NOAEL Studies
Cosmetic Ingredient
2,6-Dihydroxyethylaminotoluene NOAEL Studies
INCI: 2,6-DIHYDROXYETHYLAMINOTOLUENE
CAS: 149330-25-6
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 100 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCS; Hruby, R. 90-day toxicity study with “WSI-111” in rats. ÖsterreichischesForschungszentrum Seibersdorf, Seibersdor f, Austria, internal study code: SON7. Archive code at Henkel KGaA, Düsseldorf, Report No. R 9601546 |
SCCNFP_vision_codex 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"The NOAEL was reported to be 100 mg/kg bw/day.","effect":"rved in high-dosed recovery group males only. High-dosed females had a significantly increased relative weight of kidneys and high-dosed recovery females had an increased absolute adrenal weight. Study results have been described by means of descriptive statistics. Due to multiple testing, some probably unspecific effects have been reported as \"significantly different from actual corresponding controls\" (i.e., elevated mean cell volume of females on day 84, caused by an unusual low mean of the control group). The NOAEL was reported to be 100 mg/kg bw/day. Target organs of the substance toxicity were the liver (based on serum bilirubin, urine urobilinogen and bilirubin, organ weight changes) and the kidney (based on serum creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD n°","page":7,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg bw | - | - | - | NOAEL study | {"citation":"Ref. : 14","dose":"Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.","effect":"was assumed due to a \"statistically significant\" decreased body weight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. The overall NOAEL is 200 mg/kg bw. Ref. : 14","page":9,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg | rat | oral | 13 weeks | dermal absorption | {"dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.","effect":"Y (2,6-Dihydroxyethylaminotoluene) (oxidative) The maximum concentration of 2.0 % 2,6-Dihydroxyethylaminotoluene is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 010 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in r","page":18,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw | rat | oral | 13 weeks | sensitisation | {"dose":"mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12.","effect":"mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw, target organs were the liver and the kidneys. The results of a teratogenicity study showed a NOAEL of 200 mg/kg bw. No teratological abnormalities were recorded. 2,6-Dihydroxyethylaminotoluene can be classified as non-irritating for both the skin and mucous membranes at 1% in water. The induction concentration used was far too low and therefore the sensitisation study is considered inadequate. Experiments carried out with radio-labelled test formulations in","page":18,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"The NOAEL was reported to be 100 mg/kg bw/day.","effect":"rved in high-dosed recovery group males only. High-dosed females had a significantly increased relative weight of kidneys and high-dosed recovery females had an increased absolute adrenal weight. Study results have been described by means of descriptive statistics. Due to multiple testing, some probably unspecific effects have been reported as \"significantly different from actual corresponding controls\" (i.e., elevated mean cell volume of females on day 84, caused by an unusual low mean of the control group). The NOAEL was reported to be 100 mg/kg bw/day. Target organs of the substance toxicity were the liver (based on serum bilirubin, urine urobilinogen and bilirubin, organ weight changes) and the kidney (based on serum creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD n°","page":7,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg bw | - | - | - | NOAEL study | {"citation":"Ref. : 14","dose":"Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.","effect":"was assumed due to a \"statistically significant\" decreased body weight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. The overall NOAEL is 200 mg/kg bw. Ref. : 14","page":9,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg | rat | oral | 13 weeks | dermal absorption | {"dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.","effect":"Y (2,6-Dihydroxyethylaminotoluene) (oxidative) The maximum concentration of 2.0 % 2,6-Dihydroxyethylaminotoluene is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 010 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in r","page":18,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw | rat | oral | 13 weeks | sensitisation | {"dose":"mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12.","effect":"mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw, target organs were the liver and the kidneys. The results of a teratogenicity study showed a NOAEL of 200 mg/kg bw. No teratological abnormalities were recorded. 2,6-Dihydroxyethylaminotoluene can be classified as non-irritating for both the skin and mucous membranes at 1% in water. The induction concentration used was far too low and therefore the sensitisation study is considered inadequate. Experiments carried out with radio-labelled test formulations in","page":18,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"The NOAEL was reported to be 100 mg/kg bw/day.","effect":"rved in high-dosed recovery group males only. High-dosed females had a significantly increased relative weight of kidneys and high-dosed recovery females had an increased absolute adrenal weight. Study results have been described by means of descriptive statistics. Due to multiple testing, some probably unspecific effects have been reported as \"significantly different from actual corresponding controls\" (i.e., elevated mean cell volume of females on day 84, caused by an unusual low mean of the control group). The NOAEL was reported to be 100 mg/kg bw/day. Target organs of the substance toxicity were the liver (based on serum bilirubin, urine urobilinogen and bilirubin, organ weight changes) and the kidney (based on serum creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD n°","page":7,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg bw | - | - | - | NOAEL study | {"citation":"Ref. : 14","dose":"Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.","effect":"was assumed due to a \"statistically significant\" decreased body weight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. The overall NOAEL is 200 mg/kg bw. Ref. : 14","page":9,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg | rat | oral | 13 weeks | dermal absorption | {"dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.","effect":"Y (2,6-Dihydroxyethylaminotoluene) (oxidative) The maximum concentration of 2.0 % 2,6-Dihydroxyethylaminotoluene is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 010 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in r","page":18,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw | rat | oral | 13 weeks | sensitisation | {"dose":"mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12.","effect":"mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw, target organs were the liver and the kidneys. The results of a teratogenicity study showed a NOAEL of 200 mg/kg bw. No teratological abnormalities were recorded. 