NOAEL Studies Cosmetic Ingredient

3-Amino-2,4-Dichlorophenol NOAEL Studies

INCI: 3-AMINO-2,4-DICHLOROPHENOL

CAS: 61693-42-3

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 28 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =480 mg/kg bw/d rat - 90 days genotoxicity {"citation":"Ref.: 11 3","dose":"t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found.","effect":"t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found. At 480 mg/kg bw/d some changes in haematological parameters were observed. In clinical chemistry significantly increased phosphorus, sodium and chloride in males also of the mid dose were observed. The histopathological examination viz. kidney and liver revealed degenerative changes suggestive of nephrotoxicity and hepatotoxicity at 160 and 480 mg/kg bw/d. The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was concluded to be 80 mg/kg bw/d. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.2 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test subst","page":15,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_001"}
SCCS_vision_codex NOAEL =115 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 12 3","dose":"ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d.","effect":"ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d. Whereas no treatment-related changes were recorded in the frequency of external anomalies, visceral observations and section findings, a significant increase in incompletely ossified os parietale and sternebral ossification centers was observed at 460 mg/kg. This was interpreted as related to maternal toxicity and may also be due to the reduced foetal weight. Conclusion For 3-amino-2,4-dichlorophenol hydrochloride the NOAEL of maternal toxicity is 115 mg/kg bw/d and the NOAEL of embryo-/foetal toxicity is 230 mg/kg bw/d. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 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 O","page":20,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_003"}
SCCS_vision_codex NOAEL =0.74 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","effect":"photoclastogenicity 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 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","page":20,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_005"}
SCCS_vision_codex NOAEL =80 mg/kg bw rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","effect":"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 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","page":20,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_006"}
SCCS_vision_codex NOAEL =2000 mg/kg bw rat - 90 days irritation {"dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","effect":"SCCS-rejected applicant NOAEL: SCCP/1074/07 Opinion on 3-amino-2,4-dichlorophenol HCl 21 3.3.14. Discussion Physico-chemical specifications 3-Amino-2,4-dichlorophenol HCl is used in oxidation hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results i","page":21,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_008"}
SCCS_vision_codex NOAEL =80 mg/kg bw/d rat dermal 90 days dermal absorption {"dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","effect":"tion hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results indicate that 3-Amino-2,4-dichlorophenol HCl is a moderate skin sensitiser. Dermal absorption Although too few chambers (8) were used i","page":21,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_010"}
SCCS_vision_codex NOAEL =0.41 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemi...","effect":"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 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","page":20,"pdf":"sccp_o_150.pdf","row_type":"noael_study","study_id":"sccp_o_150_noael_005"}
SCCS_vision_codex NOAEL =480 mg/kg bw/d rat - 90 days genotoxicity {"citation":"Ref.: 11 3","dose":"t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found.","effect":"t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found. At 480 mg/kg bw/d some changes in haematological parameters were observed. In clinical chemistry significantly increased phosphorus, sodium and chloride in males also of the mid dose were observed. The histopathological examination viz. kidney and liver revealed degenerative changes suggestive of nephrotoxicity and hepatotoxicity at 160 and 480 mg/kg bw/d. The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was concluded to be 80 mg/kg bw/d. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.2 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test subst","page":15,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_001"}
SCCS_vision_codex NOAEL =115 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 12 3","dose":"ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d.","effect":"ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d. Whereas no treatment-related changes were recorded in the frequency of external anomalies, visceral observations and section findings, a significant increase in incompletely ossified os parietale and sternebral ossification centers was observed at 460 mg/kg. This was interpreted as related to maternal toxicity and may also be due to the reduced foetal weight. Conclusion For 3-amino-2,4-dichlorophenol hydrochloride the NOAEL of maternal toxicity is 115 mg/kg bw/d and the NOAEL of embryo-/foetal toxicity is 230 mg/kg bw/d. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 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 O","page":20,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_003"}
