NOAEL Studies Cosmetic Ingredient

6-Amino-M-Cresol NOAEL Studies

INCI: 6-AMINO-M-CRESOL

CAS: 2835-98-5

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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SCCS_vision_codex 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral Sub-chronic repeated dose toxicity {"dose":"SCCS/1400/11 Opinion on 2-amino-5-methylcresol 6-Amino-m-cresol (INCI) ___________________________________________________________________________________________ 16 The oral dose of 50 mg/kg bw/d represents the NOAEL.","effect":"SCCS/1400/11 Opinion on 2-amino-5-methylcresol 6-Amino-m-cresol (INCI) ___________________________________________________________________________________________ 16 The oral dose of 50 mg/kg bw/d represents the NOAEL. 3.3.5.2. Sub-chronic (90 days) toxicity (oral) Guideline: / Species/strain: rat, Wistar Bor: WISW/TNO (SPF) Group size: 10 males and 10 females Test substance: 1-hydroxy-2-amino-5-methylbenzol Batch: / Purity: 98% Vehicle: 10% suspension in 5% Gummi Arabicum Dose levels: 800 (reduced to 500 from week 6 onwards) mg/kg bw/d Stability: / Route: oral Administration: gavage GLP: in compliance Study period: 13 July – 21 October 1981 The compound (98% purity) as 10% suspension in 5% gum Arabic was administered orally","page":16,"pdf":"sccs_o_095.pdf","row_type":"noael_study","study_id":"sccs_o_095_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat - Chronic genotoxicity {"citation":"Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used","dose":"g/kg bw/d which due to clinical signs was reduced in the sixth week to 500 mg/kg bw/d.","effect":"g/kg bw/d which due to clinical signs was reduced in the sixth week to 500 mg/kg bw/d. 2 rats died during the treatment. Results Food consumption, body weight and body weight gain were significantly reduced in both sexes. Urine analysis revealed sedimentation of tyrosine crystals. Relative and absolute weights of the liver, kidney and spleen were increased. Elevation of bilirubin (both sexes) and reduction of iron concentrations (males) were observed. No macroscopic and histopathological effects were detected. No NOAEL could be identified. Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Studies with 2-amino-5-methylphenol Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicat","page":16,"pdf":"sccs_o_095.pdf","row_type":"noael_study","study_id":"sccs_o_095_noael_002"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - - NOAEL study {"citation":"Ref.: 25","dose":"d with 15 mg/kg bw/d Vitamin A.","effect":"d with 15 mg/kg bw/d Vitamin A. Animals were observed daily for clinical signs during the dosing period. Body weight was recorded on days 0, 6, 15, and 19 of gestation. At day 19 the study was terminated and the animals subjected to necropsy. The common sectio parameters were recorded. Skeletal and visceral abnormalities were registered. Results No clinical signs of toxicity were observed in the dams. Body weights and body weight gain were similar to controls. No embryotoxicity or teratogenicity was observed. The NOAEL of both embryo- and maternal toxicity was 200 mg/kg bw/d. Ref.: 25","page":25,"pdf":"sccs_o_095.pdf","row_type":"noael_study","study_id":"sccs_o_095_noael_003"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral Sub-chronic repeated dose toxicity {"dose":"SCCS/1400/11 Opinion on 2-amino-5-methylcresol 6-Amino-m-cresol (INCI) ___________________________________________________________________________________________ 16 The oral dose of 50 mg/kg bw/d represents the NOAEL.","effect":"SCCS/1400/11 Opinion on 2-amino-5-methylcresol 6-Amino-m-cresol (INCI) ___________________________________________________________________________________________ 16 The oral dose of 50 mg/kg bw/d represents the NOAEL. 