NOAEL Studies
Cosmetic Ingredient
O-Aminophenol NOAEL Studies
INCI: O-AMINOPHENOL
CAS: 95-55-6
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 2 | mg/kg bw/day | rat | oral | 28 day | Short Term Toxicity | SCCS; Coleman M. et al. (1989) Orthoaminophenol 4-week oral (gavage) toxicity study in therat.Toxicol Laboratories Ltd, England. Reference n° LRL/1/89 |
NTP_ICE_acute_oral 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | =951 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM ChemIDplus TEST (undated); record_id=acute_oral_11714; row=13777; data_type=In Vivo; mixture=Chemical; chemical_name=2-Aminophenol; preferred_name=2-Aminophenol; dtxsid=DTXSID8024498; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8024498; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1300 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_11715; row=13778; data_type=In Vivo; mixture=Chemical; chemical_name=2-Aminophenol; preferred_name=2-Aminophenol; dtxsid=DTXSID8024498; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8024498; source_file=acute_oral.xlsx |
NTP_ICE_skin_sensitization 23 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | CD86, EC150 | 1.1 | ug/mL | - | Dermal | - | In Vitro; CE_hCLAT2018; h-CLAT | sheet=Data_invitro; excel_row=1956; Record_ID=skin_sensitization_invitro_495; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=h-CLAT; Endpoint=CD86, EC150; Reported_Response=1.1000000000000001; Reported_Response_Unit=ug/mL; Response=1.1; 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/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | CD86, EC150 | 0.32 | ug/mL | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; U-SENS | sheet=Data_invitro; excel_row=8309; Record_ID=skin_sensitization_invitro_2303; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=2.932282599; Reported_Response_Unit=uM; Conversion_Factor_Value=109.128; Conversion_Factor_Source=EPA Dashboard; Converted_Response=0.32; Converted_Response_Unit=ug/mL; Response=0.32; 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/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | CD86, EC150 | <0.1 | ug/mL | - | Dermal | - | In Vitro; CE_USENSE2018; U-SENS | sheet=Data_invitro; excel_row=8504; Record_ID=skin_sensitization_invitro_2344; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=U-SENS; Endpoint=CD86, EC150; Response_Modifier=<; Reported_Response_Modifier=<; Reported_Response=0.1; Reported_Response_Unit=ug/mL; Response=0.1; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | CV70 | 8.02 | ug/mL | - | Dermal | - | In Vitro; CE_USENSE2018; U-SENS | sheet=Data_invitro; excel_row=8505; Record_ID=skin_sensitization_invitro_2344; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=U-SENS; Endpoint=CV70; Reported_Response=8.02; Reported_Response_Unit=ug/mL; Response=8.02; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | CV75 | 6 | ug/mL | - | Dermal | - | In Vitro; CE_hCLAT2018; h-CLAT | sheet=Data_invitro; excel_row=1958; Record_ID=skin_sensitization_invitro_495; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=h-CLAT; Endpoint=CV75; Reported_Response=6; Reported_Response_Unit=ug/mL; Response=6; 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/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | Depletion Cys | 96.2 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=686; Record_ID=skin_sensitization_invitro_195; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=96.2; Reported_Response_Unit=%; Response=96.2; Response_Unit=%; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | Depletion Lys | 18.1 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=685; Record_ID=skin_sensitization_invitro_195; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=18.100000000000001; Reported_Response_Unit=%; Response=18.1; Response_Unit=%; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 57.15 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=687; Record_ID=skin_sensitization_invitro_195; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=57.15; Reported_Response_Unit=%; Response=57.15; Response_Unit=%; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | EC1.5 | 1.1 | uM | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=7052; Record_ID=skin_sensitization_invitro_1674; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=1.1000000000000001; Reported_Response_Unit=uM; Response=1.1; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | EC1.5 | 1.451 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=7053; Record_ID=skin_sensitization_invitro_1675; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=1.4510000000000001; Reported_Response_Unit=uM; Response=1.451; Response_Unit=uM; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | EC3 | 5.367 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=7054; Record_ID=skin_sensitization_invitro_1675; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=KeratinoSens; Endpoint=EC3; Reported_Response=5.367; Reported_Response_Unit=uM; Response=5.367; Response_Unit=uM; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | EC3 | 0.5 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13176; Record_ID=skin_sensitization_invivo_3201; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=LLNA; Endpoint=EC3; Response=0.5; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2007; 16938465; 10.1016/j.ymeth.2006.07.006; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | EC3 | 0.4 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13192; Record_ID=skin_sensitization_invivo_3229; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID8024498; 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/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | EC3 | 0.5 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13176; Record_ID=skin_sensitization_invivo_3201; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=LLNA; Endpoint=EC3; Response=0.5; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2007; 16938465; 10.1016/j.ymeth.2006.07.006; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | EC3 | 0.4 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13192; Record_ID=skin_sensitization_invivo_3229; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID8024498; 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/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | EC3 | 0.5 