SCCS_vision_codex NOAEL =0.74 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","effect":"photoclastogenicity 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 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","page":20,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_005"}
SCCS_vision_codex NOAEL =80 mg/kg bw rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","effect":"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 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","page":20,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_006"}
SCCS_vision_codex NOAEL =2000 mg/kg bw rat - 90 days irritation {"dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","effect":"SCCS-rejected applicant NOAEL: SCCP/1074/07 Opinion on 3-amino-2,4-dichlorophenol HCl 21 3.3.14. Discussion Physico-chemical specifications 3-Amino-2,4-dichlorophenol HCl is used in oxidation hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results i","page":21,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_008"}
SCCS_vision_codex NOAEL =80 mg/kg bw/d rat dermal 90 days dermal absorption {"dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","effect":"tion hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results indicate that 3-Amino-2,4-dichlorophenol HCl is a moderate skin sensitiser. Dermal absorption Although too few chambers (8) were used i","page":21,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_010"}
SCCS_vision_codex NOAEL =480 mg/kg bw/d rat - 90 days genotoxicity {"citation":"Ref.: 11 3","dose":"t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found.","effect":"t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found. At 480 mg/kg bw/d some changes in haematological parameters were observed. In clinical chemistry significantly increased phosphorus, sodium and chloride in males also of the mid dose were observed. The histopathological examination viz. kidney and liver revealed degenerative changes suggestive of nephrotoxicity and hepatotoxicity at 160 and 480 mg/kg bw/d. The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was concluded to be 80 mg/kg bw/d. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.2 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test subst","page":15,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_001"}
SCCS_vision_codex NOAEL =115 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 12 3","dose":"ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d.","effect":"ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d. Whereas no treatment-related changes were recorded in the frequency of external anomalies, visceral observations and section findings, a significant increase in incompletely ossified os parietale and sternebral ossification centers was observed at 460 mg/kg. This was interpreted as related to maternal toxicity and may also be due to the reduced foetal weight. Conclusion For 3-amino-2,4-dichlorophenol hydrochloride the NOAEL of maternal toxicity is 115 mg/kg bw/d and the NOAEL of embryo-/foetal toxicity is 230 mg/kg bw/d. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 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 O","page":20,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_003"}
SCCS_vision_codex NOAEL =0.74 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","effect":"photoclastogenicity 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 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","page":20,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_005"}
SCCS_vision_codex NOAEL =80 mg/kg bw rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","effect":"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 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","page":20,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_006"}
SCCS_vision_codex NOAEL =2000 mg/kg bw rat - 90 days irritation {"dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","effect":"SCCS-rejected applicant NOAEL: SCCP/1074/07 Opinion on 3-amino-2,4-dichlorophenol HCl 21 3.3.14. Discussion Physico-chemical specifications 3-Amino-2,4-dichlorophenol HCl is used in oxidation hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results i","page":21,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_008"}
SCCS_vision_codex NOAEL =80 mg/kg bw/d rat dermal 90 days dermal absorption {"dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","effect":"tion hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results indicate that 3-Amino-2,4-dichlorophenol HCl is a moderate skin sensitiser. Dermal absorption Although too few chambers (8) were used i","page":21,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_010"}
SCCS_vision_codex NOAEL =0.41 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemi...","effect":"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 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","page":20,"pdf":"sccp_o_150.pdf","row_type":"noael_study","study_id":"sccp_o_150_noael_005"}
SCCS_vision_codex NOAEL =0.41 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemi...","effect":"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 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","page":20,"pdf":"sccp_o_150.pdf","row_type":"noael_study","study_id":"sccp_o_150_noael_005"}
