NOAEL Studies
Active Ingredient
Titanium Dioxide NOAEL Studies
INCI: TITANIUM DIOXIDE
CAS: 13463-67-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | NOAEL | 1250 | mg/kg bw/day | rat | oral | 728 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 5000 | mg/kg bw/day | mouse | oral | 14 day | Special Toxicology Study | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 7500 | mg/kg bw/day | mouse | oral | 728 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =2250 | mg/kg bw/day | Rat | oral: feed | 721 days | chronic/long term toxicity | EFSA ANS - 2016 - OutputID 2862 - no adverse effect observed at single/highest dose - Re-evaluation of titanium dioxide (E 171) as a food additive - doi:10.2903/j.efsa.2016.4545 |
IARC Monographs 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| IARC Monographs | IARC carcinogenicity classification | 2B | IARC group | - | - | 2006 | IARC Monographs | {"additional_info":"volume_publication_year=2010","evaluation_year":2006,"source_table":"iarc_classifications","volume":"47, 93"} |
| IARC Monographs | IARC carcinogenicity classification | 2B | IARC group | - | - | 2006 | IARC Monographs | {"additional_info":"volume_publication_year=2010","evaluation_year":2006,"source_table":"iarc_classifications","volume":"47, 93"} |
| IARC Monographs | IARC carcinogenicity classification | 2B | IARC group | - | - | 2006 | IARC Monographs | {"additional_info":"volume_publication_year=2010","evaluation_year":2006,"source_table":"iarc_classifications","volume":"47, 93"} |
INCHEM_WHO_jecfa_jecmono_v1051je01 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| INCHEM_WHO_jecfa_jecmono_v1051je01 | NOAEL | =250 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v1051je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1051je01.pdf; row_hash=39e982024cf86cd9; raw_unit=mg/kg bw per day; context=2309), a NOAEL of 250 mg/kg bw per day for the two structurally related substances - γ-nonalactone (No. |
| INCHEM_WHO_jecfa_jecmono_v1051je01 | NOAEL | =250 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v1051je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1051je01.pdf; row_hash=39e982024cf86cd9; raw_unit=mg/kg bw per day; context=2309), a NOAEL of 250 mg/kg bw per day for the two structurally related substances - γ-nonalactone (No. |
| INCHEM_WHO_jecfa_jecmono_v1051je01 | NOAEL | =260 | mg/kg bw/day | Mouse | - | 2-year | Chronic toxicity | document_id=jecfa_jecmono_v1051je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1051je01.pdf; row_hash=a34ee232ecf03f80; raw_unit=mg/kg bw per day; context=In a 2-year study in mice with γ-butyrolactone, a NOAEL of 260 mg/kg bw per day was established. |
| INCHEM_WHO_jecfa_jecmono_v1051je01 | NOAEL | =260 | mg/kg bw/day | Mouse | - | 2-year | Chronic toxicity | document_id=jecfa_jecmono_v1051je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1051je01.pdf; row_hash=a34ee232ecf03f80; raw_unit=mg/kg bw per day; context=In a 2-year study in mice with γ-butyrolactone, a NOAEL of 260 mg/kg bw per day was established. |
| INCHEM_WHO_jecfa_jecmono_v1051je01 | NOAEL | =1000 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v1051je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1051je01.pdf; row_hash=dd58e7e06d66ab47; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL was 1000 mg/kg bw per day, the highest dose tested. |
| INCHEM_WHO_jecfa_jecmono_v1051je01 | NOAEL | =1000 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v1051je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1051je01.pdf; row_hash=dd58e7e06d66ab47; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL was 1000 mg/kg bw per day, the highest dose tested. |
| INCHEM_WHO_jecfa_jecmono_v1051je01 | NOAEL | =1251 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v1051je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1051je01.pdf; row_hash=f4cd3985972b5abc; raw_unit=mg/kg bw per day; context=2304), the NOAEL of 1251 mg/kg bw per day for the structurally related substance isobutyl alcohol (No. |
| INCHEM_WHO_jecfa_jecmono_v1051je01 | NOAEL | =1251 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v1051je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1051je01.pdf; row_hash=f4cd3985972b5abc; raw_unit=mg/kg bw per day; context=2304), the NOAEL of 1251 mg/kg bw per day for the structurally related substance isobutyl alcohol (No. |
NTP_ICE_acute_inhalation 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | LC50 | >2.28 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1933; Record_ID=acute_inhalation_1655; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID3021352; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=2.28; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15560/7/3/3/?documentUUID=7386ba32-da5c-4d1d-a6af-48063f531f4a; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3021352; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3021352 |
| NTP_ICE_acute_inhalation | LC50 | 3.43 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1930; Record_ID=acute_inhalation_1674; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID3021352; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=3.43; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15560/7/3/3/?documentUUID=71d36a33-638f-45de-8412-46f4192750d7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3021352; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3021352 |
| NTP_ICE_acute_inhalation | LC50 | >3.56 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1932; Record_ID=acute_inhalation_1649; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID3021352; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=3.56; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15560/7/3/3/?documentUUID=1112c23b-7206-4a11-9a44-f8e8a013adb9; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3021352; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3021352 |
| NTP_ICE_acute_inhalation | LC50 | 5.09 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1929; Record_ID=acute_inhalation_1657; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID3021352; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=5.09; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15560/7/3/3/?documentUUID=71d36a33-638f-45de-8412-46f4192750d7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3021352; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3021352 |
| NTP_ICE_acute_inhalation | LC50 | >6.82 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=1931; Record_ID=acute_inhalation_1643; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID3021352; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=6.82; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15560/7/3/3/?documentUUID=2fcf00cd-8893-480f-a50b-7d24d91a2df8; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3021352; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3021352 |
NTP_ICE_cancer 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_cancer | IARC group | 2 | unitless | - | - | - | WOE; IARC Carcinogenicity | sheet=Data; excel_row=3670; Record_ID=cancer_6686; Data_Type=WOE; Formulation_Name=Titanium dioxide; Mixture=Chemical; DTXSID=DTXSID3021352; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=2B; Response_Unit=Unitless; URL=http://publications.iarc.fr/65; http://publications.iarc.fr/111; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3021352; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3021352 |
| NTP_ICE_cancer | Top dose | 50000 | ppm | Rat | - | - | In Vivo; NTP Carcinogenicity | sheet=Data; excel_row=3664; Record_ID=cancer_6682; Data_Type=In Vivo; Formulation_Name=Titanium dioxide; Mixture=Chemical; DTXSID=DTXSID3021352; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=50000; Response_Unit=ppm; Species=Rat; Strain=F344/N; Sex=Female; Reference=TR-097; URL=https://ntp.niehs.nih.gov/publications/reports/tr/000s/tr097/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3021352; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3021352 |
SCCS_vision_codex 36 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =0.6 | % | rat | oral | developmental | developmental toxicity | {"dose":"Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams.","effect":"ed by using the LOAEL 50 mg Al/kg bw/day and NOAEL 10 mg Al/kg bw/day approaches, should be established as the TWI (EFSA, 2008). In a recent drinking water developmental and chronic neurotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on reported treatment related renal damage and reduced grip strength in the pups (Poirier et al., 2011, SCCS, 2022). The maternal toxicity NOAEL can be considered as 300 mg Al/kg bw/day. The SCCS in its recent opinion on the safety of aluminium in cosmetic products, derived the systemic NOAEL (NOAELsys) as 180 μg Al/kg bw/day from Poirier et al. study NOAEL, after adjustment for the rat oral bioavailability (0.6%) of aluminium citrate (SCCS, 2023). Aluminium hydroxide was rep","page":36,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.6 | % | rat | oral | developmental | developmental toxicity | {"dose":"Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams.","effect":"ed by using the LOAEL 50 mg Al/kg bw/day and NOAEL 10 mg Al/kg bw/day approaches, should be established as the TWI (EFSA, 2008). In a recent drinking water developmental and chronic neurotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on reported treatment related renal damage and reduced grip strength in the pups (Poirier et al., 2011, SCCS, 2022). The maternal toxicity NOAEL can be considered as 300 mg Al/kg bw/day. The SCCS in its recent opinion on the safety of aluminium in cosmetic products, derived the systemic NOAEL (NOAELsys) as 180 μg Al/kg bw/day from Poirier et al. study NOAEL, after adjustment for the rat oral bioavailability (0.6%) of aluminium citrate (SCCS, 2023). Aluminium hydroxide was rep","page":36,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.6 | % | rat | oral | developmental | developmental toxicity | {"dose":"Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams.","effect":"ed by using the LOAEL 50 mg Al/kg bw/day and NOAEL 10 mg Al/kg bw/day approaches, should be established as the TWI (EFSA, 2008). In a recent drinking water developmental and chronic neurotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on reported treatment related renal damage and reduced grip strength in the pups (Poirier et al., 2011, SCCS, 2022). The maternal toxicity NOAEL can be considered as 300 mg Al/kg bw/day. The SCCS in its recent opinion on the safety of aluminium in cosmetic products, derived the systemic NOAEL (NOAELsys) as 180 μg Al/kg bw/day from Poirier et al. study NOAEL, after adjustment for the rat oral bioavailability (0.6%) of aluminium citrate (SCCS, 2023). Aluminium hydroxide was rep","page":36,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_002"} |
| SCCS_vision_codex | NOAEL | =0.6 | % | rat | oral | developmental | developmental toxicity | {"dose":"Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams.","effect":"ed by using the LOAEL 50 mg Al/kg bw/day and NOAEL 10 mg Al/kg bw/day approaches, should be established as the TWI (EFSA, 2008). In a recent drinking water developmental and chronic neurotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on reported treatment related renal damage and reduced grip strength in the pups (Poirier et al., 2011, SCCS, 2022). The maternal toxicity NOAEL can be considered as 300 mg Al/kg bw/day. The SCCS in its recent opinion on the safety of aluminium in cosmetic products, derived the systemic NOAEL (NOAELsys) as 180 μg Al/kg bw/day from Poirier et al. study NOAEL, after adjustment for the rat oral bioavailability (0.6%) of aluminium citrate (SCCS, 2023). Aluminium hydroxide was rep","page":36,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_002"} |
