NOAEL Studies
Cosmetic Ingredient
Butoxydiglycol NOAEL Studies
INCI: BUTOXYDIGLYCOL
CAS: 112-34-5
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
NTP ICE acute oral 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE acute oral | LD50 | =4500 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_1177; row=13315; data_type=In Vivo; mixture=Chemical; chemical_name=2-(2-Butoxyethoxy)ethanol; preferred_name=2-(2-Butoxyethoxy)ethanol; dtxsid=DTXSID8021519; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021519; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | >5000 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | record_id=acute_oral_1178; row=13321; data_type=In Vivo; mixture=Chemical; chemical_name=2-(2-Butoxyethoxy)ethanol; preferred_name=2-(2-Butoxyethoxy)ethanol; dtxsid=DTXSID8021519; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021519; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =5080 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | JRC AcutoxBase (undated); record_id=acute_oral_1179; row=13314; data_type=In Vivo; mixture=Chemical; chemical_name=2-(2-Butoxyethoxy)ethanol; preferred_name=2-(2-Butoxyethoxy)ethanol; dtxsid=DTXSID8021519; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021519; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =5660 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_1180; row=13313; data_type=In Vivo; mixture=Chemical; chemical_name=2-(2-Butoxyethoxy)ethanol; preferred_name=2-(2-Butoxyethoxy)ethanol; dtxsid=DTXSID8021519; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021519; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =6050 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | JRC AcutoxBase (undated); record_id=acute_oral_1181; row=13312; data_type=In Vivo; mixture=Chemical; chemical_name=2-(2-Butoxyethoxy)ethanol; preferred_name=2-(2-Butoxyethoxy)ethanol; dtxsid=DTXSID8021519; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021519; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =6530 | mg/kg bw | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | JRC AcutoxBase (undated); record_id=acute_oral_1182; row=13310; data_type=In Vivo; mixture=Chemical; chemical_name=2-(2-Butoxyethoxy)ethanol; preferred_name=2-(2-Butoxyethoxy)ethanol; dtxsid=DTXSID8021519; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021519; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =6560 | mg/kg bw | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | JRC AcutoxBase (undated); record_id=acute_oral_1183; row=13320; data_type=In Vivo; mixture=Chemical; chemical_name=2-(2-Butoxyethoxy)ethanol; preferred_name=2-(2-Butoxyethoxy)ethanol; dtxsid=DTXSID8021519; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021519; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =6600 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_1184; row=13319; data_type=In Vivo; mixture=Chemical; chemical_name=2-(2-Butoxyethoxy)ethanol; preferred_name=2-(2-Butoxyethoxy)ethanol; dtxsid=DTXSID8021519; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021519; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =7291 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | OECD eChemPortal (undated); record_id=acute_oral_1185; row=13318; data_type=In Vivo; mixture=Chemical; chemical_name=2-(2-Butoxyethoxy)ethanol; preferred_name=2-(2-Butoxyethoxy)ethanol; dtxsid=DTXSID8021519; url=https://www.echemportal.org/echemportal/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021519; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =7292 | mg/kg bw | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_1186; row=13317; data_type=In Vivo; mixture=Chemical; chemical_name=2-(2-Butoxyethoxy)ethanol; preferred_name=2-(2-Butoxyethoxy)ethanol; dtxsid=DTXSID8021519; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021519; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =7300 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | JRC AcutoxBase (undated); record_id=acute_oral_1187; row=13316; data_type=In Vivo; mixture=Chemical; chemical_name=2-(2-Butoxyethoxy)ethanol; preferred_name=2-(2-Butoxyethoxy)ethanol; dtxsid=DTXSID8021519; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021519; source_file=acute_oral.xlsx |
| NTP ICE acute oral | LD50 | =9623 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | OECD eChemPortal (undated); record_id=acute_oral_1188; row=13311; data_type=In Vivo; mixture=Chemical; chemical_name=2-(2-Butoxyethoxy)ethanol; preferred_name=2-(2-Butoxyethoxy)ethanol; dtxsid=DTXSID8021519; url=https://www.echemportal.org/echemportal/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021519; source_file=acute_oral.xlsx |
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=1402; RecordID=ARPathway2016_604; DatasetName=ARPathway2016; DTXSID=DTXSID8021519; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021519; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8021519 |
SCCS Opinion 40 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS Opinion | NOAEL | =2.6 | mg/kg | rat | oral | 13 week | dermal absorption | {"dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","effect":"n of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The ph","page":18,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_010"} |
| SCCS Opinion | NOAEL | =2.6 | mg/kg | rat | oral | 13 week | dermal absorption | {"dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","effect":"n of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The ph","page":18,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_010"} |
| SCCS Opinion | NOAEL | =2.6 | mg/kg | rat | oral | 13 week | dermal absorption | {"dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","effect":"n of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The ph","page":18,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_010"} |
| SCCS Opinion | NOAEL | =2.6 | mg/kg | rat | oral | 13 week | dermal absorption | {"dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","effect":"n of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The ph","page":18,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_010"} |
| SCCS Opinion | NOAEL | =50 | % | rat | oral | 13 week | dermal absorption | {"dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 18 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of","page":18,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_009"} |
| SCCS Opinion | NOAEL | =50 | % | rat | oral | 13 week | dermal absorption | {"dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 18 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of","page":18,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_009"} |
| SCCS Opinion | NOAEL | =50 | % | rat | oral | 13 week | dermal absorption | {"dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 18 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of","page":18,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_009"} |
| SCCS Opinion | NOAEL | =50 | % | rat | oral | 13 week | dermal absorption | {"dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 18 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of","page":18,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_009"} |
| SCCS Opinion | NOAEL | =51 | mg/kg bw/day | rat | oral | 28 days | repeated dose toxicity | {"citation":"Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk","dose":"Repeated dose toxicity 3.3.5.1.","effect":"1045/06 and 1044/06 by SCCP) it is unlikely that the dermal absorption is larger than 50%. 3.3.5. Repeated dose toxicity 3.3.5.1. Repeated dose (28 days) oral / dermal / inhalation toxicity Oral, rat Sherman rats, groups of 5 males and 5 females received 0, 51, 650, and 1830 mg/kg bw/day of DEGBE by gavage for 30 days. No effects were observed at 51 mg/kg bw/day. The food intake was reduced and slight (unspecified micro-pathological) changes in liver, kidney, spleen or testis were observed at the higher doses. NOAEL was 51 mg/kg bw/day. Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk. Hyperkeratosis in stomach (possibly fore-stomach) was observed at all doses. Increase in relative liver weight (statistically non-significant) was observed at low dose. At mid and high doses; decrease in red blood cell count, Hb, MCH, increased spleen weights (absolute and relative), increase in liver weight, lesions in spleen and kidneys. LOAEL was 891 mg/kg bw/day. Ref.:","page":9,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_002"} |
| SCCS Opinion | NOAEL | =51 | mg/kg bw/day | rat | oral | 28 days | repeated dose toxicity | {"citation":"Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk","dose":"Repeated dose toxicity 3.3.5.1.","effect":"1045/06 and 1044/06 by SCCP) it is unlikely that the dermal absorption is larger than 50%. 3.3.5. Repeated dose toxicity 3.3.5.1. Repeated dose (28 days) oral / dermal / inhalation toxicity Oral, rat Sherman rats, groups of 5 males and 5 females received 0, 51, 650, and 1830 mg/kg bw/day of DEGBE by gavage for 30 days. No effects were observed at 51 mg/kg bw/day. The food intake was reduced and slight (unspecified micro-pathological) changes in liver, kidney, spleen or testis were observed at the higher doses. NOAEL was 51 mg/kg bw/day. Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk. Hyperkeratosis in stomach (possibly fore-stomach) was observed at all doses. Increase in relative liver weight (statistically non-significant) was observed at low dose. At mid and high doses; decrease in red blood cell count, Hb, MCH, increased spleen weights (absolute and relative), increase in liver weight, lesions in spleen and kidneys. LOAEL was 891 mg/kg bw/day. Ref.:","page":9,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_002"} |