SCCS_vision_codex NOAEL =480 mg/kg bw/d rat - 90 days genotoxicity {"citation":"Ref.: 11 3","dose":"t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found.","effect":"t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found. At 480 mg/kg bw/d some changes in haematological parameters were observed. In clinical chemistry significantly increased phosphorus, sodium and chloride in males also of the mid dose were observed. The histopathological examination viz. kidney and liver revealed degenerative changes suggestive of nephrotoxicity and hepatotoxicity at 160 and 480 mg/kg bw/d. The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was concluded to be 80 mg/kg bw/d. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.2 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test subst","page":15,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_001"}
SCCS_vision_codex NOAEL =115 mg/kg bw/d human - - NOAEL study {"citation":"Ref.: 12 3","dose":"ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d.","effect":"ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d. Whereas no treatment-related changes were recorded in the frequency of external anomalies, visceral observations and section findings, a significant increase in incompletely ossified os parietale and sternebral ossification centers was observed at 460 mg/kg. This was interpreted as related to maternal toxicity and may also be due to the reduced foetal weight. Conclusion For 3-amino-2,4-dichlorophenol hydrochloride the NOAEL of maternal toxicity is 115 mg/kg bw/d and the NOAEL of embryo-/foetal toxicity is 230 mg/kg bw/d. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 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 O","page":20,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_003"}
SCCS_vision_codex NOAEL =0.74 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","effect":"photoclastogenicity 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 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","page":20,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_005"}
SCCS_vision_codex NOAEL =80 mg/kg bw rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","effect":"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 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","page":20,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_006"}
SCCS_vision_codex NOAEL =2000 mg/kg bw rat - 90 days irritation {"dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","effect":"SCCS-rejected applicant NOAEL: SCCP/1074/07 Opinion on 3-amino-2,4-dichlorophenol HCl 21 3.3.14. Discussion Physico-chemical specifications 3-Amino-2,4-dichlorophenol HCl is used in oxidation hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results i","page":21,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_008"}
SCCS_vision_codex NOAEL =80 mg/kg bw/d rat dermal 90 days dermal absorption {"dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","effect":"tion hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results indicate that 3-Amino-2,4-dichlorophenol HCl is a moderate skin sensitiser. Dermal absorption Although too few chambers (8) were used i","page":21,"pdf":"sccp_o_092.pdf","row_type":"noael_study","study_id":"sccp_o_092_noael_010"}
SCCS_vision_codex NOAEL =0.41 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemi...","effect":"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 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","page":20,"pdf":"sccp_o_150.pdf","row_type":"noael_study","study_id":"sccp_o_150_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 23 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 115 mg/kg bw/d human - - - SOURCE_SUBDIR=sccp_o_092; REPORT_TITLE=Opinion on 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1074/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 25 June 1993; VALUE_TEXT=115; DOSE=ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d.; EFFECT=ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d. Whereas no treatment-related changes were recorded in the frequency of external anomalies, visceral observations and section findings, a significant increase in incompletely ossified os parietale and sternebral ossification centers was observed at 460 mg/kg. This was interpreted as related to maternal toxicity and may also be due to the reduced foetal weight. Conclusion For 3-amino-2,4-dichlorophenol hydrochloride the NOAEL of maternal toxicity is 115 mg/kg bw/d and the NOAEL of embryo-/foetal toxicity is 230 mg/kg bw/d. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 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 O; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"61693-42-3","citation":"Ref.: 12 3","dose":"ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d.","duration":"","effect":"ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d. Whereas no treatment-related changes were recorded in the frequency of external anomalies, visceral observations and section findings, a significant increase in incompletely ossified os parietale and sternebral ossification centers was observed at 460 mg/kg. This was interpreted as related to maternal toxicity and may also be due to the reduced foetal weight. Conclusion For 3-amino-2,4-dichlorophenol hydrochloride the NOAEL of maternal toxicity is 115 mg/kg bw/d and the NOAEL of embryo-/foetal toxicity is 230 mg/kg bw/d. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 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 O","endpoint":"","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"115","page":20,"route":"","species":"human","study_id":"sccp_o_092_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 115 mg/kg bw/d human - - - SOURCE_SUBDIR=sccp_o_092; REPORT_TITLE=Opinion on 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1074/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 25 June 1993; VALUE_TEXT=115; DOSE=significantly decreased at 460 mg/kg bw/d.; EFFECT=significantly decreased at 460 mg/kg bw/d. Whereas no treatment-related changes were recorded in the frequency of external anomalies, visceral observations and section findings, a significant increase in incompletely ossified os parietale and sternebral ossification centers was observed at 460 mg/kg. This was interpreted as related to maternal toxicity and may also be due to the reduced foetal weight. Conclusion For 3-amino-2,4-dichlorophenol hydrochloride the NOAEL of maternal toxicity is 115 mg/kg bw/d and the NOAEL of embryo-/foetal toxicity is 230 mg/kg bw/d. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 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 3-Amino-2,4-dichlorophenol HC; CITATION=Ref.: 12 3; CITATION_NUMBERS=[12,3]; REFERENCE=Ref.: 12 3; DETAILS_JSON={"cas_number":"61693-42-3","citation":"Ref.: 12 3","dose":"significantly decreased at 460 mg/kg bw/d.","duration":"","effect":"significantly decreased at 460 mg/kg bw/d. Whereas no treatment-related changes were recorded in the frequency of external anomalies, visceral observations and section findings, a significant increase in incompletely ossified os parietale and sternebral ossification centers was observed at 460 mg/kg. This was interpreted as related to maternal toxicity and may also be due to the reduced foetal weight. Conclusion For 3-amino-2,4-dichlorophenol hydrochloride the NOAEL of maternal toxicity is 115 mg/kg bw/d and the NOAEL of embryo-/foetal toxicity is 230 mg/kg bw/d. Ref.: 12 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation No data submitted 3.3.10.2. Phototoxicity / photomutagenicity / photoclastogenicity 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 3-Amino-2,4-dichlorophenol HC","endpoint":"","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"115","page":20,"route":"","species":"human","study_id":"sccp_o_092_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 115 mg/kg bw/d - - - - SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT=115; DOSE=ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d.; EFFECT=ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d. Whereas no treatment-related changes were recorded in the frequency of external anomalies, visceral observations and section findings, a significant increase in incompletely ossified os parietale and sternebral ossification centers was observed at 460 mg/kg. This was interpreted as related to maternal toxicity and may also be due to the reduced foetal weight. Conclusion For 3-amino-2,4-dichlorophenol hydrochloride the NOAEL of maternal toxicity is 115 mg/kg bw/d and the NOAEL of embryo-/foetal toxicity is 230 mg/kg bw/d. Ref.: 12; CITATION=Ref.: 12; CITATION_NUMBERS=[12]; REFERENCE=Ref.: 12; DETAILS_JSON={"cas_number":"61693-42-3","citation":"Ref.: 12","dose":"ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d.","duration":"","effect":"ights and foetal body weight (males and females) were significantly decreased at 460 mg/kg bw/d. Whereas no treatment-related changes were recorded in the frequency of external anomalies, visceral observations and section findings, a significant increase in incompletely ossified os parietale and sternebral ossification centers was observed at 460 mg/kg. This was interpreted as related to maternal toxicity and may also be due to the reduced foetal weight. Conclusion For 3-amino-2,4-dichlorophenol hydrochloride the NOAEL of maternal toxicity is 115 mg/kg bw/d and the NOAEL of embryo-/foetal toxicity is 230 mg/kg bw/d. Ref.: 12","endpoint":"","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"115","page":19,"route":"","species":"","study_id":"sccp_o_150_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 115 mg/kg bw/d - - - - SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT=115; DOSE=significantly decreased at 460 mg/kg bw/d.; EFFECT=significantly decreased at 460 mg/kg bw/d. Whereas no treatment-related changes were recorded in the frequency of external anomalies, visceral observations and section findings, a significant increase in incompletely ossified os parietale and sternebral ossification centers was observed at 460 mg/kg. This was interpreted as related to maternal toxicity and may also be due to the reduced foetal weight. Conclusion For 3-amino-2,4-dichlorophenol hydrochloride the NOAEL of maternal toxicity is 115 mg/kg bw/d and the NOAEL of embryo-/foetal toxicity is 230 mg/kg bw/d. Ref.: 12; CITATION=Ref.: 12; CITATION_NUMBERS=[12]; REFERENCE=Ref.: 12; DETAILS_JSON={"cas_number":"61693-42-3","citation":"Ref.: 12","dose":"significantly decreased at 460 mg/kg bw/d.","duration":"","effect":"significantly decreased at 460 mg/kg bw/d. Whereas no treatment-related changes were recorded in the frequency of external anomalies, visceral observations and section findings, a significant increase in incompletely ossified os parietale and sternebral ossification centers was observed at 460 mg/kg. This was interpreted as related to maternal toxicity and may also be due to the reduced foetal weight. Conclusion For 3-amino-2,4-dichlorophenol hydrochloride the NOAEL of maternal toxicity is 115 mg/kg bw/d and the NOAEL of embryo-/foetal toxicity is 230 mg/kg bw/d. Ref.: 