2,6-Dihydroxyethylaminotoluene can be classified as non-irritating for both the skin and mucous membranes at 1% in water. The induction concentration used was far too low and therefore the sensitisation study is considered inadequate. Experiments carried out with radio-labelled test formulations in","page":18,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref. : 5 2","dose":"The NOAEL was reported to be 100 mg/kg bw/day.","effect":"rved in high-dosed recovery group males only. High-dosed females had a significantly increased relative weight of kidneys and high-dosed recovery females had an increased absolute adrenal weight. Study results have been described by means of descriptive statistics. Due to multiple testing, some probably unspecific effects have been reported as \"significantly different from actual corresponding controls\" (i.e., elevated mean cell volume of females on day 84, caused by an unusual low mean of the control group). The NOAEL was reported to be 100 mg/kg bw/day. Target organs of the substance toxicity were the liver (based on serum bilirubin, urine urobilinogen and bilirubin, organ weight changes) and the kidney (based on serum creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD n°","page":7,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =200 | mg/kg bw | - | - | - | NOAEL study | {"citation":"Ref. : 14","dose":"Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.","effect":"was assumed due to a \"statistically significant\" decreased body weight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. The overall NOAEL is 200 mg/kg bw. Ref. : 14","page":9,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg | rat | oral | 13 weeks | dermal absorption | {"dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.","effect":"Y (2,6-Dihydroxyethylaminotoluene) (oxidative) The maximum concentration of 2.0 % 2,6-Dihydroxyethylaminotoluene is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 010 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in r","page":18,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =100 | mg/kg bw | rat | oral | 13 weeks | sensitisation | {"dose":"mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12.","effect":"mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw, target organs were the liver and the kidneys. The results of a teratogenicity study showed a NOAEL of 200 mg/kg bw. No teratological abnormalities were recorded. 2,6-Dihydroxyethylaminotoluene can be classified as non-irritating for both the skin and mucous membranes at 1% in water. The induction concentration used was far too low and therefore the sensitisation study is considered inadequate. Experiments carried out with radio-labelled test formulations in","page":18,"pdf":"out234_en.pdf","row_type":"noael_study","study_id":"out234_en_noael_005"} |
SCCS_vision_codex 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | - | - | Chronic | genotoxicity | {"citation":"Ref.: 14 3","dose":"The NOAEL was considered to be 100 mg/kg bw/d.","effect":"SCCS/1425/11 Opinion on 2,6-dihydroxyethylaminotoluene ___________________________________________________________________________________________ 15 creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). The NOAEL was considered to be 100 mg/kg bw/d. Ref.: 14 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA1535, TA1537, TA98, TA100, TA102 Replicates: triplicate. One study with each strain Treatment: plate incorporation assay Test substance: A138 Batch: PVS 11/02 Purity: 99.7 area% Vehicle: DMSO Concentration: pre-experiment: 3, 10","page":15,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_001"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw | rat | oral | - | NOAEL study | {"citation":"Ref.: 16 3","dose":"Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.","effect":"due to a \"statistically significant\" decreased body weight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. Conclusion The overall NOAEL is 200 mg/kg bw. Ref.: 16 3.3.9. Toxicokinetics Guideline: / Species/Strain: Rats, male, female, Sprague-Dawley, SPF-quality Test substance: 14C-labelled test substance incorporated in a hair dye formulation (A, D) and in an aqueous solution (B, C, E) Batch: 2(WSI-111) (Purity: 99%) Study groups: A: 0.5 h dermal exposure (formulation), sacrifice after 72 h B: 0.5 h dermal exposure (solution), sacrifice after 72 h C: 72 h oral exposure (solution) D: 0.5 h dermal exposure (formulation), sacrifice after 24 h E: 24","page":21,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_002"} |
| SCCS_vision_codex | NOAEL | =0 | mg/kg bw | rat | oral | 90 day | reproductive toxicity | {"dose":"General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.","effect":"lculation. Toxicokinetics Experiments carried out with radio-labelled test formulations in toxicokinetic investigations including cutaneous and oral (gavage) application showed a dermal penetration rate between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases more than 99% of the radioactivity was excreted via the kidneys/urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity 2,6-Dihydroxyethylaminotoluene was tested for the 3 genetic endpoints: gene mutations, structural and chromosomal aberrations. The test item induced gene mutations in bacteria with metabolic activation, but it did not induce gene","page":24,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_003"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | rat | oral | 90 day | reproductive toxicity | {"dose":"General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.","effect":"SCCS-rejected applicant NOAEL: cation showed a dermal penetration rate between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases more than 99% of the radioactivity was excreted via the kidneys/urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity 2,6-Dihydroxyethylaminotoluene was tested for the 3 genetic endpoints: gene mutations, structural and chromosomal aberrations. The test item induced gene mutations in bacteria with metabolic activation, but it did not induce gene mutations (or chromosomal aberrations) in a mouse lymphoma assay. SCCS does not agree with the applicant that a negative mammalian cell gene mutation test can overr","page":24,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.036 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"icity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II","page":26,"pdf":"sccs_o_188.pdf","row_type":"noael_study","study_id":"sccs_o_188_noael_003"} |
