NOAEL Studies Cosmetic Ingredient

3-Nitro-P-Hydroxyethylaminophenol NOAEL Studies

CAS: 65235-31-6

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 100 mg/kg bw/day rat oral 6-15 Gestation day Developmental SCCP; M.H. Savary. IMEXINE FH: Assessment of possible embryotoxic orteratogenic effects by oral route in rats. CIT, Study N°5842 RSR
NTP_ICE_skin_sensitization 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_skin_sensitization EC3 0.1 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13339; Record_ID=skin_sensitization_invivo_3454; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID00215536; Assay=LLNA; Endpoint=EC3; Response=0.1; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID00215536
NTP_ICE_skin_sensitization EC3 0.1 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13339; Record_ID=skin_sensitization_invivo_3454; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID00215536; Assay=LLNA; Endpoint=EC3; Response=0.1; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID00215536
NTP_ICE_skin_sensitization EC3 0.1 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13339; Record_ID=skin_sensitization_invivo_3454; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID00215536; Assay=LLNA; Endpoint=EC3; Response=0.1; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID00215536
NTP_ICE_skin_sensitization EC3 0.1 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13339; Record_ID=skin_sensitization_invivo_3454; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID00215536; Assay=LLNA; Endpoint=EC3; Response=0.1; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID00215536
SCCS_vision_codex 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =1000 mg/kg/day rat oral - NOAEL study {"citation":"Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation","dose":"Conclusion The oral administration of the product Imexine FH to the rat for three months at doses of 40, 200 and 1000 mg/kg/day caused no modifications in organs with the exception of pigment deposition in thyroid follicles of most of the males treated at the high dose.","effect":"follicles. Conclusion The oral administration of the product Imexine FH to the rat for three months at doses of 40, 200 and 1000 mg/kg/day caused no modifications in organs with the exception of pigment deposition in thyroid follicles of most of the males treated at the high dose. According to the authors, this abnormality does not constitute a toxicological alteration and the dose of 1000 mg/kg/day administered under the conditions described can thus be considered as a dose without toxic effect. Accordingly, the NOAEL was set at 1000 mg/kg/day (5a). Additional work on this study included an expert report which reviewed the urinalysis, organ weight, macroscopic and microscopic findings, and confirmed the conclusion of the initial study report (5b). Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation. Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidne","page":13,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_001"}
SCCS_vision_codex NOAEL =15 % - - Chronic NOAEL study {"citation":"Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation","dose":"Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidney weight (males, females 15%), the NOAEL in this study was set at 200 mg/kg bw/day.","effect":"ditional work on this study included an expert report which reviewed the urinalysis, organ weight, macroscopic and microscopic findings, and confirmed the conclusion of the initial study report (5b). Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation. Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidney weight (males, females 15%), the NOAEL in this study was set at 200 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":13,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_002"}
SCCS_vision_codex NOAEL =1000 mg/kg rat - developmental developmental toxicity {"dose":"In the submission the applicant concluded that the NOAEL for both maternal and developmental toxicity was 1000 mg/kg day.","effect":"yotoxic and 2 foetuses showed malformations (11a). According to an additional position paper in which the significance of the polydactyly was investigated, the presence of a polydactyly was not confirmed by the re-examination of the specimen by two reviewers. The changes noted in carpals were therefore considered an artefact and not to be test item related (11b). Comments Despite the deficiencies of this study (purity unknown) this study is useful for evaluation. In the submission the applicant concluded that the NOAEL for both maternal and developmental toxicity was 1000 mg/kg day. The applicant argued that the external astomia associated with the face and brain observed in a single foetus from the 1000 mg/kg/day group is unlikely to be related to administration of the test substance, given the isolated nature of this finding and because this malformation is known to occur spontaneously in rats of this strain at a low incidence. However, no historical control data on the occurrence of external astomia is provided. It can not be","page":21,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg/day rat - developmental developmental toxicity {"citation":"Ref: 11a and 11b 3","dose":"In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group.","effect":"eously in rats of this strain at a low incidence. However, no historical control data on the occurrence of external astomia is provided. It can not be ruled out that the observed teratogenic effect (external astomia) was related to the administration of the test substance. In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group. Therefore, the SCCP considers the NOAEL for developmental toxicity to be 100 mg/kg/day and the NOAEL for maternal toxicity 1000 mg/kg/day, which means that it can not be ruled out that teratogenic (external astomia) and embryotoxic (decreased number of live foetuses and increased post-implantation loss) effects occurred at dose levels which were not toxic to the pregnant dams. Ref: 11a and 11b 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigation","page":21,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_004"}
SCCS_vision_codex NOAEL =100 mg/kg rat oral developmental developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg System...","effect":"SCCP/1036/06 OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.096 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0128 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 7792","page":22,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_006"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat - 90-day NOAEL study {"dose":"Stability of 3-Nitro-p- hydroxyethylaminophenol in marketed products is not reported General toxicity A non-lethal dose of 3-nitro-p-hydroxethylaminophenol was 1000 mg/kg.","effect":"o-p-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. It should not be used in combination with nitrosating agents. Nitrosamine content in 3-nitro-p-hydroxyethylaminophenol is not reported. Stability of 3-Nitro-p- hydroxyethylaminophenol in marketed products is not reported General toxicity A non-lethal dose of 3-nitro-p-hydroxethylaminophenol was 1000 mg/kg. A lethal dose was 2000 mg/kg in rats. On the basis of significant increase in organ weights in the highest dose group, the NOAEL in the 90-day study was 200 mg/kg bw/day.","page":22,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_010"}
