NOAEL Studies Cosmetic Ingredient

2-Methyl-5-Hydroxyethylaminophenol NOAEL Studies

INCI: 2-METHYL-5-HYDROXYETHYLAMINOPHENOL

CAS: 55302-96-0

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

COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 50 mg/kg bw/day rat oral 90 day Subchronic SCCP; J. Richard. Imexine OAG: 13-Week Toxicity Study by Oral Route in Rats. CIT Study No.9438 TCR (CIES1 92095), 1993
NTP_ICE_skin_sensitization 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_skin_sensitization EC3 0.4 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13434; Record_ID=skin_sensitization_invivo_3583; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID70203849; Assay=LLNA; Endpoint=EC3; Response=0.4; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID70203849
NTP_ICE_skin_sensitization EC3 0.4 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13434; Record_ID=skin_sensitization_invivo_3583; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID70203849; Assay=LLNA; Endpoint=EC3; Response=0.4; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID70203849
NTP_ICE_skin_sensitization EC3 0.4 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13434; Record_ID=skin_sensitization_invivo_3583; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID70203849; Assay=LLNA; Endpoint=EC3; Response=0.4; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID70203849
NTP_ICE_skin_sensitization EC3 0.4 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13434; Record_ID=skin_sensitization_invivo_3583; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID70203849; Assay=LLNA; Endpoint=EC3; Response=0.4; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID70203849
SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =0.053 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...","effect":"______________________________________ 19 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity Th","page":19,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_005"}
SCCS_vision_codex NOAEL =0.053 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...","effect":"______________________________________ 19 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity Th","page":19,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_005"}
SCCS_vision_codex NOAEL =0.053 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...","effect":"______________________________________ 19 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity Th","page":19,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_005"}
SCCS_vision_codex NOAEL =0.053 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...","effect":"______________________________________ 19 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity Th","page":19,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_005"}
SCCS_vision_codex NOAEL =220 mg/kg bw - oral subchronic repeated dose toxicity {"citation":"Ref.: 6 3","dose":"in all high and middle dose group animals and in 6/10 males of the low dose group.","effect":"in all high and middle dose group animals and in 6/10 males of the low dose group. No death occurred. Feed consumption was not changed. A treatment-related decrease in mean body weight gain was observed in females of the high dose group. Differences in some haematological parameters were within the range of historical controls. Proteinuria was observed in animals of both sexes in the 1000 mg/kg group. With the exception of colouring effects no further substance-related findings were noted at the lower doses. The NOAEL of subchronic toxicity is 220 mg/kg bw. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA102 Replicates: Two independent tests","page":12,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_001"}
SCCS_vision_codex NOAEL =220 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...","effect":"3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-","page":19,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_006"}
SCCS_vision_codex NOAEL =220 mg/kg bw - oral subchronic repeated dose toxicity {"citation":"Ref.: 6 3","dose":"in all high and middle dose group animals and in 6/10 males of the low dose group.","effect":"in all high and middle dose group animals and in 6/10 males of the low dose group. No death occurred. Feed consumption was not changed. A treatment-related decrease in mean body weight gain was observed in females of the high dose group. Differences in some haematological parameters were within the range of historical controls. Proteinuria was observed in animals of both sexes in the 1000 mg/kg group. With the exception of colouring effects no further substance-related findings were noted at the lower doses. The NOAEL of subchronic toxicity is 220 mg/kg bw. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA102 Replicates: Two independent tests","page":12,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_001"}
