NOAEL Studies Cosmetic Ingredient

4-Amino-3-Nitrophenol NOAEL Studies

INCI: 4-AMINO-3-NITROPHENOL

CAS: 610-81-1

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

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COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 10 mg/kg bw/day rat oral 91 day Subchronic SCCP; S-A. Brownlie. Imexine FN: 13-Week Oral (Gavage) Toxicity Study in the Rat.Quintiles Study No. LRL/77/95, 1997
NTP_ICE_skin_sensitization 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_skin_sensitization EC3 0.2 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13137; Record_ID=skin_sensitization_invivo_3154; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID50209864; Assay=LLNA; Endpoint=EC3; Response=0.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID50209864
SCCS_vision_codex 32 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =250 mg/kg bw - oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 5 of submission I 3","dose":"40 organs/tissues) were performed on all control and high dose animals.","effect":"an weights (c. 15) were measured and macroscopy and histopathology (c. 40 organs/tissues) were performed on all control and high dose animals. Results Two animals (high dose group) died during the study (laboured respiration). All treated groups showed orange fur-staining, from day one. In the high dose group the following effects were observed: scabbing, perinasal staining, mild convulsions, significantly decreased body weight in the males. The dose level without adverse effects was 250 mg/kg bw. Conclusion The NOAEL was defined at 250 mg/kg bw per day. Ref.: 5 of submission I 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague-Dawley, SD Group size: 40 per sex Test substance: 4-amino-3-nitrophenol (ANP) Batch: Op T268 Purity: >95.5% Dose: 0, 10, 50 and 250 mg/kg day Route: Oral in 1.0% aqueous carboxymethylcellulose and 0.5% Tween 80 Exposure: 91 days GLP: in compliance The subchronic toxicity of ANP was investigated in a 91 days oral (gavage) toxicity study in SD","page":14,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw - - - NOAEL study {"dose":"Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level.","effect":"od chemistry are reported. Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level. An increase in liver weights (+15%, relative weight) relative to control group was reported at the highest exposure group (males, 250 mg/bw/day). No abnormal histopathological findings in any tissues studied related to ANP exposure was reported. Conclusion The NOAEL was set at 250 mg/kg bw per day. Based on liver weight increase, the NOEL was set at 50 mg/kg bw per day. Ref.: 6","page":14,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg bw - - - NOAEL study {"citation":"Ref.: 12 New study Guideline: OECD 414","dose":"treated groups had yellow/orange fur staining and yellow/orange stained urine.","effect":"treated groups had yellow/orange fur staining and yellow/orange stained urine. The high dose females showed significantly reduced body weights. A dose related increase in the number of foetuses exhibiting the skeletal variant of uni- or bilateral vestigial (rudimentary) 14th rib; significant from 250 mg/kg bw onwards, was observed. No irreversible structural changes were observed. Conclusion The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). Ref.: 12 New study Guideline: OECD 414","page":21,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_004"}
SCCS_vision_codex NOAEL =400 mg/kg/day - oral developmental developmental toxicity {"citation":"Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg","dose":"An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant.","effect":"ing oral exposure to ANP. An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant. Because the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 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","page":22,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_005"}
SCCS_vision_codex NOAEL =20 mg/kg bw - - developmental developmental toxicity {"citation":"Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg","dose":"The NOAEL for maternal and developmental toxicity was 400 mg/kg/day.","effect":"the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 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","page":22,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_006"}
SCCS_vision_codex NOAEL =0.01 mg/kg rat oral 13-week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"pinion on 4-amino-3-nitrophenol 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-A","page":23,"pdf":"sccp_o_157.pdf","row_type":"noael_study","study_id":"sccp_o_157_noael_007"}
SCCS_vision_codex NOAEL =60 mg/kg bw rat oral 13-week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3","page":23,"pdf":"sccp_o_157.pdf","row_type":"noael_study","study_id":"sccp_o_157_noael_008"}
SCCS_vision_codex NOAEL =0.061 mg/kg rat oral 13-week dermal absorption {"dose":"treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) =...","effect":"treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw.","page":23,"pdf":"sccp_o_157.pdf","row_type":"noael_study","study_id":"sccp_o_157_noael_010"}
SCCS_vision_codex NOAEL =250 mg/kg bw - oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 5 of submission I 3","dose":"40 organs/tissues) were performed on all control and high dose animals.","effect":"an weights (c. 15) were measured and macroscopy and histopathology (c. 40 organs/tissues) were performed on all control and high dose animals. Results Two animals (high dose group) died during the study (laboured respiration). All treated groups showed orange fur-staining, from day one. In the high dose group the following effects were observed: scabbing, perinasal staining, mild convulsions, significantly decreased body weight in the males. The dose level without adverse effects was 250 mg/kg bw. Conclusion The NOAEL was defined at 250 mg/kg bw per day. Ref.: 5 of submission I 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague-Dawley, SD Group size: 40 per sex Test substance: 4-amino-3-nitrophenol (ANP) Batch: Op T268 Purity: >95.5% Dose: 0, 10, 50 and 250 mg/kg day Route: Oral in 1.0% aqueous carboxymethylcellulose and 0.5% Tween 80 Exposure: 91 days GLP: in compliance The subchronic toxicity of ANP was investigated in a 91 days oral (gavage) toxicity study in SD","page":14,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw - - - NOAEL study {"dose":"Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level.","effect":"od chemistry are reported. Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level. An increase in liver weights (+15%, relative weight) relative to control group was reported at the highest exposure group (males, 250 mg/bw/day). No abnormal histopathological findings in any tissues studied related to ANP exposure was reported. Conclusion The NOAEL was set at 250 mg/kg bw per day. Based on liver weight increase, the NOEL was set at 50 mg/kg bw per day. Ref.: 6","page":14,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg bw - - - NOAEL study {"citation":"Ref.: 12 New study Guideline: OECD 414","dose":"treated groups had yellow/orange fur staining and yellow/orange stained urine.","effect":"treated groups had yellow/orange fur staining and yellow/orange stained urine. The high dose females showed significantly reduced body weights. A dose related increase in the number of foetuses exhibiting the skeletal variant of uni- or bilateral vestigial (rudimentary) 14th rib; significant from 250 mg/kg bw onwards, was observed. No irreversible structural changes were observed. Conclusion The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). Ref.: 12 New study Guideline: OECD 414","page":21,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_004"}
