gavage LOAEL = 222 Haematological effects at all doses and irritant effects on the stomach 52 90 days in food NOAEL = 76 LOAEL = 310 Poorly reported 53 90 days in food NOAEL = 0.05 % (38 and 41 mg/kg in male and females respectively) Decrease in food consumption and body weight gain in males. Testes atrophy. 54 13 weeks in drinking water LOAEL of 69 and 82 mg/kg bw/day for males and females respectively. (Alternatively, based on mild Slight cytoplasmic alterations in hepatocytes of both male and female rats 55","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"41 mg/kg","noael_unit":"%","noael_value":"= 0.05","page":23,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 129 | mg/kg bw/d | rat | oral | - | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=129; DOSE=A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats.; LOAEL_VALUE=82 mg/kg bw/d; EFFECT=55 General comments Effects seen by oral route were body weight reduction, haemolysis, hepatic effects and local irritation effects. Irritation to the forestomach was seen after gavage dosing. A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats. Alternatively, based on mild anaemia indicated by a decrease in RBC counts and liver damage in male rats in the three highest dose groups in ref 55 a NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. It should be noted (see 3.3.1.1) that humans are much more resistant to haemolysis than rodents. 3.3.5.2. Repeated dose dermal toxicity Mice Guideline: / Species/strain: BALB/c female mice Group size: / Test substance: EGB; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats.","duration":"","effect":"55 General comments Effects seen by oral route were body weight reduction, haemolysis, hepatic effects and local irritation effects. Irritation to the forestomach was seen after gavage dosing. A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats. Alternatively, based on mild anaemia indicated by a decrease in RBC counts and liver damage in male rats in the three highest dose groups in ref 55 a NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. It should be noted (see 3.3.1.1) that humans are much more resistant to haemolysis than rodents. 3.3.5.2. Repeated dose dermal toxicity Mice Guideline: / Species/strain: BALB/c female mice Group size: / Test substance: EGB","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"82 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"129","page":24,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 150 | mg/kg bw/d | rat | oral | 4 days | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=150; DOSE=A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats.; LOAEL_VALUE=82 mg/kg bw/d; EFFECT=fter gavage dosing. A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats. Alternatively, based on mild anaemia indicated by a decrease in RBC counts and liver damage in male rats in the three highest dose groups in ref 55 a NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. It should be noted (see 3.3.1.1) that humans are much more resistant to haemolysis than rodents. 3.3.5.2. Repeated dose dermal toxicity Mice Guideline: / Species/strain: BALB/c female mice Group size: / Test substance: EGBE Batch: / Purity: / Dose levels: 0, 100, 500, 1000 and 1500 mg/kg bw/day Route: Dermal Exposures: 4 days GLP: / EGBE was administered to BALB/c mice (5-6 weeks old) to asses; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats.","duration":"4 days","effect":"fter gavage dosing. A LOAEL of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats. Alternatively, based on mild anaemia indicated by a decrease in RBC counts and liver damage in male rats in the three highest dose groups in ref 55 a NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. It should be noted (see 3.3.1.1) that humans are much more resistant to haemolysis than rodents. 3.3.5.2. Repeated dose dermal toxicity Mice Guideline: / Species/strain: BALB/c female mice Group size: / Test substance: EGBE Batch: / Purity: / Dose levels: 0, 100, 500, 1000 and 1500 mg/kg bw/day Route: Dermal Exposures: 4 days GLP: / EGBE was administered to BALB/c mice (5-6 weeks old) to asses","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"82 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"150","page":24,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 1500 | mg/kg bw/day | mouse | dermal | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=1500; DOSE=Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.; EFFECT=SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolys; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.","duration":"subchronic","effect":"SCCP/1045/06, 3.04.07 Opinion on Ethylene glycol monobutyl ether ___________________________________________________________________________________________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolys","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1500","page":27,"route":"dermal","species":"mouse","study_id":"sccp_o_095_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 900 | mg/kg bw/d | mouse | dermal | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=900; DOSE=Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.; EFFECT=butyl ether ___________________________________________________________________________________________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.","duration":"subchronic","effect":"butyl ether ___________________________________________________________________________________________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"900","page":27,"route":"dermal","species":"mouse","study_id":"sccp_o_095_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 150 | mg/kg bw/d | mouse | dermal | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=150; DOSE=Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.; EFFECT=_______________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. Thi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref.","duration":"subchronic","effect":"_______________ 27 The subchronic toxicity after dermal application of EGBE has been determined in several animal experiments. The results are summarized in Table 3.8. Table 3.8. Summary of the studies performed by dermal route Study NOAEL (mg/kg bw/d) Effects Ref. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. Thi","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"150","page":27,"route":"dermal","species":"mouse","study_id":"sccp_o_095_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 450 | mg/kg bw/d | rat | inhalation | 4 days | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=450; DOSE=0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500.; EFFECT=f. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whol; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500.","duration":"4 days","effect":"f. Mice 4 days. Doses: 0, 100, 500, 1000, 1500 mg/kg bw/day NOAEL=1000 Effects on splenic cellularity at 1500. 56 Rabbits 9 days. Doses: 45, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whol","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"450","page":27,"route":"inhalation","species":"rat","study_id":"sccp_o_095_noael_026"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 900 | mg/kg bw/d | rat | inhalation | 13 weeks | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=900; DOSE=5, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks.; EFFECT=5, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whole body) to various concentrations of EGBE and for different periods of time. Rats were maintained in the exposure chamber for periods of u; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"5, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks.","duration":"13 weeks","effect":"5, 225, 450, 900 mg/kg bw/d NOAEL = 450 Transient haematological effects 57 13 weeks. Doses: 10, 50, 150 mg/kg bw/d NOAEL > 150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whole body) to various concentrations of EGBE and for different periods of time. Rats were maintained in the exposure chamber for periods of u","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"900","page":27,"route":"inhalation","species":"rat","study_id":"sccp_o_095_noael_027"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 150 | mg/kg bw/d | rat | inhalation | 9 days | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=150; DOSE=150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally.; EFFECT=150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whole body) to various concentrations of EGBE and for different periods of time. Rats were maintained in the exposure chamber for periods of up to 6 hours, and between repeated daily exposures they were returned to their cages where food and water were freely avail; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally.","duration":"9 days","effect":"150 No effects 58 Comment Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whole body) to various concentrations of EGBE and for different periods of time. Rats were maintained in the exposure chamber for periods of up to 6 hours, and between repeated daily exposures they were returned to their cages where food and water were freely avail","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"150","page":27,"route":"inhalation","species":"rat","study_id":"sccp_o_095_noael_028"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 1000 | mg/kg | rat | inhalation | 9 days | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=1000; DOSE=This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d.; EFFECT=ministered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whole body) to various concentrations of EGBE and for different periods of time. Rats were maintained in the exposure chamber for periods of up to 6 hours, and between repeated daily exposures they were returned to their cages where food and water were freely available. In the initial experiments the concentrations were selected to produce, if possible, acute effects after short; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d.","duration":"9 days","effect":"ministered dermally. In only one study, signs of toxicity were recorded and were limited to transient signs of haemolysis. This study led to a NOAEL of 450 mg/kg bw/d due to haematological effects seen at 900 mg/kg bw/d. Given that this study was performed only during 9 days, the NOAEL of the second study, which was performed during 13 weeks, could be more reliable for the risk characterisation. This NOAEL was 150 mg/kg bw/d. The mouse study designed for the assessment of EGBE effects on the immune system, gives a NOAEL of 1000 mg/kg. 3.3.5.3. Repeated dose inhalation toxicity Rats Groups of Alderly Park rats (4 males and 4 females/group) were exposed (whole body) to various concentrations of EGBE and for different periods of time. Rats were maintained in the exposure chamber for periods of up to 6 