SCCS_vision_codex NOAEL =220 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...","effect":"3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-","page":19,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_006"}
SCCS_vision_codex NOAEL =220 mg/kg bw - oral subchronic repeated dose toxicity {"citation":"Ref.: 6 3","dose":"in all high and middle dose group animals and in 6/10 males of the low dose group.","effect":"in all high and middle dose group animals and in 6/10 males of the low dose group. No death occurred. Feed consumption was not changed. A treatment-related decrease in mean body weight gain was observed in females of the high dose group. Differences in some haematological parameters were within the range of historical controls. Proteinuria was observed in animals of both sexes in the 1000 mg/kg group. With the exception of colouring effects no further substance-related findings were noted at the lower doses. The NOAEL of subchronic toxicity is 220 mg/kg bw. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA102 Replicates: Two independent tests","page":12,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_001"}
SCCS_vision_codex NOAEL =220 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...","effect":"3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-","page":19,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_006"}
SCCS_vision_codex NOAEL =220 mg/kg bw - oral subchronic repeated dose toxicity {"citation":"Ref.: 6 3","dose":"in all high and middle dose group animals and in 6/10 males of the low dose group.","effect":"in all high and middle dose group animals and in 6/10 males of the low dose group. No death occurred. Feed consumption was not changed. A treatment-related decrease in mean body weight gain was observed in females of the high dose group. Differences in some haematological parameters were within the range of historical controls. Proteinuria was observed in animals of both sexes in the 1000 mg/kg group. With the exception of colouring effects no further substance-related findings were noted at the lower doses. The NOAEL of subchronic toxicity is 220 mg/kg bw. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA102 Replicates: Two independent tests","page":12,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_001"}
SCCS_vision_codex NOAEL =220 mg/kg rat oral 90 day dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...","effect":"3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-","page":19,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_006"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d human oral - NOAEL study {"citation":"Ref.: 13 3","dose":"During treatment all treated females of the 1000 mg/kg group had brown discoloured urine (due to the test substance), 1/24 at 100 mg/kg and 19/24 at 300 mg/kg.","effect":"o animal died during the study. During treatment all treated females of the 1000 mg/kg group had brown discoloured urine (due to the test substance), 1/24 at 100 mg/kg and 19/24 at 300 mg/kg. No clinical signs of toxicity were observed. Feed consumption and body weight gain were not affected in a dose-related way. No treatment related effects were found with regard to litter data, external and visceral observations. No treatment-related changes in the frequency of variations and malformations were registered. The NOAEL of maternal toxicity and embryo-/foetotoxicity were both 1000 mg/kg bw/d. Ref.: 13 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","page":18,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_004"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d human oral - NOAEL study {"citation":"Ref.: 13 3","dose":"During treatment all treated females of the 1000 mg/kg group had brown discoloured urine (due to the test substance), 1/24 at 100 mg/kg and 19/24 at 300 mg/kg.","effect":"o animal died during the study. During treatment all treated females of the 1000 mg/kg group had brown discoloured urine (due to the test substance), 1/24 at 100 mg/kg and 19/24 at 300 mg/kg. No clinical signs of toxicity were observed. Feed consumption and body weight gain were not affected in a dose-related way. No treatment related effects were found with regard to litter data, external and visceral observations. No treatment-related changes in the frequency of variations and malformations were registered. The NOAEL of maternal toxicity and embryo-/foetotoxicity were both 1000 mg/kg bw/d. Ref.: 13 