| SCCS_vision_codex | NOAEL | =2 | % | rat | oral | 24 months | reproductive toxicity | {"dose":"re observed in lesions, fertility, mortality, haematology, or body weight gain between rats of the control and treated groups.","effect":"re observed in lesions, fertility, mortality, haematology, or body weight gain between rats of the control and treated groups. At 24 months, the only consistent difference that could be attributed to the test substance was minor hyperplasia of the stratified squamous epithelium with excess keratin formation of the cardiac mucosa of the stomach in rats receiving the highest exposure to the test substance, 0.05% dose group (2% in the diet after 6 months) and 1% dose group (CIR, 2001). Based on the study results, the NOAEL was established at ≥2% (equivalent to 1578 mg/kg bw/day) (ECHA, 2023b). SMS was tested negative in an in vitro genotoxicity battery of tests, i.e., bacterial reverse mutation assay (Ames test), chromosome aberration study in using human lymphocytes and mouse lymphoma assay (ECHA, 2023c). Based on the study results, SMS is not expected to be genotoxic. As per the CIR’s Expert Panel report, fatty acyl sarcosines and their salts are not considered likely carcinogens as they and their metabolites “do not belong to any","page":37,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_007"} |
| SCCS_vision_codex | NOAEL | =2 | % | rat | oral | 24 months | reproductive toxicity | {"dose":"re observed in lesions, fertility, mortality, haematology, or body weight gain between rats of the control and treated groups.","effect":"re observed in lesions, fertility, mortality, haematology, or body weight gain between rats of the control and treated groups. At 24 months, the only consistent difference that could be attributed to the test substance was minor hyperplasia of the stratified squamous epithelium with excess keratin formation of the cardiac mucosa of the stomach in rats receiving the highest exposure to the test substance, 0.05% dose group (2% in the diet after 6 months) and 1% dose group (CIR, 2001). Based on the study results, the NOAEL was established at ≥2% (equivalent to 1578 mg/kg bw/day) (ECHA, 2023b). SMS was tested negative in an in vitro genotoxicity battery of tests, i.e., bacterial reverse mutation assay (Ames test), chromosome aberration study in using human lymphocytes and mouse lymphoma assay (ECHA, 2023c). Based on the study results, SMS is not expected to be genotoxic. As per the CIR’s Expert Panel report, fatty acyl sarcosines and their salts are not considered likely carcinogens as they and their metabolites “do not belong to any","page":37,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_007"} |
| SCCS_vision_codex | NOAEL | =2 | % | rat | oral | 24 months | reproductive toxicity | {"dose":"re observed in lesions, fertility, mortality, haematology, or body weight gain between rats of the control and treated groups.","effect":"re observed in lesions, fertility, mortality, haematology, or body weight gain between rats of the control and treated groups. At 24 months, the only consistent difference that could be attributed to the test substance was minor hyperplasia of the stratified squamous epithelium with excess keratin formation of the cardiac mucosa of the stomach in rats receiving the highest exposure to the test substance, 0.05% dose group (2% in the diet after 6 months) and 1% dose group (CIR, 2001). Based on the study results, the NOAEL was established at ≥2% (equivalent to 1578 mg/kg bw/day) (ECHA, 2023b). SMS was tested negative in an in vitro genotoxicity battery of tests, i.e., bacterial reverse mutation assay (Ames test), chromosome aberration study in using human lymphocytes and mouse lymphoma assay (ECHA, 2023c). Based on the study results, SMS is not expected to be genotoxic. As per the CIR’s Expert Panel report, fatty acyl sarcosines and their salts are not considered likely carcinogens as they and their metabolites “do not belong to any","page":37,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_007"} |
| SCCS_vision_codex | NOAEL | =2 | % | rat | oral | 24 months | reproductive toxicity | {"dose":"re observed in lesions, fertility, mortality, haematology, or body weight gain between rats of the control and treated groups.","effect":"re observed in lesions, fertility, mortality, haematology, or body weight gain between rats of the control and treated groups. At 24 months, the only consistent difference that could be attributed to the test substance was minor hyperplasia of the stratified squamous epithelium with excess keratin formation of the cardiac mucosa of the stomach in rats receiving the highest exposure to the test substance, 0.05% dose group (2% in the diet after 6 months) and 1% dose group (CIR, 2001). Based on the study results, the NOAEL was established at ≥2% (equivalent to 1578 mg/kg bw/day) (ECHA, 2023b). SMS was tested negative in an in vitro genotoxicity battery of tests, i.e., bacterial reverse mutation assay (Ames test), chromosome aberration study in using human lymphocytes and mouse lymphoma assay (ECHA, 2023c). Based on the study results, SMS is not expected to be genotoxic. As per the CIR’s Expert Panel report, fatty acyl sarcosines and their salts are not considered likely carcinogens as they and their metabolites “do not belong to any","page":37,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_007"} |
| SCCS_vision_codex | NOAEL | =62.5 | mg/kg bw/d | rat | oral | Sub-chronic | repeated dose toxicity | {"dose":"13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d.","effect":"rpuscular volume, mean corpuscular haemoglobin, red 8 (cell) distribution width, platelets, hematocrit, mean platelet volume of mice. 9 Disruption of the liver function in terms of enhanced activities of alanine 10 aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate 11 dehydrogenase and cholinesterase, increase of total protein, and reduction of albumin to 12 globulin ratio, total bilirubin, triglycerides, and the total cholesterol levels. 13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d. 14 15 SCCS Comment 16 NOAEL derived from this study is 62.5 mg/kg bw/d. 17 1.5.5.2 Sub-chronic (90 days) toxicity (oral, dermal) 18 19 Subchronic oral toxicity – Rat 90 day oral (diet) 20 21 Guideline: No guideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Ora","page":61,"pdf":"sccs_o_136.pdf","row_type":"noael_study","study_id":"sccs_o_136_noael_001"} |
| SCCS_vision_codex | NOAEL | =62.5 | mg/kg bw/d | rat | oral | Sub-chronic | repeated dose toxicity | {"dose":"13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d.","effect":"rpuscular volume, mean corpuscular haemoglobin, red 8 (cell) distribution width, platelets, hematocrit, mean platelet volume of mice. 9 Disruption of the liver function in terms of enhanced activities of alanine 10 aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate 11 dehydrogenase and cholinesterase, increase of total protein, and reduction of albumin to 12 globulin ratio, total bilirubin, triglycerides, and the total cholesterol levels. 13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d. 14 15 SCCS Comment 16 NOAEL derived from this study is 62.5 mg/kg bw/d. 17 1.5.5.2 Sub-chronic (90 days) toxicity (oral, dermal) 18 19 Subchronic oral toxicity – Rat 90 day oral (diet) 20 21 Guideline: No guideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Ora","page":61,"pdf":"sccs_o_136.pdf","row_type":"noael_study","study_id":"sccs_o_136_noael_001"} |
| SCCS_vision_codex | NOAEL | =62.5 | mg/kg bw/d | rat | oral | Sub-chronic | repeated dose toxicity | {"dose":"13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d.","effect":"rpuscular volume, mean corpuscular haemoglobin, red 8 (cell) distribution width, platelets, hematocrit, mean platelet volume of mice. 9 Disruption of the liver function in terms of enhanced activities of alanine 10 aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate 11 dehydrogenase and cholinesterase, increase of total protein, and reduction of albumin to 12 globulin ratio, total bilirubin, triglycerides, and the total cholesterol levels. 13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d. 14 15 SCCS Comment 16 NOAEL derived from this study is 62.5 mg/kg bw/d. 17 1.5.5.2 Sub-chronic (90 days) toxicity (oral, dermal) 18 19 Subchronic oral toxicity – Rat 90 day oral (diet) 20 21 Guideline: No guideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Ora","page":61,"pdf":"sccs_o_136.pdf","row_type":"noael_study","study_id":"sccs_o_136_noael_001"} |
| SCCS_vision_codex | NOAEL | =62.5 | mg/kg bw/d | rat | oral | Sub-chronic | repeated dose toxicity | {"dose":"13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d.","effect":"rpuscular volume, mean corpuscular haemoglobin, red 8 (cell) distribution width, platelets, hematocrit, mean platelet volume of mice. 9 Disruption of the liver function in terms of enhanced activities of alanine 10 aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate 11 dehydrogenase and cholinesterase, increase of total protein, and reduction of albumin to 12 globulin ratio, total bilirubin, triglycerides, and the total cholesterol levels. 13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d. 14 15 SCCS Comment 16 NOAEL derived from this study is 62.5 mg/kg bw/d. 17 1.5.5.2 Sub-chronic (90 days) toxicity (oral, dermal) 18 19 Subchronic oral toxicity – Rat 90 day oral (diet) 20 21 Guideline: No guideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Ora","page":61,"pdf":"sccs_o_136.pdf","row_type":"noael_study","study_id":"sccs_o_136_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"However, in another study performed by the same group of researchers, with administration of aluminium lactate from conception throughout the whole lifespan at 100 mg/kg bw/day no clear signs of neurotoxicity were observed in the same strain of mice.","effect":"during lactation could also be identified. However, in another study performed by the same group of researchers, with administration of aluminium lactate from conception throughout the whole lifespan at 100 mg/kg bw/day no clear signs of neurotoxicity were observed in the same strain of mice. The European Food Safety Authority (EFSA) expert panel concluded that a value of 1 mg Al/kg bw/week, representing a rounded value between the Tolerable Weekly Intakes (TWIs) provided by using the LOAEL 50 mg Al/kg bw/day and NOAEL 10 mg Al/kg bw/day approaches, should be established as the TWI (EFSA, 2008). In a recent drinking water developmental and chronic neurotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on re","page":36,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"However, in another study performed by the same group of researchers, with administration of aluminium lactate from conception throughout the whole lifespan at 100 mg/kg bw/day no clear signs of neurotoxicity were observed in the same strain of mice.","effect":"during lactation could also be identified. However, in another study performed by the same group of researchers, with administration of aluminium lactate from conception throughout the whole lifespan at 100 mg/kg bw/day no clear signs of neurotoxicity were observed in the same strain of mice. The European Food Safety Authority (EFSA) expert panel concluded that a value of 1 mg Al/kg bw/week, representing a rounded value between the Tolerable Weekly Intakes (TWIs) provided by using the LOAEL 50 mg Al/kg bw/day and NOAEL 10 mg Al/kg bw/day approaches, should be established as the TWI (EFSA, 2008). In a recent drinking water developmental and chronic neurotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on re","page":36,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"However, in another study performed by the same group of researchers, with administration of aluminium lactate from conception throughout the whole lifespan at 100 mg/kg bw/day no clear signs of neurotoxicity were observed in the same strain of mice.","effect":"during lactation could also be identified. However, in another study performed by the same group of researchers, with administration of aluminium lactate from conception throughout the whole lifespan at 100 mg/kg bw/day no clear signs of neurotoxicity were observed in the same strain of mice. The European Food Safety Authority (EFSA) expert panel concluded that a value of 1 mg Al/kg bw/week, representing a rounded value between the Tolerable Weekly Intakes (TWIs) provided by using the LOAEL 50 mg Al/kg bw/day and NOAEL 10 mg Al/kg bw/day approaches, should be established as the TWI (EFSA, 2008). In a recent drinking water developmental and chronic neurotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on