hours, and between repeated daily exposures they were returned to their cages where food and water were freely available. In the initial experiments the concentrations were selected to produce, if possible, acute effects after short","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"1000","page":27,"route":"inhalation","species":"rat","study_id":"sccp_o_095_noael_029"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 129 | mg/kg bw/d | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=129; DOSE=LOAELs of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats.; EFFECT=ber of animal subchronic and chronic studies have been performed. Effects seen by oral route were body weight reduction, haemolysis, hepatic effects and local irritation effects. Irritation to the forestomach was seen after gavage dosing. LOAELs of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats. Alternatively, based on mild anaemia indicated by a decrease in RBC counts and liver damage in male rats a NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. This value is also in agreement with results from the skin painting experiment below. Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"LOAELs of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats.","duration":"subchronic","effect":"ber of animal subchronic and chronic studies have been performed. Effects seen by oral route were body weight reduction, haemolysis, hepatic effects and local irritation effects. Irritation to the forestomach was seen after gavage dosing. LOAELs of 69 and 82 mg/kg bw/d (in males and females respectively) were observed in rats based on slight cytoplasmic alterations in hepatocytes of both male and female rats. Alternatively, based on mild anaemia indicated by a decrease in RBC counts and liver damage in male rats a NOAEL of 129 mg/kg bw/d may be used. The French Authorities (The Conseil Supérieur d’Hygiéne Publique de France (CSHPF), 7 November 2002) used 150 mg/kg bw/d representing the NOAEL for female rats since the effects in the female rats were more severe than in the male rats for their MOS calculation. This value is also in agreement with results from the skin painting experiment below. Two studies are available on rabbits to assess the toxicity of repeated doses of EGBE administered dermally. In only one study, signs of t","endpoint":"repeated dose toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"129","page":55,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_052"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 720 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=720; DOSE=66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death.; LOAEL_VALUE=720 mg/kg bw/day; EFFECT=of reproductive organs, sperm motility, morphology and the oestrous cycle length and frequency were noted. However, a significant increase in relative kidney weight in the females and a significant increase in relative liver weight in both the males and females were observed. Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death. Under the conditions of the study, the NOAEL for reproductive toxicity of EGBE (fertility) can be set as 720 mg/kg bw/day. For developmental toxicity, no NOAEL can be derived. A conservative LOAEL of 720 mg/kg bw/day can be taken as only a slight decrease in pup weight (p<0.05) was observed at this dose. 3.3.8.2. Teratogenicity Oral route Rats Guideline: / Species/strain: Fisher 344 rats Group size: See below Test substance: EGBE Batch: / Purity: >99% Dose levels: 0 (control), 30, 100, and 200 mg/kg bw/day (GD 9-11); 0 (control), 30, 100, and 300 mg/kg bw; CITATION=Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, i; CITATION_NUMBERS=[66,67,68,1340]; REFERENCE=Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, i; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, i","dose":"66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death.","duration":"developmental","effect":"of reproductive organs, sperm motility, morphology and the oestrous cycle length and frequency were noted. However, a significant increase in relative kidney weight in the females and a significant increase in relative liver weight in both the males and females were observed. Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death. Under the conditions of the study, the NOAEL for reproductive toxicity of EGBE (fertility) can be set as 720 mg/kg bw/day. For developmental toxicity, no NOAEL can be derived. A conservative LOAEL of 720 mg/kg bw/day can be taken as only a slight decrease in pup weight (p<0.05) was observed at this dose. 3.3.8.2. Teratogenicity Oral route Rats Guideline: / Species/strain: Fisher 344 rats Group size: See below Test substance: EGBE Batch: / Purity: >99% Dose levels: 0 (control), 30, 100, and 200 mg/kg bw/day (GD 9-11); 0 (control), 30, 100, and 300 mg/kg bw","endpoint":"reproductive toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"720 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"720","page":47,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_030"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 720 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=720; DOSE=66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death.; LOAEL_VALUE=720 mg/kg bw/day; EFFECT=, a significant increase in relative kidney weight in the females and a significant increase in relative liver weight in both the males and females were observed. Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death. Under the conditions of the study, the NOAEL for reproductive toxicity of EGBE (fertility) can be set as 720 mg/kg bw/day. For developmental toxicity, no NOAEL can be derived. A conservative LOAEL of 720 mg/kg bw/day can be taken as only a slight decrease in pup weight (p<0.05) was observed at this dose. 3.3.8.2. Teratogenicity Oral route Rats Guideline: / Species/strain: Fisher 344 rats Group size: See below Test substance: EGBE Batch: / Purity: >99% Dose levels: 0 (control), 30, 100, and 200 mg/kg bw/day (GD 9-11); 0 (control), 30, 100, and 300 mg/kg bw/day (GD 11-13) Route: Oral, gavage Exposures: Gestation days 9 through 11 or 11 through 13 GLP: In compliance The; CITATION=Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, i; CITATION_NUMBERS=[66,67,68,1340]; REFERENCE=Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, i; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, i","dose":"66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death.","duration":"developmental","effect":", a significant increase in relative kidney weight in the females and a significant increase in relative liver weight in both the males and females were observed. Ref.: 66, 67, 68 Comment Significant adverse reproductive effects were observed in the females at very high dose levels (1340 mg/kg bw/day and above) which also caused severe toxicity, including death. Under the conditions of the study, the NOAEL for reproductive toxicity of EGBE (fertility) can be set as 720 mg/kg bw/day. For developmental toxicity, no NOAEL can be derived. A conservative LOAEL of 720 mg/kg bw/day can be taken as only a slight decrease in pup weight (p<0.05) was observed at this dose. 3.3.8.2. Teratogenicity Oral route Rats Guideline: / Species/strain: Fisher 344 rats Group size: See below Test substance: EGBE Batch: / Purity: >99% Dose levels: 0 (control), 30, 100, and 200 mg/kg bw/day (GD 9-11); 0 (control), 30, 100, and 300 mg/kg bw/day (GD 11-13) Route: Oral, gavage Exposures: Gestation days 9 through 11 or 11 through 13 GLP: In compliance The","endpoint":"reproductive toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"720 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"720","page":47,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_031"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 200 | ppm | rat | - | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=200; DOSE=A statistically significant decrease in foetal weights was observed in the 150 ppm exposure group.; EFFECT=oup. A statistically significant decrease in foetal weights was observed in the 150 ppm exposure group. Since differences in foetal weights between experimental and control groups were slight, and, also, that significant differences were not observed in the 200 ppm exposure group, these differences were not thought to have been of biological significance. For this study a very conservative LOAEL of 150 ppm can be determined for dams for haematuria seen in the first day of treatment. For developmental toxicity, the NOAEL is 200 ppm. Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99.6 %) for 6hr/day on GD 6-15 (GD0 = sperm plug positive). No adverse reproductive or developmental effects were observed in animals exposed to 25 ppm or 50 ppm. Maternal toxicity was observed in a dose-related incidence during the exposure period, included evidence of haematuria from 100 ppm and pale, cold extremities with necrosis of the; CITATION=Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99; CITATION_NUMBERS=[75,344,36,25,50,100,200,121,242,483,966,3,99]; REFERENCE=Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99; DETAILS_JSON={"cas_number":"111-76-2","citation":"Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99","dose":"A statistically significant decrease in foetal weights was observed in the 150 ppm exposure group.","duration":"developmental","effect":"oup. A statistically significant decrease in foetal weights was observed in the 150 ppm exposure group. Since differences in foetal weights between experimental and control groups were slight, and, also, that significant differences were not observed in the 200 ppm exposure group, these differences were not thought to have been of biological significance. For this study a very conservative LOAEL of 150 ppm can be determined for dams for haematuria seen in the first day of treatment. For developmental toxicity, the NOAEL is 200 ppm. Ref.: 75 Mated female Fischer 344 rats (36 per group) were exposed whole body to 0, 25, 50, 100, and 200 ppm (0, 121, 242, 483, and 966 mg/m3) EGBE vapour (purity 99.6 %) for 6hr/day on GD 6-15 (GD0 = sperm plug positive). No adverse reproductive or developmental effects were observed in animals exposed to 25 ppm or 50 ppm. Maternal toxicity was observed in a dose-related incidence during the exposure period, included evidence of haematuria from 100 ppm and pale, cold extremities with necrosis of the","endpoint":"reproductive toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"ppm","noael_value":"200","page":49,"route":"","species":"rat","study_id":"sccp_o_095_noael_046"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 100 | mg/kg bw/day | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=100; DOSE=25 ppm in rats (about 9 mg/ kg bw/d) and a LOAEC of 31 ppm in mice and rats was established (based on haemolysis, as the only significant primary effect).; EFFECT=25 ppm in rats (about 9 