12","endpoint":"","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"115","page":19,"route":"","species":"","study_id":"sccp_o_150_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.74 mg/kg rat oral 90 day dermal absorption SOURCE_SUBDIR=sccp_o_092; REPORT_TITLE=Opinion on 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1074/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 25 June 1993; VALUE_TEXT== 0.74; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...; EFFECT=photoclastogenicity 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 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","duration":"90 day","effect":"photoclastogenicity 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 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","endpoint":"dermal absorption","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.74","page":20,"route":"oral","species":"rat","study_id":"sccp_o_092_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =80 mg/kg bw rat oral 90 day dermal absorption SOURCE_SUBDIR=sccp_o_092; REPORT_TITLE=Opinion on 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1074/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 25 June 1993; VALUE_TEXT== 80; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...; EFFECT=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 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","duration":"90 day","effect":"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 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","endpoint":"dermal absorption","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 80","page":20,"route":"oral","species":"rat","study_id":"sccp_o_092_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =80 mg/kg bw rat oral 90 day dermal absorption SOURCE_SUBDIR=sccp_o_092; REPORT_TITLE=Opinion on 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1074/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 25 June 1993; VALUE_TEXT== 80; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...; EFFECT=estigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SA...","duration":"90 day","effect":"estigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl Maximum absorption through the skin A (µg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level (mg/kg) NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","endpoint":"dermal absorption","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 80","page":20,"route":"oral","species":"rat","study_id":"sccp_o_092_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 80 mg/kg bw/d rat dermal 90 days dermal absorption SOURCE_SUBDIR=sccp_o_092; REPORT_TITLE=Opinion on 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1074/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 25 June 1993; VALUE_TEXT=80; DOSE=General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).; EFFECT=tion hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results indicate that 3-Amino-2,4-dichlorophenol HCl is a moderate skin sensitiser. Dermal absorption Although too few chambers (8) were used i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","duration":"90 days","effect":"tion hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results indicate that 3-Amino-2,4-dichlorophenol HCl is a moderate skin sensitiser. Dermal absorption Although too few chambers (8) were used i","endpoint":"dermal absorption","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"80","page":21,"route":"dermal","species":"rat","study_id":"sccp_o_092_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.41 mg/kg rat oral 90 day dermal absorption SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT== 0.41; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemi...; EFFECT=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 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemi...","duration":"90 day","effect":"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 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","endpoint":"dermal absorption","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.41","page":20,"route":"oral","species":"rat","study_id":"sccp_o_150_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =80 mg/kg bw rat oral 90 day dermal absorption SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT== 80; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemi...; EFFECT=a 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 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemi...","duration":"90 day","effect":"a 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 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","endpoint":"dermal absorption","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 80","page":20,"route":"oral","species":"rat","study_id":"sccp_o_150_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =80 mg/kg bw rat oral 90 day dermal absorption SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT== 80; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemi...; EFFECT=ata submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemi...","duration":"90 day","effect":"ata submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 3-Amino-2,4-dichlorophenol HCl (Oxidative / permanent) Maximum absorption through the skin A (μg/cm2) = 35.28 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","endpoint":"dermal absorption","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 80","page":20,"route":"oral","species":"rat","study_id":"sccp_o_150_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.74 