SCCS_vision_codex NOAEL =400 mg/kg/day - oral developmental developmental toxicity {"citation":"Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg","dose":"An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant.","effect":"ing oral exposure to ANP. An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant. Because the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 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","page":22,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_005"}
SCCS_vision_codex NOAEL =20 mg/kg bw - - developmental developmental toxicity {"citation":"Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg","dose":"The NOAEL for maternal and developmental toxicity was 400 mg/kg/day.","effect":"the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 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","page":22,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_006"}
SCCS_vision_codex NOAEL =250 mg/kg bw - oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 5 of submission I 3","dose":"40 organs/tissues) were performed on all control and high dose animals.","effect":"an weights (c. 15) were measured and macroscopy and histopathology (c. 40 organs/tissues) were performed on all control and high dose animals. Results Two animals (high dose group) died during the study (laboured respiration). All treated groups showed orange fur-staining, from day one. In the high dose group the following effects were observed: scabbing, perinasal staining, mild convulsions, significantly decreased body weight in the males. The dose level without adverse effects was 250 mg/kg bw. Conclusion The NOAEL was defined at 250 mg/kg bw per day. Ref.: 5 of submission I 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague-Dawley, SD Group size: 40 per sex Test substance: 4-amino-3-nitrophenol (ANP) Batch: Op T268 Purity: >95.5% Dose: 0, 10, 50 and 250 mg/kg day Route: Oral in 1.0% aqueous carboxymethylcellulose and 0.5% Tween 80 Exposure: 91 days GLP: in compliance The subchronic toxicity of ANP was investigated in a 91 days oral (gavage) toxicity study in SD","page":14,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw - - - NOAEL study {"dose":"Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level.","effect":"od chemistry are reported. Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level. An increase in liver weights (+15%, relative weight) relative to control group was reported at the highest exposure group (males, 250 mg/bw/day). No abnormal histopathological findings in any tissues studied related to ANP exposure was reported. Conclusion The NOAEL was set at 250 mg/kg bw per day. Based on liver weight increase, the NOEL was set at 50 mg/kg bw per day. Ref.: 6","page":14,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg bw - - - NOAEL study {"citation":"Ref.: 12 New study Guideline: OECD 414","dose":"treated groups had yellow/orange fur staining and yellow/orange stained urine.","effect":"treated groups had yellow/orange fur staining and yellow/orange stained urine. The high dose females showed significantly reduced body weights. A dose related increase in the number of foetuses exhibiting the skeletal variant of uni- or bilateral vestigial (rudimentary) 14th rib; significant from 250 mg/kg bw onwards, was observed. No irreversible structural changes were observed. Conclusion The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). Ref.: 12 New study Guideline: OECD 414","page":21,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_004"}
SCCS_vision_codex NOAEL =400 mg/kg/day - oral developmental developmental toxicity {"citation":"Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg","dose":"An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant.","effect":"ing oral exposure to ANP. An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant. Because the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 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","page":22,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_005"}
SCCS_vision_codex NOAEL =20 mg/kg bw - - developmental developmental toxicity {"citation":"Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg","dose":"The NOAEL for maternal and developmental toxicity was 400 mg/kg/day.","effect":"the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 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","page":22,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_006"}
SCCS_vision_codex NOAEL =0.01 mg/kg rat oral 13-week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"pinion on 4-amino-3-nitrophenol 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-A","page":23,"pdf":"sccp_o_157.pdf","row_type":"noael_study","study_id":"sccp_o_157_noael_007"}
SCCS_vision_codex NOAEL =60 mg/kg bw rat oral 13-week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3","page":23,"pdf":"sccp_o_157.pdf","row_type":"noael_study","study_id":"sccp_o_157_noael_008"}
SCCS_vision_codex NOAEL =0.061 mg/kg rat oral 13-week dermal absorption {"dose":"treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) =...","effect":"treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw.","page":23,"pdf":"sccp_o_157.pdf","row_type":"noael_study","study_id":"sccp_o_157_noael_010"}
SCCS_vision_codex NOAEL =0.01 mg/kg rat oral 13-week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"pinion on 4-amino-3-nitrophenol 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-A","page":23,"pdf":"sccp_o_157.pdf","row_type":"noael_study","study_id":"sccp_o_157_noael_007"}
SCCS_vision_codex NOAEL =60 mg/kg bw rat oral 13-week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3","page":23,"pdf":"sccp_o_157.pdf","row_type":"noael_study","study_id":"sccp_o_157_noael_008"}
SCCS_vision_codex NOAEL =0.061 mg/kg rat oral 13-week dermal absorption {"dose":"treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) =...","effect":"treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw.","page":23,"pdf":"sccp_o_157.pdf","row_type":"noael_study","study_id":"sccp_o_157_noael_010"}