mg/ kg bw/d) and a LOAEC of 31 ppm in mice and rats was established (based on haemolysis, as the only significant primary effect). Compared to a control group, workers exposed to EGBE (0.59+0.27 ppm) had a significant decrease (3.3%; p=0.03) in haematocrit, while mean corpuscular haemoglobin concentration (MCHC) was increased (2.1%; p=0.02). No significant difference was observed either in other erythroid parameters or hepatic and renal biomarkers. Reproductive toxicity The lowest foetal NOAEL is 100 mg/kg bw/day in an oral rat study. It is based on effects seen at 200 mg/kg bw/day: increase in foetal lethality without malformations. These effects; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"25 ppm in rats (about 9 mg/ kg bw/d) and a LOAEC of 31 ppm in mice and rats was established (based on haemolysis, as the only significant primary effect).","duration":"","effect":"25 ppm in rats (about 9 mg/ kg bw/d) and a LOAEC of 31 ppm in mice and rats was established (based on haemolysis, as the only significant primary effect). Compared to a control group, workers exposed to EGBE (0.59+0.27 ppm) had a significant decrease (3.3%; p=0.03) in haematocrit, while mean corpuscular haemoglobin concentration (MCHC) was increased (2.1%; p=0.02). No significant difference was observed either in other erythroid parameters or hepatic and renal biomarkers. Reproductive toxicity The lowest foetal NOAEL is 100 mg/kg bw/day in an oral rat study. It is based on effects seen at 200 mg/kg bw/day: increase in foetal lethality without malformations. These effects","endpoint":"reproductive toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":55,"route":"oral","species":"rat","study_id":"sccp_o_095_noael_058"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 30 | mg/kg bw/d | rabbit | - | 3 day | reproductive toxicity | SOURCE_SUBDIR=sccp_o_095; REPORT_TITLE=OPINION ON ETHYLENE GLYCOL MONOBUTYL ETHER (EGBE) Butoxyethanol (INCI); OPINION_NUMBER=SCCP/1045/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=30; DOSE=The lowest NOAEL was 30 mg/kg bw/d obtained a reproductive toxicity study and represent maternal toxicity after 3 day exposure.; EFFECT=K model. The toxicodynamics factor needs to be set to an appropriate value to reflect the lower sensitivity of humans to haemolysis. The data available on the most sensitive measure (pre-haemolytic changes) suggests that a value of 0.01 would be realistic. However, a more cautious and conservative initial approach would be to propose a value of 0.1. This imply that a factor of (4.0 x 0.1) 0.4 is just for species differences and gives a minimal MOS of 4 taking intra species variation into consideration. The lowest NOAEL was 30 mg/kg bw/d obtained a reproductive toxicity study and represent maternal toxicity after 3 day exposure. The effect was due to haematological effects and probably secondary reaction to this at a dose of 100 mg/kg bw/d. Irritation / sensitisation Studies performed on rabbits and guinea pigs have shown that EGBE have caused moderate irritation (erythema and oedema) when applied occlusively on the skin for a period of 4 hours. If the substance was applied on scarified skin or for a longer period of time, sign; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"111-76-2","citation":"","dose":"The lowest NOAEL was 30 mg/kg bw/d obtained a reproductive toxicity study and represent maternal toxicity after 3 day exposure.","duration":"3 day","effect":"K model. The toxicodynamics factor needs to be set to an appropriate value to reflect the lower sensitivity of humans to haemolysis. The data available on the most sensitive measure (pre-haemolytic changes) suggests that a value of 0.01 would be realistic. However, a more cautious and conservative initial approach would be to propose a value of 0.1. This imply that a factor of (4.0 x 0.1) 0.4 is just for species differences and gives a minimal MOS of 4 taking intra species variation into consideration. The lowest NOAEL was 30 mg/kg bw/d obtained a reproductive toxicity study and represent maternal toxicity after 3 day exposure. The effect was due to haematological effects and probably secondary reaction to this at a dose of 100 mg/kg bw/d. Irritation / sensitisation Studies performed on rabbits and guinea pigs have shown that EGBE have caused moderate irritation (erythema and oedema) when applied occlusively on the skin for a period of 4 hours. If the substance was applied on scarified skin or for a longer period of time, sign","endpoint":"reproductive toxicity","ingredient":"Butoxyethanol (INCI)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"30","page":56,"route":"","species":"rabbit","study_id":"sccp_o_095_noael_061"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | I0P9XEZ9WV | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H14O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"I0P9XEZ9WV"} |
| openFDA substances | FDA UNII substance identifier | I0P9XEZ9WV | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H14O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"I0P9XEZ9WV"} |
| openFDA substances | FDA UNII substance identifier | I0P9XEZ9WV | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H14O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"I0P9XEZ9WV"} |
| openFDA substances | FDA UNII substance identifier | I0P9XEZ9WV | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H14O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"I0P9XEZ9WV"} |