3.3.5.2. Sub-chronic (90 days) toxicity (oral) Guideline: / Species/strain: rat, Wistar Bor: WISW/TNO (SPF) Group size: 10 males and 10 females Test substance: 1-hydroxy-2-amino-5-methylbenzol Batch: / Purity: 98% Vehicle: 10% suspension in 5% Gummi Arabicum Dose levels: 800 (reduced to 500 from week 6 onwards) mg/kg bw/d Stability: / Route: oral Administration: gavage GLP: in compliance Study period: 13 July – 21 October 1981 The compound (98% purity) as 10% suspension in 5% gum Arabic was administered orally","page":16,"pdf":"sccs_o_095.pdf","row_type":"noael_study","study_id":"sccs_o_095_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat - Chronic genotoxicity {"citation":"Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used","dose":"g/kg bw/d which due to clinical signs was reduced in the sixth week to 500 mg/kg bw/d.","effect":"g/kg bw/d which due to clinical signs was reduced in the sixth week to 500 mg/kg bw/d. 2 rats died during the treatment. Results Food consumption, body weight and body weight gain were significantly reduced in both sexes. Urine analysis revealed sedimentation of tyrosine crystals. Relative and absolute weights of the liver, kidney and spleen were increased. Elevation of bilirubin (both sexes) and reduction of iron concentrations (males) were observed. No macroscopic and histopathological effects were detected. No NOAEL could be identified. Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Studies with 2-amino-5-methylphenol Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicat","page":16,"pdf":"sccs_o_095.pdf","row_type":"noael_study","study_id":"sccs_o_095_noael_002"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - - NOAEL study {"citation":"Ref.: 25","dose":"d with 15 mg/kg bw/d Vitamin A.","effect":"d with 15 mg/kg bw/d Vitamin A. Animals were observed daily for clinical signs during the dosing period. Body weight was recorded on days 0, 6, 15, and 19 of gestation. At day 19 the study was terminated and the animals subjected to necropsy. The common sectio parameters were recorded. Skeletal and visceral abnormalities were registered. Results No clinical signs of toxicity were observed in the dams. Body weights and body weight gain were similar to controls. No embryotoxicity or teratogenicity was observed. The NOAEL of both embryo- and maternal toxicity was 200 mg/kg bw/d. Ref.: 25","page":25,"pdf":"sccs_o_095.pdf","row_type":"noael_study","study_id":"sccs_o_095_noael_003"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral Sub-chronic repeated dose toxicity {"dose":"SCCS/1400/11 Opinion on 2-amino-5-methylcresol 6-Amino-m-cresol (INCI) ___________________________________________________________________________________________ 16 The oral dose of 50 mg/kg bw/d represents the NOAEL.","effect":"SCCS/1400/11 Opinion on 2-amino-5-methylcresol 6-Amino-m-cresol (INCI) ___________________________________________________________________________________________ 16 The oral dose of 50 mg/kg bw/d represents the NOAEL. 3.3.5.2. Sub-chronic (90 days) toxicity (oral) Guideline: / Species/strain: rat, Wistar Bor: WISW/TNO (SPF) Group size: 10 males and 10 females Test substance: 1-hydroxy-2-amino-5-methylbenzol Batch: / Purity: 98% Vehicle: 10% suspension in 5% Gummi Arabicum Dose levels: 800 (reduced to 500 from week 6 onwards) mg/kg bw/d Stability: / Route: oral Administration: gavage GLP: in compliance Study period: 13 July – 21 October 1981 The compound (98% purity) as 10% suspension in 5% gum Arabic was administered orally","page":16,"pdf":"sccs_o_095.pdf","row_type":"noael_study","study_id":"sccs_o_095_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat - Chronic genotoxicity {"citation":"Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used","dose":"g/kg bw/d which due to clinical signs was reduced in the sixth week to 500 mg/kg bw/d.","effect":"g/kg bw/d which due to clinical signs was reduced in the sixth week to 500 mg/kg bw/d. 2 rats died during the treatment. Results Food consumption, body weight and body weight gain were significantly reduced in both sexes. Urine analysis revealed sedimentation of tyrosine crystals. Relative and absolute weights of the liver, kidney and spleen were increased. Elevation of bilirubin (both sexes) and reduction of iron concentrations (males) were observed. No macroscopic and histopathological effects were detected. No NOAEL could be identified. Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Studies with 2-amino-5-methylphenol Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicat","page":16,"pdf":"sccs_o_095.pdf","row_type":"noael_study","study_id":"sccs_o_095_noael_002"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - - NOAEL study {"citation":"Ref.: 25","dose":"d with 15 mg/kg bw/d Vitamin A.","effect":"d with 15 mg/kg bw/d Vitamin A. Animals were observed daily for clinical signs during the dosing period. Body weight was recorded on days 0, 6, 15, and 19 of gestation. At day 19 the study was terminated and the animals subjected to necropsy. The common sectio parameters were recorded. Skeletal and visceral abnormalities were registered. Results No clinical signs of toxicity were observed in the dams. Body weights and body weight gain were similar to controls. No embryotoxicity or teratogenicity was observed. The NOAEL of both embryo- and maternal toxicity was 200 mg/kg bw/d. Ref.: 25","page":25,"pdf":"sccs_o_095.pdf","row_type":"noael_study","study_id":"sccs_o_095_noael_003"}
SCCS_vision_codex NOAEL =50 mg/kg bw/d rat oral Sub-chronic repeated dose toxicity {"dose":"SCCS/1400/11 Opinion on 2-amino-5-methylcresol 6-Amino-m-cresol (INCI) ___________________________________________________________________________________________ 16 The oral dose of 50 mg/kg bw/d represents the NOAEL.","effect":"SCCS/1400/11 Opinion on 2-amino-5-methylcresol 6-Amino-m-cresol (INCI) ___________________________________________________________________________________________ 16 The oral dose of 50 mg/kg bw/d represents the NOAEL. 3.3.5.2. Sub-chronic (90 days) toxicity (oral) Guideline: / Species/strain: rat, Wistar Bor: WISW/TNO (SPF) Group size: 10 males and 10 females Test substance: 1-hydroxy-2-amino-5-methylbenzol Batch: / Purity: 98% Vehicle: 10% suspension in 5% Gummi Arabicum Dose levels: 800 (reduced to 500 from week 6 onwards) mg/kg bw/d Stability: / Route: oral Administration: gavage GLP: in compliance Study period: 13 July – 21 October 1981 The compound (98% purity) as 10% suspension in 5% gum Arabic was administered orally","page":16,"pdf":"sccs_o_095.pdf","row_type":"noael_study","study_id":"sccs_o_095_noael_001"}
SCCS_vision_codex NOAEL =500 mg/kg bw/d rat - Chronic genotoxicity {"citation":"Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used","dose":"g/kg bw/d which due to clinical signs was reduced in the sixth week to 500 mg/kg bw/d.","effect":"g/kg bw/d which due to clinical signs was reduced in the sixth week to 500 mg/kg bw/d. 2 rats died during the treatment. Results Food consumption, body weight and body weight gain were significantly reduced in both sexes. Urine analysis revealed sedimentation of tyrosine crystals. Relative and absolute weights of the liver, kidney and spleen were increased. Elevation of bilirubin (both sexes) and reduction of iron concentrations (males) were observed. No macroscopic and histopathological effects were detected. No NOAEL could be identified. Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Studies with 2-amino-5-methylphenol Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicat","page":16,"pdf":"sccs_o_095.pdf","row_type":"noael_study","study_id":"sccs_o_095_noael_002"}
SCCS_vision_codex NOAEL =200 mg/kg bw/d - - - NOAEL study {"citation":"Ref.: 25","dose":"d with 15 mg/kg bw/d Vitamin A.","effect":"d with 15 mg/kg bw/d Vitamin A. Animals were observed daily for clinical signs during the dosing period. Body weight was recorded on days 0, 6, 15, and 19 of gestation. At day 19 the study was terminated and the animals subjected to necropsy. The common sectio parameters were recorded. Skeletal and visceral abnormalities were registered. Results No clinical signs of toxicity were observed in the dams. Body weights and body weight gain were similar to controls. No embryotoxicity or teratogenicity was observed. The NOAEL of both embryo- and maternal toxicity was 200 mg/kg bw/d. Ref.: 25","page":25,"pdf":"sccs_o_095.pdf","row_type":"noael_study","study_id":"sccs_o_095_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 200 mg/kg bw/d - - - - SOURCE_SUBDIR=sccs_o_095; REPORT_TITLE=OPINION