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","page":18,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_004"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d human oral - NOAEL study {"citation":"Ref.: 13 3","dose":"During treatment all treated females of the 1000 mg/kg group had brown discoloured urine (due to the test substance), 1/24 at 100 mg/kg and 19/24 at 300 mg/kg.","effect":"o animal died during the study. During treatment all treated females of the 1000 mg/kg group had brown discoloured urine (due to the test substance), 1/24 at 100 mg/kg and 19/24 at 300 mg/kg. No clinical signs of toxicity were observed. Feed consumption and body weight gain were not affected in a dose-related way. No treatment related effects were found with regard to litter data, external and visceral observations. No treatment-related changes in the frequency of variations and malformations were registered. The NOAEL of maternal toxicity and embryo-/foetotoxicity were both 1000 mg/kg bw/d. Ref.: 13 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","page":18,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_004"}
SCCS_vision_codex NOAEL =1000 mg/kg bw/d human oral - NOAEL study {"citation":"Ref.: 13 3","dose":"During treatment all treated females of the 1000 mg/kg group had brown discoloured urine (due to the test substance), 1/24 at 100 mg/kg and 19/24 at 300 mg/kg.","effect":"o animal died during the study. During treatment all treated females of the 1000 mg/kg group had brown discoloured urine (due to the test substance), 1/24 at 100 mg/kg and 19/24 at 300 mg/kg. No clinical signs of toxicity were observed. Feed consumption and body weight gain were not affected in a dose-related way. No treatment related effects were found with regard to litter data, external and visceral observations. No treatment-related changes in the frequency of variations and malformations were registered. The NOAEL of maternal toxicity and embryo-/foetotoxicity were both 1000 mg/kg bw/d. Ref.: 13 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","page":18,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_004"}
SCCS_vision_codex NOAEL =1800 mg/kg bw/d rat oral developmental developmental toxicity {"citation":"Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","dose":"0 mg/kg/day, was considered to be spontaneous and not compound related.","effect":"0 mg/kg/day, was considered to be spontaneous and not compound related. Embryonic and foetal development (evaluated by incidence of minor internal organ changes and skeletal malformations) were not affected by the treatment. There is no evidence for teratogenicity, embryotoxicity or foetotoxicity. The No Effect Level in this study was 50 mg/kg bw/day, based on embryotoxicity. There was no evidence of compound related teratogenicity at any dose level. Comment The evaluation was adequate, but the derivation of the NOAEL was erroneous. The NOAEL of both maternal and embryo-/foetotoxicity was 1800 mg/kg bw/d. But no data on purity and on the batch were provided. Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","page":17,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_002"}
SCCS_vision_codex NOAEL =1800 mg/kg bw/d rat oral developmental developmental toxicity {"citation":"Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","dose":"0 mg/kg/day, was considered to be spontaneous and not compound related.","effect":"0 mg/kg/day, was considered to be spontaneous and not compound related. Embryonic and foetal development (evaluated by incidence of minor internal organ changes and skeletal malformations) were not affected by the treatment. There is no evidence for teratogenicity, embryotoxicity or foetotoxicity. The No Effect Level in this study was 50 mg/kg bw/day, based on embryotoxicity. There was no evidence of compound related teratogenicity at any dose level. Comment The evaluation was adequate, but the derivation of the NOAEL was erroneous. The NOAEL of both maternal and embryo-/foetotoxicity was 1800 mg/kg bw/d. But no data on purity and on the batch were provided. Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","page":17,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_002"}