| SCCS Opinion | NOAEL | =51 | mg/kg bw/day | rat | oral | 28 days | repeated dose toxicity | {"citation":"Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk","dose":"Repeated dose toxicity 3.3.5.1.","effect":"1045/06 and 1044/06 by SCCP) it is unlikely that the dermal absorption is larger than 50%. 3.3.5. Repeated dose toxicity 3.3.5.1. Repeated dose (28 days) oral / dermal / inhalation toxicity Oral, rat Sherman rats, groups of 5 males and 5 females received 0, 51, 650, and 1830 mg/kg bw/day of DEGBE by gavage for 30 days. No effects were observed at 51 mg/kg bw/day. The food intake was reduced and slight (unspecified micro-pathological) changes in liver, kidney, spleen or testis were observed at the higher doses. NOAEL was 51 mg/kg bw/day. Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk. Hyperkeratosis in stomach (possibly fore-stomach) was observed at all doses. Increase in relative liver weight (statistically non-significant) was observed at low dose. At mid and high doses; decrease in red blood cell count, Hb, MCH, increased spleen weights (absolute and relative), increase in liver weight, lesions in spleen and kidneys. LOAEL was 891 mg/kg bw/day. Ref.:","page":9,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_002"} |
| SCCS Opinion | NOAEL | =51 | mg/kg bw/day | rat | oral | 28 days | repeated dose toxicity | {"citation":"Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk","dose":"Repeated dose toxicity 3.3.5.1.","effect":"1045/06 and 1044/06 by SCCP) it is unlikely that the dermal absorption is larger than 50%. 3.3.5. Repeated dose toxicity 3.3.5.1. Repeated dose (28 days) oral / dermal / inhalation toxicity Oral, rat Sherman rats, groups of 5 males and 5 females received 0, 51, 650, and 1830 mg/kg bw/day of DEGBE by gavage for 30 days. No effects were observed at 51 mg/kg bw/day. The food intake was reduced and slight (unspecified micro-pathological) changes in liver, kidney, spleen or testis were observed at the higher doses. NOAEL was 51 mg/kg bw/day. Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk. Hyperkeratosis in stomach (possibly fore-stomach) was observed at all doses. Increase in relative liver weight (statistically non-significant) was observed at low dose. At mid and high doses; decrease in red blood cell count, Hb, MCH, increased spleen weights (absolute and relative), increase in liver weight, lesions in spleen and kidneys. LOAEL was 891 mg/kg bw/day. Ref.:","page":9,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_002"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/day | rat | dermal | 5 days | NOAEL study | {"citation":"Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0","dose":"NOAEL was 250 mg/kg bw/day.","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 12 slight decrease in total proteins, cholesterol, and amino transferase was observed. Minor histopathological changes in the liver of female rats. No effects on sperm motility, morphology, sperm counts, or testis histopathology were observed. NOAEL was 250 mg/kg bw/day. The liver was the primary target of toxicity. Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0.2, 0.6, and 2 ml/kg bw/d (0, 190, 580, and 1900 mg/kg bw/day) 6 hrs/day, 5 days/wk for 13 wk with DEGBE (occluded). No systemic or neurotoxic effects were observed in the group of low- or mid-dosed groups. Renal tubular epithelium degeneration was found in 2 high-dosed males. NOAEL was 580 mg/kg bw/day. Ref.: 26 Guideline: / Species/strain: Sprague-Dawley rats Group","page":12,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_003"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/d | rat | oral | 5 days | genotoxicity | {"citation":"Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats","dose":"29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats.","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 13 Inhalation, rat Wistar rats, groups of 10 males and 10 females received 0, 13, 40, and 94 mg/m3 DEGBE 6 hrs/day, 5 days/wk for 90 days followed by a 4 wk recovery period. No effects were recorded. NOAEL was 94 mg/m3. Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats. The value is based on decreased bodyweight (4%) and increased relative liver weight (7 – 10%) in the higher dose group. 3.3.5.3. Chronic (> 12 months) toxicity No data found. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The in vitro genotoxicity of DEGBE has been studied in several experiments. The results are summarized in Table 3.2. Table 3","page":13,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_005"} |
| SCCS Opinion | NOAEL | =250 | mg/kg | rat | oral | 13 week | dermal absorption | {"dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","effect":"OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The physico- chemica","page":18,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_011"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/day | rat | dermal | 5 days | NOAEL study | {"citation":"Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0","dose":"NOAEL was 250 mg/kg bw/day.","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 12 slight decrease in total proteins, cholesterol, and amino transferase was observed. Minor histopathological changes in the liver of female rats. No effects on sperm motility, morphology, sperm counts, or testis histopathology were observed. NOAEL was 250 mg/kg bw/day. The liver was the primary target of toxicity. Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0.2, 0.6, and 2 ml/kg bw/d (0, 190, 580, and 1900 mg/kg bw/day) 6 hrs/day, 5 days/wk for 13 wk with DEGBE (occluded). No systemic or neurotoxic effects were observed in the group of low- or mid-dosed groups. Renal tubular epithelium degeneration was found in 2 high-dosed males. NOAEL was 580 mg/kg bw/day. Ref.: 26 Guideline: / Species/strain: Sprague-Dawley rats Group","page":12,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_003"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/d | rat | oral | 5 days | genotoxicity | {"citation":"Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats","dose":"29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats.","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 13 Inhalation, rat Wistar rats, groups of 10 males and 10 females received 0, 13, 40, and 94 mg/m3 DEGBE 6 hrs/day, 5 days/wk for 90 days followed by a 4 wk recovery period. No effects were recorded. NOAEL was 94 mg/m3. Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats. The value is based on decreased bodyweight (4%) and increased relative liver weight (7 – 10%) in the higher dose group. 3.3.5.3. Chronic (> 12 months) toxicity No data found. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The in vitro genotoxicity of DEGBE has been studied in several experiments. The results are summarized in Table 3.2. Table 3","page":13,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_005"} |
| SCCS Opinion | NOAEL | =250 | mg/kg | rat | oral | 13 week | dermal absorption | {"dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","effect":"OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The physico- chemica","page":18,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_011"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/day | rat | dermal | 5 days | NOAEL study | {"citation":"Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0","dose":"NOAEL was 250 mg/kg bw/day.","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 12 slight decrease in total proteins, cholesterol, and amino transferase was observed. Minor histopathological changes in the liver of female rats. No effects on sperm motility, morphology, sperm counts, or testis histopathology were observed. NOAEL was 250 mg/kg bw/day. The liver was the primary target of toxicity. Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0.2, 0.6, and 2 ml/kg bw/d (0, 190, 580, and 1900 mg/kg bw/day) 6 hrs/day, 5 days/wk for 13 wk with DEGBE (occluded). No systemic or neurotoxic effects were observed in the group of low- or mid-dosed groups. Renal tubular epithelium degeneration was found in 2 high-dosed males. NOAEL was 580 mg/kg bw/day. Ref.: 26 Guideline: / Species/strain: Sprague-Dawley rats Group","page":12,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_003"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/d | rat | oral | 5 days | genotoxicity | {"citation":"Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats","dose":"29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats.","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 13 Inhalation, rat Wistar rats, groups of 10 males and 10 females received 0, 13, 40, and 94 mg/m3 DEGBE 6 hrs/day, 5 days/wk for 90 days followed by a 4 wk recovery period. No effects were recorded. NOAEL was 94 mg/m3. Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats. The value is based on decreased bodyweight (4%) and increased relative liver weight (7 – 10%) in the higher dose group. 3.3.5.3. Chronic (> 12 months) toxicity No data found. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The in vitro genotoxicity of DEGBE has been studied in several experiments. The results are summarized in Table 3.2. Table 3","page":13,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_005"} |
| SCCS Opinion | NOAEL | =250 | mg/kg | rat | oral | 13 week | dermal absorption | {"dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","effect":"OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The physico- chemica","page":18,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_011"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/day | rat | dermal | 5 days | NOAEL study | {"citation":"Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0","dose":"NOAEL was 250 mg/kg bw/day.","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 12 slight decrease in total proteins, cholesterol, and amino transferase was observed. Minor histopathological changes in the liver of female rats. No effects on sperm motility, morphology, sperm counts, or testis histopathology were observed. NOAEL was 250 mg/kg bw/day. The liver was the primary target of toxicity. Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0.2, 0.6, and 2 ml/kg bw/d (0, 190, 580, and 1900 mg/kg bw/day) 6 hrs/day, 5 days/wk for 13 wk with DEGBE (occluded). No systemic or neurotoxic effects were observed in the group of low- or mid-dosed groups. Renal tubular epithelium degeneration was found in 2 high-dosed males. NOAEL was 580 mg/kg bw/day. Ref.: 26 Guideline: / Species/strain: Sprague-Dawley rats Group","page":12,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_003"} |
