NOAEL Studies
Cosmetic Ingredient
4-Amino-2-Hydroxytoluene NOAEL Studies
INCI: 4-AMINO-2-HYDROXYTOLUENE
CAS: 2835-99-6
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 120 | mg/kg bw/day | rat | oral | 91 day | Subchronic | SCCP; Sterner, W.; Korn, W.-D.; Three month toxicity study with Oxyrot after repeated oraladministration to rats; IBR; 21.12.1984 |
| COSMOS_DB | NOAEL | 60 | mg/kg bw/day | rat | oral | 91 day | Subchronic | SCCP; Sterner, W.; Korn, W.-D.; Three month toxicity study with Oxyrot after repeated oraladministration to rats; IBR; 21.12.1984 |
NTP_ICE_skin_sensitization 7 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | CD86, EC150 | 1.03 | ug/mL | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; U-SENS | sheet=Data_invitro; excel_row=8267; Record_ID=skin_sensitization_invitro_2290; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2049262; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=8.36038961; Reported_Response_Unit=uM; Conversion_Factor_Value=123.155; Conversion_Factor_Source=EPA Dashboard; Converted_Response=1.03; Converted_Response_Unit=ug/mL; Response=1.03; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2049262 |
| NTP_ICE_skin_sensitization | Depletion Cys | 90 | % | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; DPRA | sheet=Data_invitro; excel_row=123; Record_ID=skin_sensitization_invitro_38; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2049262; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=90; Reported_Response_Unit=%; Response=90; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2049262 |
| NTP_ICE_skin_sensitization | Depletion Lys | 28.8 | % | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; DPRA | sheet=Data_invitro; excel_row=173; Record_ID=skin_sensitization_invitro_38; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2049262; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=28.8; Reported_Response_Unit=%; Response=28.8; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2049262 |
| NTP_ICE_skin_sensitization | EC1.5 | 5.278 | uM | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; KeratinoSens | sheet=Data_invitro; excel_row=8802; Record_ID=skin_sensitization_invitro_2437; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2049262; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=5.277549079; Reported_Response_Unit=uM; Response=5.278; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2049262 |
| NTP_ICE_skin_sensitization | EC3 | 1.5 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13113; Record_ID=skin_sensitization_invivo_3115; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID2049262; Assay=LLNA; Endpoint=EC3; Response=1.5; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2049262 |
| NTP_ICE_skin_sensitization | IC50 | 77.67 | uM | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; KeratinoSens | sheet=Data_invitro; excel_row=8803; Record_ID=skin_sensitization_invitro_2437; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2049262; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=77.67494303; Reported_Response_Unit=uM; Response=77.67; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2049262 |
| NTP_ICE_skin_sensitization | Imax | 7.609 | ratio | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; KeratinoSens | sheet=Data_invitro; excel_row=8805; Record_ID=skin_sensitization_invitro_2437; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID2049262; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=7.608534599; Reported_Response_Unit=Unitless; Response=7.609; Response_Unit=Ratio; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2049262 |
SCCS_vision_codex 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =60 | mg/kg | rat | oral | subchronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg N...","effect":"SCCP/0898/05 Opinion on 4-Amino-m-cresol 24 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg No observed effect level (mg/kg) NOAEL = 60 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 124 3.3.14. Discussion Toxicity The No Observable Adverse Effect Level (NOAEL) was 60 mg/kg bw/day (90-day, oral, rat). No treatment related effects were seen in a prenatal developmental toxicity study on maternal toxicity or on developmental toxicity parameters up to the highest tested dose of 80 mg/kg bw/day. Irritation A 3 % dilution of 4-amino-m-cresol in 0.5 % aqueous tylose showed no irritant effects to the guinea pig skin after repe","page":24,"pdf":"sccp_o_003.pdf","row_type":"noael_study","study_id":"sccp_o_003_noael_001"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg | rat | oral | subchronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg N...","effect":"SCCP/0898/05 Opinion on 4-Amino-m-cresol 24 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg No observed effect level (mg/kg) NOAEL = 60 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 124 3.3.14. Discussion