SCCS_vision_codex NOAEL =250 mg/kg bw - oral Sub-chronic repeated dose toxicity {"citation":"Ref.: 5 of submission I 3","dose":"40 organs/tissues) were performed on all control and high dose animals.","effect":"an weights (c. 15) were measured and macroscopy and histopathology (c. 40 organs/tissues) were performed on all control and high dose animals. Results Two animals (high dose group) died during the study (laboured respiration). All treated groups showed orange fur-staining, from day one. In the high dose group the following effects were observed: scabbing, perinasal staining, mild convulsions, significantly decreased body weight in the males. The dose level without adverse effects was 250 mg/kg bw. Conclusion The NOAEL was defined at 250 mg/kg bw per day. Ref.: 5 of submission I 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague-Dawley, SD Group size: 40 per sex Test substance: 4-amino-3-nitrophenol (ANP) Batch: Op T268 Purity: >95.5% Dose: 0, 10, 50 and 250 mg/kg day Route: Oral in 1.0% aqueous carboxymethylcellulose and 0.5% Tween 80 Exposure: 91 days GLP: in compliance The subchronic toxicity of ANP was investigated in a 91 days oral (gavage) toxicity study in SD","page":14,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_001"}
SCCS_vision_codex NOAEL =50 mg/kg bw - - - NOAEL study {"dose":"Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level.","effect":"od chemistry are reported. Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level. An increase in liver weights (+15%, relative weight) relative to control group was reported at the highest exposure group (males, 250 mg/bw/day). No abnormal histopathological findings in any tissues studied related to ANP exposure was reported. Conclusion The NOAEL was set at 250 mg/kg bw per day. Based on liver weight increase, the NOEL was set at 50 mg/kg bw per day. Ref.: 6","page":14,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg bw - - - NOAEL study {"citation":"Ref.: 12 New study Guideline: OECD 414","dose":"treated groups had yellow/orange fur staining and yellow/orange stained urine.","effect":"treated groups had yellow/orange fur staining and yellow/orange stained urine. The high dose females showed significantly reduced body weights. A dose related increase in the number of foetuses exhibiting the skeletal variant of uni- or bilateral vestigial (rudimentary) 14th rib; significant from 250 mg/kg bw onwards, was observed. No irreversible structural changes were observed. Conclusion The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). Ref.: 12 New study Guideline: OECD 414","page":21,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_004"}
SCCS_vision_codex NOAEL =400 mg/kg/day - oral developmental developmental toxicity {"citation":"Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg","dose":"An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant.","effect":"ing oral exposure to ANP. An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant. Because the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 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","page":22,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_005"}
SCCS_vision_codex NOAEL =20 mg/kg bw - - developmental developmental toxicity {"citation":"Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg","dose":"The NOAEL for maternal and developmental toxicity was 400 mg/kg/day.","effect":"the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 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","page":22,"pdf":"sccp_o_094.pdf","row_type":"noael_study","study_id":"sccp_o_094_noael_006"}
SCCS_vision_codex NOAEL =0.01 mg/kg rat oral 13-week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"pinion on 4-amino-3-nitrophenol 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-A","page":23,"pdf":"sccp_o_157.pdf","row_type":"noael_study","study_id":"sccp_o_157_noael_007"}
SCCS_vision_codex NOAEL =60 mg/kg bw rat oral 13-week dermal absorption {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","effect":"3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3","page":23,"pdf":"sccp_o_157.pdf","row_type":"noael_study","study_id":"sccp_o_157_noael_008"}
SCCS_vision_codex NOAEL =0.061 mg/kg rat oral 13-week dermal absorption {"dose":"treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) =...","effect":"treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw.","page":23,"pdf":"sccp_o_157.pdf","row_type":"noael_study","study_id":"sccp_o_157_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 250 mg/kg bw - - - - SOURCE_SUBDIR=sccp_o_094; REPORT_TITLE=OPINION ON 4-AMINO-3-NITROPHENOL COLIPA n° B51; OPINION_NUMBER=SCCP/1059/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=250; DOSE=Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level.; EFFECT=considered a sign of systemic exposure. No findings in haematology and blood chemistry are reported. Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level. An increase in liver weights (+15%, relative weight) relative to control group was reported at the highest exposure group (males, 250 mg/bw/day). No abnormal histopathological findings in any tissues studied related to ANP exposure was reported. Conclusion The NOAEL was set at 250 mg/kg bw per day. Based on liver weight increase, the NOEL was set at 50 mg/kg bw per day. Ref.: 6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level.","duration":"","effect":"considered a sign of systemic exposure. No findings in haematology and blood chemistry are reported. Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level. An increase in liver weights (+15%, relative weight) relative to control group was reported at the highest exposure group (males, 250 mg/bw/day). No abnormal histopathological findings in any tissues studied related to ANP exposure was reported. Conclusion The NOAEL was set at 250 mg/kg bw per day. Based on liver weight increase, the NOEL was set at 50 mg/kg bw per day. Ref.: 6","endpoint":"","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"250","page":14,"route":"","species":"","study_id":"sccp_o_094_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 50 mg/kg bw - - - - SOURCE_SUBDIR=sccp_o_094; REPORT_TITLE=OPINION ON 4-AMINO-3-NITROPHENOL COLIPA n° B51; OPINION_NUMBER=SCCP/1059/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=50; DOSE=Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level.; EFFECT=od chemistry are reported. Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level. An increase in liver weights (+15%, relative weight) relative to control group was reported at the highest exposure group (males, 250 mg/bw/day). No abnormal histopathological findings in any tissues studied related to ANP exposure was reported. Conclusion The NOAEL was set at 250 mg/kg bw per day. Based on liver weight increase, the NOEL was set at 50 mg/kg bw per day. Ref.: 6; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level.","duration":"","effect":"od chemistry are reported. Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level. An increase in liver weights (+15%, relative weight) relative to control group was reported at the highest exposure group (males, 250 mg/bw/day). No abnormal histopathological findings in any tissues studied related to ANP exposure was reported. Conclusion The NOAEL was set at 250 mg/kg bw per day. Based on liver weight increase, the NOEL was set at 50 mg/kg bw per day. Ref.: 6","endpoint":"","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":14,"route":"","species":"","study_id":"sccp_o_094_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw - - - - SOURCE_SUBDIR=sccp_o_094; REPORT_TITLE=OPINION ON 4-AMINO-3-NITROPHENOL COLIPA n° B51; OPINION_NUMBER=SCCP/1059/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=100; DOSE=treated groups had yellow/orange fur staining and yellow/orange stained urine.; EFFECT=treated groups had yellow/orange fur staining and yellow/orange stained urine. The high dose females showed significantly reduced body weights. A dose related increase in the number of foetuses exhibiting the skeletal variant of uni- or bilateral vestigial (rudimentary) 14th rib; significant from 250 mg/kg bw onwards, was observed. No irreversible structural changes were observed. Conclusion The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). Ref.: 12 New study Guideline: OECD 414; CITATION=Ref.: 12 New study Guideline: OECD 414; CITATION_NUMBERS=[12,414]; REFERENCE=Ref.: 12 New study Guideline: OECD 414; DETAILS_JSON={"cas_number":"610-81-1","citation":"Ref.: 12 New study Guideline: OECD 414","dose":"treated groups had yellow/orange fur staining and yellow/orange stained urine.","duration":"","effect":"treated groups had yellow/orange fur staining and yellow/orange stained urine. The high dose females showed significantly reduced body weights. A dose related increase in the number of foetuses exhibiting the skeletal variant of uni- or bilateral vestigial (rudimentary) 14th rib; significant from 250 mg/kg bw onwards, was observed. No irreversible structural changes were observed. Conclusion The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). Ref.: 12 New study Guideline: OECD 414","endpoint":"","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":21,"route":"","species":"","study_id":"sccp_o_094_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 100 mg/kg bw rat oral - - SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=100; DOSE=SCCP/1207/08 Opinion on 4-amino-3-nitrophenol Conclusion The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL).; EFFECT=SCCP/1207/08 Opinion on 4-amino-3-nitrophenol Conclusion The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). Ref.: 12 New study Guideline: OECD 414 Species/strain: Sprague-Dawley, SD Group size: 96 Test substance: 4-amino-3-nitrophenol (ANP) Batch: 0508916 Purity: >97.5% Dose: 0, 5, 20 and 400 mg/kg day Route: Oral in 0.5 % aqueous carboxymethylcellulose Exposure: from day 6 to 19 of gestation GLP: in compliance Pregnant SD rats were exposed to APN daily using oral gavage administration at 0, 5, 20, and 400 mg/kg/day from day 6 through day 19 of gestation. ANP was administered in 0.5% aqueous carboxymethylcellulose; CITATION=Ref.: 12 New study Guideline: OECD 414 Species/strain: Sprague-Dawley, SD Group size: 96 Test substance: 4-amino-3-nitrophenol (ANP) Batch: 0508916 Purity: >97; CITATION_NUMBERS=[12,414,96,4,3,508,916,97]; REFERENCE=Ref.: 12 New study Guideline: OECD 414 Species/strain: Sprague-Dawley, SD Group size: 96 Test substance: 4-amino-3-nitrophenol (ANP) Batch: 0508916 Purity: >97; DETAILS_JSON={"cas_number":"610-81-1","citation":"Ref.: 12 New study Guideline: OECD 414 Species/strain: Sprague-Dawley, SD Group size: 96 Test substance: 4-amino-3-nitrophenol (ANP) Batch: 0508916 Purity: >97","dose":"SCCP/1207/08 Opinion on 4-amino-3-nitrophenol Conclusion The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL).","duration":"","effect":"SCCP/1207/08 Opinion on 4-amino-3-nitrophenol Conclusion The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). Ref.: 12 New study Guideline: OECD 414 Species/strain: Sprague-Dawley, SD Group size: 96 Test substance: 4-amino-3-nitrophenol (ANP) Batch: 0508916 Purity: >97.5% Dose: 0, 5, 20 and 400 mg/kg day Route: Oral in 0.5 % aqueous carboxymethylcellulose Exposure: from day 6 to 19 of gestation GLP: in compliance Pregnant SD rats were exposed to APN daily using oral gavage administration at 0, 5, 20, and 400 mg/kg/day from day 6 through day 19 of gestation. ANP was administered in 0.5% aqueous carboxymethylcellulose","endpoint":"","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":22,"route":"oral","species":"rat","study_id":"sccp_o_157_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.01 mg/kg rat oral 13-week dermal absorption SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT== 0.01; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...; EFFECT=pinion on 4-amino-3-nitrophenol 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-A; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","duration":"13-week","effect":"pinion on 4-amino-3-nitrophenol 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-A","endpoint":"dermal absorption","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.01","page":23,"route":"oral","species":"rat","study_id":"sccp_o_157_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =60 mg/kg bw rat oral 13-week dermal absorption SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT== 60; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...; EFFECT=3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","duration":"13-week","effect":"3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3","endpoint":"dermal absorption","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 60","page":23,"route":"oral","species":"rat","study_id":"sccp_o_157_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =60 mg/kg bw rat oral 13-week dermal absorption SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT== 60; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...; EFFECT=estigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SE...","duration":"13-week","effect":"estigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY 4-amino-3-nitrophenol (non-oxidative) Maximum absorption through the skin A (μg/cm2) = 0.83 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye","endpoint":"dermal absorption","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 60","page":23,"route":"oral","species":"rat","study_id":"sccp_o_157_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =0.061 mg/kg rat oral 13-week dermal absorption SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT== 0.061; DOSE=treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) =...; EFFECT=treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) =...","duration":"13-week","effect":"treatment SAS x A x 0.001 = 0.58 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw.","endpoint":"dermal absorption","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.061","page":23,"route":"oral","species":"rat","study_id":"sccp_o_157_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =60 mg/kg bw rat oral 13-week dermal absorption SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT== 60; DOSE=mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per tre...; EFFECT=mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per tre...","duration":"13-week","effect":"mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw.","endpoint":"dermal absorption","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 60","page":23,"route":"oral","species":"rat","study_id":"sccp_o_157_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies dermal absorption =60 mg/kg bw rat oral 13-week dermal absorption SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT== 