| SCCS_vision_codex | NOAEL | =84 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"(including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"(including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II","page":26,"pdf":"sccs_o_188.pdf","row_type":"noael_study","study_id":"sccs_o_188_noael_005"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | - | - | Chronic | genotoxicity | {"citation":"Ref.: 14 3","dose":"The NOAEL was considered to be 100 mg/kg bw/d.","effect":"SCCS/1425/11 Opinion on 2,6-dihydroxyethylaminotoluene ___________________________________________________________________________________________ 15 creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). The NOAEL was considered to be 100 mg/kg bw/d. Ref.: 14 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA1535, TA1537, TA98, TA100, TA102 Replicates: triplicate. One study with each strain Treatment: plate incorporation assay Test substance: A138 Batch: PVS 11/02 Purity: 99.7 area% Vehicle: DMSO Concentration: pre-experiment: 3, 10","page":15,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_001"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw | rat | oral | - | NOAEL study | {"citation":"Ref.: 16 3","dose":"Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.","effect":"due to a \"statistically significant\" decreased body weight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. Conclusion The overall NOAEL is 200 mg/kg bw. Ref.: 16 3.3.9. Toxicokinetics Guideline: / Species/Strain: Rats, male, female, Sprague-Dawley, SPF-quality Test substance: 14C-labelled test substance incorporated in a hair dye formulation (A, D) and in an aqueous solution (B, C, E) Batch: 2(WSI-111) (Purity: 99%) Study groups: A: 0.5 h dermal exposure (formulation), sacrifice after 72 h B: 0.5 h dermal exposure (solution), sacrifice after 72 h C: 72 h oral exposure (solution) D: 0.5 h dermal exposure (formulation), sacrifice after 24 h E: 24","page":21,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_002"} |
| SCCS_vision_codex | NOAEL | =0 | mg/kg bw | rat | oral | 90 day | reproductive toxicity | {"dose":"General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.","effect":"lculation. Toxicokinetics Experiments carried out with radio-labelled test formulations in toxicokinetic investigations including cutaneous and oral (gavage) application showed a dermal penetration rate between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases more than 99% of the radioactivity was excreted via the kidneys/urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity 2,6-Dihydroxyethylaminotoluene was tested for the 3 genetic endpoints: gene mutations, structural and chromosomal aberrations. The test item induced gene mutations in bacteria with metabolic activation, but it did not induce gene","page":24,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_003"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | rat | oral | 90 day | reproductive toxicity | {"dose":"General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.","effect":"SCCS-rejected applicant NOAEL: cation showed a dermal penetration rate between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases more than 99% of the radioactivity was excreted via the kidneys/urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity 2,6-Dihydroxyethylaminotoluene was tested for the 3 genetic endpoints: gene mutations, structural and chromosomal aberrations. The test item induced gene mutations in bacteria with metabolic activation, but it did not induce gene mutations (or chromosomal aberrations) in a mouse lymphoma assay. SCCS does not agree with the applicant that a negative mammalian cell gene mutation test can overr","page":24,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_004"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | - | - | Chronic | genotoxicity | {"citation":"Ref.: 14 3","dose":"The NOAEL was considered to be 100 mg/kg bw/d.","effect":"SCCS/1425/11 Opinion on 2,6-dihydroxyethylaminotoluene ___________________________________________________________________________________________ 15 creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). The NOAEL was considered to be 100 mg/kg bw/d. Ref.: 14 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA1535, TA1537, TA98, TA100, TA102 Replicates: triplicate. One study with each strain Treatment: plate incorporation assay Test substance: A138 Batch: PVS 11/02 Purity: 99.7 area% Vehicle: DMSO Concentration: pre-experiment: 3, 10","page":15,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_001"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw | rat | oral | - | NOAEL study | {"citation":"Ref.: 16 3","dose":"Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.","effect":"due to a \"statistically significant\" decreased body weight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. Conclusion The overall NOAEL is 200 mg/kg bw. Ref.: 16 3.3.9. Toxicokinetics Guideline: / Species/Strain: Rats, male, female, Sprague-Dawley, SPF-quality Test substance: 14C-labelled test substance incorporated in a hair dye formulation (A, D) and in an aqueous solution (B, C, E) Batch: 2(WSI-111) (Purity: 99%) Study groups: A: 0.5 h dermal exposure (formulation), sacrifice after 72 h B: 0.5 h dermal exposure (solution), sacrifice after 72 h C: 72 h oral exposure (solution) D: 0.5 h dermal exposure (formulation), sacrifice after 24 h E: 24","page":21,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_002"} |
| SCCS_vision_codex | NOAEL | =0 | mg/kg bw | rat | oral | 90 day | reproductive toxicity | {"dose":"General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.","effect":"lculation. Toxicokinetics Experiments carried out with radio-labelled test formulations in toxicokinetic investigations including cutaneous and oral (gavage) application showed a dermal penetration rate between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases more than 99% of the radioactivity was excreted via the kidneys/urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity 2,6-Dihydroxyethylaminotoluene was tested for the 3 genetic endpoints: gene mutations, structural and chromosomal aberrations. The test item induced gene mutations in bacteria with metabolic activation, but it did not induce gene","page":24,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_003"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | rat | oral | 90 day | reproductive toxicity | {"dose":"General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.","effect":"SCCS-rejected applicant NOAEL: cation showed a dermal penetration rate between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases more than 99% of the radioactivity was excreted via the kidneys/urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity 2,6-Dihydroxyethylaminotoluene was tested for the 3 genetic endpoints: gene mutations, structural and chromosomal aberrations. The test item induced gene mutations in bacteria with metabolic activation, but it did not induce gene mutations (or chromosomal aberrations) in a mouse lymphoma assay. SCCS does not agree with the applicant that a negative mammalian cell gene mutation test can overr","page":24,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.036 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"icity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II","page":26,"pdf":"sccs_o_188.pdf","row_type":"noael_study","study_id":"sccs_o_188_noael_003"} |
| SCCS_vision_codex | NOAEL | =84 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"(including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"(including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II","page":26,"pdf":"sccs_o_188.pdf","row_type":"noael_study","study_id":"sccs_o_188_noael_005"} |
| SCCS_vision_codex | NOAEL | =0.036 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"icity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II","page":26,"pdf":"sccs_o_188.pdf","row_type":"noael_study","study_id":"sccs_o_188_noael_003"} |