| SCCS Opinion | NOAEL | =250 | mg/kg bw/d | rat | oral | 5 days | genotoxicity | {"citation":"Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats","dose":"29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats.","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 13 Inhalation, rat Wistar rats, groups of 10 males and 10 females received 0, 13, 40, and 94 mg/m3 DEGBE 6 hrs/day, 5 days/wk for 90 days followed by a 4 wk recovery period. No effects were recorded. NOAEL was 94 mg/m3. Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats. The value is based on decreased bodyweight (4%) and increased relative liver weight (7 – 10%) in the higher dose group. 3.3.5.3. Chronic (> 12 months) toxicity No data found. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The in vitro genotoxicity of DEGBE has been studied in several experiments. The results are summarized in Table 3.2. Table 3","page":13,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_005"} |
| SCCS Opinion | NOAEL | =250 | mg/kg | rat | oral | 13 week | dermal absorption | {"dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","effect":"OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The physico- chemica","page":18,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_011"} |
| SCCS Opinion | NOAEL | =500 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | {"citation":"Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested)","dose":"esponse in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed.","effect":"esponse in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed. The two high dose levels caused skin irritation after about one week, which persisted until the end of the study. There were no indications for developmental or teratogenic effects at any of the dose levels tested. Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested). As for developmental effects, the oral NOAEL was established at 500 mg/kg bw/d. The only effect observed at the next higher dose level tested was reduced body weight gain of the pups. DEGBE caused no teratogenic effects. No effects were observed in a dermal one-generation study of rats at a dose of 2000 mg/kg bw/d. Neither systemic maternal toxicity nor developmental or teratogenic effects were observed in rabbits dermally exposed to dose levels up to 1000 mg/kg bw/d.","page":16,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_008"} |
| SCCS Opinion | NOAEL | =500 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | {"citation":"Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested)","dose":"esponse in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed.","effect":"esponse in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed. The two high dose levels caused skin irritation after about one week, which persisted until the end of the study. There were no indications for developmental or teratogenic effects at any of the dose levels tested. Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested). As for developmental effects, the oral NOAEL was established at 500 mg/kg bw/d. The only effect observed at the next higher dose level tested was reduced body weight gain of the pups. DEGBE caused no teratogenic effects. No effects were observed in a dermal one-generation study of rats at a dose of 2000 mg/kg bw/d. Neither systemic maternal toxicity nor developmental or teratogenic effects were observed in rabbits dermally exposed to dose levels up to 1000 mg/kg bw/d.","page":16,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_008"} |
| SCCS Opinion | NOAEL | =500 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | {"citation":"Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested)","dose":"esponse in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed.","effect":"esponse in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed. The two high dose levels caused skin irritation after about one week, which persisted until the end of the study. There were no indications for developmental or teratogenic effects at any of the dose levels tested. Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested). As for developmental effects, the oral NOAEL was established at 500 mg/kg bw/d. The only effect observed at the next higher dose level tested was reduced body weight gain of the pups. DEGBE caused no teratogenic effects. No effects were observed in a dermal one-generation study of rats at a dose of 2000 mg/kg bw/d. Neither systemic maternal toxicity nor developmental or teratogenic effects were observed in rabbits dermally exposed to dose levels up to 1000 mg/kg bw/d.","page":16,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_008"} |
| SCCS Opinion | NOAEL | =500 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | {"citation":"Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested)","dose":"esponse in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed.","effect":"esponse in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed. The two high dose levels caused skin irritation after about one week, which persisted until the end of the study. There were no indications for developmental or teratogenic effects at any of the dose levels tested. Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested). As for developmental effects, the oral NOAEL was established at 500 mg/kg bw/d. The only effect observed at the next higher dose level tested was reduced body weight gain of the pups. DEGBE caused no teratogenic effects. No effects were observed in a dermal one-generation study of rats at a dose of 2000 mg/kg bw/d. Neither systemic maternal toxicity nor developmental or teratogenic effects were observed in rabbits dermally exposed to dose levels up to 1000 mg/kg bw/d.","page":16,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_008"} |
| SCCS Opinion | NOAEL | =580 | mg/kg bw/day | rat | dermal | 5 days | NOAEL study | {"citation":"Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0","dose":"NOAEL was 250 mg/kg bw/day.","effect":"cts on sperm motility, morphology, sperm counts, or testis histopathology were observed. NOAEL was 250 mg/kg bw/day. The liver was the primary target of toxicity. Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0.2, 0.6, and 2 ml/kg bw/d (0, 190, 580, and 1900 mg/kg bw/day) 6 hrs/day, 5 days/wk for 13 wk with DEGBE (occluded). No systemic or neurotoxic effects were observed in the group of low- or mid-dosed groups. Renal tubular epithelium degeneration was found in 2 high-dosed males. NOAEL was 580 mg/kg bw/day. Ref.: 26 Guideline: / Species/strain: Sprague-Dawley rats Group size: 10 males and 10 females Test substance: DEGBE Batch: / Purity: 99.5 – 99.8% Dose levels: 0, 10%, 30%, and 100%, 2ml/kg bw (0, 200, 600, and 2000 mg/kg bw/d) Route: Dermal under occlusion Exposures: 13 weeks, 5 h/d, 5d/w GLP: / Sprague-Dawley, groups of 10 males and 10 females, received 2ml/kg bw of a 0, 10, 30, and 100% solution of DEGBE (0, 200, 600, 2000 mg/kg bw/d) dermally under occlusion 5 h/d, 5d/w for 13 weeks. DE","page":12,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_004"} |
| SCCS Opinion | NOAEL | =580 | mg/kg bw/day | rat | dermal | 5 days | NOAEL study | {"citation":"Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0","dose":"NOAEL was 250 mg/kg bw/day.","effect":"cts on sperm motility, morphology, sperm counts, or testis histopathology were observed. NOAEL was 250 mg/kg bw/day. The liver was the primary target of toxicity. Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0.2, 0.6, and 2 ml/kg bw/d (0, 190, 580, and 1900 mg/kg bw/day) 6 hrs/day, 5 days/wk for 13 wk with DEGBE (occluded). No systemic or neurotoxic effects were observed in the group of low- or mid-dosed groups. Renal tubular epithelium degeneration was found in 2 high-dosed males. NOAEL was 580 mg/kg bw/day. Ref.: 26 Guideline: / Species/strain: Sprague-Dawley rats Group size: 10 males and 10 females Test substance: DEGBE Batch: / Purity: 99.5 – 99.8% Dose levels: 0, 10%, 30%, and 100%, 2ml/kg bw (0, 200, 600, and 2000 mg/kg bw/d) Route: Dermal under occlusion Exposures: 13 weeks, 5 h/d, 5d/w GLP: / Sprague-Dawley, groups of 10 males and 10 females, received 2ml/kg bw of a 0, 10, 30, and 100% solution of DEGBE (0, 200, 600, 2000 mg/kg bw/d) dermally under occlusion 5 h/d, 5d/w for 13 weeks. DE","page":12,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_004"} |
| SCCS Opinion | NOAEL | =580 | mg/kg bw/day | rat | dermal | 5 days | NOAEL study | {"citation":"Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0","dose":"NOAEL was 250 mg/kg bw/day.","effect":"cts on sperm motility, morphology, sperm counts, or testis histopathology were observed. NOAEL was 250 mg/kg bw/day. The liver was the primary target of toxicity. Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0.2, 0.6, and 2 ml/kg bw/d (0, 190, 580, and 1900 mg/kg bw/day) 6 hrs/day, 5 days/wk for 13 wk with DEGBE (occluded). No systemic or neurotoxic effects were observed in the group of low- or mid-dosed groups. Renal tubular epithelium degeneration was found in 2 high-dosed males. NOAEL was 580 mg/kg bw/day. Ref.: 26 Guideline: / Species/strain: Sprague-Dawley rats Group size: 10 males and 10 females Test substance: DEGBE Batch: / Purity: 99.5 – 99.8% Dose levels: 0, 10%, 30%, and 100%, 2ml/kg bw (0, 200, 600, and 2000 mg/kg bw/d) Route: Dermal under occlusion Exposures: 13 weeks, 5 h/d, 5d/w GLP: / Sprague-Dawley, groups of 10 males and 10 females, received 2ml/kg bw of a 0, 10, 30, and 100% solution of DEGBE (0, 200, 600, 2000 mg/kg bw/d) dermally under occlusion 5 h/d, 5d/w for 13 weeks. DE","page":12,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_004"} |