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13176; Record_ID=skin_sensitization_invivo_3201; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=LLNA; Endpoint=EC3; Response=0.5; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2007; 16938465; 10.1016/j.ymeth.2006.07.006; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | EC3 | 0.4 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13192; Record_ID=skin_sensitization_invivo_3229; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID8024498; 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/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | EC3 | 0.5 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13176; Record_ID=skin_sensitization_invivo_3201; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=LLNA; Endpoint=EC3; Response=0.5; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2007; 16938465; 10.1016/j.ymeth.2006.07.006; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | EC3 | 0.4 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13192; Record_ID=skin_sensitization_invivo_3229; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID8024498; 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/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | IC50 | 138.2 | uM | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=7055; Record_ID=skin_sensitization_invitro_1674; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=138.19999999999999; Reported_Response_Unit=uM; Response=138.2; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | IC50 | 94.78 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=7056; Record_ID=skin_sensitization_invitro_1675; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=94.78; Reported_Response_Unit=uM; Response=94.78; Response_Unit=uM; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | Imax | 13.1 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=7057; Record_ID=skin_sensitization_invitro_1674; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=13.1; Reported_Response_Unit=Unitless; Response=13.1; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
| NTP_ICE_skin_sensitization | Imax | 13.53 | ratio | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=7058; Record_ID=skin_sensitization_invitro_1675; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID8024498; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=13.53; Reported_Response_Unit=Unitless; Response=13.53; Response_Unit=Ratio; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8024498; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8024498 |
SCCS_vision_codex 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =0.5 | % | rat | oral | 30 days | repeated dose toxicity | {"citation":"Ref.: 36 (Subm","dose":"IV) 30 days repeated dose oral toxicity, study 2 Guideline:","effect":"ary proteins in group IV males and females. Renal cells were seen in the urine in males of group II. Increased relative liver and kidney weights in group IV males and females were recorded. Kidneys were pale or mottled at macroscopic examination and showed renal tubular lesions at histopathological examination in males of group III and IV. Increased vacuolisation of the urothelium of the bladder in males and females in group II and III was present. Conclusion None of the three tested doses could be considered as NOAEL. Ref.: 36 (Subm. IV) 30 days repeated dose oral toxicity, study 2 Guideline: OECD 407 (1981) Species/strain: rat, Sprague Dawley Crl:CD(SD)BR (VAF plus) Group size: 10 males and 10 females per group Test substance: orthoaminophenol Batch: TOES 189001 Purity: / Vehicle: 0.5% aqueous carboxymethylcellulose Dose volume 10 ml/kg bw Dose levels: 0, 2, 5 and 15 mg/kg bw/d Route: oral gavage Administration: daily for 28 days GLP: in compliance Study period: 5/1989 to 6/1989 The test substance (suspended in 0.5% w/v","page":14,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_001"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw/d | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 37 (Subm","dose":"Increases in absolute (not significant) and relative (significant) thyroid weights were recorded in females group IV Conclusions The reduced bodyweight gains are not considered to be related to treatment as there is no dose relationship.","effect":"creased plasma glucose level was recorded in males group IV. Increases in absolute (not significant) and relative (significant) thyroid weights were recorded in females group IV Conclusions The reduced bodyweight gains are not considered to be related to treatment as there is no dose relationship. The thyroid weight changes are also considered by the study authors of questionable toxicological importance as no histopathological evidence was related. Ref.: 37 (Subm. IV) Comment Due to the thyroid weight changes a NOAEL of 5 mg/kg bw/d is set. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) 3-Month oral toxicity in rats 1-Hydroxy-2-aminobenzene was administered orally to 20 Sprague-Dawley rats (10 males and 10 females) at a dosage of 50 mg/kg bw/d as a 1% solution in propylene glycol during 3 months. A group of 20 animals receiving 1 ml of a 1% propylene glycol solution per 100 g body weight served as a control. No mortality was observed. Body weight gain, haematological parameters, blood biochemistry and urine examinat","page":15,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_002"} |