| SCCS_vision_codex | NOAEL | =84 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"(including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"(including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II","page":26,"pdf":"sccs_o_188.pdf","row_type":"noael_study","study_id":"sccs_o_188_noael_005"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | - | - | Chronic | genotoxicity | {"citation":"Ref.: 14 3","dose":"The NOAEL was considered to be 100 mg/kg bw/d.","effect":"SCCS/1425/11 Opinion on 2,6-dihydroxyethylaminotoluene ___________________________________________________________________________________________ 15 creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). The NOAEL was considered to be 100 mg/kg bw/d. Ref.: 14 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA1535, TA1537, TA98, TA100, TA102 Replicates: triplicate. One study with each strain Treatment: plate incorporation assay Test substance: A138 Batch: PVS 11/02 Purity: 99.7 area% Vehicle: DMSO Concentration: pre-experiment: 3, 10","page":15,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_001"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw | rat | oral | - | NOAEL study | {"citation":"Ref.: 16 3","dose":"Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.","effect":"due to a \"statistically significant\" decreased body weight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. Conclusion The overall NOAEL is 200 mg/kg bw. Ref.: 16 3.3.9. Toxicokinetics Guideline: / Species/Strain: Rats, male, female, Sprague-Dawley, SPF-quality Test substance: 14C-labelled test substance incorporated in a hair dye formulation (A, D) and in an aqueous solution (B, C, E) Batch: 2(WSI-111) (Purity: 99%) Study groups: A: 0.5 h dermal exposure (formulation), sacrifice after 72 h B: 0.5 h dermal exposure (solution), sacrifice after 72 h C: 72 h oral exposure (solution) D: 0.5 h dermal exposure (formulation), sacrifice after 24 h E: 24","page":21,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_002"} |
| SCCS_vision_codex | NOAEL | =0 | mg/kg bw | rat | oral | 90 day | reproductive toxicity | {"dose":"General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.","effect":"lculation. Toxicokinetics Experiments carried out with radio-labelled test formulations in toxicokinetic investigations including cutaneous and oral (gavage) application showed a dermal penetration rate between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases more than 99% of the radioactivity was excreted via the kidneys/urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity 2,6-Dihydroxyethylaminotoluene was tested for the 3 genetic endpoints: gene mutations, structural and chromosomal aberrations. The test item induced gene mutations in bacteria with metabolic activation, but it did not induce gene","page":24,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_003"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | rat | oral | 90 day | reproductive toxicity | {"dose":"General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.","effect":"SCCS-rejected applicant NOAEL: cation showed a dermal penetration rate between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases more than 99% of the radioactivity was excreted via the kidneys/urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity 2,6-Dihydroxyethylaminotoluene was tested for the 3 genetic endpoints: gene mutations, structural and chromosomal aberrations. The test item induced gene mutations in bacteria with metabolic activation, but it did not induce gene mutations (or chromosomal aberrations) in a mouse lymphoma assay. SCCS does not agree with the applicant that a negative mammalian cell gene mutation test can overr","page":24,"pdf":"sccs_o_063.pdf","row_type":"noael_study","study_id":"sccs_o_063_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.036 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose...","effect":"icity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II","page":26,"pdf":"sccs_o_188.pdf","row_type":"noael_study","study_id":"sccs_o_188_noael_003"} |
| SCCS_vision_codex | NOAEL | =84 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | {"dose":"(including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","effect":"(including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II","page":26,"pdf":"sccs_o_188.pdf","row_type":"noael_study","study_id":"sccs_o_188_noael_005"} |
UnifiedCodex:SCCNFP:beta.noael_studies 7 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 200 | mg/kg bw | - | - | - | - | SOURCE_SUBDIR=out234_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2,6-DIHYDROXYETHYLAMINOTOLUENE COLIPA n° A138; OPINION_NUMBER=SCCNFP/0697/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=200; DOSE=Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.; EFFECT=was assumed due to a "statistically significant" decreased body weight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. The overall NOAEL is 200 mg/kg bw. Ref. : 14; CITATION=Ref. : 14; CITATION_NUMBERS=[14]; REFERENCE=Ref. : 14; DETAILS_JSON={"cas_number":"149330-25-6","citation":"Ref. : 14","dose":"Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.","duration":"","effect":"was assumed due to a \"statistically significant\" decreased body weight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. The overall NOAEL is 200 mg/kg bw. Ref. : 14","endpoint":"","ingredient":"1-Methyl-2,6-bis-(2-hydroxyethylamino)-benzene","loael_value":"","noael_unit":"mg/kg bw","noael_value":"200","page":9,"route":"","species":"","study_id":"out234_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 100 | mg/kg | rat | oral | 13 weeks | - | SOURCE_SUBDIR=out234_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2,6-DIHYDROXYETHYLAMINOTOLUENE COLIPA n° A138; OPINION_NUMBER=SCCNFP/0697/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=100; DOSE=No observed effect level (mg/kg) (rat, 13 weeks oral) | NOAEL | = | 100 mg/kg; EFFECT=CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxyethylaminotoluene) (oxidative): No observed effect level (mg/kg) (rat, 13 weeks oral) | NOAEL | = | 100 mg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149330-25-6","citation":"","dose":"No observed effect level (mg/kg) (rat, 13 weeks oral) | NOAEL | = | 100 mg/kg","duration":"13 weeks","effect":"CALCULATION OF THE MARGIN OF SAFETY (2,6-Dihydroxyethylaminotoluene) (oxidative): No observed effect level (mg/kg) (rat, 13 weeks oral) | NOAEL | = | 100 mg/kg","endpoint":"","ingredient":"1-Methyl-2,6-bis-(2-hydroxyethylamino)-benzene","loael_value":"","noael_unit":"mg/kg","noael_value":"100","page":18,"route":"oral","species":"rat","study_id":"out234_en_noael_007"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | =100 | mg/kg | rat | oral | 13 weeks | dermal absorption | SOURCE_SUBDIR=out234_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2,6-DIHYDROXYETHYLAMINOTOLUENE COLIPA n° A138; OPINION_NUMBER=SCCNFP/0697/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT== 100; DOSE=Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.; EFFECT=Y (2,6-Dihydroxyethylaminotoluene) (oxidative) The maximum concentration of 2.0 % 2,6-Dihydroxyethylaminotoluene is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 010 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in r; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149330-25-6","citation":"","dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.","duration":"13 weeks","effect":"Y (2,6-Dihydroxyethylaminotoluene) (oxidative) The maximum concentration of 2.0 % 2,6-Dihydroxyethylaminotoluene is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 010 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in r","endpoint":"dermal absorption","ingredient":"1-Methyl-2,6-bis-(2-hydroxyethylamino)-benzene","loael_value":"","noael_unit":"mg/kg","noael_value":"= 