| SCCS Opinion | NOAEL | =580 | mg/kg bw/day | rat | dermal | 5 days | NOAEL study | {"citation":"Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0","dose":"NOAEL was 250 mg/kg bw/day.","effect":"cts on sperm motility, morphology, sperm counts, or testis histopathology were observed. NOAEL was 250 mg/kg bw/day. The liver was the primary target of toxicity. Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0.2, 0.6, and 2 ml/kg bw/d (0, 190, 580, and 1900 mg/kg bw/day) 6 hrs/day, 5 days/wk for 13 wk with DEGBE (occluded). No systemic or neurotoxic effects were observed in the group of low- or mid-dosed groups. Renal tubular epithelium degeneration was found in 2 high-dosed males. NOAEL was 580 mg/kg bw/day. Ref.: 26 Guideline: / Species/strain: Sprague-Dawley rats Group size: 10 males and 10 females Test substance: DEGBE Batch: / Purity: 99.5 – 99.8% Dose levels: 0, 10%, 30%, and 100%, 2ml/kg bw (0, 200, 600, and 2000 mg/kg bw/d) Route: Dermal under occlusion Exposures: 13 weeks, 5 h/d, 5d/w GLP: / Sprague-Dawley, groups of 10 males and 10 females, received 2ml/kg bw of a 0, 10, 30, and 100% solution of DEGBE (0, 200, 600, 2000 mg/kg bw/d) dermally under occlusion 5 h/d, 5d/w for 13 weeks. DE","page":12,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_004"} |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | rat | oral | 60 days | reproductive toxicity | {"citation":"Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation","dose":"No signs of parental toxicity or effects on fertility were observed when the males were treated 60 days prior to mating and until end of mating period.","effect":"sisted of 25 rats. No signs of parental toxicity or effects on fertility were observed when the males were treated 60 days prior to mating and until end of mating period. The females were treated from 14 days prior to mating until sacrificed on day 13 of gestation or at day 21 of lactation. Reduced body weight of the pups from the high-dose females was the only treatment-related effect. The number of liveborn pups was slight, but not statistically significantly decreased at 1000 mg/kg bw/day. It was concluded that NOAEL for development effect was 500 mg/kg bw/day and for parental toxicity and fertility 1000 mg/kg bw/day. Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation. According to the authors reduction in body weight gain was observed at all dose levels and was the only sign of maternal toxicity. No effect on developmental toxicity or teratogenic effects were observed. There were a statistical insignificant decrease in number of implants (10.4 ± 1","page":15,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_006"} |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | rat | oral | 60 days | reproductive toxicity | {"citation":"Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation","dose":"No signs of parental toxicity or effects on fertility were observed when the males were treated 60 days prior to mating and until end of mating period.","effect":"sisted of 25 rats. No signs of parental toxicity or effects on fertility were observed when the males were treated 60 days prior to mating and until end of mating period. The females were treated from 14 days prior to mating until sacrificed on day 13 of gestation or at day 21 of lactation. Reduced body weight of the pups from the high-dose females was the only treatment-related effect. The number of liveborn pups was slight, but not statistically significantly decreased at 1000 mg/kg bw/day. It was concluded that NOAEL for development effect was 500 mg/kg bw/day and for parental toxicity and fertility 1000 mg/kg bw/day. Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation. According to the authors reduction in body weight gain was observed at all dose levels and was the only sign of maternal toxicity. No effect on developmental toxicity or teratogenic effects were observed. There were a statistical insignificant decrease in number of implants (10.4 ± 1","page":15,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_006"} |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | rat | oral | 60 days | reproductive toxicity | {"citation":"Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation","dose":"No signs of parental toxicity or effects on fertility were observed when the males were treated 60 days prior to mating and until end of mating period.","effect":"sisted of 25 rats. No signs of parental toxicity or effects on fertility were observed when the males were treated 60 days prior to mating and until end of mating period. The females were treated from 14 days prior to mating until sacrificed on day 13 of gestation or at day 21 of lactation. Reduced body weight of the pups from the high-dose females was the only treatment-related effect. The number of liveborn pups was slight, but not statistically significantly decreased at 1000 mg/kg bw/day. It was concluded that NOAEL for development effect was 500 mg/kg bw/day and for parental toxicity and fertility 1000 mg/kg bw/day. Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation. According to the authors reduction in body weight gain was observed at all dose levels and was the only sign of maternal toxicity. No effect on developmental toxicity or teratogenic effects were observed. There were a statistical insignificant decrease in number of implants (10.4 ± 1","page":15,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_006"} |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | rat | oral | 60 days | reproductive toxicity | {"citation":"Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation","dose":"No signs of parental toxicity or effects on fertility were observed when the males were treated 60 days prior to mating and until end of mating period.","effect":"sisted of 25 rats. No signs of parental toxicity or effects on fertility were observed when the males were treated 60 days prior to mating and until end of mating period. The females were treated from 14 days prior to mating until sacrificed on day 13 of gestation or at day 21 of lactation. Reduced body weight of the pups from the high-dose females was the only treatment-related effect. The number of liveborn pups was slight, but not statistically significantly decreased at 1000 mg/kg bw/day. It was concluded that NOAEL for development effect was 500 mg/kg bw/day and for parental toxicity and fertility 1000 mg/kg bw/day. Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation. According to the authors reduction in body weight gain was observed at all dose levels and was the only sign of maternal toxicity. No effect on developmental toxicity or teratogenic effects were observed. There were a statistical insignificant decrease in number of implants (10.4 ± 1","page":15,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_006"} |
| SCCS Opinion | NOAEL | =2000 | mg/kg | - | - | - | NOAEL study | {"dose":"Based on a NOAEL 2000 mg/kg and 100% absorption as no study was available the member state concluded that the substance could be considered safe for the consumers, when used in a concentration up to 9% in hair dyes.","effect":"ETHER (DEGBE) 4 1. BACKGROUND A risk assessment of DEGBE with the chemical name 2-(2-butoxyethoxy)ethanol or diethylene 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 DEGBE is used in cosmetic products only as a solvent in hair dyes. Based on a NOAEL 2000 mg/kg and 100% absorption as no study was available the member state concluded that the substance could be considered safe for the consumers, when used in a concentration up to 9% in hair dyes. 2. TERMS OF REFERENCE 1. Does the SCCP consider the use of DEGBE as solvent in hair dyes in a concentration up to 9% safe for the consumer, taken into consideration the scientific data provided? 2. If not, does the SCCP foresee any other restrictions to the safe use of DEGBE? 3. OPINION 3.1. Chemical and Physi","page":4,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_001"} |
| SCCS Opinion | NOAEL | =2000 | mg/kg | - | - | - | NOAEL study | {"dose":"Based on a NOAEL 2000 mg/kg and 100% absorption as no study was available the member state concluded that the substance could be considered safe for the consumers, when used in a concentration up to 9% in hair dyes.","effect":"ETHER (DEGBE) 4 1. BACKGROUND A risk assessment of DEGBE with the chemical name 2-(2-butoxyethoxy)ethanol or diethylene 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 DEGBE is used in cosmetic products only as a solvent in hair dyes. Based on a NOAEL 2000 mg/kg and 100% absorption as no study was available the member state concluded that the substance could be considered safe for the consumers, when used in a concentration up to 9% in hair dyes. 2. TERMS OF REFERENCE 1. Does the SCCP consider the use of DEGBE as solvent in hair dyes in a concentration up to 9% safe for the consumer, taken into consideration the scientific data provided? 2. If not, does the SCCP foresee any other restrictions to the safe use of DEGBE? 3. OPINION 3.1. Chemical and Physi","page":4,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_001"} |
| SCCS Opinion | NOAEL | =2000 | mg/kg | - | - | - | NOAEL study | {"dose":"Based on a NOAEL 2000 mg/kg and 100% absorption as no study was available the member state concluded that the substance could be considered safe for the consumers, when used in a concentration up to 9% in hair dyes.","effect":"ETHER (DEGBE) 4 1. BACKGROUND A risk assessment of DEGBE with the chemical name 2-(2-butoxyethoxy)ethanol or diethylene 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 DEGBE is used in cosmetic products only as a solvent in hair dyes. Based on a NOAEL 2000 mg/kg and 100% absorption as no study was available the member state concluded that the substance could be considered safe for the consumers, when used in a concentration up to 9% in hair dyes. 2. TERMS OF REFERENCE 1. Does the SCCP consider the use of DEGBE as solvent in hair dyes in a concentration up to 9% safe for the consumer, taken into consideration the scientific data provided? 2. If not, does the SCCP foresee any other restrictions to the safe use of DEGBE? 3. OPINION 3.1. Chemical and Physi","page":4,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_001"} |