| SCCS_vision_codex | NOAEL | =70 | mg/kg bw/d | human | - | - | NOAEL study | {"citation":"Ref.: 39 (Subm","dose":"Conclusions The NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.","effect":"ed body weight gain (from days 7 to 10) and food consumption (from days 6 to 15) were observed in group IV. Decreased mean weight of the foetuses in group IV was observed, probably related to maternal toxicity. 2 foetuses in one litter animal of group IV shown bilateral anophthalmies associated with micrognathy and a dilatation of the lateral cerebral ventricles in one of these foetuses. These anomalies are likely related to maternal toxicity. Slight ossification retardation occurred in group IV. Conclusions The NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d. Ref.: 39 (Subm. I) 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 Several publications dealing with effects of o-aminophenol on haemoglobin and mitochondria were pr","page":29,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_003"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/d | rat | oral | subacute | repeated dose toxicity | {"dose":"General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw.","effect":"o data were supplied on the amount present in stratum corneum, epidermis and dermis. The variability is very high. Because of these many shortcomings, the studies were not considered suitable for safety assessment. General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw. Two subacute oral toxicity studies in rats were performed with o-aminophenol. In study 1 with treatment over 30 days at daily doses 0, 20, 80, 320 mg/kg bw, none of the three tested doses could be considered as a NOAEL. In study 2 with doses of 0, 2. 5 and 15 mg/kg bw/d, a NOAEL of 5 mg/kg bw/d was derived based on the thyroid weight changes observed. A three-month oral toxicity study was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic","page":30,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_004"} |
| SCCS_vision_codex | NOAEL | =1.7 | mg/kg bw/d | rat | oral | 13-week | repeated dose toxicity | {"dose":"As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive.","effect":"tudy was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic toxicity according to the Notes of Guidance was submitted. By using an adjustment factor of 3 (30 day to 90 day study) from the data on general toxicity available, a NOAEL of 1.7 mg/kg bw/d could be deduced. o-Aminophenol was moderately toxic in an in vivo hen’s egg test and had no teratogenic potential in this test. o-Aminophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all tr","page":30,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_006"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg | rat | oral | - | developmental toxicity | {"dose":"ophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d.","effect":"ophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all treated animals 24 hours after the first administration of the test substance; pathological findings were only observed in 250 mg/kg treated group. Thus the NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.","page":30,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | rat | oral | 30 days | repeated dose toxicity | {"citation":"Ref.: 36 (Subm","dose":"IV) 30 days repeated dose oral toxicity, study 2 Guideline:","effect":"ary proteins in group IV males and females. Renal cells were seen in the urine in males of group II. Increased relative liver and kidney weights in group IV males and females were recorded. Kidneys were pale or mottled at macroscopic examination and showed renal tubular lesions at histopathological examination in males of group III and IV. Increased vacuolisation of the urothelium of the bladder in males and females in group II and III was present. Conclusion None of the three tested doses could be considered as NOAEL. Ref.: 36 (Subm. IV) 30 days repeated dose oral toxicity, study 2 Guideline: OECD 407 (1981) Species/strain: rat, Sprague Dawley Crl:CD(SD)BR (VAF plus) Group size: 10 males and 10 females per group Test substance: orthoaminophenol Batch: TOES 189001 Purity: / Vehicle: 0.5% aqueous carboxymethylcellulose Dose volume 10 ml/kg bw Dose levels: 0, 2, 5 and 15 mg/kg bw/d Route: oral gavage Administration: daily for 28 days GLP: in compliance Study period: 5/1989 to 6/1989 The test substance (suspended in 0.5% w/v","page":14,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_001"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw/d | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 37 (Subm","dose":"Increases in absolute (not significant) and relative (significant) thyroid weights were recorded in females group IV Conclusions The reduced bodyweight gains are not considered to be related to treatment as there is no dose relationship.","effect":"creased plasma glucose level was recorded in males group IV. Increases in absolute (not significant) and relative (significant) thyroid weights were recorded in females group IV Conclusions The reduced bodyweight gains are not considered to be related to treatment as there is no dose relationship. The thyroid weight changes are also considered by the study authors of questionable toxicological importance as no histopathological evidence was related. Ref.: 37 (Subm. IV) Comment Due to the thyroid weight changes a NOAEL of 5 mg/kg bw/d is set. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) 3-Month oral toxicity in rats 1-Hydroxy-2-aminobenzene was administered orally to 20 Sprague-Dawley rats (10 males and 10 females) at a dosage of 50 mg/kg bw/d as a 1% solution in propylene glycol during 3 months. A group of 20 animals receiving 1 ml of a 1% propylene glycol solution per 100 g body weight served as a control. No mortality was observed. Body weight gain, haematological parameters, blood biochemistry and urine examinat","page":15,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_002"} |
| SCCS_vision_codex | NOAEL | =70 | mg/kg bw/d | human | - | - | NOAEL study | {"citation":"Ref.: 39 (Subm","dose":"Conclusions The NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.","effect":"ed body weight gain (from days 7 to 10) and food consumption (from days 6 to 15) were observed in group IV. Decreased mean weight of the foetuses in group IV was observed, probably related to maternal toxicity. 2 foetuses in one litter animal of group IV shown bilateral anophthalmies associated with micrognathy and a dilatation of the lateral cerebral ventricles in one of these foetuses. These anomalies are likely related to maternal toxicity. Slight ossification retardation occurred in group IV. Conclusions The NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d. Ref.: 39 (Subm. I) 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 Several publications dealing with effects of o-aminophenol on haemoglobin and mitochondria were pr","page":29,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_003"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/d | rat | oral | subacute | repeated dose toxicity | {"dose":"General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw.","effect":"o data were supplied on the amount present in stratum corneum, epidermis and dermis. The variability is very high. Because of these many shortcomings, the studies were not considered suitable for safety assessment. General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw. Two subacute oral toxicity studies in rats were performed with o-aminophenol. In study 1 with treatment over 30 days at daily doses 0, 20, 80, 320 mg/kg bw, none of the three tested doses could be considered as a NOAEL. In study 2 with doses of 0, 2. 5 and 15 mg/kg bw/d, a NOAEL of 5 mg/kg bw/d was derived based on the thyroid weight changes observed. A three-month oral toxicity study was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic","page":30,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_004"} |