re","page":36,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_001"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"However, in another study performed by the same group of researchers, with administration of aluminium lactate from conception throughout the whole lifespan at 100 mg/kg bw/day no clear signs of neurotoxicity were observed in the same strain of mice.","effect":"during lactation could also be identified. However, in another study performed by the same group of researchers, with administration of aluminium lactate from conception throughout the whole lifespan at 100 mg/kg bw/day no clear signs of neurotoxicity were observed in the same strain of mice. The European Food Safety Authority (EFSA) expert panel concluded that a value of 1 mg Al/kg bw/week, representing a rounded value between the Tolerable Weekly Intakes (TWIs) provided by using the LOAEL 50 mg Al/kg bw/day and NOAEL 10 mg Al/kg bw/day approaches, should be established as the TWI (EFSA, 2008). In a recent drinking water developmental and chronic neurotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on re","page":36,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/day | rat | oral | 2023d | repeated dose toxicity | {"dose":"In a subchronic oral toxicity study conducted in rats, the animals were orally administered the structural analogue SLS at dose levels of 0, 30, 100 or 250 mg/kg bw/day for 90 days.","effect":"no skin sensitization response following exposure to 5% SLS, a structural analogue of SMS (ECHA, 2023d). In a human repeat-insult patch test (HRIPT), 5% SLS, a structural analogue of SMS was not assessed to be a skin sensitiser (CIR, 2001). Considering the overall weight of evidence, SMS is not considered to be a skin sensitiser. In a subchronic oral toxicity study conducted in rats, the animals were orally administered the structural analogue SLS at dose levels of 0, 30, 100 or 250 mg/kg bw/day for 90 days. The NOAEL and LOAEL were established at 100 and 250 mg/kg bw/day, respectively (CIR, 2021). In a 2-year chronic dietary toxicity study conducted in rats, the animals were fed SLS at the dose levels of 0, 0.05, 0.2 and 1% (equivalent to 0, 39.4, 157.8 and 789 mg/kg bw/day for 2 years (CIR, 2001, US EPA, 1988). The low dose group was fed 0.05% SLS in the daily diet for the first 6 months of the study and 2% SLS in the diet (equivalent to 1578 mg/kg bw/day) for the remaining 18 months. At 1, 3 and 6 months, no significant diff","page":37,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_006"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/day | rat | oral | 2023d | repeated dose toxicity | {"dose":"In a subchronic oral toxicity study conducted in rats, the animals were orally administered the structural analogue SLS at dose levels of 0, 30, 100 or 250 mg/kg bw/day for 90 days.","effect":"no skin sensitization response following exposure to 5% SLS, a structural analogue of SMS (ECHA, 2023d). In a human repeat-insult patch test (HRIPT), 5% SLS, a structural analogue of SMS was not assessed to be a skin sensitiser (CIR, 2001). Considering the overall weight of evidence, SMS is not considered to be a skin sensitiser. In a subchronic oral toxicity study conducted in rats, the animals were orally administered the structural analogue SLS at dose levels of 0, 30, 100 or 250 mg/kg bw/day for 90 days. The NOAEL and LOAEL were established at 100 and 250 mg/kg bw/day, respectively (CIR, 2021). In a 2-year chronic dietary toxicity study conducted in rats, the animals were fed SLS at the dose levels of 0, 0.05, 0.2 and 1% (equivalent to 0, 39.4, 157.8 and 789 mg/kg bw/day for 2 years (CIR, 2001, US EPA, 1988). The low dose group was fed 0.05% SLS in the daily diet for the first 6 months of the study and 2% SLS in the diet (equivalent to 1578 mg/kg bw/day) for the remaining 18 months. At 1, 3 and 6 months, no significant diff","page":37,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_006"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/day | rat | oral | 2023d | repeated dose toxicity | {"dose":"In a subchronic oral toxicity study conducted in rats, the animals were orally administered the structural analogue SLS at dose levels of 0, 30, 100 or 250 mg/kg bw/day for 90 days.","effect":"no skin sensitization response following exposure to 5% SLS, a structural analogue of SMS (ECHA, 2023d). In a human repeat-insult patch test (HRIPT), 5% SLS, a structural analogue of SMS was not assessed to be a skin sensitiser (CIR, 2001). Considering the overall weight of evidence, SMS is not considered to be a skin sensitiser. In a subchronic oral toxicity study conducted in rats, the animals were orally administered the structural analogue SLS at dose levels of 0, 30, 100 or 250 mg/kg bw/day for 90 days. The NOAEL and LOAEL were established at 100 and 250 mg/kg bw/day, respectively (CIR, 2021). In a 2-year chronic dietary toxicity study conducted in rats, the animals were fed SLS at the dose levels of 0, 0.05, 0.2 and 1% (equivalent to 0, 39.4, 157.8 and 789 mg/kg bw/day for 2 years (CIR, 2001, US EPA, 1988). The low dose group was fed 0.05% SLS in the daily diet for the first 6 months of the study and 2% SLS in the diet (equivalent to 1578 mg/kg bw/day) for the remaining 18 months. At 1, 3 and 6 months, no significant diff","page":37,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_006"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/day | rat | oral | 2023d | repeated dose toxicity | {"dose":"In a subchronic oral toxicity study conducted in rats, the animals were orally administered the structural analogue SLS at dose levels of 0, 30, 100 or 250 mg/kg bw/day for 90 days.","effect":"no skin sensitization response following exposure to 5% SLS, a structural analogue of SMS (ECHA, 2023d). In a human repeat-insult patch test (HRIPT), 5% SLS, a structural analogue of SMS was not assessed to be a skin sensitiser (CIR, 2001). Considering the overall weight of evidence, SMS is not considered to be a skin sensitiser. In a subchronic oral toxicity study conducted in rats, the animals were orally administered the structural analogue SLS at dose levels of 0, 30, 100 or 250 mg/kg bw/day for 90 days. The NOAEL and LOAEL were established at 100 and 250 mg/kg bw/day, respectively (CIR, 2021). In a 2-year chronic dietary toxicity study conducted in rats, the animals were fed SLS at the dose levels of 0, 0.05, 0.2 and 1% (equivalent to 0, 39.4, 157.8 and 789 mg/kg bw/day for 2 years (CIR, 2001, US EPA, 1988). The low dose group was fed 0.05% SLS in the daily diet for the first 6 months of the study and 2% SLS in the diet (equivalent to 1578 mg/kg bw/day) for the remaining 18 months. At 1, 3 and 6 months, no significant diff","page":37,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_006"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | rat | oral | 2-year | carcinogenicity | {"dose":"There were no treatment-related macroscopic or microscopic (neoplastic or non-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011).","effect":"Dimethicone was tested negative in an in vitro (Ames test, BALB/C-3T3 mouse cell transformation assay, CHO/HGPRT forward mutation assay and Chinese hamster ovary (CHO) chromosome aberration assay) and in vivo (mice micronucleus assay) genotoxicity tests (CIR, 2003). In a 2-year combined chronic toxicity/carcinogenicity study, rats were dosed with 10 cSt dimethicone for 103 weeks. There were no treatment-related macroscopic or microscopic (neoplastic or non-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011). In a 26-month dietary carcinogenicity study performed in rats, no toxicologically relevant treatment-related effects or increased incidences of any non-neoplastic or neoplastic lesions were reported in females/male animals up to highest tested dimethicone dose of 1742/2055 mg/kg bw/day. The EFSA panel considered 1742/2055 mg/kg bw/day as the study NOAEL (EFSA, 2020). In a 76-week carcinogenicity dietary study,","page":38,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_008"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | rat | oral | 2-year | carcinogenicity | {"dose":"There were no treatment-related macroscopic or microscopic (neoplastic or non-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011).","effect":"Dimethicone was tested negative in an in vitro (Ames test, BALB/C-3T3 mouse cell transformation assay, CHO/HGPRT forward mutation assay and Chinese hamster ovary (CHO) chromosome aberration assay) and in vivo (mice micronucleus assay) genotoxicity tests (CIR, 2003). In a 2-year combined chronic toxicity/carcinogenicity study, rats were dosed with 10 cSt dimethicone for 103 weeks. There were no treatment-related macroscopic or microscopic (neoplastic or non-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011). In a 26-month dietary carcinogenicity study performed in rats, no toxicologically relevant treatment-related effects or increased incidences of any non-neoplastic or neoplastic lesions were reported in females/male animals up to highest tested dimethicone dose of 1742/2055 mg/kg bw/day. The EFSA panel considered 1742/2055 mg/kg bw/day as the study NOAEL (EFSA, 2020). In a 76-week carcinogenicity dietary study,","page":38,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_008"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | rat | oral | 2-year | carcinogenicity | {"dose":"There were no treatment-related macroscopic or microscopic (neoplastic or non-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011).","effect":"Dimethicone was tested negative in an in vitro (Ames test, BALB/C-3T3 mouse cell transformation assay, CHO/HGPRT forward mutation assay and Chinese hamster ovary (CHO) chromosome aberration assay) and in vivo (mice micronucleus assay) genotoxicity tests (CIR, 2003). In a 2-year combined chronic toxicity/carcinogenicity study, rats were dosed with 10 cSt dimethicone for 103 weeks. There were no treatment-related macroscopic or microscopic (neoplastic or non-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011). In a 26-month dietary carcinogenicity study performed in rats, no toxicologically relevant treatment-related effects or increased incidences of any non-neoplastic or neoplastic lesions were reported in females/male animals up to highest tested dimethicone dose of 1742/2055 mg/kg bw/day. The EFSA panel considered 1742/2055 mg/kg bw/day as the study NOAEL (EFSA, 2020). In a 76-week carcinogenicity dietary study,","page":38,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_008"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | rat | oral | 2-year | carcinogenicity | {"dose":"There were no treatment-related macroscopic or microscopic (neoplastic or non-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011).","effect":"Dimethicone was tested negative in an in vitro (Ames test, BALB/C-3T3 mouse cell transformation assay, CHO/HGPRT forward mutation assay and Chinese hamster ovary (CHO) chromosome aberration assay) and in vivo (mice micronucleus assay) genotoxicity tests (CIR, 2003). In a 2-year combined chronic toxicity/carcinogenicity study, rats were dosed with 10 cSt dimethicone for 103 weeks. There were no treatment-related macroscopic or microscopic (neoplastic or non-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011). In a 26-month dietary carcinogenicity study performed in rats, no toxicologically relevant treatment-related effects or increased incidences of any non-neoplastic or neoplastic lesions were reported in females/male animals up to highest tested dimethicone dose of 1742/2055 mg/kg bw/day. The EFSA panel considered 1742/2055 mg/kg bw/day as the study NOAEL (EFSA, 2020). In a 76-week carcinogenicity dietary study,","page":38,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_008"} |