SCCS_vision_codex NOAEL =1800 mg/kg bw/d rat oral developmental developmental toxicity {"citation":"Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","dose":"0 mg/kg/day, was considered to be spontaneous and not compound related.","effect":"0 mg/kg/day, was considered to be spontaneous and not compound related. Embryonic and foetal development (evaluated by incidence of minor internal organ changes and skeletal malformations) were not affected by the treatment. There is no evidence for teratogenicity, embryotoxicity or foetotoxicity. The No Effect Level in this study was 50 mg/kg bw/day, based on embryotoxicity. There was no evidence of compound related teratogenicity at any dose level. Comment The evaluation was adequate, but the derivation of the NOAEL was erroneous. The NOAEL of both maternal and embryo-/foetotoxicity was 1800 mg/kg bw/d. But no data on purity and on the batch were provided. Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","page":17,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_002"}
SCCS_vision_codex NOAEL =1800 mg/kg bw/d rat oral developmental developmental toxicity {"citation":"Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","dose":"0 mg/kg/day, was considered to be spontaneous and not compound related.","effect":"0 mg/kg/day, was considered to be spontaneous and not compound related. Embryonic and foetal development (evaluated by incidence of minor internal organ changes and skeletal malformations) were not affected by the treatment. There is no evidence for teratogenicity, embryotoxicity or foetotoxicity. The No Effect Level in this study was 50 mg/kg bw/day, based on embryotoxicity. There was no evidence of compound related teratogenicity at any dose level. Comment The evaluation was adequate, but the derivation of the NOAEL was erroneous. The NOAEL of both maternal and embryo-/foetotoxicity was 1800 mg/kg bw/d. But no data on purity and on the batch were provided. Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","page":17,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_002"}
SCCS_vision_codex NOAEL >2000 mg/kg bw rat - subchronic repeated dose toxicity {"dose":"General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw.","effect":"of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw. The NOAEL of subchronic toxicity in rats is 220 mg/kg bw. The NOAEL of maternal toxicity and embryo-/foetotoxicity in rats were both 1000 mg/kg bw/d. Irritation/sensitisation When tested undiluted, 2-methyl-5-hydroxyethylaminophenol was non-irritant to rabbit skin. It is an irritant to rabbit eyes when tested undiluted. The single instillation of 0.1 ml of 2 % 2- methyl-5-hydroxyethylaminophenol in a 0.5 % carboxymethylcellulose suspension was non- irritating to rabbit eyes. 2-Methyl-5-hydroxyethylaminophenol did not induc","page":19,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_008"}
SCCS_vision_codex NOAEL >2000 mg/kg bw rat - subchronic repeated dose toxicity {"dose":"General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw.","effect":"of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw. The NOAEL of subchronic toxicity in rats is 220 mg/kg bw. The NOAEL of maternal toxicity and embryo-/foetotoxicity in rats were both 1000 mg/kg bw/d. Irritation/sensitisation When tested undiluted, 2-methyl-5-hydroxyethylaminophenol was non-irritant to rabbit skin. It is an irritant to rabbit eyes when tested undiluted. The single instillation of 0.1 ml of 2 % 2- methyl-5-hydroxyethylaminophenol in a 0.5 % carboxymethylcellulose suspension was non- irritating to rabbit eyes. 2-Methyl-5-hydroxyethylaminophenol did not induc","page":19,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_008"}
SCCS_vision_codex NOAEL >2000 mg/kg bw rat - subchronic repeated dose toxicity {"dose":"General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw.","effect":"of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw. The NOAEL of subchronic toxicity in rats is 220 mg/kg bw. The NOAEL of maternal toxicity and embryo-/foetotoxicity in rats were both 1000 mg/kg bw/d. Irritation/sensitisation When tested undiluted, 2-methyl-5-hydroxyethylaminophenol was non-irritant to rabbit skin. It is an irritant to rabbit eyes when tested undiluted. The single instillation of 0.1 ml of 2 % 2- methyl-5-hydroxyethylaminophenol in a 0.5 % carboxymethylcellulose suspension was non- irritating to rabbit eyes. 2-Methyl-5-hydroxyethylaminophenol did not induc","page":19,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_008"}
SCCS_vision_codex NOAEL >2000 mg/kg bw rat - subchronic repeated dose toxicity {"dose":"General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw.","effect":"of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw. The NOAEL of subchronic toxicity in rats is 220 mg/kg bw. The NOAEL of maternal toxicity and embryo-/foetotoxicity in rats were both 1000 mg/kg bw/d. Irritation/sensitisation When tested undiluted, 2-methyl-5-hydroxyethylaminophenol was non-irritant to rabbit skin. It is an irritant to rabbit eyes when tested undiluted. The single instillation of 0.1 ml of 2 % 2- methyl-5-hydroxyethylaminophenol in a 0.5 % carboxymethylcellulose suspension was non- irritating to rabbit eyes. 2-Methyl-5-hydroxyethylaminophenol did not induc","page":19,"pdf":"sccp_o_040.pdf","row_type":"noael_study","study_id":"sccp_o_040_noael_008"}