| SCCS_vision_codex | NOAEL | =1.7 | mg/kg bw/d | rat | oral | 13-week | repeated dose toxicity | {"dose":"As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive.","effect":"tudy was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic toxicity according to the Notes of Guidance was submitted. By using an adjustment factor of 3 (30 day to 90 day study) from the data on general toxicity available, a NOAEL of 1.7 mg/kg bw/d could be deduced. o-Aminophenol was moderately toxic in an in vivo hen’s egg test and had no teratogenic potential in this test. o-Aminophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all tr","page":30,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_006"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg | rat | oral | - | developmental toxicity | {"dose":"ophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d.","effect":"ophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all treated animals 24 hours after the first administration of the test substance; pathological findings were only observed in 250 mg/kg treated group. Thus the NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.","page":30,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | rat | oral | 30 days | repeated dose toxicity | {"citation":"Ref.: 36 (Subm","dose":"IV) 30 days repeated dose oral toxicity, study 2 Guideline:","effect":"ary proteins in group IV males and females. Renal cells were seen in the urine in males of group II. Increased relative liver and kidney weights in group IV males and females were recorded. Kidneys were pale or mottled at macroscopic examination and showed renal tubular lesions at histopathological examination in males of group III and IV. Increased vacuolisation of the urothelium of the bladder in males and females in group II and III was present. Conclusion None of the three tested doses could be considered as NOAEL. Ref.: 36 (Subm. IV) 30 days repeated dose oral toxicity, study 2 Guideline: OECD 407 (1981) Species/strain: rat, Sprague Dawley Crl:CD(SD)BR (VAF plus) Group size: 10 males and 10 females per group Test substance: orthoaminophenol Batch: TOES 189001 Purity: / Vehicle: 0.5% aqueous carboxymethylcellulose Dose volume 10 ml/kg bw Dose levels: 0, 2, 5 and 15 mg/kg bw/d Route: oral gavage Administration: daily for 28 days GLP: in compliance Study period: 5/1989 to 6/1989 The test substance (suspended in 0.5% w/v","page":14,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_001"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw/d | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 37 (Subm","dose":"Increases in absolute (not significant) and relative (significant) thyroid weights were recorded in females group IV Conclusions The reduced bodyweight gains are not considered to be related to treatment as there is no dose relationship.","effect":"creased plasma glucose level was recorded in males group IV. Increases in absolute (not significant) and relative (significant) thyroid weights were recorded in females group IV Conclusions The reduced bodyweight gains are not considered to be related to treatment as there is no dose relationship. The thyroid weight changes are also considered by the study authors of questionable toxicological importance as no histopathological evidence was related. Ref.: 37 (Subm. IV) Comment Due to the thyroid weight changes a NOAEL of 5 mg/kg bw/d is set. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) 3-Month oral toxicity in rats 1-Hydroxy-2-aminobenzene was administered orally to 20 Sprague-Dawley rats (10 males and 10 females) at a dosage of 50 mg/kg bw/d as a 1% solution in propylene glycol during 3 months. A group of 20 animals receiving 1 ml of a 1% propylene glycol solution per 100 g body weight served as a control. No mortality was observed. Body weight gain, haematological parameters, blood biochemistry and urine examinat","page":15,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_002"} |
| SCCS_vision_codex | NOAEL | =70 | mg/kg bw/d | human | - | - | NOAEL study | {"citation":"Ref.: 39 (Subm","dose":"Conclusions The NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.","effect":"ed body weight gain (from days 7 to 10) and food consumption (from days 6 to 15) were observed in group IV. Decreased mean weight of the foetuses in group IV was observed, probably related to maternal toxicity. 2 foetuses in one litter animal of group IV shown bilateral anophthalmies associated with micrognathy and a dilatation of the lateral cerebral ventricles in one of these foetuses. These anomalies are likely related to maternal toxicity. Slight ossification retardation occurred in group IV. Conclusions The NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d. Ref.: 39 (Subm. I) 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 Several publications dealing with effects of o-aminophenol on haemoglobin and mitochondria were pr","page":29,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_003"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/d | rat | oral | subacute | repeated dose toxicity | {"dose":"General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw.","effect":"o data were supplied on the amount present in stratum corneum, epidermis and dermis. The variability is very high. Because of these many shortcomings, the studies were not considered suitable for safety assessment. General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw. Two subacute oral toxicity studies in rats were performed with o-aminophenol. In study 1 with treatment over 30 days at daily doses 0, 20, 80, 320 mg/kg bw, none of the three tested doses could be considered as a NOAEL. In study 2 with doses of 0, 2. 5 and 15 mg/kg bw/d, a NOAEL of 5 mg/kg bw/d was derived based on the thyroid weight changes observed. A three-month oral toxicity study was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic","page":30,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_004"} |