60; DOSE=dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of hu...; EFFECT=dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of hu...","duration":"13-week","effect":"dose (SED) SAS x A x 0.001/60 = 0.01 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 6000 (oxidative) Maximum absorption through the skin A (μg/cm2) = 5.19 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 3.63 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.061 mg/kg No observed adverse effect level NOAEL = 60 mg/kg bw (13-week, oral, rat) Margin of Safety NOAEL / SED = 984 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw.","endpoint":"dermal absorption","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 60","page":23,"route":"oral","species":"rat","study_id":"sccp_o_157_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 400 mg/kg/day - oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_094; REPORT_TITLE=OPINION ON 4-AMINO-3-NITROPHENOL COLIPA n° B51; OPINION_NUMBER=SCCP/1059/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=400; DOSE=An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant.; EFFECT=ing oral exposure to ANP. An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant. Because the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 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; CITATION=Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg; CITATION_NUMBERS=[13,400,20]; REFERENCE=Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg; DETAILS_JSON={"cas_number":"610-81-1","citation":"Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg","dose":"An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant.","duration":"developmental","effect":"ing oral exposure to ANP. An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant. Because the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 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","endpoint":"developmental toxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg/day","noael_value":"400","page":22,"route":"oral","species":"","study_id":"sccp_o_094_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 20 mg/kg bw - - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_094; REPORT_TITLE=OPINION ON 4-AMINO-3-NITROPHENOL COLIPA n° B51; OPINION_NUMBER=SCCP/1059/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=20; DOSE=The NOAEL for maternal and developmental toxicity was 400 mg/kg/day.; EFFECT=the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 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; CITATION=Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg; CITATION_NUMBERS=[13,400,20]; REFERENCE=Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg; DETAILS_JSON={"cas_number":"610-81-1","citation":"Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg","dose":"The NOAEL for maternal and developmental toxicity was 400 mg/kg/day.","duration":"developmental","effect":"the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 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","endpoint":"developmental toxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"20","page":22,"route":"","species":"","study_id":"sccp_o_094_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 250 mg/kg bw rat oral 28 day developmental toxicity SOURCE_SUBDIR=sccp_o_094; REPORT_TITLE=OPINION ON 4-AMINO-3-NITROPHENOL COLIPA n° B51; OPINION_NUMBER=SCCP/1059/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=250; DOSE=General toxicity LD50 was determined to be > 500 mg/kg bw.; EFFECT=ON OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw. In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day. In an oral 90 day study in rat, the NOAEL was set at 250 mg/kg bw per day. The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). In a more recent study, the NOAEL for maternal and developmental toxicity was set at 400 mg/kg/day. Irritation / sensitisation A 6% solution of 4-amino-3-nitrophenol in 1,2-propanediol was not irritating to rabbit skin under semi-occlusive conditions. There were no reaction; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"General toxicity LD50 was determined to be > 500 mg/kg bw.","duration":"28 day","effect":"ON OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion Physico-chemical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw. In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day. In an oral 90 day study in rat, the NOAEL was set at 250 mg/kg bw per day. The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). In a more recent study, the NOAEL for maternal and developmental toxicity was set at 400 mg/kg/day. Irritation / sensitisation A 6% solution of 4-amino-3-nitrophenol in 1,2-propanediol was not irritating to rabbit skin under semi-occlusive conditions. There were no reaction","endpoint":"developmental toxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"250","page":23,"route":"oral","species":"rat","study_id":"sccp_o_094_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 250 mg/kg bw rat oral 28 day developmental toxicity SOURCE_SUBDIR=sccp_o_094; REPORT_TITLE=OPINION ON 4-AMINO-3-NITROPHENOL COLIPA n° B51; OPINION_NUMBER=SCCP/1059/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=250; DOSE=General toxicity LD50 was determined to be > 500 mg/kg bw.; EFFECT=ical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw. In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day. In an oral 90 day study in rat, the NOAEL was set at 250 mg/kg bw per day. The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). In a more recent study, the NOAEL for maternal and developmental toxicity was set at 400 mg/kg/day. Irritation / sensitisation A 6% solution of 4-amino-3-nitrophenol in 1,2-propanediol was not irritating to rabbit skin under semi-occlusive conditions. There were no reactions following instillation of 4-amino-3- nitrophenol at 6% in rabbit eye. It is a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"General toxicity LD50 was determined to be > 500 mg/kg bw.","duration":"28 day","effect":"ical specifications 4-Amino-3-nitrophenol is used as an ingredient in oxidative hair dye formulations at a maximum concentration of 1.5%, after mixing with hydrogen peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw. In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day. In an oral 90 day study in rat, the NOAEL was set at 250 mg/kg bw per day. The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). In a more recent study, the NOAEL for maternal and developmental toxicity was set at 400 mg/kg/day. Irritation / sensitisation A 6% solution of 4-amino-3-nitrophenol in 1,2-propanediol was not irritating to rabbit skin under semi-occlusive conditions. There were no reactions following instillation of 4-amino-3- nitrophenol at 6% in rabbit eye. It is a","endpoint":"developmental toxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"250","page":23,"route":"oral","species":"rat","study_id":"sccp_o_094_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg bw rat oral 28 day developmental toxicity SOURCE_SUBDIR=sccp_o_094; REPORT_TITLE=OPINION ON 4-AMINO-3-NITROPHENOL COLIPA n° B51; OPINION_NUMBER=SCCP/1059/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=100; DOSE=General toxicity LD50 was determined to be > 500 mg/kg bw.; EFFECT=n peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw. In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day. In an oral 90 day study in rat, the NOAEL was set at 250 mg/kg bw per day. The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). In a more recent study, the NOAEL for maternal and developmental toxicity was set at 400 mg/kg/day. Irritation / sensitisation A 6% solution of 4-amino-3-nitrophenol in 1,2-propanediol was not irritating to rabbit skin under semi-occlusive conditions. There were no reactions following instillation of 4-amino-3- nitrophenol at 6% in rabbit eye. It is an irritant for the rabbit eye, when tested undiluted. 