100","page":18,"route":"oral","species":"rat","study_id":"out234_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | =100 | mg/kg | rat | oral | 13 weeks | dermal absorption | SOURCE_SUBDIR=out234_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2,6-DIHYDROXYETHYLAMINOTOLUENE COLIPA n° A138; OPINION_NUMBER=SCCNFP/0697/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT== 100; DOSE=Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.; EFFECT=centration of 2.0 % 2,6-Dihydroxyethylaminotoluene is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 010 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/k; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149330-25-6","citation":"","dose":"Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0.","duration":"13 weeks","effect":"centration of 2.0 % 2,6-Dihydroxyethylaminotoluene is mixed before use with H2O2. Thus the usage volume of 100 ml contains at maximum 1.0 % Maximum absorption through the skin A (µg/cm²) = 0.838 µg/cm² Typical body weight of human = 60 kg Skin Area Surface (scalp) SAS = 700 cm² Dermal absorption per treatment SAS x A x 0.001 = 0.587 mg Systemic exposure dose (SED) SAS x A x 0.001/ 60 = 0. 010 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/k","endpoint":"dermal absorption","ingredient":"1-Methyl-2,6-bis-(2-hydroxyethylamino)-benzene","loael_value":"","noael_unit":"mg/kg","noael_value":"= 100","page":18,"route":"oral","species":"rat","study_id":"out234_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 100 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out234_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2,6-DIHYDROXYETHYLAMINOTOLUENE COLIPA n° A138; OPINION_NUMBER=SCCNFP/0697/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=100; DOSE=The NOAEL was reported to be 100 mg/kg bw/day.; EFFECT=rved in high-dosed recovery group males only. High-dosed females had a significantly increased relative weight of kidneys and high-dosed recovery females had an increased absolute adrenal weight. Study results have been described by means of descriptive statistics. Due to multiple testing, some probably unspecific effects have been reported as "significantly different from actual corresponding controls" (i.e., elevated mean cell volume of females on day 84, caused by an unusual low mean of the control group). The NOAEL was reported to be 100 mg/kg bw/day. Target organs of the substance toxicity were the liver (based on serum bilirubin, urine urobilinogen and bilirubin, organ weight changes) and the kidney (based on serum creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD n°; CITATION=Ref. : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref. : 5 2; DETAILS_JSON={"cas_number":"149330-25-6","citation":"Ref. : 5 2","dose":"The NOAEL was reported to be 100 mg/kg bw/day.","duration":"Sub-chronic","effect":"rved in high-dosed recovery group males only. High-dosed females had a significantly increased relative weight of kidneys and high-dosed recovery females had an increased absolute adrenal weight. Study results have been described by means of descriptive statistics. Due to multiple testing, some probably unspecific effects have been reported as \"significantly different from actual corresponding controls\" (i.e., elevated mean cell volume of females on day 84, caused by an unusual low mean of the control group). The NOAEL was reported to be 100 mg/kg bw/day. Target organs of the substance toxicity were the liver (based on serum bilirubin, urine urobilinogen and bilirubin, organ weight changes) and the kidney (based on serum creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data 2.3.9. Sub-chronic inhalation toxicity No data 2.3.10. Chronic toxicity No data 2.4. Irritation and corrosivity 2.4.1. Irritation (skin) Guideline : OECD n°","endpoint":"repeated dose toxicity","ingredient":"1-Methyl-2,6-bis-(2-hydroxyethylamino)-benzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":7,"route":"dermal","species":"","study_id":"out234_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | sensitisation | 100 | mg/kg bw | rat | oral | 13 weeks | sensitisation | SOURCE_SUBDIR=out234_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2,6-DIHYDROXYETHYLAMINOTOLUENE COLIPA n° A138; OPINION_NUMBER=SCCNFP/0697/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=100; DOSE=mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12.; EFFECT=mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw, target organs were the liver and the kidneys. The results of a teratogenicity study showed a NOAEL of 200 mg/kg bw. No teratological abnormalities were recorded. 2,6-Dihydroxyethylaminotoluene can be classified as non-irritating for both the skin and mucous membranes at 1% in water. The induction concentration used was far too low and therefore the sensitisation study is considered inadequate. Experiments carried out with radio-labelled test formulations in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149330-25-6","citation":"","dose":"mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12.","duration":"13 weeks","effect":"mg/kg (rat, 13 weeks oral) Margin of Safety NOAEL / SED = 10000 2.12. Conclusions 2,6-Dihydroxyethylaminotoluene is a secondary alkanolamine, and thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw, target organs were the liver and the kidneys. The results of a teratogenicity study showed a NOAEL of 200 mg/kg bw. No teratological abnormalities were recorded. 2,6-Dihydroxyethylaminotoluene can be classified as non-irritating for both the skin and mucous membranes at 1% in water. The induction concentration used was far too low and therefore the sensitisation study is considered inadequate. Experiments carried out with radio-labelled test formulations in","endpoint":"sensitisation","ingredient":"1-Methyl-2,6-bis-(2-hydroxyethylamino)-benzene","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":18,"route":"oral","species":"rat","study_id":"out234_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | sensitisation | 200 | mg/kg bw | rat | oral | 90 day | sensitisation | SOURCE_SUBDIR=out234_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING 2,6-DIHYDROXYETHYLAMINOTOLUENE COLIPA n° A138; OPINION_NUMBER=SCCNFP/0697/03; COMMITTEE=SCCNFP; REPORT_DATE=20 October 2003; VALUE_TEXT=200; DOSE=2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in rats.; EFFECT=d thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw, target organs were the liver and the kidneys. The results of a teratogenicity study showed a NOAEL of 200 mg/kg bw. No teratological abnormalities were recorded. 2,6-Dihydroxyethylaminotoluene can be classified as non-irritating for both the skin and mucous membranes at 1% in water. The induction concentration used was far too low and therefore the sensitisation study is considered inadequate. Experiments carried out with radio-labelled test formulations in toxicokinetic investigations including cutaneous and oral (gavage) application showed a low dermal penetration rate – between 0,08 and 0,13 % of the appli; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149330-25-6","citation":"","dose":"2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in rats.","duration":"90 day","effect":"d thus it is prone to nitrosation. No data are provided on the nitrosamine content of the dye and its formulations. The physico- chemical profile of the substance is insufficiently characterized (e.g., density and log POW not reported), although essential parameters are given. 