| SCCS_vision_codex | NOAEL | =1.7 | mg/kg bw/d | rat | oral | 13-week | repeated dose toxicity | {"dose":"As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive.","effect":"tudy was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic toxicity according to the Notes of Guidance was submitted. By using an adjustment factor of 3 (30 day to 90 day study) from the data on general toxicity available, a NOAEL of 1.7 mg/kg bw/d could be deduced. o-Aminophenol was moderately toxic in an in vivo hen’s egg test and had no teratogenic potential in this test. o-Aminophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all tr","page":30,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_006"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg | rat | oral | - | developmental toxicity | {"dose":"ophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d.","effect":"ophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all treated animals 24 hours after the first administration of the test substance; pathological findings were only observed in 250 mg/kg treated group. Thus the NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.","page":30,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.5 | % | rat | oral | 30 days | repeated dose toxicity | {"citation":"Ref.: 36 (Subm","dose":"IV) 30 days repeated dose oral toxicity, study 2 Guideline:","effect":"ary proteins in group IV males and females. Renal cells were seen in the urine in males of group II. Increased relative liver and kidney weights in group IV males and females were recorded. Kidneys were pale or mottled at macroscopic examination and showed renal tubular lesions at histopathological examination in males of group III and IV. Increased vacuolisation of the urothelium of the bladder in males and females in group II and III was present. Conclusion None of the three tested doses could be considered as NOAEL. Ref.: 36 (Subm. IV) 30 days repeated dose oral toxicity, study 2 Guideline: OECD 407 (1981) Species/strain: rat, Sprague Dawley Crl:CD(SD)BR (VAF plus) Group size: 10 males and 10 females per group Test substance: orthoaminophenol Batch: TOES 189001 Purity: / Vehicle: 0.5% aqueous carboxymethylcellulose Dose volume 10 ml/kg bw Dose levels: 0, 2, 5 and 15 mg/kg bw/d Route: oral gavage Administration: daily for 28 days GLP: in compliance Study period: 5/1989 to 6/1989 The test substance (suspended in 0.5% w/v","page":14,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_001"} |
| SCCS_vision_codex | NOAEL | =5 | mg/kg bw/d | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 37 (Subm","dose":"Increases in absolute (not significant) and relative (significant) thyroid weights were recorded in females group IV Conclusions The reduced bodyweight gains are not considered to be related to treatment as there is no dose relationship.","effect":"creased plasma glucose level was recorded in males group IV. Increases in absolute (not significant) and relative (significant) thyroid weights were recorded in females group IV Conclusions The reduced bodyweight gains are not considered to be related to treatment as there is no dose relationship. The thyroid weight changes are also considered by the study authors of questionable toxicological importance as no histopathological evidence was related. Ref.: 37 (Subm. IV) Comment Due to the thyroid weight changes a NOAEL of 5 mg/kg bw/d is set. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) 3-Month oral toxicity in rats 1-Hydroxy-2-aminobenzene was administered orally to 20 Sprague-Dawley rats (10 males and 10 females) at a dosage of 50 mg/kg bw/d as a 1% solution in propylene glycol during 3 months. A group of 20 animals receiving 1 ml of a 1% propylene glycol solution per 100 g body weight served as a control. No mortality was observed. Body weight gain, haematological parameters, blood biochemistry and urine examinat","page":15,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_002"} |
| SCCS_vision_codex | NOAEL | =70 | mg/kg bw/d | human | - | - | NOAEL study | {"citation":"Ref.: 39 (Subm","dose":"Conclusions The NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.","effect":"ed body weight gain (from days 7 to 10) and food consumption (from days 6 to 15) were observed in group IV. Decreased mean weight of the foetuses in group IV was observed, probably related to maternal toxicity. 2 foetuses in one litter animal of group IV shown bilateral anophthalmies associated with micrognathy and a dilatation of the lateral cerebral ventricles in one of these foetuses. These anomalies are likely related to maternal toxicity. Slight ossification retardation occurred in group IV. Conclusions The NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d. Ref.: 39 (Subm. I) 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 Several publications dealing with effects of o-aminophenol on haemoglobin and mitochondria were pr","page":29,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_003"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/d | rat | oral | subacute | repeated dose toxicity | {"dose":"General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw.","effect":"o data were supplied on the amount present in stratum corneum, epidermis and dermis. The variability is very high. Because of these many shortcomings, the studies were not considered suitable for safety assessment. General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw. Two subacute oral toxicity studies in rats were performed with o-aminophenol. In study 1 with treatment over 30 days at daily doses 0, 20, 80, 320 mg/kg bw, none of the three tested doses could be considered as a NOAEL. In study 2 with doses of 0, 2. 5 and 15 mg/kg bw/d, a NOAEL of 5 mg/kg bw/d was derived based on the thyroid weight changes observed. A three-month oral toxicity study was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic","page":30,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_004"} |