4- Amino-3-nitrophenol is an extreme sensitiser. Dermal absorption Too few chambers were used. Because of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"General toxicity LD50 was determined to be > 500 mg/kg bw.","duration":"28 day","effect":"n peroxide. It is also used in semi-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw. In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day. In an oral 90 day study in rat, the NOAEL was set at 250 mg/kg bw per day. The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). In a more recent study, the NOAEL for maternal and developmental toxicity was set at 400 mg/kg/day. Irritation / sensitisation A 6% solution of 4-amino-3-nitrophenol in 1,2-propanediol was not irritating to rabbit skin under semi-occlusive conditions. There were no reactions following instillation of 4-amino-3- nitrophenol at 6% in rabbit eye. It is an irritant for the rabbit eye, when tested undiluted. 4- Amino-3-nitrophenol is an extreme sensitiser. Dermal absorption Too few chambers were used. Because of","endpoint":"developmental toxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":23,"route":"oral","species":"rat","study_id":"sccp_o_094_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg bw rat oral 28 day developmental toxicity SOURCE_SUBDIR=sccp_o_094; REPORT_TITLE=OPINION ON 4-AMINO-3-NITROPHENOL COLIPA n° B51; OPINION_NUMBER=SCCP/1059/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=100; DOSE=General toxicity LD50 was determined to be > 500 mg/kg bw.; EFFECT=-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw. In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day. In an oral 90 day study in rat, the NOAEL was set at 250 mg/kg bw per day. The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). In a more recent study, the NOAEL for maternal and developmental toxicity was set at 400 mg/kg/day. Irritation / sensitisation A 6% solution of 4-amino-3-nitrophenol in 1,2-propanediol was not irritating to rabbit skin under semi-occlusive conditions. There were no reactions following instillation of 4-amino-3- nitrophenol at 6% in rabbit eye. It is an irritant for the rabbit eye, when tested undiluted. 4- Amino-3-nitrophenol is an extreme sensitiser. Dermal absorption Too few chambers were used. Because of the high variability of skin penetra; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"General toxicity LD50 was determined to be > 500 mg/kg bw.","duration":"28 day","effect":"-permanent hair dye formulations at a maximum concentration of 1.0%. The stability of 4-Amino-3-nitrophenol in marketed products is not reported. General toxicity LD50 was determined to be > 500 mg/kg bw. In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day. In an oral 90 day study in rat, the NOAEL was set at 250 mg/kg bw per day. The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). In a more recent study, the NOAEL for maternal and developmental toxicity was set at 400 mg/kg/day. Irritation / sensitisation A 6% solution of 4-amino-3-nitrophenol in 1,2-propanediol was not irritating to rabbit skin under semi-occlusive conditions. There were no reactions following instillation of 4-amino-3- nitrophenol at 6% in rabbit eye. It is an irritant for the rabbit eye, when tested undiluted. 4- Amino-3-nitrophenol is an extreme sensitiser. Dermal absorption Too few chambers were used. Because of the high variability of skin penetra","endpoint":"developmental toxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":23,"route":"oral","species":"rat","study_id":"sccp_o_094_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 400 mg/kg/day - oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=400; DOSE=An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant.; EFFECT=ing oral exposure to ANP. An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant. Because the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted; CITATION=Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg; CITATION_NUMBERS=[13,400,20]; REFERENCE=Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg; DETAILS_JSON={"cas_number":"610-81-1","citation":"Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg","dose":"An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant.","duration":"developmental","effect":"ing oral exposure to ANP. An increase of short supernumerary rib was reported at 400 mg/kg/day in foetuses of some of the litters which was however, not statistically significant. Because the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted","endpoint":"developmental toxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg/day","noael_value":"400","page":22,"route":"oral","species":"","study_id":"sccp_o_157_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 20 mg/kg bw - - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=20; DOSE=The NOAEL for maternal and developmental toxicity was 400 mg/kg/day.; EFFECT=the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted; CITATION=Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg; CITATION_NUMBERS=[13,400,20]; REFERENCE=Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg; DETAILS_JSON={"cas_number":"610-81-1","citation":"Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the marg","dose":"The NOAEL for maternal and developmental toxicity was 400 mg/kg/day.","duration":"developmental","effect":"the incidence (4.1%) was within the historical control range (0.0 – 7.6%) and because no foetuses had full supernumerary rib or abnormal pre-sacral vertebrae, the observation was considered not to be adverse. Conclusion There was no maternal toxicity or effects on embryo-foetal development in any of the exposure levels used. The NOAEL for maternal and developmental toxicity was 400 mg/kg/day. Ref.: 13 Comment Although the effect seen at 400 mg/kg bw was considered as part of the normal variation, a conservative NOEL of 20 mg/kg bw could be used for the calculation of the margin of safety. 