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2.000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw, target organs were the liver and the kidneys. The results of a teratogenicity study showed a NOAEL of 200 mg/kg bw. No teratological abnormalities were recorded. 2,6-Dihydroxyethylaminotoluene can be classified as non-irritating for both the skin and mucous membranes at 1% in water. The induction concentration used was far too low and therefore the sensitisation study is considered inadequate. Experiments carried out with radio-labelled test formulations in toxicokinetic investigations including cutaneous and oral (gavage) application showed a low dermal penetration rate – between 0,08 and 0,13 % of the appli","endpoint":"sensitisation","ingredient":"1-Methyl-2,6-bis-(2-hydroxyethylamino)-benzene","loael_value":"","noael_unit":"mg/kg bw","noael_value":"200","page":18,"route":"oral","species":"rat","study_id":"out234_en_noael_006"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 11 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 200 | mg/kg bw | rat | oral | - | - | SOURCE_SUBDIR=sccs_o_063; REPORT_TITLE=OPINION ON 2,6-Dihydroxyethylaminotoluene COLIPA n° A138; OPINION_NUMBER=SCCS/1425/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=200; DOSE=Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.; EFFECT=due to a "statistically significant" decreased body weight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. Conclusion The overall NOAEL is 200 mg/kg bw. Ref.: 16 3.3.9. Toxicokinetics Guideline: / Species/Strain: Rats, male, female, Sprague-Dawley, SPF-quality Test substance: 14C-labelled test substance incorporated in a hair dye formulation (A, D) and in an aqueous solution (B, C, E) Batch: 2(WSI-111) (Purity: 99%) Study groups: A: 0.5 h dermal exposure (formulation), sacrifice after 72 h B: 0.5 h dermal exposure (solution), sacrifice after 72 h C: 72 h oral exposure (solution) D: 0.5 h dermal exposure (formulation), sacrifice after 24 h E: 24; CITATION=Ref.: 16 3; CITATION_NUMBERS=[16,3]; REFERENCE=Ref.: 16 3; DETAILS_JSON={"cas_number":"149330-25-6","citation":"Ref.: 16 3","dose":"Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.","duration":"","effect":"due to a \"statistically significant\" decreased body weight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. Conclusion The overall NOAEL is 200 mg/kg bw. Ref.: 16 3.3.9. Toxicokinetics Guideline: / Species/Strain: Rats, male, female, Sprague-Dawley, SPF-quality Test substance: 14C-labelled test substance incorporated in a hair dye formulation (A, D) and in an aqueous solution (B, C, E) Batch: 2(WSI-111) (Purity: 99%) Study groups: A: 0.5 h dermal exposure (formulation), sacrifice after 72 h B: 0.5 h dermal exposure (solution), sacrifice after 72 h C: 72 h oral exposure (solution) D: 0.5 h dermal exposure (formulation), sacrifice after 24 h E: 24","endpoint":"","ingredient":"2,6-Dihydroxyethylaminotoluene","loael_value":"","noael_unit":"mg/kg bw","noael_value":"200","page":21,"route":"oral","species":"rat","study_id":"sccs_o_063_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 200 | mg/kg bw | rat | oral | - | - | SOURCE_SUBDIR=sccs_o_188; REPORT_TITLE=OPINION ON 2,6-Dihydroxyethylaminotoluene COLIPA n° A138; OPINION_NUMBER=SCCS/1563/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT=200; DOSE=Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.; EFFECT=due to a "statistically significant" decreased bodyweight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. Conclusion The overall NOAEL is 200 mg/kg bw. Ref.: 14 (Submission I) 3.3.9. Toxicokinetics Taken from SCCS/1425/11 (=submission II) Guideline: / Species/Strain: Rats, male, female, Sprague-Dawley, SPF-quality Test substance: 14C-labelled test substance incorporated in a hair dye formulation (A, D) and in an aqueous solution (B, C, E) Batch: 2(WSI-111) (Purity: 99%) Study groups: A: 0.5 h dermal exposure (formulation), sacrifice after 72 h B: 0.5 h dermal exposure (solution), sacrifice after 72 h C: 72 h oral exposure (solution) D: 0.5 h; CITATION=Ref.: 14 (Submission I) 3; CITATION_NUMBERS=[14,3]; REFERENCE=Ref.: 14 (Submission I) 3; DETAILS_JSON={"cas_number":"149330-25-6","citation":"Ref.: 14 (Submission I) 3","dose":"Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed.","duration":"","effect":"due to a \"statistically significant\" decreased bodyweight at the beginning of the dosing period. This finding is limited to one recorded measurement period only and inconsistent with the overall weight development. Thus, the relevance of this result is limited, no clear-cut dose for maternal toxicity was observed. A slight but dose-dependent increase in post implantation losses was noted (mean values: group K, 5.8; group A, 6.4; group B, 7.8; group C, 10.9) but not interpreted as abnormal. Conclusion The overall NOAEL is 200 mg/kg bw. Ref.: 14 (Submission I) 3.3.9. Toxicokinetics Taken from SCCS/1425/11 (=submission II) Guideline: / Species/Strain: Rats, male, female, Sprague-Dawley, SPF-quality Test substance: 14C-labelled test substance incorporated in a hair dye formulation (A, D) and in an aqueous solution (B, C, E) Batch: 2(WSI-111) (Purity: 99%) Study groups: A: 0.5 h dermal exposure (formulation), sacrifice after 72 h B: 0.5 h dermal exposure (solution), sacrifice after 72 h C: 72 h oral exposure (solution) D: 0.5 h","endpoint":"","ingredient":"2,6-Dihydroxyethylaminotoluene","loael_value":"","noael_unit":"mg/kg bw","noael_value":"200","page":24,"route":"oral","species":"rat","study_id":"sccs_o_188_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.036 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_188; REPORT_TITLE=OPINION ON 2,6-Dihydroxyethylaminotoluene COLIPA n° A138; OPINION_NUMBER=SCCS/1563/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT== 0.036; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose...; EFFECT=icity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149330-25-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose...","duration":"90-day","effect":"icity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II","endpoint":"dermal absorption","ingredient":"2,6-Dihydroxyethylaminotoluene","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.036","page":26,"route":"oral","species":"rat","study_id":"sccs_o_188_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =100 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_188; REPORT_TITLE=OPINION ON 2,6-Dihydroxyethylaminotoluene COLIPA n° A138; OPINION_NUMBER=SCCS/1563/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT== 100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose...; EFFECT=Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149330-25-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose...","duration":"90-day","effect":"Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II","endpoint":"dermal absorption","ingredient":"2,6-Dihydroxyethylaminotoluene","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 100","page":26,"route":"oral","species":"rat","study_id":"sccs_o_188_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =84 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | SOURCE_SUBDIR=sccs_o_188; REPORT_TITLE=OPINION ON 2,6-Dihydroxyethylaminotoluene COLIPA n° A138; OPINION_NUMBER=SCCS/1563/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT== 84; DOSE=(including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....; EFFECT=(including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149330-25-6","citation":"","dose":"(including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0....","duration":"90-day","effect":"(including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (……. conditions) (…..