| SCCS_vision_codex | NOAEL | =1742 | mg/kg bw/day | - | oral | developmental | reproductive toxicity | {"dose":"The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011).","effect":"y (ECETOC, 2003). Based on the results of the above studies it can be concluded that the potential of dimethicone to be a reproductive or developmental toxicant is low. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011). The EFSA panel established an ADI of 17 mg/kg bw/day for dimethyl polysiloxane (E 900) using the NOAEL 1742 mg/kg bw/day from 26-month dietary carcinogenicity study (EFSA, 2020). Dimethicone was reported to be used in leave-on products up to 85% and in rinse-off products up to 23.4%. The CIR Expert Panel concluded that dimethicone is safe in cosmetics in the present practices of use and reported concentration ranges when formulated to be non- irritating, with the exception that the available data are insufficient to make a determination of safety for use in products that may be incidentally inhaled when applied usi","page":39,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_012"} |
| SCCS_vision_codex | NOAEL | =1742 | mg/kg bw/day | - | oral | developmental | reproductive toxicity | {"dose":"The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011).","effect":"y (ECETOC, 2003). Based on the results of the above studies it can be concluded that the potential of dimethicone to be a reproductive or developmental toxicant is low. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011). The EFSA panel established an ADI of 17 mg/kg bw/day for dimethyl polysiloxane (E 900) using the NOAEL 1742 mg/kg bw/day from 26-month dietary carcinogenicity study (EFSA, 2020). Dimethicone was reported to be used in leave-on products up to 85% and in rinse-off products up to 23.4%. The CIR Expert Panel concluded that dimethicone is safe in cosmetics in the present practices of use and reported concentration ranges when formulated to be non- irritating, with the exception that the available data are insufficient to make a determination of safety for use in products that may be incidentally inhaled when applied usi","page":39,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_012"} |
| SCCS_vision_codex | NOAEL | =1742 | mg/kg bw/day | - | oral | developmental | reproductive toxicity | {"dose":"The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011).","effect":"y (ECETOC, 2003). Based on the results of the above studies it can be concluded that the potential of dimethicone to be a reproductive or developmental toxicant is low. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011). The EFSA panel established an ADI of 17 mg/kg bw/day for dimethyl polysiloxane (E 900) using the NOAEL 1742 mg/kg bw/day from 26-month dietary carcinogenicity study (EFSA, 2020). Dimethicone was reported to be used in leave-on products up to 85% and in rinse-off products up to 23.4%. The CIR Expert Panel concluded that dimethicone is safe in cosmetics in the present practices of use and reported concentration ranges when formulated to be non- irritating, with the exception that the available data are insufficient to make a determination of safety for use in products that may be incidentally inhaled when applied usi","page":39,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_012"} |
| SCCS_vision_codex | NOAEL | =1742 | mg/kg bw/day | - | oral | developmental | reproductive toxicity | {"dose":"The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011).","effect":"y (ECETOC, 2003). Based on the results of the above studies it can be concluded that the potential of dimethicone to be a reproductive or developmental toxicant is low. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011). The EFSA panel established an ADI of 17 mg/kg bw/day for dimethyl polysiloxane (E 900) using the NOAEL 1742 mg/kg bw/day from 26-month dietary carcinogenicity study (EFSA, 2020). Dimethicone was reported to be used in leave-on products up to 85% and in rinse-off products up to 23.4%. The CIR Expert Panel concluded that dimethicone is safe in cosmetics in the present practices of use and reported concentration ranges when formulated to be non- irritating, with the exception that the available data are insufficient to make a determination of safety for use in products that may be incidentally inhaled when applied usi","page":39,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_012"} |
| SCCS_vision_codex | NOAEL | =2055 | mg/kg bw/day | rat | oral | 26-month | carcinogenicity | {"dose":"-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011).","effect":"-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011). In a 26-month dietary carcinogenicity study performed in rats, no toxicologically relevant treatment-related effects or increased incidences of any non-neoplastic or neoplastic lesions were reported in females/male animals up to highest tested dimethicone dose of 1742/2055 mg/kg bw/day. The EFSA panel considered 1742/2055 mg/kg bw/day as the study NOAEL (EFSA, 2020). In a 76-week carcinogenicity dietary study, mice were orally fed with 91% dimethicone at 0.25% and 2.5% (equivalent to 520 and 5200 mg/kg bw/day) in diet. Another group received a single 0.2 mL subcutaneous injection of dimethicone (201 mg) into the left flank. The study author concluded that there was no treatment-related increase in the incidence of malignant or benign tumours in the mice groups receiving dimethicone by either oral diet or subcutaneous injection. Also, no treatment-related toxic ef","page":38,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_009"} |
| SCCS_vision_codex | NOAEL | =2055 | mg/kg bw/day | rat | oral | 26-month | carcinogenicity | {"dose":"-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011).","effect":"-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011). In a 26-month dietary carcinogenicity study performed in rats, no toxicologically relevant treatment-related effects or increased incidences of any non-neoplastic or neoplastic lesions were reported in females/male animals up to highest tested dimethicone dose of 1742/2055 mg/kg bw/day. The EFSA panel considered 1742/2055 mg/kg bw/day as the study NOAEL (EFSA, 2020). In a 76-week carcinogenicity dietary study, mice were orally fed with 91% dimethicone at 0.25% and 2.5% (equivalent to 520 and 5200 mg/kg bw/day) in diet. Another group received a single 0.2 mL subcutaneous injection of dimethicone (201 mg) into the left flank. The study author concluded that there was no treatment-related increase in the incidence of malignant or benign tumours in the mice groups receiving dimethicone by either oral diet or subcutaneous injection. Also, no treatment-related toxic ef","page":38,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_009"} |
| SCCS_vision_codex | NOAEL | =2055 | mg/kg bw/day | rat | oral | 26-month | carcinogenicity | {"dose":"-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011).","effect":"-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011). In a 26-month dietary carcinogenicity study performed in rats, no toxicologically relevant treatment-related effects or increased incidences of any non-neoplastic or neoplastic lesions were reported in females/male animals up to highest tested dimethicone dose of 1742/2055 mg/kg bw/day. The EFSA panel considered 1742/2055 mg/kg bw/day as the study NOAEL (EFSA, 2020). In a 76-week carcinogenicity dietary study, mice were orally fed with 91% dimethicone at 0.25% and 2.5% (equivalent to 520 and 5200 mg/kg bw/day) in diet. Another group received a single 0.2 mL subcutaneous injection of dimethicone (201 mg) into the left flank. The study author concluded that there was no treatment-related increase in the incidence of malignant or benign tumours in the mice groups receiving dimethicone by either oral diet or subcutaneous injection. Also, no treatment-related toxic ef","page":38,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_009"} |
| SCCS_vision_codex | NOAEL | =2055 | mg/kg bw/day | rat | oral | 26-month | carcinogenicity | {"dose":"-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011).","effect":"-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011). In a 26-month dietary carcinogenicity study performed in rats, no toxicologically relevant treatment-related effects or increased incidences of any non-neoplastic or neoplastic lesions were reported in females/male animals up to highest tested dimethicone dose of 1742/2055 mg/kg bw/day. The EFSA panel considered 1742/2055 mg/kg bw/day as the study NOAEL (EFSA, 2020). In a 76-week carcinogenicity dietary study, mice were orally fed with 91% dimethicone at 0.25% and 2.5% (equivalent to 520 and 5200 mg/kg bw/day) in diet. Another group received a single 0.2 mL subcutaneous injection of dimethicone (201 mg) into the left flank. The study author concluded that there was no treatment-related increase in the incidence of malignant or benign tumours in the mice groups receiving dimethicone by either oral diet or subcutaneous injection. Also, no treatment-related toxic ef","page":38,"pdf":"sccs_o_289.pdf","row_type":"noael_study","study_id":"sccs_o_289_noael_009"} |
| SCCS_vision_codex | NOAEL | =100000 | ppm | rat | oral | Subchronic | repeated dose toxicity | {"citation":"Reference: I-NCI, 1979 (22)","dose":"6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume:","effect":"ideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Oral 31 Administration: Diet 32 GLP: No 33 Study period: 1978 34 Reference: I-NCI, 1979 (22); DHS-NCI, 1979 (9) 35 36 Results 37 No deaths, no differences in body weight gains, no substance-related gross or microscopic 38 pathological finding, NOAEL: 100000 ppm. 39 40 SCCS Comment 41 No information has been provided on the particle size profile of the material tested in this 42 study. The study is therefore of little value in relation to the current assessment for nano- 43 forms of TiO2. 44 45 Note 46 The two references provided (I-NCI, 1979 (22) and DHS-NCI, 1979 (9)) are in fact the 47 same. 48 49 50 Subchronic oral toxicity – Mouse 90 day oral (diet) 51 52 Guideline: No guideline 53 Species/strain: Mouse/B6C3Fi 54","page":61,"pdf":"sccs_o_136.pdf","row_type":"noael_study","study_id":"sccs_o_136_noael_003"} |
| SCCS_vision_codex | NOAEL | =100000 | ppm | rat | oral | Subchronic | repeated dose toxicity | {"citation":"Reference: I-NCI, 1979 (22)","dose":"6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume:","effect":"ideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Oral 31 Administration: Diet 32 GLP: No 33 Study period: 1978 34 Reference: I-NCI, 1979 (22); DHS-NCI, 1979 (9) 35 36 Results 37 No deaths, no differences in body weight gains, no substance-related gross or microscopic 38 pathological finding, NOAEL: 100000 ppm. 39 40 SCCS Comment 41 No information has been provided on the particle size profile of the material tested in this 42 study. The study is therefore of little value in relation to the current assessment for nano- 43 forms of TiO2. 44 45 Note 46 The two references provided (I-NCI, 1979 (22) and DHS-NCI, 1979 (9)) are in fact the 47 same. 48 49 50 Subchronic oral toxicity – Mouse 90 day oral (diet) 51 52 Guideline: No guideline 53 Species/strain: Mouse/B6C3Fi 54","page":61,"pdf":"sccs_o_136.pdf","row_type":"noael_study","study_id":"sccs_o_136_noael_003"} |
| SCCS_vision_codex | NOAEL | =100000 | ppm | rat | oral | Subchronic | repeated dose toxicity | {"citation":"Reference: I-NCI, 1979 (22)","dose":"6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume:","effect":"ideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Oral 31 Administration: Diet 32 GLP: No 33 Study period: 1978 34 Reference: I-NCI, 1979 (22); DHS-NCI, 1979 (9) 35 36 Results 37 No deaths, no differences in body weight gains, no substance-related gross or microscopic 38 pathological finding, NOAEL: 100000 ppm. 39 40 SCCS Comment 41 No information has been provided on the particle size profile of the material tested in this 42 study. The study is therefore of little value in relation to the current assessment for nano- 43 forms of TiO2. 44 45 Note 46 The two references provided (I-NCI, 1979 (22) and DHS-NCI, 1979 (9)) are in fact the 47 same. 48 49 50 Subchronic oral toxicity – Mouse 90 day oral (diet) 51 52 Guideline: No guideline 53 Species/strain: Mouse/B6C3Fi 54","page":61,"pdf":"sccs_o_136.pdf","row_type":"noael_study","study_id":"sccs_o_136_noael_003"} |