ToxValDB_ECHA_IUCLID 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =220 mg/kg bw/day Rat oral subchronic; 13 weeks subchronic QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eae66e4b0a7c65d1c917c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/21638/7/6/2?documentUUID=5215fe22-0bef-47d2-bd2f-e948bab4c937; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical signs|urinalysis; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|urinalysis; STUDY_GROUP=ECHA IUCLID:15836564:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_95624a89c3cf6e243fecbd818190d9d1
ToxValDB_ECHA_IUCLID NOAEL =1000 mg/kg bw/day Rat oral - developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac3ee4b0a7c65d1be111; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/21638/7/9/3?documentUUID=5215fe22-0bef-47d2-bd2f-e948bab4c937; YEAR=2017; ORIGINAL_YEAR=2017; STUDY_GROUP=ECHA IUCLID:15821641:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_43a6c72938deac0b41a6cd64062c569c
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =7.8 mg/m3 Human inhalation - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15632684:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_cbea58cead046ae979b968bf051c72c5
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg bw/d human oral - - SOURCE_SUBDIR=sccp_o_040; REPORT_TITLE=Opinion on 2-METHYL-5-HYDROXYETHYLAMINOPHENOL COLIPA N° A31; OPINION_NUMBER=SCCP/0957/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=1000; DOSE=During treatment all treated females of the 1000 mg/kg group had brown discoloured urine (due to the test substance), 1/24 at 100 mg/kg and 19/24 at 300 mg/kg.; EFFECT=o animal died during the study. During treatment all treated females of the 1000 mg/kg group had brown discoloured urine (due to the test substance), 1/24 at 100 mg/kg and 19/24 at 300 mg/kg. No clinical signs of toxicity were observed. Feed consumption and body weight gain were not affected in a dose-related way. No treatment related effects were found with regard to litter data, external and visceral observations. No treatment-related changes in the frequency of variations and malformations were registered. The NOAEL of maternal toxicity and embryo-/foetotoxicity were both 1000 mg/kg bw/d. Ref.: 13 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; CITATION=Ref.: 13 3; CITATION_NUMBERS=[13,3]; REFERENCE=Ref.: 13 3; DETAILS_JSON={"cas_number":"55302-96-0","citation":"Ref.: 13 3","dose":"During treatment all treated females of the 1000 mg/kg group had brown discoloured urine (due to the test substance), 1/24 at 100 mg/kg and 19/24 at 300 mg/kg.","duration":"","effect":"o animal died during the study. During treatment all treated females of the 1000 mg/kg group had brown discoloured urine (due to the test substance), 1/24 at 100 mg/kg and 19/24 at 300 mg/kg. No clinical signs of toxicity were observed. Feed consumption and body weight gain were not affected in a dose-related way. No treatment related effects were found with regard to litter data, external and visceral observations. No treatment-related changes in the frequency of variations and malformations were registered. The NOAEL of maternal toxicity and embryo-/foetotoxicity were both 1000 mg/kg bw/d. Ref.: 13 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","endpoint":"","ingredient":"2-Methyl-5-hydroxyethylaminophenol (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":18,"route":"oral","species":"human","study_id":"sccp_o_040_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.053 mg/kg rat oral 90 day dermal absorption SOURCE_SUBDIR=sccp_o_040; REPORT_TITLE=Opinion on 2-METHYL-5-HYDROXYETHYLAMINOPHENOL COLIPA N° A31; OPINION_NUMBER=SCCP/0957/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 0.053; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...; EFFECT=______________________________________ 19 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity Th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55302-96-0","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...","duration":"90 day","effect":"______________________________________ 19 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity Th","endpoint":"dermal absorption","ingredient":"2-Methyl-5-hydroxyethylaminophenol (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.053","page":19,"route":"oral","species":"rat","study_id":"sccp_o_040_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =220 mg/kg rat oral 90 day dermal absorption SOURCE_SUBDIR=sccp_o_040; REPORT_TITLE=Opinion