% formulation, on head concentration …..%) Absorption through the skin A = 3.73 µg/cm² Skin Area surface SAS = 580 cm2 Dermal absorption per treatment SAS x A x 0.001 = 2.16 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.036 mg/kg bw/d No observed adverse effect level NOAEL = 100 mg/kg bw/d (90-day, oral, rat) Bioavailability 84%* = 84 mg/kg bw/d Margin of Safety adjusted NOAEL/SED = 2300 *.see reference 15, submission II","endpoint":"dermal absorption","ingredient":"2,6-Dihydroxyethylaminotoluene","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 84","page":26,"route":"oral","species":"rat","study_id":"sccs_o_188_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 100 | mg/kg bw/d | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_063; REPORT_TITLE=OPINION ON 2,6-Dihydroxyethylaminotoluene COLIPA n° A138; OPINION_NUMBER=SCCS/1425/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=100; DOSE=The NOAEL was considered to be 100 mg/kg bw/d.; EFFECT=SCCS/1425/11 Opinion on 2,6-dihydroxyethylaminotoluene ___________________________________________________________________________________________ 15 creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). The NOAEL was considered to be 100 mg/kg bw/d. Ref.: 14 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA1535, TA1537, TA98, TA100, TA102 Replicates: triplicate. One study with each strain Treatment: plate incorporation assay Test substance: A138 Batch: PVS 11/02 Purity: 99.7 area% Vehicle: DMSO Concentration: pre-experiment: 3, 10; CITATION=Ref.: 14 3; CITATION_NUMBERS=[14,3]; REFERENCE=Ref.: 14 3; DETAILS_JSON={"cas_number":"149330-25-6","citation":"Ref.: 14 3","dose":"The NOAEL was considered to be 100 mg/kg bw/d.","duration":"Chronic","effect":"SCCS/1425/11 Opinion on 2,6-dihydroxyethylaminotoluene ___________________________________________________________________________________________ 15 creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). The NOAEL was considered to be 100 mg/kg bw/d. Ref.: 14 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA1535, TA1537, TA98, TA100, TA102 Replicates: triplicate. One study with each strain Treatment: plate incorporation assay Test substance: A138 Batch: PVS 11/02 Purity: 99.7 area% Vehicle: DMSO Concentration: pre-experiment: 3, 10","endpoint":"genotoxicity","ingredient":"2,6-Dihydroxyethylaminotoluene","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":15,"route":"","species":"","study_id":"sccs_o_063_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 100 | mg/kg bw/d | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_188; REPORT_TITLE=OPINION ON 2,6-Dihydroxyethylaminotoluene COLIPA n° A138; OPINION_NUMBER=SCCS/1563/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT=100; DOSE=The NOAEL was considered to be 100 mg/kg bw/d.; EFFECT=. Due to multiple testing, some probably unspecific effects have been reported as "significantly different from actual corresponding controls" (i.e., elevated mean cell volume of females on day 84, caused by an unusual low mean of the control group). Target organs of the substance toxicity were the liver (based on serum bilirubin, urine urobilinogen and bilirubin, organ weight changes) and the kidney (based on serum creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). The NOAEL was considered to be 100 mg/kg bw/d. Ref.: 5 (Submission I) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Gene Mutation test in bacteria Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in a single experiment Test substance: A 138 [2-((3-((2-hydroxyethyl)-2-methylphenyl)amino)ethanol)} Batch: PVS 11/02 Purity: 99.7 area% Solvent: DMSO Con; CITATION=Ref.: 5 (Submission I) 3; CITATION_NUMBERS=[5,3]; REFERENCE=Ref.: 5 (Submission I) 3; DETAILS_JSON={"cas_number":"149330-25-6","citation":"Ref.: 5 (Submission I) 3","dose":"The NOAEL was considered to be 100 mg/kg bw/d.","duration":"Chronic","effect":". Due to multiple testing, some probably unspecific effects have been reported as \"significantly different from actual corresponding controls\" (i.e., elevated mean cell volume of females on day 84, caused by an unusual low mean of the control group). Target organs of the substance toxicity were the liver (based on serum bilirubin, urine urobilinogen and bilirubin, organ weight changes) and the kidney (based on serum creatinine, organ weights and histopathological changes, i.e., tubular epithelial basophilia). The NOAEL was considered to be 100 mg/kg bw/d. Ref.: 5 (Submission I) 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Gene Mutation test in bacteria Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 Replicates: triplicates in a single experiment Test substance: A 138 [2-((3-((2-hydroxyethyl)-2-methylphenyl)amino)ethanol)} Batch: PVS 11/02 Purity: 99.7 area% Solvent: DMSO Con","endpoint":"genotoxicity","ingredient":"2,6-Dihydroxyethylaminotoluene","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":15,"route":"","species":"","study_id":"sccs_o_188_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 0 | mg/kg bw | rat | oral | 90 day | reproductive toxicity | SOURCE_SUBDIR=sccs_o_063; REPORT_TITLE=OPINION ON 2,6-Dihydroxyethylaminotoluene COLIPA n° A138; OPINION_NUMBER=SCCS/1425/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=000; DOSE=General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.; EFFECT=lculation. Toxicokinetics Experiments carried out with radio-labelled test formulations in toxicokinetic investigations including cutaneous and oral (gavage) application showed a dermal penetration rate between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases more than 99% of the radioactivity was excreted via the kidneys/urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity 2,6-Dihydroxyethylaminotoluene was tested for the 3 genetic endpoints: gene mutations, structural and chromosomal aberrations. The test item induced gene mutations in bacteria with metabolic activation, but it did not induce gene; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149330-25-6","citation":"","dose":"General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.","duration":"90 day","effect":"lculation. Toxicokinetics Experiments carried out with radio-labelled test formulations in toxicokinetic investigations including cutaneous and oral (gavage) application showed a dermal penetration rate between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases more than 99% of the radioactivity was excreted via the kidneys/urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity 2,6-Dihydroxyethylaminotoluene was tested for the 3 genetic endpoints: gene mutations, structural and chromosomal aberrations. The test item induced gene mutations in bacteria with metabolic activation, but it did not induce gene","endpoint":"reproductive toxicity","ingredient":"2,6-Dihydroxyethylaminotoluene","loael_value":"","noael_unit":"mg/kg bw","noael_value":"000","page":24,"route":"oral","species":"rat","study_id":"sccs_o_063_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 