| SCCS_vision_codex | NOAEL | =100000 | ppm | rat | oral | Subchronic | repeated dose toxicity | {"citation":"Reference: I-NCI, 1979 (22)","dose":"6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume:","effect":"ideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Oral 31 Administration: Diet 32 GLP: No 33 Study period: 1978 34 Reference: I-NCI, 1979 (22); DHS-NCI, 1979 (9) 35 36 Results 37 No deaths, no differences in body weight gains, no substance-related gross or microscopic 38 pathological finding, NOAEL: 100000 ppm. 39 40 SCCS Comment 41 No information has been provided on the particle size profile of the material tested in this 42 study. The study is therefore of little value in relation to the current assessment for nano- 43 forms of TiO2. 44 45 Note 46 The two references provided (I-NCI, 1979 (22) and DHS-NCI, 1979 (9)) are in fact the 47 same. 48 49 50 Subchronic oral toxicity – Mouse 90 day oral (diet) 51 52 Guideline: No guideline 53 Species/strain: Mouse/B6C3Fi 54","page":61,"pdf":"sccs_o_136.pdf","row_type":"noael_study","study_id":"sccs_o_136_noael_003"} |
ToxValDB_ECHA_IUCLID 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LOAEC | =10.5 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15560/7/6/3?documentUUID=3360473e-6431-4bb1-8453-460a7e20d99d; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827769_15827770:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2a7a664d71ee92620287dd98f19fb594 |
| ToxValDB_ECHA_IUCLID | LOAEC | =10.8 | mg/m3 | Mouse | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15560/7/6/3?documentUUID=3360473e-6431-4bb1-8453-460a7e20d99d; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15828371_15828372:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c23f527cd08b240cf2ca8826579a0a21 |
| ToxValDB_ECHA_IUCLID | NOAEC | =2.1 | mg/m3 | Rat | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15560/7/6/3?documentUUID=3360473e-6431-4bb1-8453-460a7e20d99d; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15827769_15827770:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c3b0f53bd3e2366d266a2692420dedef |
| ToxValDB_ECHA_IUCLID | NOAEC | =2.2 | mg/m3 | Mouse | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15560/7/6/3?documentUUID=3360473e-6431-4bb1-8453-460a7e20d99d; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15828371_15828372:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_b3c7931419d3519cc3a7787fe0fabad5 |
| ToxValDB_ECHA_IUCLID | NOAEC | =10.7 | mg/m3 | Hamster | inhalation | subchronic; 13 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15560/7/6/3?documentUUID=3360473e-6431-4bb1-8453-460a7e20d99d; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID:15827963:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4601c85f666361db96a11ab237d25bc9 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1000 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabdde4b0a7c65d1bc2d3; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15560/7/9/3?documentUUID=3360473e-6431-4bb1-8453-460a7e20d99d; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID:15824217:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_627303d0f5d63c1f7508b720cf64ab51 |
ToxValDB_ECOTOX 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | NOEL | =1000 | ppm | Rat | oral | acute; 0.875 days | acute | LONG_REF=Teratog. Carcinog. Mutagen.9(5): 273-285 Kitchin,K.T., and J.L. Brown Biochemical Studies of Promoters of Carcinogenesis in Rat Liver 1989; TITLE=Biochemical Studies of Promoters of Carcinogenesis in Rat Liver; AUTHOR=Kitchin,K.T., and J.L. Brown; DOI=10.1002/tcm.1770090503; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=103823; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=Biochemistry: Glutathione (reduced glutathione)|Enzyme(s): Alanine transaminase (ALT)|Enzyme(s): Cytochrome P-450|Enzyme(s): Ornithine decarboxylase|Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|enzyme activity|other; STUDY_GROUP=ECOTOX:15605027:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=8a3fa52ac689e5b5da6e6b0d6c2a1772 |
| ToxValDB_ECOTOX | NOEL | =2000 | mg/kg bw/day | Mouse | oral | short-term; 2 days | short-term | LONG_REF=Mutat. Res.343(2/3): 157-183 Miyagawa,M., H. Takasawa, A. Sugiyama, Y. Inoue, T. Murata, Y. Uno, and K. Yoshikawa The In Vivo-In Vitro Replicative DNA Synthesis (RDS) Test with Hepatocytes Prepared from Male B6C3F1 Mice as an Early Prediction Assay for Putative Nongenotoxic (Ames-Negative) Mouse Hepatocarcinogens 1995; TITLE=The In Vivo-In Vitro Replicative DNA Synthesis (RDS) Test with Hepatocytes Prepared from Male B6C3F1 Mice as an Early Prediction Assay for Putative Nongenotoxic (Ames-Negative) Mouse Hepatocarcinogens; AUTHOR=Miyagawa,M., H. Takasawa, A. Sugiyama, Y. Inoue, T. Murata, Y. Uno, and K. Yoshikawa; DOI=10.1016/0165-1218(95)90082-9; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=75052; 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=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=Cell(s): Viability; STUDY_GROUP=ECOTOX:15607327:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=046fb9c87e0a4abf520717303dc2140e |
ToxValDB_EFSA 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_EFSA | NOAEL | =2250 | mg/kg bw/day | Rat | oral | chronic; 103 weeks | chronic | LONG_REF=EFSA ANS (2016). Re-evaluation of titanium dioxide (E 171) as a food additive. doi:10.2903/j.efsa.2016.4545.; TITLE=Re-evaluation of titanium dioxide (E 171) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2016.4545; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15614211:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_cc495356b39e06395dc79d96bdffb238 |
ToxValDB_GESTIS_DNEL 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL local | =0.17 | 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_dup_-_15635273_15635274_15635275:-:--; 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_b0dd3ec205970e84a2cdb0aa1d31fde0 |
| ToxValDB_GESTIS_DNEL | DNEL local | =0.8 | 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_dup_-_15635273_15635274_15635275:-:--; 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_41e790dec87b1d884b0e55fe62af7d49 |
| ToxValDB_GESTIS_DNEL | DNEL local | =1.25 | 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_dup_-_15635273_15635274_15635275:-:--; 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_83cf42f310bacf42aea2fd41d807f8f3 |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 1000 | mg/kg bw/day | rat | oral | 2-year | carcinogenicity | SOURCE_SUBDIR=sccs_o_289; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON new coating for Titanium Dioxide (nano form); OPINION_NUMBER=SCCS/1667/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2024; VALUE_TEXT=1000; DOSE=There were no treatment-related macroscopic or microscopic (neoplastic or non-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011).; EFFECT=Dimethicone was tested negative in an in vitro (Ames test, BALB/C-3T3 mouse cell transformation assay, CHO/HGPRT forward mutation assay and Chinese hamster ovary (CHO) chromosome aberration assay) and in vivo (mice micronucleus assay) genotoxicity tests (CIR, 2003). In a 2-year combined chronic toxicity/carcinogenicity study, rats were dosed with 10 cSt dimethicone for 103 weeks. There were no treatment-related macroscopic or microscopic (neoplastic or non-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011). In a 26-month dietary carcinogenicity study performed in rats, no toxicologically relevant treatment-related effects or increased incidences of any non-neoplastic or neoplastic lesions were reported in females/male animals up to highest tested dimethicone dose of 1742/2055 mg/kg bw/day. The EFSA panel considered 1742/2055 mg/kg bw/day as the study NOAEL (EFSA, 2020). In a 76-week carcinogenicity dietary study,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"There were no treatment-related macroscopic or microscopic (neoplastic or non-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011).","duration":"2-year","effect":"Dimethicone was tested negative in an in vitro (Ames test, BALB/C-3T3 mouse cell transformation assay, CHO/HGPRT forward mutation assay and Chinese hamster ovary (CHO) chromosome aberration assay) and in vivo (mice micronucleus assay) genotoxicity tests (CIR, 2003). In a 2-year combined chronic toxicity/carcinogenicity study, rats were dosed with 10 cSt dimethicone for 103 weeks. There were no treatment-related macroscopic or microscopic (neoplastic or non-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011). In a 26-month dietary carcinogenicity study performed in rats, no toxicologically relevant treatment-related effects or increased incidences of any non-neoplastic or neoplastic lesions were reported in females/male animals up to highest tested dimethicone dose of 1742/2055 mg/kg bw/day. The EFSA panel considered 1742/2055 mg/kg bw/day as the study NOAEL (EFSA, 2020). In a 76-week carcinogenicity dietary study,","endpoint":"carcinogenicity","ingredient":"codes ................................... 11","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":38,"route":"oral","species":"rat","study_id":"sccs_o_289_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 2055 | mg/kg bw/day | rat | oral | 26-month | carcinogenicity | SOURCE_SUBDIR=sccs_o_289; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON new coating for Titanium Dioxide (nano form); OPINION_NUMBER=SCCS/1667/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2024; VALUE_TEXT=2055; DOSE=-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011).; EFFECT=-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011). In a 26-month dietary carcinogenicity study performed in rats, no toxicologically relevant treatment-related effects or increased incidences of any non-neoplastic or neoplastic lesions were reported in females/male animals up to highest tested dimethicone dose of 1742/2055 mg/kg bw/day. The EFSA panel considered 1742/2055 mg/kg bw/day as the study NOAEL (EFSA, 2020). In a 76-week carcinogenicity dietary study, mice were orally fed with 91% dimethicone at 0.25% and 2.5% (equivalent to 520 and 5200 mg/kg bw/day) in diet. Another group received a single 0.2 mL subcutaneous injection of dimethicone (201 mg) into the left flank. The study author concluded that there was no treatment-related increase in the incidence of malignant or benign tumours in the mice groups receiving dimethicone by either oral diet or subcutaneous injection. Also, no treatment-related toxic ef; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011).","duration":"26-month","effect":"-neoplastic) findings at any dose level and a freestanding NOEL in rats was determined to be at the highest tested dose of 1000 mg/kg bw/day (ECETOC, 2003, JECFA, 2011). In a 26-month dietary carcinogenicity study performed in rats, no toxicologically relevant treatment-related effects or increased incidences of any non-neoplastic or neoplastic lesions were reported in females/male animals up to highest tested dimethicone dose of 1742/2055 mg/kg bw/day. The EFSA panel considered 1742/2055 mg/kg bw/day as the study NOAEL (EFSA, 2020). In a 76-week carcinogenicity dietary study, mice were orally fed with 91% dimethicone at 0.25% and 2.5% (equivalent to 520 and 5200 mg/kg bw/day) in diet. Another group received a single 0.2 mL subcutaneous injection of dimethicone (201 mg) into the left flank. The study author concluded that there was no treatment-related increase in the incidence of malignant or benign tumours in the mice groups receiving dimethicone by either oral diet or subcutaneous injection. Also, no treatment-related toxic ef","endpoint":"carcinogenicity","ingredient":"codes ................................... 