| SCCS Opinion | NOAEL | =2000 | mg/kg | - | - | - | NOAEL study | {"dose":"Based on a NOAEL 2000 mg/kg and 100% absorption as no study was available the member state concluded that the substance could be considered safe for the consumers, when used in a concentration up to 9% in hair dyes.","effect":"ETHER (DEGBE) 4 1. BACKGROUND A risk assessment of DEGBE with the chemical name 2-(2-butoxyethoxy)ethanol or diethylene 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 DEGBE is used in cosmetic products only as a solvent in hair dyes. Based on a NOAEL 2000 mg/kg and 100% absorption as no study was available the member state concluded that the substance could be considered safe for the consumers, when used in a concentration up to 9% in hair dyes. 2. TERMS OF REFERENCE 1. Does the SCCP consider the use of DEGBE as solvent in hair dyes in a concentration up to 9% safe for the consumer, taken into consideration the scientific data provided? 2. If not, does the SCCP foresee any other restrictions to the safe use of DEGBE? 3. OPINION 3.1. Chemical and Physi","page":4,"pdf":"sccp_o_081.pdf","row_type":"noael_study","study_id":"sccp_o_081_noael_001"} |
ToxValDB DOE Protective Action Criteria 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB DOE Protective Action Criteria | LEL | =56398.9 | 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:15513007:-:--; 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_d5e1276a7e681a6d57eaa1691c09a25f |
ECHA 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ECHA | LOAEC | =250 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa7ee4b0a7c65d1b61f6; 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; TOXICOLOGICAL_EFFECT=P0: organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=ECHA IUCLID:15861286: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_40d99c057a1b4026b30caf0581cec3f5 |
| ECHA | NOAEC | =500 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa7ee4b0a7c65d1b61f8; 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:15861195: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_847dd628418ed8c693d0f74bf12afd42 |
| ECHA | NOAEL | =500 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabd2e4b0a7c65d1bbee2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14826/7/9/3?documentUUID=71ba2e45-fbd7-417d-9132-f7c68b1eee7d; YEAR=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=maternal: mortality; TOXICOLOGICAL_EFFECT_CATEGORY=mortality/survival; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822423_15823034: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_3555bc870c8ae578952cbd4c26fabd28 |
ToxValDB ECOTOX 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB ECOTOX | NOEL | =2050 | 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: Carrier or solvent 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|Mortality: Survival|Growth: Weight|Reproduction: Progeny counts/numbers|Reproduction: Viability; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|mortality/survival|reproduction; STUDY_GROUP=ECOTOX:15611583: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=a41e6056d6db3139d9474e5a412c12d1 |
ToxValDB EU SCOEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB EU SCOEL | NOEL | =94 | mg/m3 | Rat | inhalation | subchronic; 90 days | subchronic | LONG_REF=BASF (1992) Study on the inhalation toxicity of butylglycol as a vapor in rats, 90-day test, Report of Project No. 50I0030/87002; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c985c4e4b02565fc7d38d9; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu; SUBSOURCE_URL=https://echa.europa.eu/documents/10162/35144386/081_2_2-butoxyethoxy_ethanol_oel_en.pdf; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=local irritation of the lung; STUDY_GROUP=EU SCOEL:15952257:-:--; 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_9f9d2297a6b371e7f14046514d70fe54 |
ToxValDB GESTIS DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB GESTIS DNEL | DNEL local | =67.5 | 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:15630380:-:--; 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_36c0aea3e44cd00faba938c6c1060832 |
ToxValDB HESS 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB HESS | NOAEL | =250 | mg/kg bw/day | Rat | oral | chronic; 91 days | chronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/60da0defe4b0a676289de8e7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.nite.go.jp/en/chem/qsar/hess_update-e.html; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Body Weight Changes: Terminal body weight decrease|Food Consumption: decrease|Water Consumption: decrease|Hematology: RBC decrease, HGB decrease, HCT decrease|Blood Chemistry: TP decrease, T-Cho decrease|Absolute Organ Weight: Kidney increase|Relative Organ Weight: Liver increase, Kidney increase; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|food and/or water consumption|hematology|organ weight; STUDY_GROUP=HESS:15638178: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_10bc53042643f459759a7097b911797f |
ToxValDB PPRTV (CPHEA) 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB PPRTV (CPHEA) | BMCL (10 HEC) | =0.32 | mg/m3 | Rat | inhalation | subchronic; 5 weeks | subchronic | LONG_REF=Gushow et al. 1984; AUTHOR=Gushow et al; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754bee4b08a6b3934b3c5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1695; TOXICOLOGICAL_EFFECT=hepatocellular vacuolization; STUDY_GROUP=PPRTV (CPHEA):15653537: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_ba6dd5e20e4ba1ee71406de655dc6bab |
| ToxValDB PPRTV (CPHEA) | BMDL | =81 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=Johnson et al. 2005; AUTHOR=Johnson et al; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754bee4b08a6b3934b3c5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1695; TOXICOLOGICAL_EFFECT=rbc changes; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=PPRTV (CPHEA):15654021: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_9f0f490a7b5f586872ffc0162cdb224b |
| ToxValDB PPRTV (CPHEA) | RfC (provisional) | =0.0001 | mg/m3 | Human | inhalation | - | Toxicity Value | LONG_REF=Gushow et al. 1984; AUTHOR=Gushow et al; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754bee4b08a6b3934b3c5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1695; TOXICOLOGICAL_EFFECT=Hepatocellular vacuolization in male/female rats; STUDY_GROUP=PPRTV (CPHEA)_dup_PPRTV Summary_15653535_15653536:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_dcea5355b4945efbfb396c1c7835f98f |
| ToxValDB PPRTV (CPHEA) | RfC (provisional) | =0.001 | mg/m3 | Human | inhalation | - | Toxicity Value | LONG_REF=Gushow et al. 1984; AUTHOR=Gushow et al; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754bee4b08a6b3934b3c5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1695; TOXICOLOGICAL_EFFECT=Hepatocellular vacuolization in male/female rats; STUDY_GROUP=PPRTV (CPHEA)_dup_PPRTV Summary_15653535_15653536:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_63bbeeea71fc2ed4b394719f68c23746 |
| ToxValDB PPRTV (CPHEA) | RfD (provisional) | =0.03 | mg/kg bw/day | Human | oral | - | Toxicity Value | LONG_REF=Johnson et al. 2005; AUTHOR=Johnson et al; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754bee4b08a6b3934b3c5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1695; TOXICOLOGICAL_EFFECT=RBC changes in male/female rats; STUDY_GROUP=PPRTV (CPHEA)_dup_PPRTV Summary_15653533_15653691:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_6a201085eda51fcf4399f9f850b1767f |
| ToxValDB PPRTV (CPHEA) | RfD (provisional) | =0.3 | mg/kg bw/day | Human | oral | - | Toxicity Value | LONG_REF=Johnson et al. 2005; AUTHOR=Johnson et al; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754bee4b08a6b3934b3c5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1695; TOXICOLOGICAL_EFFECT=RBC changes in male/female rats; STUDY_GROUP=PPRTV (CPHEA)_dup_PPRTV Summary_15653533_15653691:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_67f763d08a06ad4a0483d2102b2c1ebb |
Regulatory source 15 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 250 | mg/kg bw/day | rat | dermal | 5 days | - | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=250; DOSE=NOAEL was 250 mg/kg bw/day.; EFFECT=SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 12 slight decrease in total proteins, cholesterol, and amino transferase was observed. Minor histopathological changes in the liver of female rats. No effects on sperm motility, morphology, sperm counts, or testis histopathology were observed. NOAEL was 250 mg/kg bw/day. The liver was the primary target of toxicity. Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0.2, 0.6, and 2 ml/kg bw/d (0, 190, 580, and 1900 mg/kg bw/day) 6 hrs/day, 5 days/wk for 13 wk with DEGBE (occluded). No systemic or neurotoxic effects were observed in the group of low- or mid-dosed groups. Renal tubular epithelium degeneration was found in 2 high-dosed males. NOAEL was 580 mg/kg bw/day. Ref.: 26 Guideline: / Species/strain: Sprague-Dawley rats Group; CITATION=Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0; CITATION_NUMBERS=[25,12]; REFERENCE=Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0; DETAILS_JSON={"cas_number":"112-34-5","citation":"Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0","dose":"NOAEL was 250 mg/kg bw/day.","duration":"5 days","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 12 slight decrease in total proteins, cholesterol, and amino transferase was observed. Minor histopathological changes in the liver of female rats. No effects on sperm motility, morphology, sperm counts, or testis histopathology were observed. NOAEL was 250 mg/kg bw/day. The liver was the primary target of toxicity. Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0.2, 0.6, and 2 ml/kg bw/d (0, 190, 580, and 1900 mg/kg bw/day) 6 hrs/day, 5 days/wk for 13 wk with DEGBE (occluded). No systemic or neurotoxic effects were observed in the group of low- or mid-dosed groups. Renal tubular epithelium degeneration was found in 2 high-dosed males. NOAEL was 580 mg/kg bw/day. Ref.: 26 Guideline: / Species/strain: Sprague-Dawley rats Group","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"250","page":12,"route":"dermal","species":"rat","study_id":"sccp_o_081_noael_003"} |