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted","endpoint":"developmental toxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"20","page":22,"route":"","species":"","study_id":"sccp_o_157_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 250 mg/kg bw rat oral 28 day developmental toxicity SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=250; DOSE=SCCP/1207/08 Opinion on 4-amino-3-nitrophenol In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day.; EFFECT=SCCP/1207/08 Opinion on 4-amino-3-nitrophenol In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day. In an oral 90 day study in rat, the NOAEL was set at 250 mg/kg bw per day. The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). In a more recent study, the NOAEL for maternal and developmental toxicity was set at 400 mg/kg/day. Irritation / sensitisation A 6% solution of 4-amino-3-nitrophenol in 1,2-propanediol was not irritating to rabbit skin under semi-occlusive conditions. There were no reaction; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"SCCP/1207/08 Opinion on 4-amino-3-nitrophenol In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day.","duration":"28 day","effect":"SCCP/1207/08 Opinion on 4-amino-3-nitrophenol In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day. In an oral 90 day study in rat, the NOAEL was set at 250 mg/kg bw per day. The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). In a more recent study, the NOAEL for maternal and developmental toxicity was set at 400 mg/kg/day. Irritation / sensitisation A 6% solution of 4-amino-3-nitrophenol in 1,2-propanediol was not irritating to rabbit skin under semi-occlusive conditions. There were no reaction","endpoint":"developmental toxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"250","page":24,"route":"oral","species":"rat","study_id":"sccp_o_157_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg bw rat oral 28 day developmental toxicity SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=100; DOSE=SCCP/1207/08 Opinion on 4-amino-3-nitrophenol In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day.; EFFECT=SCCP/1207/08 Opinion on 4-amino-3-nitrophenol In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day. In an oral 90 day study in rat, the NOAEL was set at 250 mg/kg bw per day. The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). In a more recent study, the NOAEL for maternal and developmental toxicity was set at 400 mg/kg/day. Irritation / sensitisation A 6% solution of 4-amino-3-nitrophenol in 1,2-propanediol was not irritating to rabbit skin under semi-occlusive conditions. There were no reactions following instillation of 4-amino-3- nitrophenol at 6% in rabbit eye. It is an irritant for the rabbit eye, when tested undiluted. 4- Amino-3-nitrophenol is an extreme sensitiser. Dermal absorption Because of the high variability observe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"610-81-1","citation":"","dose":"SCCP/1207/08 Opinion on 4-amino-3-nitrophenol In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day.","duration":"28 day","effect":"SCCP/1207/08 Opinion on 4-amino-3-nitrophenol In a 28 day oral study in rats, the NOAEL was defined at 250 mg/kg bw per day. In an oral 90 day study in rat, the NOAEL was set at 250 mg/kg bw per day. The dose level without maternal toxicity was 250 mg/kg bw and the dose level without embryo/foetotoxicity was 100 mg/kg bw (NOEL). In a more recent study, the NOAEL for maternal and developmental toxicity was set at 400 mg/kg/day. Irritation / sensitisation A 6% solution of 4-amino-3-nitrophenol in 1,2-propanediol was not irritating to rabbit skin under semi-occlusive conditions. There were no reactions following instillation of 4-amino-3- nitrophenol at 6% in rabbit eye. It is an irritant for the rabbit eye, when tested undiluted. 4- Amino-3-nitrophenol is an extreme sensitiser. Dermal absorption Because of the high variability observe","endpoint":"developmental toxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"100","page":24,"route":"oral","species":"rat","study_id":"sccp_o_157_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 250 mg/kg bw - - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=250; DOSE=Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level.; EFFECT=207/08 Opinion on 4-amino-3-nitrophenol No findings in haematology and blood chemistry are reported. Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level. An increase in liver weights (+15%, relative weight) relative to control group was reported at the highest exposure group (males, 250 mg/bw/day). No abnormal histopathological findings in any tissues studied related to ANP exposure was reported. Conclusion The NOAEL was set at 250 mg/kg bw per day. Based on liver weight increase, the NOEL was set at 50 mg/kg bw per day. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Three independent experiments Test substance: 4-amino-3-nitrophenol (B051) Batch: 0508916 Solvent: DMSO Purity: 97.5% Concent; CITATION=Ref.: 6 3; CITATION_NUMBERS=[6,3]; REFERENCE=Ref.: 6 3; DETAILS_JSON={"cas_number":"610-81-1","citation":"Ref.: 6 3","dose":"Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level.","duration":"Chronic","effect":"207/08 Opinion on 4-amino-3-nitrophenol No findings in haematology and blood chemistry are reported. Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level. An increase in liver weights (+15%, relative weight) relative to control group was reported at the highest exposure group (males, 250 mg/bw/day). No abnormal histopathological findings in any tissues studied related to ANP exposure was reported. Conclusion The NOAEL was set at 250 mg/kg bw per day. Based on liver weight increase, the NOEL was set at 50 mg/kg bw per day. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Three independent experiments Test substance: 4-amino-3-nitrophenol (B051) Batch: 0508916 Solvent: DMSO Purity: 97.5% Concent","endpoint":"genotoxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"250","page":15,"route":"","species":"","study_id":"sccp_o_157_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies genotoxicity 50 mg/kg bw - - Chronic genotoxicity SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=50; DOSE=Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level.; EFFECT=od chemistry are reported. Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level. An increase in liver weights (+15%, relative weight) relative to control group was reported at the highest exposure group (males, 250 mg/bw/day). No abnormal histopathological findings in any tissues studied related to ANP exposure was reported. Conclusion The NOAEL was set at 250 mg/kg bw per day. Based on liver weight increase, the NOEL was set at 50 mg/kg bw per day. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Three independent experiments Test substance: 4-amino-3-nitrophenol (B051) Batch: 0508916 Solvent: DMSO Purity: 97.5% Concentrations: 312.5, 625, 1250, 2500 and 5000 µg/plate, for all the strains in; CITATION=Ref.: 6 3; CITATION_NUMBERS=[6,3]; REFERENCE=Ref.: 6 3; DETAILS_JSON={"cas_number":"610-81-1","citation":"Ref.: 6 3","dose":"Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level.","duration":"Chronic","effect":"od chemistry are reported. Due to the strong discolouration of the urine of animals given 250 mg/kg day, most urinary parameters could not be evaluated at this particular dose level. An increase in liver weights (+15%, relative weight) relative to control group was reported at the highest exposure group (males, 250 mg/bw/day). No abnormal histopathological findings in any tissues studied related to ANP exposure was reported. Conclusion The NOAEL was set at 250 mg/kg bw per day. Based on liver weight increase, the NOEL was set at 50 mg/kg bw per day. Ref.: 6 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity/Genotoxicity in vitro Bacterial gene mutation assay Guideline: OECD 471 Species/strain: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, TA1538 Replicates: Three independent experiments Test substance: 4-amino-3-nitrophenol (B051) Batch: 0508916 Solvent: DMSO Purity: 97.5% Concentrations: 312.5, 625, 1250, 2500 and 5000 µg/plate, for all the strains in","endpoint":"genotoxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"50","page":15,"route":"","species":"","study_id":"sccp_o_157_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 250 mg/kg bw - oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_094; REPORT_TITLE=OPINION ON 4-AMINO-3-NITROPHENOL COLIPA n° B51; OPINION_NUMBER=SCCP/1059/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=21 March 2007; VALUE_TEXT=250; DOSE=40 organs/tissues) were performed on all control and high dose animals.; EFFECT=an weights (c. 15) were measured and macroscopy and histopathology (c. 40 organs/tissues) were performed on all control and high dose animals. Results Two animals (high dose group) died during the study (laboured respiration). All treated groups showed orange fur-staining, from day one. In the high dose group the following effects were observed: scabbing, perinasal staining, mild convulsions, significantly decreased body weight in the males. The dose level without adverse effects was 250 mg/kg bw. Conclusion The NOAEL was defined at 250 mg/kg bw per day. Ref.: 5 of submission I 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague-Dawley, SD Group size: 40 per sex Test substance: 4-amino-3-nitrophenol (ANP) Batch: Op T268 Purity: >95.5% Dose: 0, 10, 50 and 250 mg/kg day Route: Oral in 1.0% aqueous carboxymethylcellulose and 0.5% Tween 80 Exposure: 91 days GLP: in compliance The subchronic toxicity of ANP was investigated in a 91 days oral (gavage) toxicity study in SD; CITATION=Ref.: 5 of submission I 3; CITATION_NUMBERS=[5,3]; REFERENCE=Ref.: 5 of submission I 3; DETAILS_JSON={"cas_number":"610-81-1","citation":"Ref.: 5 of submission I 3","dose":"40 organs/tissues) were performed on all control and high dose animals.","duration":"Sub-chronic","effect":"an weights (c. 15) were measured and macroscopy and histopathology (c. 40 organs/tissues) were performed on all control and high dose animals. Results Two animals (high dose group) died during the study (laboured respiration). All treated groups showed orange fur-staining, from day one. In the high dose group the following effects were observed: scabbing, perinasal staining, mild convulsions, significantly decreased body weight in the males. The dose level without adverse effects was 250 mg/kg bw. Conclusion The NOAEL was defined at 250 mg/kg bw per day. Ref.: 5 of submission I 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague-Dawley, SD Group size: 40 per sex Test substance: 4-amino-3-nitrophenol (ANP) Batch: Op T268 Purity: >95.5% Dose: 0, 10, 50 and 250 mg/kg day Route: Oral in 1.0% aqueous carboxymethylcellulose and 0.5% Tween 80 Exposure: 91 days GLP: in compliance The subchronic toxicity of ANP was investigated in a 91 days oral (gavage) toxicity study in SD","endpoint":"repeated dose toxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"250","page":14,"route":"oral","species":"","study_id":"sccp_o_094_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 250 mg/kg bw - oral Sub-chronic repeated dose toxicity SOURCE_SUBDIR=sccp_o_157; REPORT_TITLE=OPINION ON 4-Amino-3-nitrophenol COLIPA n° B51; OPINION_NUMBER=SCCP/1207/08; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=adopted on 19 June 2007; VALUE_TEXT=250; DOSE=40 organs/tissues) were performed on all control and high dose animals.; EFFECT=an weights (c. 15) were measured and macroscopy and histopathology (c. 40 organs/tissues) were performed on all control and high dose animals. Results Two animals (high dose group) died during the study (laboured respiration). All treated groups showed orange fur-staining, from day one. In the high dose group the following effects were observed: scabbing, perinasal staining, mild convulsions, significantly decreased body weight in the males. The dose level without adverse effects was 250 mg/kg bw. Conclusion The NOAEL was defined at 250 mg/kg bw per day. Ref.: 5 of submission I 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague-Dawley, SD Group size: 40 per sex Test substance: 4-amino-3-nitrophenol (ANP) Batch: Op T268 Purity: >95.5% Dose: 0, 10, 50 and 250 mg/kg day Route: Oral in 1.0% aqueous carboxymethylcellulose and 0.5% Tween 80 Exposure: 91 days GLP: in compliance The subchronic toxicity of ANP was investigated in a 91 days oral (gavage) toxicity study in SD; CITATION=Ref.: 5 of submission I 3; CITATION_NUMBERS=[5,3]; REFERENCE=Ref.: 5 of submission I 3; DETAILS_JSON={"cas_number":"610-81-1","citation":"Ref.: 5 of submission I 3","dose":"40 organs/tissues) were performed on all control and high dose animals.","duration":"Sub-chronic","effect":"an weights (c. 15) were measured and macroscopy and histopathology (c. 40 organs/tissues) were performed on all control and high dose animals. Results Two animals (high dose group) died during the study (laboured respiration). All treated groups showed orange fur-staining, from day one. In the high dose group the following effects were observed: scabbing, perinasal staining, mild convulsions, significantly decreased body weight in the males. The dose level without adverse effects was 250 mg/kg bw. Conclusion The NOAEL was defined at 250 mg/kg bw per day. Ref.: 5 of submission I 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Guideline: OECD 408 Species/strain: Sprague-Dawley, SD Group size: 40 per sex Test substance: 4-amino-3-nitrophenol (ANP) Batch: Op T268 Purity: >95.5% Dose: 0, 10, 50 and 250 mg/kg day Route: Oral in 1.0% aqueous carboxymethylcellulose and 0.5% Tween 80 Exposure: 91 days GLP: in compliance The subchronic toxicity of ANP was investigated in a 91 days oral (gavage) toxicity study in SD","endpoint":"repeated dose toxicity","ingredient":"4-Amino-3-nitrophenol","loael_value":"","noael_unit":"mg/kg bw","noael_value":"250","page":14,"route":"oral","species":"","study_id":"sccp_o_157_noael_001"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier R5WY41Q95Z UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H6N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"R5WY41Q95Z"}
openFDA substances FDA UNII substance identifier R5WY41Q95Z UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H6N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"R5WY41Q95Z"}
openFDA substances FDA UNII substance identifier R5WY41Q95Z UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H6N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"R5WY41Q95Z"}
openFDA substances FDA UNII substance identifier R5WY41Q95Z UNII - - - chemical {"approval_status":null,"molecular_formula":"C6H6N2O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"R5WY41Q95Z"}