11","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"2055","page":38,"route":"oral","species":"rat","study_id":"sccs_o_289_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 0.6 | % | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_289; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON new coating for Titanium Dioxide (nano form); OPINION_NUMBER=SCCS/1667/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2024; VALUE_TEXT=0.6; DOSE=Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams.; EFFECT=ed by using the LOAEL 50 mg Al/kg bw/day and NOAEL 10 mg Al/kg bw/day approaches, should be established as the TWI (EFSA, 2008). In a recent drinking water developmental and chronic neurotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on reported treatment related renal damage and reduced grip strength in the pups (Poirier et al., 2011, SCCS, 2022). The maternal toxicity NOAEL can be considered as 300 mg Al/kg bw/day. The SCCS in its recent opinion on the safety of aluminium in cosmetic products, derived the systemic NOAEL (NOAELsys) as 180 μg Al/kg bw/day from Poirier et al. study NOAEL, after adjustment for the rat oral bioavailability (0.6%) of aluminium citrate (SCCS, 2023). Aluminium hydroxide was rep; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams.","duration":"developmental","effect":"ed by using the LOAEL 50 mg Al/kg bw/day and NOAEL 10 mg Al/kg bw/day approaches, should be established as the TWI (EFSA, 2008). In a recent drinking water developmental and chronic neurotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on reported treatment related renal damage and reduced grip strength in the pups (Poirier et al., 2011, SCCS, 2022). The maternal toxicity NOAEL can be considered as 300 mg Al/kg bw/day. The SCCS in its recent opinion on the safety of aluminium in cosmetic products, derived the systemic NOAEL (NOAELsys) as 180 μg Al/kg bw/day from Poirier et al. study NOAEL, after adjustment for the rat oral bioavailability (0.6%) of aluminium citrate (SCCS, 2023). Aluminium hydroxide was rep","endpoint":"developmental toxicity","ingredient":"codes ................................... 11","loael_value":"","noael_unit":"%","noael_value":"0.6","page":36,"route":"oral","species":"rat","study_id":"sccs_o_289_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 0.6 | % | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_289; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON new coating for Titanium Dioxide (nano form); OPINION_NUMBER=SCCS/1667/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2024; VALUE_TEXT=0.6; DOSE=Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams.; EFFECT=urotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on reported treatment related renal damage and reduced grip strength in the pups (Poirier et al., 2011, SCCS, 2022). The maternal toxicity NOAEL can be considered as 300 mg Al/kg bw/day. The SCCS in its recent opinion on the safety of aluminium in cosmetic products, derived the systemic NOAEL (NOAELsys) as 180 μg Al/kg bw/day from Poirier et al. study NOAEL, after adjustment for the rat oral bioavailability (0.6%) of aluminium citrate (SCCS, 2023). Aluminium hydroxide was reported to be used in leave-on products up to 10.1% (in eye products) and in rinse-off products up to 8.8% (in oral hygiene products). The CIR Expert Panel concluded that aluminium hydro; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams.","duration":"developmental","effect":"urotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on reported treatment related renal damage and reduced grip strength in the pups (Poirier et al., 2011, SCCS, 2022). The maternal toxicity NOAEL can be considered as 300 mg Al/kg bw/day. The SCCS in its recent opinion on the safety of aluminium in cosmetic products, derived the systemic NOAEL (NOAELsys) as 180 μg Al/kg bw/day from Poirier et al. study NOAEL, after adjustment for the rat oral bioavailability (0.6%) of aluminium citrate (SCCS, 2023). Aluminium hydroxide was reported to be used in leave-on products up to 10.1% (in eye products) and in rinse-off products up to 8.8% (in oral hygiene products). The CIR Expert Panel concluded that aluminium hydro","endpoint":"developmental toxicity","ingredient":"codes ................................... 11","loael_value":"","noael_unit":"%","noael_value":"0.6","page":36,"route":"oral","species":"rat","study_id":"sccs_o_289_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 0.6 | % | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_289; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON new coating for Titanium Dioxide (nano form); OPINION_NUMBER=SCCS/1667/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2024; VALUE_TEXT=0.6; DOSE=um citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams.; EFFECT=um citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on reported treatment related renal damage and reduced grip strength in the pups (Poirier et al., 2011, SCCS, 2022). The maternal toxicity NOAEL can be considered as 300 mg Al/kg bw/day. The SCCS in its recent opinion on the safety of aluminium in cosmetic products, derived the systemic NOAEL (NOAELsys) as 180 μg Al/kg bw/day from Poirier et al. study NOAEL, after adjustment for the rat oral bioavailability (0.6%) of aluminium citrate (SCCS, 2023). Aluminium hydroxide was reported to be used in leave-on products up to 10.1% (in eye products) and in rinse-off products up to 8.8% (in oral hygiene products). The CIR Expert Panel concluded that aluminium hydroxide is safe in the present practices of use and concentration described in its 2016 safety assessment (CIR, 2016). Sodium myristoyl sarcosinate (SM; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"um citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams.","duration":"developmental","effect":"um citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on reported treatment related renal damage and reduced grip strength in the pups (Poirier et al., 2011, SCCS, 2022). The maternal toxicity NOAEL can be considered as 300 mg Al/kg bw/day. The SCCS in its recent opinion on the safety of aluminium in cosmetic products, derived the systemic NOAEL (NOAELsys) as 180 μg Al/kg bw/day from Poirier et al. study NOAEL, after adjustment for the rat oral bioavailability (0.6%) of aluminium citrate (SCCS, 2023). Aluminium hydroxide was reported to be used in leave-on products up to 10.1% (in eye products) and in rinse-off products up to 8.8% (in oral hygiene products). The CIR Expert Panel concluded that aluminium hydroxide is safe in the present practices of use and concentration described in its 2016 safety assessment (CIR, 2016). Sodium myristoyl sarcosinate (SM","endpoint":"developmental toxicity","ingredient":"codes ................................... 11","loael_value":"","noael_unit":"%","noael_value":"0.6","page":36,"route":"oral","species":"rat","study_id":"sccs_o_289_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 0.6 | % | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_289; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON new coating for Titanium Dioxide (nano form); OPINION_NUMBER=SCCS/1667/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2024; VALUE_TEXT=0.6; DOSE=except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams.; EFFECT=except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on reported treatment related renal damage and reduced grip strength in the pups (Poirier et al., 2011, SCCS, 2022). The maternal toxicity NOAEL can be considered as 300 mg Al/kg bw/day. The SCCS in its recent opinion on the safety of aluminium in cosmetic products, derived the systemic NOAEL (NOAELsys) as 180 μg Al/kg bw/day from Poirier et al. study NOAEL, after adjustment for the rat oral bioavailability (0.6%) of aluminium citrate (SCCS, 2023). Aluminium hydroxide was reported to be used in leave-on products up to 10.1% (in eye products) and in rinse-off products up to 8.8% (in oral hygiene products). The CIR Expert Panel concluded that aluminium hydroxide is safe in the present practices of use and concentration described in its 2016 safety assessment (CIR, 2016). Sodium myristoyl sarcosinate (SMS) Sodium myristoyl sarcosinate (SMS) is included in the EU CosIng; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams.","duration":"developmental","effect":"except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on reported treatment related renal damage and reduced grip strength in the pups (Poirier et al., 2011, SCCS, 2022). The maternal toxicity NOAEL can be considered as 300 mg Al/kg bw/day. The SCCS in its recent opinion on the safety of aluminium in cosmetic products, derived the systemic NOAEL (NOAELsys) as 180 μg Al/kg bw/day from Poirier et al. study NOAEL, after adjustment for the rat oral bioavailability (0.6%) of aluminium citrate (SCCS, 2023). Aluminium hydroxide was reported to be used in leave-on products up to 10.1% (in eye products) and in rinse-off products up to 8.8% (in oral hygiene products). The CIR Expert Panel concluded that aluminium hydroxide is safe in the present practices of use and concentration described in its 2016 safety assessment (CIR, 2016). Sodium myristoyl sarcosinate (SMS) Sodium myristoyl sarcosinate (SMS) is included in the EU CosIng","endpoint":"developmental toxicity","ingredient":"codes ................................... 11","loael_value":"","noael_unit":"%","noael_value":"0.6","page":36,"route":"oral","species":"rat","study_id":"sccs_o_289_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_289; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON new coating for Titanium Dioxide (nano form); OPINION_NUMBER=SCCS/1667/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2024; VALUE_TEXT=100; DOSE=However, in another study performed by the same group of researchers, with administration of aluminium lactate from conception throughout the whole lifespan at 100 mg/kg bw/day no clear signs of neurotoxicity were observed in the same strain of mice.; EFFECT=during lactation could also be identified. However, in another study performed by the same group of researchers, with administration of aluminium lactate from conception throughout the whole lifespan at 100 mg/kg bw/day no clear signs of neurotoxicity were observed in the same strain of mice. The European Food Safety Authority (EFSA) expert panel concluded that a value of 1 mg Al/kg bw/week, representing a rounded value between the Tolerable Weekly Intakes (TWIs) provided by using the LOAEL 50 mg Al/kg bw/day and NOAEL 10 mg Al/kg bw/day approaches, should be established as the TWI (EFSA, 2008). In a recent drinking water developmental and chronic neurotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on re; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"However, in another study performed by the same group of researchers, with administration of aluminium lactate from conception throughout the whole lifespan at 100 mg/kg bw/day no clear signs of neurotoxicity were observed in the same strain of mice.","duration":"developmental","effect":"during lactation could also be identified. However, in another study performed by the same group of researchers, with administration of aluminium lactate from conception throughout the whole lifespan at 100 mg/kg bw/day no clear signs of neurotoxicity were observed in the same strain of mice. The European Food Safety Authority (EFSA) expert panel concluded that a value of 1 mg Al/kg bw/week, representing a rounded value between the Tolerable Weekly Intakes (TWIs) provided by using the LOAEL 50 mg Al/kg bw/day and NOAEL 10 mg Al/kg bw/day approaches, should be established as the TWI (EFSA, 2008). In a recent drinking water developmental and chronic neurotoxicity study, the rats were exposed to aluminium citrate (30, 100 and 300 mg Al/kg bw/day), one of the more soluble aluminium compounds. Aluminium citrate was generally well tolerated in the dams at all doses, except the high dose (300 mg Al/kg bw/day) where diarrhoea occurred in 8 of the treated dams. The developmental toxicity NOAEL 30 mg AI/kg bw/day was reported, based on re","endpoint":"developmental toxicity","ingredient":"codes ................................... 11","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":36,"route":"oral","species":"rat","study_id":"sccs_o_289_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 62.5 | mg/kg bw/d | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_136; REPORT_TITLE=OPINION ON Titanium Dioxide (nano form) COLIPA n° S75; OPINION_NUMBER=SCCS/1516/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 24 October 2000; VALUE_TEXT=62.5; DOSE=13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d.; EFFECT=rpuscular volume, mean corpuscular haemoglobin, red 8 (cell) distribution width, platelets, hematocrit, mean platelet volume of mice. 9 Disruption of the liver function in terms of enhanced activities of alanine 10 aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate 11 dehydrogenase and cholinesterase, increase of total protein, and reduction of albumin to 12 globulin ratio, total bilirubin, triglycerides, and the total cholesterol levels. 