200 | mg/kg bw/d | rat | oral | 90 day | reproductive toxicity | SOURCE_SUBDIR=sccs_o_063; REPORT_TITLE=OPINION ON 2,6-Dihydroxyethylaminotoluene COLIPA n° A138; OPINION_NUMBER=SCCS/1425/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=14 December 2011; VALUE_TEXT=200; DOSE=General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.; EFFECT=SCCS-rejected applicant NOAEL: cation showed a dermal penetration rate between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases more than 99% of the radioactivity was excreted via the kidneys/urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity 2,6-Dihydroxyethylaminotoluene was tested for the 3 genetic endpoints: gene mutations, structural and chromosomal aberrations. The test item induced gene mutations in bacteria with metabolic activation, but it did not induce gene mutations (or chromosomal aberrations) in a mouse lymphoma assay. SCCS does not agree with the applicant that a negative mammalian cell gene mutation test can overr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149330-25-6","citation":"","dose":"General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.","duration":"90 day","effect":"SCCS-rejected applicant NOAEL: cation showed a dermal penetration rate between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases more than 99% of the radioactivity was excreted via the kidneys/urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90 day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity 2,6-Dihydroxyethylaminotoluene was tested for the 3 genetic endpoints: gene mutations, structural and chromosomal aberrations. The test item induced gene mutations in bacteria with metabolic activation, but it did not induce gene mutations (or chromosomal aberrations) in a mouse lymphoma assay. SCCS does not agree with the applicant that a negative mammalian cell gene mutation test can overr","endpoint":"reproductive toxicity","ingredient":"2,6-Dihydroxyethylaminotoluene","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":24,"route":"oral","species":"rat","study_id":"sccs_o_063_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 0 | mg/kg bw | rat | oral | 90-day | reproductive toxicity | SOURCE_SUBDIR=sccs_o_188; REPORT_TITLE=OPINION ON 2,6-Dihydroxyethylaminotoluene COLIPA n° A138; OPINION_NUMBER=SCCS/1563/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT=000; DOSE=General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.; EFFECT=t with radio-labelled test formulations in toxicokinetic investigations including cutaneous and oral (gavage) application showed a low dermal penetration rate – between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases, more than 99% of the radioactivity was excreted during the first 24 hours after application, about 88% via urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90-day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity Overall, the genotoxicity of 2,6-dihydroxyethylaminotoluene was investigated for the three endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. 2,6-dihydroxyethylaminotoluene did induce gene mutations; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149330-25-6","citation":"","dose":"General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.","duration":"90-day","effect":"t with radio-labelled test formulations in toxicokinetic investigations including cutaneous and oral (gavage) application showed a low dermal penetration rate – between 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases, more than 99% of the radioactivity was excreted during the first 24 hours after application, about 88% via urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90-day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity Overall, the genotoxicity of 2,6-dihydroxyethylaminotoluene was investigated for the three endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. 2,6-dihydroxyethylaminotoluene did induce gene mutations","endpoint":"reproductive toxicity","ingredient":"2,6-Dihydroxyethylaminotoluene","loael_value":"","noael_unit":"mg/kg bw","noael_value":"000","page":27,"route":"oral","species":"rat","study_id":"sccs_o_188_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 200 | mg/kg bw/d | rat | oral | 90-day | reproductive toxicity | SOURCE_SUBDIR=sccs_o_188; REPORT_TITLE=OPINION ON 2,6-Dihydroxyethylaminotoluene COLIPA n° A138; OPINION_NUMBER=SCCS/1563/15; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=25 June 2015; VALUE_TEXT=200; DOSE=General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.; EFFECT=een 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases, more than 99% of the radioactivity was excreted during the first 24 hours after application, about 88% via urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90-day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity Overall, the genotoxicity of 2,6-dihydroxyethylaminotoluene was investigated for the three endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. 2,6-dihydroxyethylaminotoluene did induce gene mutations in bacteria. Two well performed gene mutation tests in mammalian cells (mouse lymphoma cells) were negative. The negative results in these gene mutation tests in ma; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"149330-25-6","citation":"","dose":"General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats.","duration":"90-day","effect":"een 0.08 and 0.13% of the applied radioactivity – compared with an absorption rate of about 84% after oral application; in both cases, more than 99% of the radioactivity was excreted during the first 24 hours after application, about 88% via urine. General toxicity 2,6-Dihydroxyethylaminotoluene is of low acute toxicity; > 2 000 mg/kg bw in rats. The NOAEL, derived from a 90-day study in rats, is 100 mg/kg bw/d, target organs were the liver and the kidneys. The results of a teratogenicity study showed an overall NOAEL of 200 mg/kg bw/d. No teratological abnormalities were recorded. No reproductive toxicity study was provided. Mutagenicity Overall, the genotoxicity of 2,6-dihydroxyethylaminotoluene was investigated for the three endpoints of genotoxicity: gene mutations, chromosome aberrations and aneuploidy. 2,6-dihydroxyethylaminotoluene did induce gene mutations in bacteria. Two well performed gene mutation tests in mammalian cells (mouse lymphoma cells) were negative. The negative results in these gene mutation tests in ma","endpoint":"reproductive toxicity","ingredient":"2,6-Dihydroxyethylaminotoluene","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":27,"route":"oral","species":"rat","study_id":"sccs_o_188_noael_007"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | I50F7J73SU | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C11H18N2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"I50F7J73SU"} |
| openFDA substances | FDA UNII substance identifier | I50F7J73SU | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C11H18N2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"I50F7J73SU"} |
| openFDA substances | FDA UNII substance identifier | I50F7J73SU | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C11H18N2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"I50F7J73SU"} |
| openFDA substances | FDA UNII substance identifier | I50F7J73SU | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C11H18N2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"I50F7J73SU"} |