Toxicity The No Observable Adverse Effect Level (NOAEL) was 60 mg/kg bw/day (90-day, oral, rat). No treatment related effects were seen in a prenatal developmental toxicity study on maternal toxicity or on developmental toxicity parameters up to the highest tested dose of 80 mg/kg bw/day. Irritation A 3 % dilution of 4-amino-m-cresol in 0.5 % aqueous tylose showed no irritant effects to the guinea pig skin after repe","page":24,"pdf":"sccp_o_003.pdf","row_type":"noael_study","study_id":"sccp_o_003_noael_001"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg | rat | oral | subchronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg N...","effect":"SCCP/0898/05 Opinion on 4-Amino-m-cresol 24 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg No observed effect level (mg/kg) NOAEL = 60 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 124 3.3.14. Discussion Toxicity The No Observable Adverse Effect Level (NOAEL) was 60 mg/kg bw/day (90-day, oral, rat). No treatment related effects were seen in a prenatal developmental toxicity study on maternal toxicity or on developmental toxicity parameters up to the highest tested dose of 80 mg/kg bw/day. Irritation A 3 % dilution of 4-amino-m-cresol in 0.5 % aqueous tylose showed no irritant effects to the guinea pig skin after repe","page":24,"pdf":"sccp_o_003.pdf","row_type":"noael_study","study_id":"sccp_o_003_noael_001"} |
| SCCS_vision_codex | NOAEL | =60 | mg/kg | rat | oral | subchronic | repeated dose toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg N...","effect":"SCCP/0898/05 Opinion on 4-Amino-m-cresol 24 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg No observed effect level (mg/kg) NOAEL = 60 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 124 3.3.14. Discussion Toxicity The No Observable Adverse Effect Level (NOAEL) was 60 mg/kg bw/day (90-day, oral, rat). No treatment related effects were seen in a prenatal developmental toxicity study on maternal toxicity or on developmental toxicity parameters up to the highest tested dose of 80 mg/kg bw/day. Irritation A 3 % dilution of 4-amino-m-cresol in 0.5 % aqueous tylose showed no irritant effects to the guinea pig skin after repe","page":24,"pdf":"sccp_o_003.pdf","row_type":"noael_study","study_id":"sccp_o_003_noael_001"} |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =1.5 | 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:15629724:-:--; 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_ed43f9c8a6f712d6e4f5c5db094f84b7 |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =60 | mg/kg | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_003; REPORT_TITLE=Opinion on 4-Amino-m-cresol COLIPA N° A74; OPINION_NUMBER=SCCP/0898/05; COMMITTEE=SCCP; REPORT_DATE=20 September 2005; VALUE_TEXT== 60; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg N...; EFFECT=SCCP/0898/05 Opinion on 4-Amino-m-cresol 24 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg No observed effect level (mg/kg) NOAEL = 60 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 124 3.3.14. Discussion Toxicity The No Observable Adverse Effect Level (NOAEL) was 60 mg/kg bw/day (90-day, oral, rat). No treatment related effects were seen in a prenatal developmental toxicity study on maternal toxicity or on developmental toxicity parameters up to the highest tested dose of 80 mg/kg bw/day. Irritation A 3 % dilution of 4-amino-m-cresol in 0.5 % aqueous tylose showed no irritant effects to the guinea pig skin after repe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2835-99-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg N...","duration":"subchronic","effect":"SCCP/0898/05 Opinion on 4-Amino-m-cresol 24 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg No observed effect level (mg/kg) NOAEL = 60 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 124 3.3.14. Discussion Toxicity The No Observable Adverse Effect Level (NOAEL) was 60 mg/kg bw/day (90-day, oral, rat). No treatment related effects were seen in a prenatal developmental toxicity study on maternal toxicity or on developmental toxicity parameters up to the highest tested dose of 80 mg/kg bw/day. Irritation A 3 % dilution of 4-amino-m-cresol in 0.5 % aqueous tylose showed no irritant effects to the guinea pig skin after repe","endpoint":"repeated dose toxicity","ingredient":"4-Amino-m-cresol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 60","page":24,"route":"oral","species":"rat","study_id":"sccp_o_003_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | =60 | mg/kg | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_003; REPORT_TITLE=Opinion on 4-Amino-m-cresol COLIPA N° A74; OPINION_NUMBER=SCCP/0898/05; COMMITTEE=SCCP; REPORT_DATE=20 September 2005; VALUE_TEXT== 60; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg N...; EFFECT=-m-cresol 24 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg No observed effect level (mg/kg) NOAEL = 60 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 124 3.3.14. Discussion Toxicity The No Observable Adverse Effect Level (NOAEL) was 60 mg/kg bw/day (90-day, oral, rat). No treatment related effects were seen in a prenatal developmental toxicity study on maternal toxicity or on developmental toxicity parameters up to the highest tested dose of 80 mg/kg bw/day. Irritation A 3 % dilution of 4-amino-m-cresol in 0.5 % aqueous tylose showed no irritant effects to the guinea pig skin after repeated application under the test conditions. At 1.5 %, it may ha; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2835-99-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg N...","duration":"subchronic","effect":"-m-cresol 24 3.3.12. Special investigations No data 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg No observed effect level (mg/kg) NOAEL = 60 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 124 3.3.14. Discussion Toxicity The No Observable Adverse Effect Level (NOAEL) was 60 mg/kg bw/day (90-day, oral, rat). No treatment related effects were seen in a prenatal developmental toxicity study on maternal toxicity or on developmental toxicity parameters up to the highest tested dose of 80 mg/kg bw/day. Irritation A 3 % dilution of 4-amino-m-cresol in 0.5 % aqueous tylose showed no irritant effects to the guinea pig skin after repeated application under the test conditions. At 1.5 %, it may ha","endpoint":"repeated dose toxicity","ingredient":"4-Amino-m-cresol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 60","page":24,"route":"oral","species":"rat","study_id":"sccp_o_003_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 60 | mg/kg bw/day | rat | oral | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccp_o_003; REPORT_TITLE=Opinion on 4-Amino-m-cresol COLIPA N° A74; OPINION_NUMBER=SCCP/0898/05; COMMITTEE=SCCP; REPORT_DATE=20 September 2005; VALUE_TEXT=60; DOSE=ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg No observed effect level (m...; EFFECT=ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg No observed effect level (mg/kg) NOAEL = 60 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 124 3.3.14. Discussion Toxicity The No Observable Adverse Effect Level (NOAEL) was 60 mg/kg bw/day (90-day, oral, rat). No treatment related effects were seen in a prenatal developmental toxicity study on maternal toxicity or on developmental toxicity parameters up to the highest tested dose of 80 mg/kg bw/day. Irritation A 3 % dilution of 4-amino-m-cresol in 0.5 % aqueous tylose showed no irritant effects to the guinea pig skin after repeated application under the test conditions. At 1.5 %, it may have minimal ocular irritant potential. Sensitisation Local Lymph Node Assay (LLNA): 4-amin; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2835-99-6","citation":"","dose":"ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg No observed effect level (m...","duration":"subchronic","effect":"ng calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Maximum absorption through the skin A (µg/cm2) = 41.4 µg/cm2 Typical body weight of human = 60 kg Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 28.98 mg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.483 mg/kg No observed effect level (mg/kg) NOAEL = 60 mg/kg (rat, subchronic, oral) Margin of Safety NOAEL / SED = 124 3.3.14. Discussion Toxicity The No Observable Adverse Effect Level (NOAEL) was 60 mg/kg bw/day (90-day, oral, rat). No treatment related effects were seen in a prenatal developmental toxicity study on maternal toxicity or on developmental toxicity parameters up to the highest tested dose of 80 mg/kg bw/day. Irritation A 3 % dilution of 4-amino-m-cresol in 0.5 % aqueous tylose showed no irritant effects to the guinea pig skin after repeated application under the test conditions. At 1.5 %, it may have minimal ocular irritant potential. Sensitisation Local Lymph Node Assay (LLNA): 4-amin","endpoint":"repeated dose toxicity","ingredient":"4-Amino-m-cresol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"60","page":24,"route":"oral","species":"rat","study_id":"sccp_o_003_noael_003"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 12R07I1K8C | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H9NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"12R07I1K8C"} |
| openFDA substances | FDA UNII substance identifier | 12R07I1K8C | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H9NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"12R07I1K8C"} |
| openFDA substances | FDA UNII substance identifier | 12R07I1K8C | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H9NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"12R07I1K8C"} |
| openFDA substances | FDA UNII substance identifier | 12R07I1K8C | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H9NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"12R07I1K8C"} |