13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d. 14 15 SCCS Comment 16 NOAEL derived from this study is 62.5 mg/kg bw/d. 17 1.5.5.2 Sub-chronic (90 days) toxicity (oral, dermal) 18 19 Subchronic oral toxicity – Rat 90 day oral (diet) 20 21 Guideline: No guideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Ora; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d.","duration":"Sub-chronic","effect":"rpuscular volume, mean corpuscular haemoglobin, red 8 (cell) distribution width, platelets, hematocrit, mean platelet volume of mice. 9 Disruption of the liver function in terms of enhanced activities of alanine 10 aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate 11 dehydrogenase and cholinesterase, increase of total protein, and reduction of albumin to 12 globulin ratio, total bilirubin, triglycerides, and the total cholesterol levels. 13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d. 14 15 SCCS Comment 16 NOAEL derived from this study is 62.5 mg/kg bw/d. 17 1.5.5.2 Sub-chronic (90 days) toxicity (oral, dermal) 18 19 Subchronic oral toxicity – Rat 90 day oral (diet) 20 21 Guideline: No guideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Ora","endpoint":"repeated dose toxicity","ingredient":"............................................... 7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"62.5","page":61,"route":"oral","species":"rat","study_id":"sccs_o_136_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 62.5 | mg/kg bw/d | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_136; REPORT_TITLE=OPINION ON Titanium Dioxide (nano form) COLIPA n° S75; OPINION_NUMBER=SCCS/1516/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 24 October 2000; VALUE_TEXT=62.5; DOSE=13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d.; EFFECT=distribution width, platelets, hematocrit, mean platelet volume of mice. 9 Disruption of the liver function in terms of enhanced activities of alanine 10 aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate 11 dehydrogenase and cholinesterase, increase of total protein, and reduction of albumin to 12 globulin ratio, total bilirubin, triglycerides, and the total cholesterol levels. 13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d. 14 15 SCCS Comment 16 NOAEL derived from this study is 62.5 mg/kg bw/d. 17 1.5.5.2 Sub-chronic (90 days) toxicity (oral, dermal) 18 19 Subchronic oral toxicity – Rat 90 day oral (diet) 20 21 Guideline: No guideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Oral 31 Administration: Diet 32 GLP: No 33 Study period: 1978 3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d.","duration":"Sub-chronic","effect":"distribution width, platelets, hematocrit, mean platelet volume of mice. 9 Disruption of the liver function in terms of enhanced activities of alanine 10 aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate 11 dehydrogenase and cholinesterase, increase of total protein, and reduction of albumin to 12 globulin ratio, total bilirubin, triglycerides, and the total cholesterol levels. 13 No such effects were seen at low dose, and the NOAEL appears to be 62.5 mg/kg bw/d. 14 15 SCCS Comment 16 NOAEL derived from this study is 62.5 mg/kg bw/d. 17 1.5.5.2 Sub-chronic (90 days) toxicity (oral, dermal) 18 19 Subchronic oral toxicity – Rat 90 day oral (diet) 20 21 Guideline: No guideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Oral 31 Administration: Diet 32 GLP: No 33 Study period: 1978 3","endpoint":"repeated dose toxicity","ingredient":"............................................... 7","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"62.5","page":61,"route":"oral","species":"rat","study_id":"sccs_o_136_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 250 | mg/kg bw/day | rat | oral | 2023d | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_289; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON new coating for Titanium Dioxide (nano form); OPINION_NUMBER=SCCS/1667/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2024; VALUE_TEXT=250; DOSE=In a subchronic oral toxicity study conducted in rats, the animals were orally administered the structural analogue SLS at dose levels of 0, 30, 100 or 250 mg/kg bw/day for 90 days.; LOAEL_VALUE=250 mg/kg bw/day; EFFECT=no skin sensitization response following exposure to 5% SLS, a structural analogue of SMS (ECHA, 2023d). In a human repeat-insult patch test (HRIPT), 5% SLS, a structural analogue of SMS was not assessed to be a skin sensitiser (CIR, 2001). Considering the overall weight of evidence, SMS is not considered to be a skin sensitiser. In a subchronic oral toxicity study conducted in rats, the animals were orally administered the structural analogue SLS at dose levels of 0, 30, 100 or 250 mg/kg bw/day for 90 days. The NOAEL and LOAEL were established at 100 and 250 mg/kg bw/day, respectively (CIR, 2021). In a 2-year chronic dietary toxicity study conducted in rats, the animals were fed SLS at the dose levels of 0, 0.05, 0.2 and 1% (equivalent to 0, 39.4, 157.8 and 789 mg/kg bw/day for 2 years (CIR, 2001, US EPA, 1988). The low dose group was fed 0.05% SLS in the daily diet for the first 6 months of the study and 2% SLS in the diet (equivalent to 1578 mg/kg bw/day) for the remaining 18 months. At 1, 3 and 6 months, no significant diff; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"In a subchronic oral toxicity study conducted in rats, the animals were orally administered the structural analogue SLS at dose levels of 0, 30, 100 or 250 mg/kg bw/day for 90 days.","duration":"2023d","effect":"no skin sensitization response following exposure to 5% SLS, a structural analogue of SMS (ECHA, 2023d). In a human repeat-insult patch test (HRIPT), 5% SLS, a structural analogue of SMS was not assessed to be a skin sensitiser (CIR, 2001). Considering the overall weight of evidence, SMS is not considered to be a skin sensitiser. In a subchronic oral toxicity study conducted in rats, the animals were orally administered the structural analogue SLS at dose levels of 0, 30, 100 or 250 mg/kg bw/day for 90 days. The NOAEL and LOAEL were established at 100 and 250 mg/kg bw/day, respectively (CIR, 2021). In a 2-year chronic dietary toxicity study conducted in rats, the animals were fed SLS at the dose levels of 0, 0.05, 0.2 and 1% (equivalent to 0, 39.4, 157.8 and 789 mg/kg bw/day for 2 years (CIR, 2001, US EPA, 1988). The low dose group was fed 0.05% SLS in the daily diet for the first 6 months of the study and 2% SLS in the diet (equivalent to 1578 mg/kg bw/day) for the remaining 18 months. At 1, 3 and 6 months, no significant diff","endpoint":"repeated dose toxicity","ingredient":"codes ................................... 11","loael_value":"250 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"250","page":37,"route":"oral","species":"rat","study_id":"sccs_o_289_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 100000 | ppm | rat | oral | Subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_136; REPORT_TITLE=OPINION ON Titanium Dioxide (nano form) COLIPA n° S75; OPINION_NUMBER=SCCS/1516/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 24 October 2000; VALUE_TEXT=100000; DOSE=6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume:; EFFECT=ideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Oral 31 Administration: Diet 32 GLP: No 33 Study period: 1978 34 Reference: I-NCI, 1979 (22); DHS-NCI, 1979 (9) 35 36 Results 37 No deaths, no differences in body weight gains, no substance-related gross or microscopic 38 pathological finding, NOAEL: 100000 ppm. 39 40 SCCS Comment 41 No information has been provided on the particle size profile of the material tested in this 42 study. The study is therefore of little value in relation to the current assessment for nano- 43 forms of TiO2. 44 45 Note 46 The two references provided (I-NCI, 1979 (22) and DHS-NCI, 1979 (9)) are in fact the 47 same. 48 49 50 Subchronic oral toxicity – Mouse 90 day oral (diet) 51 52 Guideline: No guideline 53 Species/strain: Mouse/B6C3Fi 54; CITATION=Reference: I-NCI, 1979 (22); CITATION_NUMBERS=[1979,22]; REFERENCE=Reference: I-NCI, 1979 (22); DETAILS_JSON={"cas_number":"13463-67-7","citation":"Reference: I-NCI, 1979 (22)","dose":"6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume:","duration":"Subchronic","effect":"ideline 22 Species/strain: Rat/F344 23 Group size: 10 m, 10 f per group 24 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 25 Batch: 402110C46 26 Purity: 98% 27 Vehicle: 28 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 29 Dose volume: 30 Route: Oral 31 Administration: Diet 32 GLP: No 33 Study period: 1978 34 Reference: I-NCI, 1979 (22); DHS-NCI, 1979 (9) 35 36 Results 37 No deaths, no differences in body weight gains, no substance-related gross or microscopic 38 pathological finding, NOAEL: 100000 ppm. 39 40 SCCS Comment 41 No information has been provided on the particle size profile of the material tested in this 42 study. The study is therefore of little value in relation to the current assessment for nano- 43 forms of TiO2. 44 45 Note 46 The two references provided (I-NCI, 1979 (22) and DHS-NCI, 1979 (9)) are in fact the 47 same. 48 49 50 Subchronic oral toxicity – Mouse 90 day oral (diet) 51 52 Guideline: No guideline 53 Species/strain: Mouse/B6C3Fi 54","endpoint":"repeated dose toxicity","ingredient":"............................................... 7","loael_value":"","noael_unit":"ppm","noael_value":"100000","page":61,"route":"oral","species":"rat","study_id":"sccs_o_136_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 100000 | ppm | mouse | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_136; REPORT_TITLE=OPINION ON Titanium Dioxide (nano form) COLIPA n° S75; OPINION_NUMBER=SCCS/1516/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 24 October 2000; VALUE_TEXT=100000; DOSE=6250, 12500, 25000, 50000, 100000 ppm 6 Dose volume:; EFFECT=___________________________________________ 62 Group size: 10 m, 10 f per group 1 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 2 Batch: 402110C46 3 Purity: 98% 4 Vehicle: 5 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 6 Dose volume: 7 Route: Oral 8 Administration: Diet 9 GLP: No 10 Study period: 1978 11 Reference: I-NCI, 1979 (22); DHS-NCI, 1979 (9) 12 13 Results 14 No deaths, no differences in body weight gains, no substance-related gross or microscopic 15 pathological finding, NOAEL: 100000 ppm. 16 17 18 SCCS Comment 19 No information has been provided on the particle size profile of the material tested in this 20 study. The study is therefore of little value in relation to the current assessment for nano- 21 forms of TiO2. 22 Note: Two references provided (I-NCI, 1979 (22); DHS-NCI, 1979 (9)) are in fact the same. 23 24 25 Exploratory subchronic oral study – Mice 60 day oral (gavage) 26 27 Guideline: No guideline 28 Species/strain: Mice/CD-1 29 Group size: 20 females per group 30 Tes; CITATION=Reference: I-NCI, 1979 (22); CITATION_NUMBERS=[1979,22]; REFERENCE=Reference: I-NCI, 1979 (22); DETAILS_JSON={"cas_number":"13463-67-7","citation":"Reference: I-NCI, 1979 (22)","dose":"6250, 12500, 25000, 50000, 100000 ppm 6 Dose volume:","duration":"subchronic","effect":"___________________________________________ 62 Group size: 10 m, 10 f per group 1 Test substance: TiO2 (uncoated, Unitane®, Anatase), CAS No. 13463-67-7 2 Batch: 402110C46 3 Purity: 98% 4 Vehicle: 5 Dose levels: 6250, 12500, 25000, 50000, 100000 ppm 6 Dose volume: 7 Route: Oral 8 Administration: Diet 9 GLP: No 10 Study period: 1978 11 Reference: I-NCI, 1979 (22); DHS-NCI, 1979 (9) 12 13 Results 14 No deaths, no differences in body weight gains, no substance-related gross or microscopic 15 pathological finding, NOAEL: 100000 ppm. 16 17 18 SCCS Comment 19 No information has been provided on the particle size profile of the material tested in this 20 study. The study is therefore of little value in relation to the current assessment for nano- 21 forms of TiO2. 