| SCCS_vision_codex | NOAEL | =1.7 | mg/kg bw/d | rat | oral | 13-week | repeated dose toxicity | {"dose":"As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive.","effect":"tudy was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic toxicity according to the Notes of Guidance was submitted. By using an adjustment factor of 3 (30 day to 90 day study) from the data on general toxicity available, a NOAEL of 1.7 mg/kg bw/d could be deduced. o-Aminophenol was moderately toxic in an in vivo hen’s egg test and had no teratogenic potential in this test. o-Aminophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all tr","page":30,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_006"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg | rat | oral | - | developmental toxicity | {"dose":"ophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d.","effect":"ophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all treated animals 24 hours after the first administration of the test substance; pathological findings were only observed in 250 mg/kg treated group. Thus the NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.","page":30,"pdf":"sccs_o_025.pdf","row_type":"noael_study","study_id":"sccs_o_025_noael_007"} |
ToxValDB_ECHA_IUCLID 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | NOAEL | =5 | mg/kg bw/day | Rat | oral | short-term; 28 days | short-term | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf80e4b0a7c65d1ce368; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/19856/7/6/2?documentUUID=c7bb55d9-8d45-43ea-946c-5ba2049c7574; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID:15831930: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_fac4eccef751a311a6f9411693d9dd96 |
ToxValDB_RSL 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_RSL | RfD | =0.004 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759b87ce4b0a7c65d37b4e2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/risk/regional-screening-levels-rsls-generic-tables; STUDY_GROUP=RSL:15654286:-:--; 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_6eb003e8a06b092f1f34d671921b08bc |
| ToxValDB_RSL | RfD | =0.04 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759b87ce4b0a7c65d37b4e2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/risk/regional-screening-levels-rsls-generic-tables; STUDY_GROUP=RSL:15663162:-:--; 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_d90613a56b0a0e5f4d8bdc3fa9a1b698 |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 7 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 70 | mg/kg bw/d | human | - | - | - | SOURCE_SUBDIR=sccs_o_025; REPORT_TITLE=OPINION ON o-Aminophenol COLIPA n° A14; OPINION_NUMBER=SCCS/1291/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=70; DOSE=Conclusions The NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.; EFFECT=ed body weight gain (from days 7 to 10) and food consumption (from days 6 to 15) were observed in group IV. Decreased mean weight of the foetuses in group IV was observed, probably related to maternal toxicity. 2 foetuses in one litter animal of group IV shown bilateral anophthalmies associated with micrognathy and a dilatation of the lateral cerebral ventricles in one of these foetuses. These anomalies are likely related to maternal toxicity. Slight ossification retardation occurred in group IV. Conclusions The NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d. Ref.: 39 (Subm. I) 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 Several publications dealing with effects of o-aminophenol on haemoglobin and mitochondria were pr; CITATION=Ref.: 39 (Subm; CITATION_NUMBERS=[39]; REFERENCE=Ref.: 39 (Subm; DETAILS_JSON={"cas_number":"95-55-6","citation":"Ref.: 39 (Subm","dose":"Conclusions The NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.","duration":"","effect":"ed body weight gain (from days 7 to 10) and food consumption (from days 6 to 15) were observed in group IV. Decreased mean weight of the foetuses in group IV was observed, probably related to maternal toxicity. 2 foetuses in one litter animal of group IV shown bilateral anophthalmies associated with micrognathy and a dilatation of the lateral cerebral ventricles in one of these foetuses. These anomalies are likely related to maternal toxicity. Slight ossification retardation occurred in group IV. Conclusions The NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d. Ref.: 39 (Subm. I) 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 Several publications dealing with effects of o-aminophenol on haemoglobin and mitochondria were pr","endpoint":"","ingredient":"s provisionally allowed which cosmetic products must not contain except","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"70","page":29,"route":"","species":"human","study_id":"sccs_o_025_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 250 | mg/kg | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=sccs_o_025; REPORT_TITLE=OPINION ON o-Aminophenol COLIPA n° A14; OPINION_NUMBER=SCCS/1291/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=250; DOSE=ophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d.; EFFECT=ophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all treated animals 24 hours after the first administration of the test substance; pathological findings were only observed in 250 mg/kg treated group. Thus the NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-55-6","citation":"","dose":"ophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d.","duration":"","effect":"ophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all treated animals 24 hours after the first administration of the test substance; pathological findings were only observed in 250 mg/kg treated group. Thus the NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.","endpoint":"developmental toxicity","ingredient":"s provisionally allowed which cosmetic products must not contain except","loael_value":"","noael_unit":"mg/kg","noael_value":"250","page":30,"route":"oral","species":"rat","study_id":"sccs_o_025_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 0.5 | % | rat | oral | 30 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_025; REPORT_TITLE=OPINION ON o-Aminophenol COLIPA n° A14; OPINION_NUMBER=SCCS/1291/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=0.5; DOSE=IV) 30 days repeated dose oral toxicity, study 2 Guideline:; EFFECT=ary proteins in group IV males and females. Renal