on 2-METHYL-5-HYDROXYETHYLAMINOPHENOL COLIPA N° A31; OPINION_NUMBER=SCCP/0957/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 220; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...; EFFECT=3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55302-96-0","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...","duration":"90 day","effect":"3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-","endpoint":"dermal absorption","ingredient":"2-Methyl-5-hydroxyethylaminophenol (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 220","page":19,"route":"oral","species":"rat","study_id":"sccp_o_040_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =220 mg/kg rat oral 90 day dermal absorption SOURCE_SUBDIR=sccp_o_040; REPORT_TITLE=Opinion on 2-METHYL-5-HYDROXYETHYLAMINOPHENOL COLIPA N° A31; OPINION_NUMBER=SCCP/0957/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT== 220; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...; EFFECT=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw. The NOAEL of subchro; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55302-96-0","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Syst...","duration":"90 day","effect":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (2-Methyl-5-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 4.56 µg/cm2 Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.192 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.053 mg/kg No observed adverse effect level (mg/kg) NOAEL = 220 mg/kg (rat, 90 day, oral) Margin of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw. The NOAEL of subchro","endpoint":"dermal absorption","ingredient":"2-Methyl-5-hydroxyethylaminophenol (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 220","page":19,"route":"oral","species":"rat","study_id":"sccp_o_040_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1800 mg/kg bw/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_040; REPORT_TITLE=Opinion on 2-METHYL-5-HYDROXYETHYLAMINOPHENOL COLIPA N° A31; OPINION_NUMBER=SCCP/0957/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=1800; DOSE=0 mg/kg/day, was considered to be spontaneous and not compound related.; EFFECT=0 mg/kg/day, was considered to be spontaneous and not compound related. Embryonic and foetal development (evaluated by incidence of minor internal organ changes and skeletal malformations) were not affected by the treatment. There is no evidence for teratogenicity, embryotoxicity or foetotoxicity. The No Effect Level in this study was 50 mg/kg bw/day, based on embryotoxicity. There was no evidence of compound related teratogenicity at any dose level. Comment The evaluation was adequate, but the derivation of the NOAEL was erroneous. The NOAEL of both maternal and embryo-/foetotoxicity was 1800 mg/kg bw/d. But no data on purity and on the batch were provided. Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; CITATION=Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; CITATION_NUMBERS=[26,2004,414]; REFERENCE=Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; DETAILS_JSON={"cas_number":"55302-96-0","citation":"Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","dose":"0 mg/kg/day, was considered to be spontaneous and not compound related.","duration":"developmental","effect":"0 mg/kg/day, was considered to be spontaneous and not compound related. Embryonic and foetal development (evaluated by incidence of minor internal organ changes and skeletal malformations) were not affected by the treatment. There is no evidence for teratogenicity, embryotoxicity or foetotoxicity. The No Effect Level in this study was 50 mg/kg bw/day, based on embryotoxicity. There was no evidence of compound related teratogenicity at any dose level. Comment The evaluation was adequate, but the derivation of the NOAEL was erroneous. The NOAEL of both maternal and embryo-/foetotoxicity was 1800 mg/kg bw/d. But no data on purity and on the batch were provided. Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","endpoint":"developmental toxicity","ingredient":"2-Methyl-5-hydroxyethylaminophenol (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1800","page":17,"route":"oral","species":"rat","study_id":"sccp_o_040_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1800 mg/kg bw/d rat oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_040; REPORT_TITLE=Opinion on 2-METHYL-5-HYDROXYETHYLAMINOPHENOL COLIPA N° A31; OPINION_NUMBER=SCCP/0957/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=1800; DOSE=The No Effect Level in this study was 50 mg/kg bw/day, based on embryotoxicity.; EFFECT=ed to be spontaneous and not compound related. Embryonic and foetal development (evaluated by incidence of minor internal organ changes and skeletal malformations) were not affected by the treatment. There is no evidence for teratogenicity, embryotoxicity or foetotoxicity. The No Effect Level in this study was 50 mg/kg bw/day, based on embryotoxicity. There was no evidence of compound related teratogenicity at any dose level. Comment The evaluation was adequate, but the derivation of the NOAEL was erroneous. The NOAEL of both maternal and embryo-/foetotoxicity was 1800 mg/kg bw/d. But no data on purity and on the batch were provided. Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; CITATION=Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; CITATION_NUMBERS=[26,2004,414]; REFERENCE=Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats; DETAILS_JSON={"cas_number":"55302-96-0","citation":"Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","dose":"The No Effect Level in this study was 50 mg/kg bw/day, based on embryotoxicity.","duration":"developmental","effect":"ed to be spontaneous and not compound related. Embryonic and foetal development (evaluated by incidence of minor internal organ changes and skeletal malformations) were not affected by the treatment. There is no evidence for teratogenicity, embryotoxicity or foetotoxicity. The No Effect Level in this study was 50 mg/kg bw/day, based on embryotoxicity. There was no evidence of compound related teratogenicity at any dose level. Comment The evaluation was adequate, but the derivation of the NOAEL was erroneous. The NOAEL of both maternal and embryo-/foetotoxicity was 1800 mg/kg bw/d. But no data on purity and on the batch were provided. Ref.: 26 Embryo-foetal developmental toxicity study by the oral route in rats, 2004 Guideline: OECD 414 Species/strain: Sprague-Dawley rats","endpoint":"developmental toxicity","ingredient":"2-Methyl-5-hydroxyethylaminophenol (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1800","page":17,"route":"oral","species":"rat","study_id":"sccp_o_040_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 220 mg/kg bw - oral subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_040; REPORT_TITLE=Opinion on 2-METHYL-5-HYDROXYETHYLAMINOPHENOL COLIPA N° A31; OPINION_NUMBER=SCCP/0957/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=220; DOSE=in all high and middle dose group animals and in 6/10 males of the low dose group.; EFFECT=in all high and middle dose group animals and in 6/10 males of the low dose group. No death occurred. Feed consumption was not changed. A treatment-related decrease in mean body weight gain was observed in females of the high dose group. Differences in some haematological parameters were within the range of historical controls. Proteinuria was observed in animals of both sexes in the 1000 mg/kg group. With the exception of colouring effects no further substance-related findings were noted at the lower doses. The NOAEL of subchronic toxicity is 220 mg/kg bw. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA102 Replicates: Two independent tests; CITATION=Ref.: 6 3; CITATION_NUMBERS=[6,3]; REFERENCE=Ref.: 6 3; DETAILS_JSON={"cas_number":"55302-96-0","citation":"Ref.: 6 3","dose":"in all high and middle dose group animals and in 6/10 males of the low dose group.","duration":"subchronic","effect":"in all high and middle dose group animals and in 6/10 males of the low dose group. No death occurred. Feed consumption was not changed. A treatment-related decrease in mean body weight gain was observed in females of the high dose group. Differences in some haematological parameters were within the range of historical controls. Proteinuria was observed in animals of both sexes in the 1000 mg/kg group. With the exception of colouring effects no further substance-related findings were noted at the lower doses. The NOAEL of subchronic toxicity is 220 mg/kg bw. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA102 Replicates: Two independent tests","endpoint":"repeated dose toxicity","ingredient":"2-Methyl-5-hydroxyethylaminophenol (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"220","page":12,"route":"oral","species":"","study_id":"sccp_o_040_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 220 mg/kg bw rat - subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_040; REPORT_TITLE=Opinion on 2-METHYL-5-HYDROXYETHYLAMINOPHENOL COLIPA N° A31; OPINION_NUMBER=SCCP/0957/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=220; DOSE=General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw.; EFFECT=co-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw. The NOAEL of subchronic toxicity in rats is 220 mg/kg bw. The NOAEL of maternal toxicity