mg/kg rat oral 90 day dermal absorption SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT== 0.74; DOSE=0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) =...; EFFECT=0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) =...","duration":"90 day","effect":"0.001 = 24.70 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","endpoint":"dermal absorption","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.74","page":20,"route":"oral","species":"rat","study_id":"sccp_o_150_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =80 mg/kg bw rat oral 90 day dermal absorption SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT== 80; DOSE=ght of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per tr...; EFFECT=ght of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"ght of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per tr...","duration":"90 day","effect":"ght of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","endpoint":"dermal absorption","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 80","page":20,"route":"oral","species":"rat","study_id":"sccp_o_150_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =80 mg/kg bw rat oral 90 day dermal absorption SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT== 80; DOSE=x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of...; EFFECT=x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of...","duration":"90 day","effect":"x 0.001/60 = 0.41 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 195 (Non-oxidative / semi-permanent) Maximum absorption through the skin A (μg/cm2) = 63.68 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 44.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.74 mg/kg No observed adverse effect level NOAEL = 80 mg/kg bw (90 day, oral, rat) Margin of Safety NOAEL / SED = 108","endpoint":"dermal absorption","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 80","page":20,"route":"oral","species":"rat","study_id":"sccp_o_150_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption 80 mg/kg bw/d rat dermal 90 days dermal absorption SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT=80; DOSE=General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).; EFFECT=tion hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results indicate that 3-Amino-2,4-dichlorophenol HCl is a moderate skin sensitiser. Dermal absorption Although too few chambers (8) were used i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","duration":"90 days","effect":"tion hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results indicate that 3-Amino-2,4-dichlorophenol HCl is a moderate skin sensitiser. Dermal absorption Although too few chambers (8) were used i","endpoint":"dermal absorption","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"80","page":21,"route":"dermal","species":"rat","study_id":"sccp_o_150_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 480 mg/kg bw/d rat - 90 days genotoxicity SOURCE_SUBDIR=sccp_o_092; REPORT_TITLE=Opinion on 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1074/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 25 June 1993; VALUE_TEXT=480; DOSE=t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found.; EFFECT=t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found. At 480 mg/kg bw/d some changes in haematological parameters were observed. In clinical chemistry significantly increased phosphorus, sodium and chloride in males also of the mid dose were observed. The histopathological examination viz. kidney and liver revealed degenerative changes suggestive of nephrotoxicity and hepatotoxicity at 160 and 480 mg/kg bw/d. The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was concluded to be 80 mg/kg bw/d. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.2 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test subst; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"61693-42-3","citation":"Ref.: 11 3","dose":"t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found.","duration":"90 days","effect":"t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found. At 480 mg/kg bw/d some changes in haematological parameters were observed. In clinical chemistry significantly increased phosphorus, sodium and chloride in males also of the mid dose were observed. The histopathological examination viz. kidney and liver revealed degenerative changes suggestive of nephrotoxicity and hepatotoxicity at 160 and 480 mg/kg bw/d. The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was concluded to be 80 mg/kg bw/d. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.2 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test subst","endpoint":"genotoxicity","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"480","page":15,"route":"","species":"rat","study_id":"sccp_o_092_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 480 mg/kg bw/d rat - 90 days genotoxicity SOURCE_SUBDIR=sccp_o_092; REPORT_TITLE=Opinion on 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1074/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 25 June 1993; VALUE_TEXT=480; DOSE=At 480 mg/kg bw/d some changes in haematological parameters were observed.; EFFECT=ificant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found. At 480 mg/kg bw/d some changes in haematological parameters were observed. In clinical chemistry significantly increased phosphorus, sodium and chloride in males also of the mid dose were observed. The histopathological examination viz. kidney and liver revealed degenerative changes suggestive of nephrotoxicity and hepatotoxicity at 160 and 480 mg/kg bw/d. The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was concluded to be 80 mg/kg bw/d. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.2 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test substance: A; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"61693-42-3","citation":"Ref.: 11 3","dose":"At 480 mg/kg bw/d some changes in haematological parameters were observed.","duration":"90 days","effect":"ificant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found. At 480 mg/kg bw/d some changes in haematological parameters were observed. In clinical chemistry significantly increased phosphorus, sodium and chloride in males also of the mid dose were observed. The histopathological examination viz. kidney and liver revealed degenerative changes suggestive of nephrotoxicity and hepatotoxicity at 160 and 480 mg/kg bw/d. The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was concluded to be 80 mg/kg bw/d. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.2 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test substance: A","endpoint":"genotoxicity","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"480","page":15,"route":"","species":"rat","study_id":"sccp_o_092_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 480 mg/kg bw/d rat - 90 days genotoxicity SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT=480; DOSE=t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found.; EFFECT=t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found. At 480 mg/kg bw/d some changes in haematological parameters were observed. In clinical chemistry significantly increased phosphorus, sodium and chloride in males also of the mid dose were observed. The histopathological examination viz. kidney and liver revealed degenerative changes suggestive of nephrotoxicity and hepatotoxicity at 160 and 480 mg/kg bw/d. The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was concluded to be 80 mg/kg bw/d. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.2 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test subst; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"61693-42-3","citation":"Ref.: 11 3","dose":"t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found.","duration":"90 days","effect":"t dose level (480 mg/kg bw/d) significant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found. At 480 mg/kg bw/d some changes in haematological parameters were observed. In clinical chemistry significantly increased phosphorus, sodium and chloride in males also of the mid dose were observed. The histopathological examination viz. kidney and liver revealed degenerative changes suggestive of nephrotoxicity and hepatotoxicity at 160 and 480 mg/kg bw/d. The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was concluded to be 80 mg/kg bw/d. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.2 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test subst","endpoint":"genotoxicity","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"480","page":15,"route":"","species":"rat","study_id":"sccp_o_150_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 480 mg/kg bw/d rat - 90 days genotoxicity SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT=480; DOSE=At 480 mg/kg bw/d some changes in haematological parameters were observed.; EFFECT=ificant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found. At 480 mg/kg bw/d some changes in haematological parameters were observed. In clinical chemistry significantly increased phosphorus, sodium and chloride in males also of the mid dose were observed. The histopathological examination viz. kidney and liver revealed degenerative changes suggestive of nephrotoxicity and hepatotoxicity at 160 and 480 mg/kg bw/d. The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was concluded to be 80 mg/kg bw/d. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.2 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test substance: A; CITATION=Ref.: 11 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref.: 11 3; DETAILS_JSON={"cas_number":"61693-42-3","citation":"Ref.: 11 3","dose":"At 480 mg/kg bw/d some changes in haematological parameters were observed.","duration":"90 days","effect":"ificant changes in absolute liver weight (males) and relative weights of liver and kidneys (males and females) were found. At 480 mg/kg bw/d some changes in haematological parameters were observed. In clinical chemistry significantly increased phosphorus, sodium and chloride in males also of the mid dose were observed. The histopathological examination viz. kidney and liver revealed degenerative changes suggestive of nephrotoxicity and hepatotoxicity at 160 and 480 mg/kg bw/d. The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was concluded to be 80 mg/kg bw/d. Ref.: 11 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.2 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium TA98, TA100, TA102, TA1535, and TA1537 Replicates: triplicates in 2 individual experiments both in the presence and absence of S9-mix Test substance: A","endpoint":"genotoxicity","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"480","page":15,"route":"","species":"rat","study_id":"sccp_o_150_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 2000 mg/kg bw rat - 90 days irritation SOURCE_SUBDIR=sccp_o_092; REPORT_TITLE=Opinion on 