| Regulatory source | - | 250 | mg/kg bw/d | rat | oral | 13-week | - | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=250; DOSE=A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats.; EFFECT=- chemical characterisation and purity of the substance is not reported in several studies. General toxicity DEGBE is excreted primarily in urine following oral, dermal or parenteral administration to rats. The major metabolite is 2-(2-butoxyethoxy)acetic acid (BEAA). DEGBE has low acute toxicity by oral and dermal routes. The available data do not allow a definite conclusion on acute toxicity of DEGBE by inhalation. In oral studies DEGBE caused effects in liver, spleen, kidneys and haematological parameters. A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats. The value is based on decreased bodyweight (4%) and increased relative liver weight (7 – 10%) in the higher dose group. Human exposure – 2 ml/kg has produced cyanosis, tachypnea, and slight uremia. There is a case report which describes kidney and liver damage in two people who worked in a closed room with paint containing DEGBE and, at the same time, consumed large quantities of alcoholic beverages.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-34-5","citation":"","dose":"A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats.","duration":"13-week","effect":"- chemical characterisation and purity of the substance is not reported in several studies. General toxicity DEGBE is excreted primarily in urine following oral, dermal or parenteral administration to rats. The major metabolite is 2-(2-butoxyethoxy)acetic acid (BEAA). DEGBE has low acute toxicity by oral and dermal routes. The available data do not allow a definite conclusion on acute toxicity of DEGBE by inhalation. In oral studies DEGBE caused effects in liver, spleen, kidneys and haematological parameters. A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats. The value is based on decreased bodyweight (4%) and increased relative liver weight (7 – 10%) in the higher dose group. Human exposure – 2 ml/kg has produced cyanosis, tachypnea, and slight uremia. There is a case report which describes kidney and liver damage in two people who worked in a closed room with paint containing DEGBE and, at the same time, consumed large quantities of alcoholic beverages.","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":18,"route":"oral","species":"rat","study_id":"sccp_o_081_noael_013"} |
| Regulatory source | - | 580 | mg/kg bw/day | rat | dermal | 5 days | - | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=580; DOSE=NOAEL was 250 mg/kg bw/day.; EFFECT=cts on sperm motility, morphology, sperm counts, or testis histopathology were observed. NOAEL was 250 mg/kg bw/day. The liver was the primary target of toxicity. Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0.2, 0.6, and 2 ml/kg bw/d (0, 190, 580, and 1900 mg/kg bw/day) 6 hrs/day, 5 days/wk for 13 wk with DEGBE (occluded). No systemic or neurotoxic effects were observed in the group of low- or mid-dosed groups. Renal tubular epithelium degeneration was found in 2 high-dosed males. NOAEL was 580 mg/kg bw/day. Ref.: 26 Guideline: / Species/strain: Sprague-Dawley rats Group size: 10 males and 10 females Test substance: DEGBE Batch: / Purity: 99.5 – 99.8% Dose levels: 0, 10%, 30%, and 100%, 2ml/kg bw (0, 200, 600, and 2000 mg/kg bw/d) Route: Dermal under occlusion Exposures: 13 weeks, 5 h/d, 5d/w GLP: / Sprague-Dawley, groups of 10 males and 10 females, received 2ml/kg bw of a 0, 10, 30, and 100% solution of DEGBE (0, 200, 600, 2000 mg/kg bw/d) dermally under occlusion 5 h/d, 5d/w for 13 weeks. DE; CITATION=Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0; CITATION_NUMBERS=[25,12]; REFERENCE=Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0; DETAILS_JSON={"cas_number":"112-34-5","citation":"Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0","dose":"NOAEL was 250 mg/kg bw/day.","duration":"5 days","effect":"cts on sperm motility, morphology, sperm counts, or testis histopathology were observed. NOAEL was 250 mg/kg bw/day. The liver was the primary target of toxicity. Ref.: 25 Dermal, rat SD rats, groups of 12 males and 12 females received 0, 0.2, 0.6, and 2 ml/kg bw/d (0, 190, 580, and 1900 mg/kg bw/day) 6 hrs/day, 5 days/wk for 13 wk with DEGBE (occluded). No systemic or neurotoxic effects were observed in the group of low- or mid-dosed groups. Renal tubular epithelium degeneration was found in 2 high-dosed males. NOAEL was 580 mg/kg bw/day. Ref.: 26 Guideline: / Species/strain: Sprague-Dawley rats Group size: 10 males and 10 females Test substance: DEGBE Batch: / Purity: 99.5 – 99.8% Dose levels: 0, 10%, 30%, and 100%, 2ml/kg bw (0, 200, 600, and 2000 mg/kg bw/d) Route: Dermal under occlusion Exposures: 13 weeks, 5 h/d, 5d/w GLP: / Sprague-Dawley, groups of 10 males and 10 females, received 2ml/kg bw of a 0, 10, 30, and 100% solution of DEGBE (0, 200, 600, 2000 mg/kg bw/d) dermally under occlusion 5 h/d, 5d/w for 13 weeks. DE","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"580","page":12,"route":"dermal","species":"rat","study_id":"sccp_o_081_noael_004"} |
| Regulatory source | - | 2000 | mg/kg | - | - | - | - | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=2000; DOSE=Based on a NOAEL 2000 mg/kg and 100% absorption as no study was available the member state concluded that the substance could be considered safe for the consumers, when used in a concentration up to 9% in hair dyes.; EFFECT=ETHER (DEGBE) 4 1. BACKGROUND A risk assessment of DEGBE with the chemical name 2-(2-butoxyethoxy)ethanol or diethylene 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 DEGBE is used in cosmetic products only as a solvent in hair dyes. Based on a NOAEL 2000 mg/kg and 100% absorption as no study was available the member state concluded that the substance could be considered safe for the consumers, when used in a concentration up to 9% in hair dyes. 2. TERMS OF REFERENCE 1. Does the SCCP consider the use of DEGBE as solvent in hair dyes in a concentration up to 9% safe for the consumer, taken into consideration the scientific data provided? 2. If not, does the SCCP foresee any other restrictions to the safe use of DEGBE? 3. OPINION 3.1. Chemical and Physi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-34-5","citation":"","dose":"Based on a NOAEL 2000 mg/kg and 100% absorption as no study was available the member state concluded that the substance could be considered safe for the consumers, when used in a concentration up to 9% in hair dyes.","duration":"","effect":"ETHER (DEGBE) 4 1. BACKGROUND A risk assessment of DEGBE with the chemical name 2-(2-butoxyethoxy)ethanol or diethylene 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 DEGBE is used in cosmetic products only as a solvent in hair dyes. Based on a NOAEL 2000 mg/kg and 100% absorption as no study was available the member state concluded that the substance could be considered safe for the consumers, when used in a concentration up to 9% in hair dyes. 2. TERMS OF REFERENCE 1. Does the SCCP consider the use of DEGBE as solvent in hair dyes in a concentration up to 9% safe for the consumer, taken into consideration the scientific data provided? 2. If not, does the SCCP foresee any other restrictions to the safe use of DEGBE? 3. OPINION 3.1. Chemical and Physi","endpoint":"","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg","noael_value":"2000","page":4,"route":"","species":"","study_id":"sccp_o_081_noael_001"} |
| Regulatory source | dermal absorption | =2.6 | mg/kg | rat | oral | 13 week | dermal absorption | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT== 2.6; DOSE=Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.; EFFECT=n of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The ph; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-34-5","citation":"","dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","duration":"13 week","effect":"n of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The ph","endpoint":"dermal absorption","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg","noael_value":"= 2.6","page":18,"route":"oral","species":"rat","study_id":"sccp_o_081_noael_010"} |
| Regulatory source | dermal absorption | 50 | % | rat | oral | 13 week | dermal absorption | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=50; DOSE=Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.; EFFECT=SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 18 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-34-5","citation":"","dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","duration":"13 week","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 18 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of","endpoint":"dermal absorption","ingredient":"UPAC name","loael_value":"","noael_unit":"%","noael_value":"50","page":18,"route":"oral","species":"rat","study_id":"sccp_o_081_noael_009"} |
| Regulatory source | dermal absorption | =250 | mg/kg | rat | oral | 13 week | dermal absorption | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT== 250; DOSE=Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.; EFFECT=OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The physico- chemica; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-34-5","citation":"","dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","duration":"13 week","effect":"OF SAFETY Diethylene glycol monobutyl ether DEGBE The safety calculation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The physico- chemica","endpoint":"dermal absorption","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg","noael_value":"= 250","page":18,"route":"oral","species":"rat","study_id":"sccp_o_081_noael_011"} |