and embryo-/foetotoxicity in rats were both 1000 mg/kg bw/d. Irritation/sensitisation When tested undiluted, 2-methyl-5-hydroxyethylaminophenol was non-irritant to rabbit skin. It is an irritant to rabbit eyes when tested undiluted. The single instillation of 0.1 ml of 2 % 2- methyl-5-hydroxyethylaminophenol in a 0.5 % carboxymethylcellulose suspension was non- irritating to rabbit eyes. 2-Methyl-5-hydroxyethylaminophenol did not induce delayed contact hypersensitivity in a Local Lymph Node A; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55302-96-0","citation":"","dose":"General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw.","duration":"subchronic","effect":"co-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw. The NOAEL of subchronic toxicity in rats is 220 mg/kg bw. The NOAEL of maternal toxicity and embryo-/foetotoxicity in rats were both 1000 mg/kg bw/d. Irritation/sensitisation When tested undiluted, 2-methyl-5-hydroxyethylaminophenol was non-irritant to rabbit skin. It is an irritant to rabbit eyes when tested undiluted. The single instillation of 0.1 ml of 2 % 2- methyl-5-hydroxyethylaminophenol in a 0.5 % carboxymethylcellulose suspension was non- irritating to rabbit eyes. 2-Methyl-5-hydroxyethylaminophenol did not induce delayed contact hypersensitivity in a Local Lymph Node A","endpoint":"repeated dose toxicity","ingredient":"2-Methyl-5-hydroxyethylaminophenol (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"220","page":19,"route":"","species":"rat","study_id":"sccp_o_040_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity >2000 mg/kg bw rat - subchronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_040; REPORT_TITLE=Opinion on 2-METHYL-5-HYDROXYETHYLAMINOPHENOL COLIPA N° A31; OPINION_NUMBER=SCCP/0957/05; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=28 March 2006; VALUE_TEXT=> 2000; DOSE=General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw.; EFFECT=of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw. The NOAEL of subchronic toxicity in rats is 220 mg/kg bw. The NOAEL of maternal toxicity and embryo-/foetotoxicity in rats were both 1000 mg/kg bw/d. Irritation/sensitisation When tested undiluted, 2-methyl-5-hydroxyethylaminophenol was non-irritant to rabbit skin. It is an irritant to rabbit eyes when tested undiluted. The single instillation of 0.1 ml of 2 % 2- methyl-5-hydroxyethylaminophenol in a 0.5 % carboxymethylcellulose suspension was non- irritating to rabbit eyes. 2-Methyl-5-hydroxyethylaminophenol did not induc; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"55302-96-0","citation":"","dose":"General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw.","duration":"subchronic","effect":"of Safety NOAEL / SED = 4150 3.3.14. Discussion Physico-chemical specifications Three of the five batches of 2-methyl-5-hydroxyethylaminophenol test materials are not characterised adequately. 2-methyl-5-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. Nitrosamine content in the test material is not reported. Stability of 2- methyl-5-hydroxyethylaminophenol in the marketed products is not reported. General toxicity The maximum non-lethal dose in rats is > 2000 mg/kg bw. The NOAEL of subchronic toxicity in rats is 220 mg/kg bw. The NOAEL of maternal toxicity and embryo-/foetotoxicity in rats were both 1000 mg/kg bw/d. Irritation/sensitisation When tested undiluted, 2-methyl-5-hydroxyethylaminophenol was non-irritant to rabbit skin. It is an irritant to rabbit eyes when tested undiluted. The single instillation of 0.1 ml of 2 % 2- methyl-5-hydroxyethylaminophenol in a 0.5 % carboxymethylcellulose suspension was non- irritating to rabbit eyes. 2-Methyl-5-hydroxyethylaminophenol did not induc","endpoint":"repeated dose toxicity","ingredient":"2-Methyl-5-hydroxyethylaminophenol (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"> 2000","page":19,"route":"","species":"rat","study_id":"sccp_o_040_noael_008"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier T872B9E83J UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H13NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"T872B9E83J"}
openFDA substances FDA UNII substance identifier T872B9E83J UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H13NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"T872B9E83J"}
openFDA substances FDA UNII substance identifier T872B9E83J UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H13NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"T872B9E83J"}
openFDA substances FDA UNII substance identifier T872B9E83J UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H13NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"T872B9E83J"}