22 Note: Two references provided (I-NCI, 1979 (22); DHS-NCI, 1979 (9)) are in fact the same. 23 24 25 Exploratory subchronic oral study – Mice 60 day oral (gavage) 26 27 Guideline: No guideline 28 Species/strain: Mice/CD-1 29 Group size: 20 females per group 30 Tes","endpoint":"repeated dose toxicity","ingredient":"............................................... 7","loael_value":"","noael_unit":"ppm","noael_value":"100000","page":62,"route":"oral","species":"mouse","study_id":"sccs_o_136_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 2 | % | rat | oral | 24 months | reproductive toxicity | SOURCE_SUBDIR=sccs_o_289; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON new coating for Titanium Dioxide (nano form); OPINION_NUMBER=SCCS/1667/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2024; VALUE_TEXT=2; DOSE=re observed in lesions, fertility, mortality, haematology, or body weight gain between rats of the control and treated groups.; EFFECT=re observed in lesions, fertility, mortality, haematology, or body weight gain between rats of the control and treated groups. At 24 months, the only consistent difference that could be attributed to the test substance was minor hyperplasia of the stratified squamous epithelium with excess keratin formation of the cardiac mucosa of the stomach in rats receiving the highest exposure to the test substance, 0.05% dose group (2% in the diet after 6 months) and 1% dose group (CIR, 2001). Based on the study results, the NOAEL was established at ≥2% (equivalent to 1578 mg/kg bw/day) (ECHA, 2023b). SMS was tested negative in an in vitro genotoxicity battery of tests, i.e., bacterial reverse mutation assay (Ames test), chromosome aberration study in using human lymphocytes and mouse lymphoma assay (ECHA, 2023c). Based on the study results, SMS is not expected to be genotoxic. As per the CIR’s Expert Panel report, fatty acyl sarcosines and their salts are not considered likely carcinogens as they and their metabolites “do not belong to any; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"re observed in lesions, fertility, mortality, haematology, or body weight gain between rats of the control and treated groups.","duration":"24 months","effect":"re observed in lesions, fertility, mortality, haematology, or body weight gain between rats of the control and treated groups. At 24 months, the only consistent difference that could be attributed to the test substance was minor hyperplasia of the stratified squamous epithelium with excess keratin formation of the cardiac mucosa of the stomach in rats receiving the highest exposure to the test substance, 0.05% dose group (2% in the diet after 6 months) and 1% dose group (CIR, 2001). Based on the study results, the NOAEL was established at ≥2% (equivalent to 1578 mg/kg bw/day) (ECHA, 2023b). SMS was tested negative in an in vitro genotoxicity battery of tests, i.e., bacterial reverse mutation assay (Ames test), chromosome aberration study in using human lymphocytes and mouse lymphoma assay (ECHA, 2023c). Based on the study results, SMS is not expected to be genotoxic. As per the CIR’s Expert Panel report, fatty acyl sarcosines and their salts are not considered likely carcinogens as they and their metabolites “do not belong to any","endpoint":"reproductive toxicity","ingredient":"codes ................................... 11","loael_value":"","noael_unit":"%","noael_value":"2","page":37,"route":"oral","species":"rat","study_id":"sccs_o_289_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 1000 | mg/kg bw/day | rat | oral | prenatal | reproductive toxicity | SOURCE_SUBDIR=sccs_o_289; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON new coating for Titanium Dioxide (nano form); OPINION_NUMBER=SCCS/1667/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2024; VALUE_TEXT=1000; DOSE=In similar dermal prenatal developmental toxicity studies in rabbits, no treatment related adverse effects were observed in the only tested dose, 200 mg/kg bw/day (CIR, 2003).; EFFECT=e of external, visceral, or skeletal abnormalities (CIR, 2003, EFSA, 2020). In similar dermal prenatal developmental toxicity studies in rabbits, no treatment related adverse effects were observed in the only tested dose, 200 mg/kg bw/day (CIR, 2003). In another developmental toxicity study, cross-linked silicone gel was implanted into rats and rabbits at doses of 3, 10 and 30 mL/kg bw equivalent to 2.8, 9.5 and 28.5 g/kg bw/day. Based on the absence of treatment related toxicity, parental as well as developmental NOEL was 28.5 g/kg bw (ECETOC, 2003). In a prenatal oral gavage developmental toxicity study, rabbits were dosed orally with 10 or 350 cSt dimethicone at doses of 0, 33, 300 and 1000 mg/kg bw/day and the NOAEL for developmental toxicity was considered to be 1000 mg/kg bw/day (ECETOC, 2003). Based on the results of the above studies it can be concluded that the potential of dimethicone to be a reproductive or developmental toxicant is low. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an accep; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"In similar dermal prenatal developmental toxicity studies in rabbits, no treatment related adverse effects were observed in the only tested dose, 200 mg/kg bw/day (CIR, 2003).","duration":"prenatal","effect":"e of external, visceral, or skeletal abnormalities (CIR, 2003, EFSA, 2020). In similar dermal prenatal developmental toxicity studies in rabbits, no treatment related adverse effects were observed in the only tested dose, 200 mg/kg bw/day (CIR, 2003). In another developmental toxicity study, cross-linked silicone gel was implanted into rats and rabbits at doses of 3, 10 and 30 mL/kg bw equivalent to 2.8, 9.5 and 28.5 g/kg bw/day. Based on the absence of treatment related toxicity, parental as well as developmental NOEL was 28.5 g/kg bw (ECETOC, 2003). In a prenatal oral gavage developmental toxicity study, rabbits were dosed orally with 10 or 350 cSt dimethicone at doses of 0, 33, 300 and 1000 mg/kg bw/day and the NOAEL for developmental toxicity was considered to be 1000 mg/kg bw/day (ECETOC, 2003). Based on the results of the above studies it can be concluded that the potential of dimethicone to be a reproductive or developmental toxicant is low. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an accep","endpoint":"reproductive toxicity","ingredient":"codes ................................... 11","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":39,"route":"oral","species":"rat","study_id":"sccs_o_289_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 1000 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_289; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON new coating for Titanium Dioxide (nano form); OPINION_NUMBER=SCCS/1667/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2024; VALUE_TEXT=1000; DOSE=only tested dose, 200 mg/kg bw/day (CIR, 2003).; EFFECT=only tested dose, 200 mg/kg bw/day (CIR, 2003). In another developmental toxicity study, cross-linked silicone gel was implanted into rats and rabbits at doses of 3, 10 and 30 mL/kg bw equivalent to 2.8, 9.5 and 28.5 g/kg bw/day. Based on the absence of treatment related toxicity, parental as well as developmental NOEL was 28.5 g/kg bw (ECETOC, 2003). In a prenatal oral gavage developmental toxicity study, rabbits were dosed orally with 10 or 350 cSt dimethicone at doses of 0, 33, 300 and 1000 mg/kg bw/day and the NOAEL for developmental toxicity was considered to be 1000 mg/kg bw/day (ECETOC, 2003). Based on the results of the above studies it can be concluded that the potential of dimethicone to be a reproductive or developmental toxicant is low. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011). The EFSA panel established an AD; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"only tested dose, 200 mg/kg bw/day (CIR, 2003).","duration":"developmental","effect":"only tested dose, 200 mg/kg bw/day (CIR, 2003). In another developmental toxicity study, cross-linked silicone gel was implanted into rats and rabbits at doses of 3, 10 and 30 mL/kg bw equivalent to 2.8, 9.5 and 28.5 g/kg bw/day. Based on the absence of treatment related toxicity, parental as well as developmental NOEL was 28.5 g/kg bw (ECETOC, 2003). In a prenatal oral gavage developmental toxicity study, rabbits were dosed orally with 10 or 350 cSt dimethicone at doses of 0, 33, 300 and 1000 mg/kg bw/day and the NOAEL for developmental toxicity was considered to be 1000 mg/kg bw/day (ECETOC, 2003). Based on the results of the above studies it can be concluded that the potential of dimethicone to be a reproductive or developmental toxicant is low. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011). The EFSA panel established an AD","endpoint":"reproductive toxicity","ingredient":"codes ................................... 11","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":39,"route":"oral","species":"rat","study_id":"sccs_o_289_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 1742 | mg/kg bw/day | - | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_289; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION ON new coating for Titanium Dioxide (nano form); OPINION_NUMBER=SCCS/1667/24; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 October 2024; VALUE_TEXT=1742; DOSE=The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011).; EFFECT=y (ECETOC, 2003). Based on the results of the above studies it can be concluded that the potential of dimethicone to be a reproductive or developmental toxicant is low. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011). The EFSA panel established an ADI of 17 mg/kg bw/day for dimethyl polysiloxane (E 900) using the NOAEL 1742 mg/kg bw/day from 26-month dietary carcinogenicity study (EFSA, 2020). Dimethicone was reported to be used in leave-on products up to 85% and in rinse-off products up to 23.4%. The CIR Expert Panel concluded that dimethicone is safe in cosmetics in the present practices of use and reported concentration ranges when formulated to be non- irritating, with the exception that the available data are insufficient to make a determination of safety for use in products that may be incidentally inhaled when applied usi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"13463-67-7","citation":"","dose":"The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011).","duration":"developmental","effect":"y (ECETOC, 2003). Based on the results of the above studies it can be concluded that the potential of dimethicone to be a reproductive or developmental toxicant is low. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily intake (ADI) level for dimethicone of 0 to 1.5 mg/kg bw/day (only to compounds with a relative molecular mass in the range of 200–300) (CIR, 2003, JECFA, 2011). The EFSA panel established an ADI of 17 mg/kg bw/day for dimethyl polysiloxane (E 900) using the NOAEL 1742 mg/kg bw/day from 26-month dietary carcinogenicity study (EFSA, 2020). Dimethicone was reported to be used in leave-on products up to 85% and in rinse-off products up to 23.4%. The CIR Expert Panel concluded that dimethicone is safe in cosmetics in the present practices of use and reported concentration ranges when formulated to be non- irritating, with the exception that the available data are insufficient to make a determination of safety for use in products that may be incidentally inhaled when applied usi","endpoint":"reproductive toxicity","ingredient":"codes ................................... 11","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1742","page":39,"route":"oral","species":"","study_id":"sccs_o_289_noael_012"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 15FIX9V2JP | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"2O.Ti","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"15FIX9V2JP"} |
| openFDA substances | FDA UNII substance identifier | 15FIX9V2JP | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"2O.Ti","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"15FIX9V2JP"} |
| openFDA substances | FDA UNII substance identifier | 15FIX9V2JP | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"2O.Ti","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"15FIX9V2JP"} |
| openFDA substances | FDA UNII substance identifier | 15FIX9V2JP | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"2O.Ti","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"15FIX9V2JP"} |