| Regulatory source | dermal absorption | =250 | mg/kg | rat | oral | 13 week | dermal absorption | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT== 250; DOSE=Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.; EFFECT=culation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The physico- chemical characterisation and purity of the substance is not reported in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-34-5","citation":"","dose":"Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE.","duration":"13 week","effect":"culation is only considering dermal exposure. Maximum dermal absorption of test substance considered being 50% NOAEL based on liver toxicity and reduced bodyweight in rats was 250 mg/kg bw/d Exposure 35 ml/week, 9% DEGBE. Retention 0.1; = 315 mg Maximum absorption through the skin per treatment 315 x 50/100 = 157.5 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) 157.5/60 = 2.6 mg/kg No observed adverse effect level (mg/kg) NOAEL = 250 mg/kg (13 week drinking water, rat) Margin of Safety NOAEL / SED = 96 The value of MOS equal to 96 is considered to give sufficient protection in relation to the use of DEGBE 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 diethylene glycol monobutyl ether (DEGBE) is not reported. The physico- chemical characterisation and purity of the substance is not reported in","endpoint":"dermal absorption","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg","noael_value":"= 250","page":18,"route":"oral","species":"rat","study_id":"sccp_o_081_noael_012"} |
| Regulatory source | genotoxicity | 250 | mg/kg bw/d | rat | oral | 5 days | genotoxicity | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=250; DOSE=29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats.; EFFECT=SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 13 Inhalation, rat Wistar rats, groups of 10 males and 10 females received 0, 13, 40, and 94 mg/m3 DEGBE 6 hrs/day, 5 days/wk for 90 days followed by a 4 wk recovery period. No effects were recorded. NOAEL was 94 mg/m3. Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats. The value is based on decreased bodyweight (4%) and increased relative liver weight (7 – 10%) in the higher dose group. 3.3.5.3. Chronic (> 12 months) toxicity No data found. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The in vitro genotoxicity of DEGBE has been studied in several experiments. The results are summarized in Table 3.2. Table 3; CITATION=Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats; CITATION_NUMBERS=[29,250,13]; REFERENCE=Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats; DETAILS_JSON={"cas_number":"112-34-5","citation":"Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats","dose":"29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats.","duration":"5 days","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 13 Inhalation, rat Wistar rats, groups of 10 males and 10 females received 0, 13, 40, and 94 mg/m3 DEGBE 6 hrs/day, 5 days/wk for 90 days followed by a 4 wk recovery period. No effects were recorded. NOAEL was 94 mg/m3. Ref.: 29 General comment A NOAEL of 250 mg/kg bw/d has been determined from a 13-week drinking water study with rats. The value is based on decreased bodyweight (4%) and increased relative liver weight (7 – 10%) in the higher dose group. 3.3.5.3. Chronic (> 12 months) toxicity No data found. 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The in vitro genotoxicity of DEGBE has been studied in several experiments. The results are summarized in Table 3.2. Table 3","endpoint":"genotoxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":13,"route":"oral","species":"rat","study_id":"sccp_o_081_noael_005"} |
| Regulatory source | repeated dose toxicity | 51 | mg/kg bw/day | rat | oral | 28 days | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=51; DOSE=Repeated dose toxicity 3.3.5.1.; LOAEL_VALUE=891 mg/kg bw/day; EFFECT=1045/06 and 1044/06 by SCCP) it is unlikely that the dermal absorption is larger than 50%. 3.3.5. Repeated dose toxicity 3.3.5.1. Repeated dose (28 days) oral / dermal / inhalation toxicity Oral, rat Sherman rats, groups of 5 males and 5 females received 0, 51, 650, and 1830 mg/kg bw/day of DEGBE by gavage for 30 days. No effects were observed at 51 mg/kg bw/day. The food intake was reduced and slight (unspecified micro-pathological) changes in liver, kidney, spleen or testis were observed at the higher doses. NOAEL was 51 mg/kg bw/day. Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk. Hyperkeratosis in stomach (possibly fore-stomach) was observed at all doses. Increase in relative liver weight (statistically non-significant) was observed at low dose. At mid and high doses; decrease in red blood cell count, Hb, MCH, increased spleen weights (absolute and relative), increase in liver weight, lesions in spleen and kidneys. LOAEL was 891 mg/kg bw/day. Ref.:; CITATION=Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk; CITATION_NUMBERS=[16,10,891,1782,3564,7,6]; REFERENCE=Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk; DETAILS_JSON={"cas_number":"112-34-5","citation":"Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk","dose":"Repeated dose toxicity 3.3.5.1.","duration":"28 days","effect":"1045/06 and 1044/06 by SCCP) it is unlikely that the dermal absorption is larger than 50%. 3.3.5. Repeated dose toxicity 3.3.5.1. Repeated dose (28 days) oral / dermal / inhalation toxicity Oral, rat Sherman rats, groups of 5 males and 5 females received 0, 51, 650, and 1830 mg/kg bw/day of DEGBE by gavage for 30 days. No effects were observed at 51 mg/kg bw/day. The food intake was reduced and slight (unspecified micro-pathological) changes in liver, kidney, spleen or testis were observed at the higher doses. NOAEL was 51 mg/kg bw/day. Ref.: 16 CD rats, groups of 10 males received 0, 891, 1782, and 3564 mg/kg bw/day of DEGBE by gavage for 7 d/wk for 6 wk. Hyperkeratosis in stomach (possibly fore-stomach) was observed at all doses. Increase in relative liver weight (statistically non-significant) was observed at low dose. At mid and high doses; decrease in red blood cell count, Hb, MCH, increased spleen weights (absolute and relative), increase in liver weight, lesions in spleen and kidneys. LOAEL was 891 mg/kg bw/day. Ref.:","endpoint":"repeated dose toxicity","ingredient":"UPAC name","loael_value":"891 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"51","page":9,"route":"oral","species":"rat","study_id":"sccp_o_081_noael_002"} |
| Regulatory source | reproductive toxicity | 500 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=500; DOSE=esponse in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed.; EFFECT=esponse in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed. The two high dose levels caused skin irritation after about one week, which persisted until the end of the study. There were no indications for developmental or teratogenic effects at any of the dose levels tested. Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested). As for developmental effects, the oral NOAEL was established at 500 mg/kg bw/d. The only effect observed at the next higher dose level tested was reduced body weight gain of the pups. DEGBE caused no teratogenic effects. No effects were observed in a dermal one-generation study of rats at a dose of 2000 mg/kg bw/d. Neither systemic maternal toxicity nor developmental or teratogenic effects were observed in rabbits dermally exposed to dose levels up to 1000 mg/kg bw/d.; CITATION=Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested); CITATION_NUMBERS=[38,1000]; REFERENCE=Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested); DETAILS_JSON={"cas_number":"112-34-5","citation":"Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested)","dose":"esponse in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed.","duration":"developmental","effect":"esponse in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed. The two high dose levels caused skin irritation after about one week, which persisted until the end of the study. There were no indications for developmental or teratogenic effects at any of the dose levels tested. Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested). As for developmental effects, the oral NOAEL was established at 500 mg/kg bw/d. The only effect observed at the next higher dose level tested was reduced body weight gain of the pups. DEGBE caused no teratogenic effects. No effects were observed in a dermal one-generation study of rats at a dose of 2000 mg/kg bw/d. Neither systemic maternal toxicity nor developmental or teratogenic effects were observed in rabbits dermally exposed to dose levels up to 1000 mg/kg bw/d.","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":16,"route":"oral","species":"rat","study_id":"sccp_o_081_noael_008"} |