ON 6-Amino-m-cresol (INCI) 2-Amino-5-methylphenol COLIPA n° A75; OPINION_NUMBER=SCCS/1400/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 June 2012; VALUE_TEXT=200; DOSE=d with 15 mg/kg bw/d Vitamin A.; EFFECT=d with 15 mg/kg bw/d Vitamin A. Animals were observed daily for clinical signs during the dosing period. Body weight was recorded on days 0, 6, 15, and 19 of gestation. At day 19 the study was terminated and the animals subjected to necropsy. The common sectio parameters were recorded. Skeletal and visceral abnormalities were registered. Results No clinical signs of toxicity were observed in the dams. Body weights and body weight gain were similar to controls. No embryotoxicity or teratogenicity was observed. The NOAEL of both embryo- and maternal toxicity was 200 mg/kg bw/d. Ref.: 25; CITATION=Ref.: 25; CITATION_NUMBERS=[25]; REFERENCE=Ref.: 25; DETAILS_JSON={"cas_number":"2835-98-5","citation":"Ref.: 25","dose":"d with 15 mg/kg bw/d Vitamin A.","duration":"","effect":"d with 15 mg/kg bw/d Vitamin A. Animals were observed daily for clinical signs during the dosing period. Body weight was recorded on days 0, 6, 15, and 19 of gestation. At day 19 the study was terminated and the animals subjected to necropsy. The common sectio parameters were recorded. Skeletal and visceral abnormalities were registered. Results No clinical signs of toxicity were observed in the dams. Body weights and body weight gain were similar to controls. No embryotoxicity or teratogenicity was observed. The NOAEL of both embryo- and maternal toxicity was 200 mg/kg bw/d. Ref.: 25","endpoint":"","ingredient":"6-Amino-m-cresol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":25,"route":"","species":"","study_id":"sccs_o_095_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 500 mg/kg bw/d rat - Chronic genotoxicity SOURCE_SUBDIR=sccs_o_095; REPORT_TITLE=OPINION ON 6-Amino-m-cresol (INCI) 2-Amino-5-methylphenol COLIPA n° A75; OPINION_NUMBER=SCCS/1400/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 June 2012; VALUE_TEXT=500; DOSE=g/kg bw/d which due to clinical signs was reduced in the sixth week to 500 mg/kg bw/d.; EFFECT=g/kg bw/d which due to clinical signs was reduced in the sixth week to 500 mg/kg bw/d. 2 rats died during the treatment. Results Food consumption, body weight and body weight gain were significantly reduced in both sexes. Urine analysis revealed sedimentation of tyrosine crystals. Relative and absolute weights of the liver, kidney and spleen were increased. Elevation of bilirubin (both sexes) and reduction of iron concentrations (males) were observed. No macroscopic and histopathological effects were detected. No NOAEL could be identified. Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Studies with 2-amino-5-methylphenol Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicat; CITATION=Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used; CITATION_NUMBERS=[14]; REFERENCE=Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used; DETAILS_JSON={"cas_number":"2835-98-5","citation":"Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used","dose":"g/kg bw/d which due to clinical signs was reduced in the sixth week to 500 mg/kg bw/d.","duration":"Chronic","effect":"g/kg bw/d which due to clinical signs was reduced in the sixth week to 500 mg/kg bw/d. 2 rats died during the treatment. Results Food consumption, body weight and body weight gain were significantly reduced in both sexes. Urine analysis revealed sedimentation of tyrosine crystals. Relative and absolute weights of the liver, kidney and spleen were increased. Elevation of bilirubin (both sexes) and reduction of iron concentrations (males) were observed. No macroscopic and histopathological effects were detected. No NOAEL could be identified. Ref.: 14 Comment This study is considered inadequate since it does not conform to a guideline, the batch number is not known and only one dose group was used. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Studies with 2-amino-5-methylphenol Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/Strain: Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA102 Replicates: triplicat","endpoint":"genotoxicity","ingredient":"6-Amino-m-cresol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":16,"route":"","species":"rat","study_id":"sccs_o_095_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 50 mg/kg bw/d rat oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_095; REPORT_TITLE=OPINION ON 6-Amino-m-cresol (INCI) 2-Amino-5-methylphenol COLIPA n° A75; OPINION_NUMBER=SCCS/1400/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 June 2012; VALUE_TEXT=50; DOSE=SCCS/1400/11 Opinion on 2-amino-5-methylcresol 6-Amino-m-cresol (INCI) ___________________________________________________________________________________________ 16 The oral dose of 50 mg/kg bw/d represents the NOAEL.; EFFECT=SCCS/1400/11 Opinion on 2-amino-5-methylcresol 6-Amino-m-cresol (INCI) ___________________________________________________________________________________________ 16 The oral dose of 50 mg/kg bw/d represents the NOAEL. 3.3.5.2. Sub-chronic (90 days) toxicity (oral) Guideline: / Species/strain: rat, Wistar Bor: WISW/TNO (SPF) Group size: 10 males and 10 females Test substance: 1-hydroxy-2-amino-5-methylbenzol Batch: / Purity: 98% Vehicle: 10% suspension in 5% Gummi Arabicum Dose levels: 800 (reduced to 500 from week 6 onwards) mg/kg bw/d Stability: / Route: oral Administration: gavage GLP: in compliance Study period: 13 July – 21 October 1981 The compound (98% purity) as 10% suspension in 5% gum Arabic was administered orally; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2835-98-5","citation":"","dose":"SCCS/1400/11 Opinion on 2-amino-5-methylcresol 6-Amino-m-cresol (INCI) ___________________________________________________________________________________________ 16 The oral dose of 50 mg/kg bw/d represents the NOAEL.","duration":"Sub-chronic","effect":"SCCS/1400/11 Opinion on 2-amino-5-methylcresol 6-Amino-m-cresol (INCI) ___________________________________________________________________________________________ 16 The oral dose of 50 mg/kg bw/d represents the NOAEL. 3.3.5.2. Sub-chronic (90 days) toxicity (oral) Guideline: / Species/strain: rat, Wistar Bor: WISW/TNO (SPF) Group size: 10 males and 10 females Test substance: 1-hydroxy-2-amino-5-methylbenzol Batch: / Purity: 98% Vehicle: 10% suspension in 5% Gummi Arabicum Dose levels: 800 (reduced to 500 from week 6 onwards) mg/kg bw/d Stability: / Route: oral Administration: gavage GLP: in compliance Study period: 13 July – 21 October 1981 The compound (98% purity) as 10% suspension in 5% gum Arabic was administered orally","endpoint":"repeated dose toxicity","ingredient":"6-Amino-m-cresol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":16,"route":"oral","species":"rat","study_id":"sccs_o_095_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 50 mg/kg bw/d rat oral 28 days repeated dose toxicity SOURCE_SUBDIR=sccs_o_095; REPORT_TITLE=OPINION ON 6-Amino-m-cresol (INCI) 2-Amino-5-methylphenol COLIPA n° A75; OPINION_NUMBER=SCCS/1400/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 June 2012; VALUE_TEXT=50; DOSE=The LD50 figures were calculated as being between 750 and 1375 mg/kg bw.; EFFECT=No macroscopic organ changes were noted. The LD50 figures were calculated as being between 750 and 1375 mg/kg bw. In a repeated dose (28 days) oral toxicity study in rats at 250 mg/kg bw/d alterations of haematology and clinical chemistry values were observed (reduction in erythrocytes and haemoglobin in males and females and iron in females; increase in reticulocytes and haematocrit in males and females). At autopsy increases in liver, kidney and spleen weights were found. The dose of 50 mg/kg bw/d represents the NOAEL. The subchronic toxicity study in rats is considered inadequate since it does not conform to a guideline, batch and purity are unknown and only one dose group was used. In a teratogenicity study with rats body weights and body weight gain of the dams were similar to controls. No embryotoxicity or teratogenicity was observed. The NOAEL of both embryo- and maternal toxicity was 200 mg/kg bw/d. No study on