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1074/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 25 June 1993; VALUE_TEXT=2000; DOSE=General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).; EFFECT=SCCS-rejected applicant NOAEL: SCCP/1074/07 Opinion on 3-amino-2,4-dichlorophenol HCl 21 3.3.14. Discussion Physico-chemical specifications 3-Amino-2,4-dichlorophenol HCl is used in oxidation hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","duration":"90 days","effect":"SCCS-rejected applicant NOAEL: SCCP/1074/07 Opinion on 3-amino-2,4-dichlorophenol HCl 21 3.3.14. Discussion Physico-chemical specifications 3-Amino-2,4-dichlorophenol HCl is used in oxidation hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results i","endpoint":"irritation","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":21,"route":"","species":"rat","study_id":"sccp_o_092_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 2000 mg/kg bw rat - 90 days irritation SOURCE_SUBDIR=sccp_o_092; REPORT_TITLE=Opinion on 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1074/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 25 June 1993; VALUE_TEXT=2000; DOSE=General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).; EFFECT=-2,4-dichlorophenol HCl 21 3.3.14. Discussion Physico-chemical specifications 3-Amino-2,4-dichlorophenol HCl is used in oxidation hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results indicate; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","duration":"90 days","effect":"-2,4-dichlorophenol HCl 21 3.3.14. Discussion Physico-chemical specifications 3-Amino-2,4-dichlorophenol HCl is used in oxidation hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results indicate","endpoint":"irritation","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":21,"route":"","species":"rat","study_id":"sccp_o_092_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 2000 mg/kg bw rat - 90 days irritation SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT=2000; DOSE=General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).; EFFECT=SCCS-rejected applicant NOAEL: SCCP/1205/08 Opinion on 3-amino-2,4-dichlorophenol HCL 21 3.3.14. Discussion Physico-chemical specifications 3-Amino-2,4-dichlorophenol HCl is used in oxidation hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","duration":"90 days","effect":"SCCS-rejected applicant NOAEL: SCCP/1205/08 Opinion on 3-amino-2,4-dichlorophenol HCL 21 3.3.14. Discussion Physico-chemical specifications 3-Amino-2,4-dichlorophenol HCl is used in oxidation hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results i","endpoint":"irritation","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":21,"route":"","species":"rat","study_id":"sccp_o_150_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies irritation 2000 mg/kg bw rat - 90 days irritation SOURCE_SUBDIR=sccp_o_150; REPORT_TITLE=OPINION ON 3-Amino-2,4-dichlorophenol HCl COLIPA n° A43; OPINION_NUMBER=SCCP/1205/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 21 March 2007; VALUE_TEXT=2000; DOSE=General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).; EFFECT=-2,4-dichlorophenol HCL 21 3.3.14. Discussion Physico-chemical specifications 3-Amino-2,4-dichlorophenol HCl is used in oxidation hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results indicate; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"61693-42-3","citation":"","dose":"General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw).","duration":"90 days","effect":"-2,4-dichlorophenol HCL 21 3.3.14. Discussion Physico-chemical specifications 3-Amino-2,4-dichlorophenol HCl is used in oxidation hair dye formulations at a maximum concentration of 3.0 %, which after mixing typically in 1:1 ratio with hydrogen peroxide prior to use, corresponds to a concentration of 1.5 % upon application. However, the physico-chemical data were not adequately reported. General toxicity The median acute lethal dose is 500 mg/kg bw (300 – 2000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) of 3-amino-2,4-dichlorophenol hydrochloride in Wistar rats exposed over a period of 90 days was set at 80 mg/kg bw/d. The NOAEL for maternal toxicity was set at 115 mg/kg bw/d. For embryo-/foetal toxicity, it was set at 230 mg/kg bw/d. Irritation / sensitisation Under the conditions of the study, A043 caused irritation to rabbit skin. It was severely irritating to the rabbit eye. However, the instillation of the test substance into the eye was not considered as the most relevant experiment. The results indicate","endpoint":"irritation","ingredient":"3-Amino-2,4-dichlorophenol HCl","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2000","page":21,"route":"","species":"rat","study_id":"sccp_o_150_noael_012"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 551I6ZAE4Q UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H5Cl2NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"551I6ZAE4Q"}
openFDA substances FDA UNII substance identifier 551I6ZAE4Q UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H5Cl2NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"551I6ZAE4Q"}
openFDA substances FDA UNII substance identifier 551I6ZAE4Q UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H5Cl2NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"551I6ZAE4Q"}
openFDA substances FDA UNII substance identifier 551I6ZAE4Q UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H5Cl2NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"551I6ZAE4Q"}