| Regulatory source | reproductive toxicity | 500 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=500; DOSE=Reproductive toxicity In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested.; EFFECT=SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 19 Irritation /sensitisation DEGEE is moderately irritant to the eye and slightly irritating to the skin. No conclusion on sensitisation can be drawn due to lack of information in relation to the available experiment. Reproductive toxicity In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested. As for developmental effects the oral NOAEL was established at 500 mg/kg bw/d. The only effect observed at the next higher dose level tested was reduced body weight gain of the pups. DEGBE caused no teratogenic effects. No effects were observed in a dermal one-generation study of rats at a dose of 2000 mg/kg bw/d. Neither systemic maternal toxicity nor developmental or teratogenic effects were observed in rabbits dermally exposed to dose levels up to 1000 mg/kg bw/d. Dermal absorption None of the available studies comply with accepted guideline and GLP. In; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-34-5","citation":"","dose":"Reproductive toxicity In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested.","duration":"developmental","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 19 Irritation /sensitisation DEGEE is moderately irritant to the eye and slightly irritating to the skin. No conclusion on sensitisation can be drawn due to lack of information in relation to the available experiment. Reproductive toxicity In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested. As for developmental effects the oral NOAEL was established at 500 mg/kg bw/d. The only effect observed at the next higher dose level tested was reduced body weight gain of the pups. DEGBE caused no teratogenic effects. No effects were observed in a dermal one-generation study of rats at a dose of 2000 mg/kg bw/d. Neither systemic maternal toxicity nor developmental or teratogenic effects were observed in rabbits dermally exposed to dose levels up to 1000 mg/kg bw/d. Dermal absorption None of the available studies comply with accepted guideline and GLP. In","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":19,"route":"oral","species":"rat","study_id":"sccp_o_081_noael_015"} |
| Regulatory source | reproductive toxicity | 1000 | mg/kg bw/day | rat | oral | 60 days | reproductive toxicity | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=No signs of parental toxicity or effects on fertility were observed when the males were treated 60 days prior to mating and until end of mating period.; EFFECT=sisted of 25 rats. No signs of parental toxicity or effects on fertility were observed when the males were treated 60 days prior to mating and until end of mating period. The females were treated from 14 days prior to mating until sacrificed on day 13 of gestation or at day 21 of lactation. Reduced body weight of the pups from the high-dose females was the only treatment-related effect. The number of liveborn pups was slight, but not statistically significantly decreased at 1000 mg/kg bw/day. It was concluded that NOAEL for development effect was 500 mg/kg bw/day and for parental toxicity and fertility 1000 mg/kg bw/day. Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation. According to the authors reduction in body weight gain was observed at all dose levels and was the only sign of maternal toxicity. No effect on developmental toxicity or teratogenic effects were observed. There were a statistical insignificant decrease in number of implants (10.4 ± 1; CITATION=Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation; CITATION_NUMBERS=[38,14,16,25,115,633,20]; REFERENCE=Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation; DETAILS_JSON={"cas_number":"112-34-5","citation":"Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation","dose":"No signs of parental toxicity or effects on fertility were observed when the males were treated 60 days prior to mating and until end of mating period.","duration":"60 days","effect":"sisted of 25 rats. No signs of parental toxicity or effects on fertility were observed when the males were treated 60 days prior to mating and until end of mating period. The females were treated from 14 days prior to mating until sacrificed on day 13 of gestation or at day 21 of lactation. Reduced body weight of the pups from the high-dose females was the only treatment-related effect. The number of liveborn pups was slight, but not statistically significantly decreased at 1000 mg/kg bw/day. It was concluded that NOAEL for development effect was 500 mg/kg bw/day and for parental toxicity and fertility 1000 mg/kg bw/day. Ref.: 38 Wistar rats, groups of 14 – 16 females were given 0, 25, 115, and 633 mg/kg bw/d (gavage) during day 0 – 20 of gestation. According to the authors reduction in body weight gain was observed at all dose levels and was the only sign of maternal toxicity. No effect on developmental toxicity or teratogenic effects were observed. There were a statistical insignificant decrease in number of implants (10.4 ± 1","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":15,"route":"oral","species":"rat","study_id":"sccp_o_081_noael_006"} |
| Regulatory source | reproductive toxicity | 1000 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=nly the difference for the group treated with 300 mg/kg bw was statistically significant.; EFFECT=nly the difference for the group treated with 300 mg/kg bw was statistically significant. The lack of dose response in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed. The two high dose levels caused skin irritation after about one week, which persisted until the end of the study. There were no indications for developmental or teratogenic effects at any of the dose levels tested. Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested). As for developmental effects, the oral NOAEL was established at 500 mg/kg bw/d. The only effect observed at the next higher dose level tested was reduced body weight gain of the pups. DEGBE caused no teratogenic effects. No effects were observed in a dermal one-generation study of rats at a dose of 2000 mg/kg bw/d. Neither systemic maternal toxicity nor developmental or teratogenic effects were observed in rabbits dermally exposed to dose levels up to; CITATION=Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested); CITATION_NUMBERS=[38,1000]; REFERENCE=Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested); DETAILS_JSON={"cas_number":"112-34-5","citation":"Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested)","dose":"nly the difference for the group treated with 300 mg/kg bw was statistically significant.","duration":"developmental","effect":"nly the difference for the group treated with 300 mg/kg bw was statistically significant. The lack of dose response in the treated groups suggested that the lower weight gain was not directly related to the amount of DEGBE absorbed. The two high dose levels caused skin irritation after about one week, which persisted until the end of the study. There were no indications for developmental or teratogenic effects at any of the dose levels tested. Ref.: 38 General comments In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested). As for developmental effects, the oral NOAEL was established at 500 mg/kg bw/d. The only effect observed at the next higher dose level tested was reduced body weight gain of the pups. DEGBE caused no teratogenic effects. No effects were observed in a dermal one-generation study of rats at a dose of 2000 mg/kg bw/d. Neither systemic maternal toxicity nor developmental or teratogenic effects were observed in rabbits dermally exposed to dose levels up to","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":16,"route":"oral","species":"rat","study_id":"sccp_o_081_noael_007"} |
| Regulatory source | reproductive toxicity | 1000 | mg/kg bw/d | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_081; REPORT_TITLE=OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE); OPINION_NUMBER=SCCP/1043/06; COMMITTEE=SCCP; REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=Reproductive toxicity In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested.; EFFECT=SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 19 Irritation /sensitisation DEGEE is moderately irritant to the eye and slightly irritating to the skin. No conclusion on sensitisation can be drawn due to lack of information in relation to the available experiment. Reproductive toxicity In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested. As for developmental effects the oral NOAEL was established at 500 mg/kg bw/d. The only effect observed at the next higher dose level tested was reduced body weight gain of the pups. DEGBE caused no teratogenic effects. No effects were observed in a dermal one-generation study of rats at a dose of 2000 mg/kg bw/d. Neither systemic maternal toxicity nor developmental or teratogenic effects were observed in rabbits dermally exposed to dose levels up to 10; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"112-34-5","citation":"","dose":"Reproductive toxicity In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested.","duration":"developmental","effect":"SCCP/1043/06 OPINION ON DIETHYLENE GLYCOL MONOBUTYL ETHER (DEGBE) 19 Irritation /sensitisation DEGEE is moderately irritant to the eye and slightly irritating to the skin. No conclusion on sensitisation can be drawn due to lack of information in relation to the available experiment. Reproductive toxicity In a one-generation gavage study by rats the NOAEL for fertility was 1000 mg/kg bw/d (highest dose level tested. As for developmental effects the oral NOAEL was established at 500 mg/kg bw/d. The only effect observed at the next higher dose level tested was reduced body weight gain of the pups. DEGBE caused no teratogenic effects. No effects were observed in a dermal one-generation study of rats at a dose of 2000 mg/kg bw/d. Neither systemic maternal toxicity nor developmental or teratogenic effects were observed in rabbits dermally exposed to dose levels up to 10","endpoint":"reproductive toxicity","ingredient":"UPAC name","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":19,"route":"oral","species":"rat","study_id":"sccp_o_081_noael_014"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 9TB90IYC0E | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C8H18O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9TB90IYC0E"} |
| openFDA substances | FDA UNII substance identifier | 9TB90IYC0E | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C8H18O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9TB90IYC0E"} |
| openFDA substances | FDA UNII substance identifier | 9TB90IYC0E | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C8H18O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9TB90IYC0E"} |
| openFDA substances | FDA UNII substance identifier | 9TB90IYC0E | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C8H18O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9TB90IYC0E"} |