reproductive toxicity was provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2835-98-5","citation":"","dose":"The LD50 figures were calculated as being between 750 and 1375 mg/kg bw.","duration":"28 days","effect":"No macroscopic organ changes were noted. The LD50 figures were calculated as being between 750 and 1375 mg/kg bw. In a repeated dose (28 days) oral toxicity study in rats at 250 mg/kg bw/d alterations of haematology and clinical chemistry values were observed (reduction in erythrocytes and haemoglobin in males and females and iron in females; increase in reticulocytes and haematocrit in males and females). At autopsy increases in liver, kidney and spleen weights were found. The dose of 50 mg/kg bw/d represents the NOAEL. The subchronic toxicity study in rats is considered inadequate since it does not conform to a guideline, batch and purity are unknown and only one dose group was used. In a teratogenicity study with rats body weights and body weight gain of the dams were similar to controls. No embryotoxicity or teratogenicity was observed. The NOAEL of both embryo- and maternal toxicity was 200 mg/kg bw/d. No study on reproductive toxicity was provided.","endpoint":"repeated dose toxicity","ingredient":"6-Amino-m-cresol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":36,"route":"oral","species":"rat","study_id":"sccs_o_095_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 200 mg/kg bw/d rat - subchronic repeated dose toxicity SOURCE_SUBDIR=sccs_o_095; REPORT_TITLE=OPINION ON 6-Amino-m-cresol (INCI) 2-Amino-5-methylphenol COLIPA n° A75; OPINION_NUMBER=SCCS/1400/11; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=27 June 2012; VALUE_TEXT=200; DOSE=The dose of 50 mg/kg bw/d represents the NOAEL.; EFFECT=emales; increase in reticulocytes and haematocrit in males and females). At autopsy increases in liver, kidney and spleen weights were found. The dose of 50 mg/kg bw/d represents the NOAEL. The subchronic toxicity study in rats is considered inadequate since it does not conform to a guideline, batch and purity are unknown and only one dose group was used. In a teratogenicity study with rats body weights and body weight gain of the dams were similar to controls. No embryotoxicity or teratogenicity was observed. The NOAEL of both embryo- and maternal toxicity was 200 mg/kg bw/d. No study on reproductive toxicity was provided.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2835-98-5","citation":"","dose":"The dose of 50 mg/kg bw/d represents the NOAEL.","duration":"subchronic","effect":"emales; increase in reticulocytes and haematocrit in males and females). At autopsy increases in liver, kidney and spleen weights were found. The dose of 50 mg/kg bw/d represents the NOAEL. The subchronic toxicity study in rats is considered inadequate since it does not conform to a guideline, batch and purity are unknown and only one dose group was used. In a teratogenicity study with rats body weights and body weight gain of the dams were similar to controls. No embryotoxicity or teratogenicity was observed. The NOAEL of both embryo- and maternal toxicity was 200 mg/kg bw/d. No study on reproductive toxicity was provided.","endpoint":"repeated dose toxicity","ingredient":"6-Amino-m-cresol","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":36,"route":"","species":"rat","study_id":"sccs_o_095_noael_005"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier QCG4ES2A26 UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H9NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"QCG4ES2A26"}
openFDA substances FDA UNII substance identifier QCG4ES2A26 UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H9NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"QCG4ES2A26"}
openFDA substances FDA UNII substance identifier QCG4ES2A26 UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H9NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"QCG4ES2A26"}
openFDA substances FDA UNII substance identifier QCG4ES2A26 UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H9NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"QCG4ES2A26"}