cells were seen in the urine in males of group II. Increased relative liver and kidney weights in group IV males and females were recorded. Kidneys were pale or mottled at macroscopic examination and showed renal tubular lesions at histopathological examination in males of group III and IV. Increased vacuolisation of the urothelium of the bladder in males and females in group II and III was present. Conclusion None of the three tested doses could be considered as NOAEL. Ref.: 36 (Subm. IV) 30 days repeated dose oral toxicity, study 2 Guideline: OECD 407 (1981) Species/strain: rat, Sprague Dawley Crl:CD(SD)BR (VAF plus) Group size: 10 males and 10 females per group Test substance: orthoaminophenol Batch: TOES 189001 Purity: / Vehicle: 0.5% aqueous carboxymethylcellulose Dose volume 10 ml/kg bw Dose levels: 0, 2, 5 and 15 mg/kg bw/d Route: oral gavage Administration: daily for 28 days GLP: in compliance Study period: 5/1989 to 6/1989 The test substance (suspended in 0.5% w/v; CITATION=Ref.: 36 (Subm; CITATION_NUMBERS=[36]; REFERENCE=Ref.: 36 (Subm; DETAILS_JSON={"cas_number":"95-55-6","citation":"Ref.: 36 (Subm","dose":"IV) 30 days repeated dose oral toxicity, study 2 Guideline:","duration":"30 days","effect":"ary proteins in group IV males and females. Renal cells were seen in the urine in males of group II. Increased relative liver and kidney weights in group IV males and females were recorded. Kidneys were pale or mottled at macroscopic examination and showed renal tubular lesions at histopathological examination in males of group III and IV. Increased vacuolisation of the urothelium of the bladder in males and females in group II and III was present. Conclusion None of the three tested doses could be considered as NOAEL. Ref.: 36 (Subm. IV) 30 days repeated dose oral toxicity, study 2 Guideline: OECD 407 (1981) Species/strain: rat, Sprague Dawley Crl:CD(SD)BR (VAF plus) Group size: 10 males and 10 females per group Test substance: orthoaminophenol Batch: TOES 189001 Purity: / Vehicle: 0.5% aqueous carboxymethylcellulose Dose volume 10 ml/kg bw Dose levels: 0, 2, 5 and 15 mg/kg bw/d Route: oral gavage Administration: daily for 28 days GLP: in compliance Study period: 5/1989 to 6/1989 The test substance (suspended in 0.5% w/v","endpoint":"repeated dose toxicity","ingredient":"s provisionally allowed which cosmetic products must not contain except","loael_value":"","noael_unit":"%","noael_value":"0.5","page":14,"route":"oral","species":"rat","study_id":"sccs_o_025_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 5 | mg/kg bw/d | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_025; REPORT_TITLE=OPINION ON o-Aminophenol COLIPA n° A14; OPINION_NUMBER=SCCS/1291/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=5; DOSE=Increases in absolute (not significant) and relative (significant) thyroid weights were recorded in females group IV Conclusions The reduced bodyweight gains are not considered to be related to treatment as there is no dose relationship.; EFFECT=creased plasma glucose level was recorded in males group IV. Increases in absolute (not significant) and relative (significant) thyroid weights were recorded in females group IV Conclusions The reduced bodyweight gains are not considered to be related to treatment as there is no dose relationship. The thyroid weight changes are also considered by the study authors of questionable toxicological importance as no histopathological evidence was related. Ref.: 37 (Subm. IV) Comment Due to the thyroid weight changes a NOAEL of 5 mg/kg bw/d is set. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) 3-Month oral toxicity in rats 1-Hydroxy-2-aminobenzene was administered orally to 20 Sprague-Dawley rats (10 males and 10 females) at a dosage of 50 mg/kg bw/d as a 1% solution in propylene glycol during 3 months. A group of 20 animals receiving 1 ml of a 1% propylene glycol solution per 100 g body weight served as a control. No mortality was observed. Body weight gain, haematological parameters, blood biochemistry and urine examinat; CITATION=Ref.: 37 (Subm; CITATION_NUMBERS=[37]; REFERENCE=Ref.: 37 (Subm; DETAILS_JSON={"cas_number":"95-55-6","citation":"Ref.: 37 (Subm","dose":"Increases in absolute (not significant) and relative (significant) thyroid weights were recorded in females group IV Conclusions The reduced bodyweight gains are not considered to be related to treatment as there is no dose relationship.","duration":"Sub-chronic","effect":"creased plasma glucose level was recorded in males group IV. Increases in absolute (not significant) and relative (significant) thyroid weights were recorded in females group IV Conclusions The reduced bodyweight gains are not considered to be related to treatment as there is no dose relationship. The thyroid weight changes are also considered by the study authors of questionable toxicological importance as no histopathological evidence was related. Ref.: 37 (Subm. IV) Comment Due to the thyroid weight changes a NOAEL of 5 mg/kg bw/d is set. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) 3-Month oral toxicity in rats 1-Hydroxy-2-aminobenzene was administered orally to 20 Sprague-Dawley rats (10 males and 10 females) at a dosage of 50 mg/kg bw/d as a 1% solution in propylene glycol during 3 months. A group of 20 animals receiving 1 ml of a 1% propylene glycol solution per 100 g body weight served as a control. No mortality was observed. Body weight gain, haematological parameters, blood biochemistry and urine examinat","endpoint":"repeated dose toxicity","ingredient":"s provisionally allowed which cosmetic products must not contain except","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"5","page":15,"route":"oral","species":"rat","study_id":"sccs_o_025_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 15 | mg/kg bw/d | rat | oral | subacute | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_025; REPORT_TITLE=OPINION ON o-Aminophenol COLIPA n° A14; OPINION_NUMBER=SCCS/1291/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=15; DOSE=General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw.; EFFECT=o data were supplied on the amount present in stratum corneum, epidermis and dermis. The variability is very high. Because of these many shortcomings, the studies were not considered suitable for safety assessment. General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw. Two subacute oral toxicity studies in rats were performed with o-aminophenol. In study 1 with treatment over 30 days at daily doses 0, 20, 80, 320 mg/kg bw, none of the three tested doses could be considered as a NOAEL. In study 2 with doses of 0, 2. 5 and 15 mg/kg bw/d, a NOAEL of 5 mg/kg bw/d was derived based on the thyroid weight changes observed. A three-month oral toxicity study was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-55-6","citation":"","dose":"General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw.","duration":"subacute","effect":"o data were supplied on the amount present in stratum corneum, epidermis and dermis. The variability is very high. Because of these many shortcomings, the studies were not considered suitable for safety assessment. General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw. Two subacute oral toxicity studies in rats were performed with o-aminophenol. In study 1 with treatment over 30 days at daily doses 0, 20, 80, 320 mg/kg bw, none of the three tested doses could be considered as a NOAEL. In study 2 with doses of 0, 2. 5 and 15 mg/kg bw/d, a NOAEL of 5 mg/kg bw/d was derived based on the thyroid weight changes observed. A three-month oral toxicity study was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic","endpoint":"repeated dose toxicity","ingredient":"s provisionally allowed which cosmetic products must not contain except","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"15","page":30,"route":"oral","species":"rat","study_id":"sccs_o_025_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 5 | mg/kg bw/d | rat | oral | subacute | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_025; REPORT_TITLE=OPINION ON o-Aminophenol COLIPA n° A14; OPINION_NUMBER=SCCS/1291/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=5; DOSE=General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw.; EFFECT=, epidermis and dermis. The variability is very high. Because of these many shortcomings, the studies were not considered suitable for safety assessment. General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw. Two subacute oral toxicity studies in rats were performed with o-aminophenol. In study 1 with treatment over 30 days at daily doses 0, 20, 80, 320 mg/kg bw, none of the three tested doses could be considered as a NOAEL. In study 2 with doses of 0, 2. 5 and 15 mg/kg bw/d, a NOAEL of 5 mg/kg bw/d was derived based on the thyroid weight changes observed. A three-month oral toxicity study was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic toxicity according to the Notes of Guidance was submitted. By; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-55-6","citation":"","dose":"General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw.","duration":"subacute","effect":", epidermis and dermis. The variability is very high. Because of these many shortcomings, the studies were not considered suitable for safety assessment. General toxicity The oral LD50 of o-aminophenol in rat and mice was above 1,000 mg/kg bw. Two subacute oral toxicity studies in rats were performed with o-aminophenol. In study 1 with treatment over 30 days at daily doses 0, 20, 80, 320 mg/kg bw, none of the three tested doses could be considered as a NOAEL. In study 2 with doses of 0, 2. 5 and 15 mg/kg bw/d, a NOAEL of 5 mg/kg bw/d was derived based on the thyroid weight changes observed. A three-month oral toxicity study was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic toxicity according to the Notes of Guidance was submitted. By","endpoint":"repeated dose toxicity","ingredient":"s provisionally allowed which cosmetic products must not contain except","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"5","page":30,"route":"oral","species":"rat","study_id":"sccs_o_025_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 1.7 | mg/kg bw/d | rat | oral | 13-week | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_025; REPORT_TITLE=OPINION ON o-Aminophenol COLIPA n° A14; OPINION_NUMBER=SCCS/1291/10; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 June 2010; VALUE_TEXT=1.7; DOSE=As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive.; EFFECT=tudy was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic toxicity according to the Notes of Guidance was submitted. By using an adjustment factor of 3 (30 day to 90 day study) from the data on general toxicity available, a NOAEL of 1.7 mg/kg bw/d could be deduced. o-Aminophenol was moderately toxic in an in vivo hen’s egg test and had no teratogenic potential in this test. o-Aminophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all tr; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"95-55-6","citation":"","dose":"As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive.","duration":"13-week","effect":"tudy was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic toxicity according to the Notes of Guidance was submitted. By using an adjustment factor of 3 (30 day to 90 day study) from the data on general toxicity available, a NOAEL of 1.7 mg/kg bw/d could be deduced. o-Aminophenol was moderately toxic in an in vivo hen’s egg test and had no teratogenic potential in this test. o-Aminophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all tr","endpoint":"repeated dose toxicity","ingredient":"s provisionally allowed which cosmetic products must not contain except","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1.7","page":30,"route":"oral","species":"rat","study_id":"sccs_o_025_noael_006"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 23RH73DZ65 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H7NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"23RH73DZ65"} |
| openFDA substances | FDA UNII substance identifier | 23RH73DZ65 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H7NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"23RH73DZ65"} |
| openFDA substances | FDA UNII substance identifier | 23RH73DZ65 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H7NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"23RH73DZ65"} |
| openFDA substances | FDA UNII substance identifier | 23RH73DZ65 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C6H7NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"23RH73DZ65"} |