SCCS_vision_codex NOAEL =1000 mg/kg/day rat oral - NOAEL study {"citation":"Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation","dose":"Conclusion The oral administration of the product Imexine FH to the rat for three months at doses of 40, 200 and 1000 mg/kg/day caused no modifications in organs with the exception of pigment deposition in thyroid follicles of most of the males treated at the high dose.","effect":"follicles. Conclusion The oral administration of the product Imexine FH to the rat for three months at doses of 40, 200 and 1000 mg/kg/day caused no modifications in organs with the exception of pigment deposition in thyroid follicles of most of the males treated at the high dose. According to the authors, this abnormality does not constitute a toxicological alteration and the dose of 1000 mg/kg/day administered under the conditions described can thus be considered as a dose without toxic effect. Accordingly, the NOAEL was set at 1000 mg/kg/day (5a). Additional work on this study included an expert report which reviewed the urinalysis, organ weight, macroscopic and microscopic findings, and confirmed the conclusion of the initial study report (5b). Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation. Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidne","page":13,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_001"}
SCCS_vision_codex NOAEL =15 % - - Chronic NOAEL study {"citation":"Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation","dose":"Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidney weight (males, females 15%), the NOAEL in this study was set at 200 mg/kg bw/day.","effect":"ditional work on this study included an expert report which reviewed the urinalysis, organ weight, macroscopic and microscopic findings, and confirmed the conclusion of the initial study report (5b). Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation. Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidney weight (males, females 15%), the NOAEL in this study was set at 200 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":13,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_002"}
SCCS_vision_codex NOAEL =1000 mg/kg rat - developmental developmental toxicity {"dose":"In the submission the applicant concluded that the NOAEL for both maternal and developmental toxicity was 1000 mg/kg day.","effect":"yotoxic and 2 foetuses showed malformations (11a). According to an additional position paper in which the significance of the polydactyly was investigated, the presence of a polydactyly was not confirmed by the re-examination of the specimen by two reviewers. The changes noted in carpals were therefore considered an artefact and not to be test item related (11b). Comments Despite the deficiencies of this study (purity unknown) this study is useful for evaluation. In the submission the applicant concluded that the NOAEL for both maternal and developmental toxicity was 1000 mg/kg day. The applicant argued that the external astomia associated with the face and brain observed in a single foetus from the 1000 mg/kg/day group is unlikely to be related to administration of the test substance, given the isolated nature of this finding and because this malformation is known to occur spontaneously in rats of this strain at a low incidence. However, no historical control data on the occurrence of external astomia is provided. It can not be","page":21,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg/day rat - developmental developmental toxicity {"citation":"Ref: 11a and 11b 3","dose":"In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group.","effect":"eously in rats of this strain at a low incidence. However, no historical control data on the occurrence of external astomia is provided. It can not be ruled out that the observed teratogenic effect (external astomia) was related to the administration of the test substance. In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group. Therefore, the SCCP considers the NOAEL for developmental toxicity to be 100 mg/kg/day and the NOAEL for maternal toxicity 1000 mg/kg/day, which means that it can not be ruled out that teratogenic (external astomia) and embryotoxic (decreased number of live foetuses and increased post-implantation loss) effects occurred at dose levels which were not toxic to the pregnant dams. Ref: 11a and 11b 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigation","page":21,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_004"}
SCCS_vision_codex NOAEL =100 mg/kg rat oral developmental developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg System...","effect":"SCCP/1036/06 OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.096 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0128 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 7792","page":22,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_006"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat - 90-day NOAEL study {"dose":"Stability of 3-Nitro-p- hydroxyethylaminophenol in marketed products is not reported General toxicity A non-lethal dose of 3-nitro-p-hydroxethylaminophenol was 1000 mg/kg.","effect":"o-p-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. It should not be used in combination with nitrosating agents. Nitrosamine content in 3-nitro-p-hydroxyethylaminophenol is not reported. Stability of 3-Nitro-p- hydroxyethylaminophenol in marketed products is not reported General toxicity A non-lethal dose of 3-nitro-p-hydroxethylaminophenol was 1000 mg/kg. A lethal dose was 2000 mg/kg in rats. On the basis of significant increase in organ weights in the highest dose group, the NOAEL in the 90-day study was 200 mg/kg bw/day.","page":22,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_010"}
SCCS_vision_codex NOAEL =1000 mg/kg/day rat oral - NOAEL study {"citation":"Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation","dose":"Conclusion The oral administration of the product Imexine FH to the rat for three months at doses of 40, 200 and 1000 mg/kg/day caused no modifications in organs with the exception of pigment deposition in thyroid follicles of most of the males treated at the high dose.","effect":"follicles. Conclusion The oral administration of the product Imexine FH to the rat for three months at doses of 40, 200 and 1000 mg/kg/day caused no modifications in organs with the exception of pigment deposition in thyroid follicles of most of the males treated at the high dose. According to the authors, this abnormality does not constitute a toxicological alteration and the dose of 1000 mg/kg/day administered under the conditions described can thus be considered as a dose without toxic effect. Accordingly, the NOAEL was set at 1000 mg/kg/day (5a). Additional work on this study included an expert report which reviewed the urinalysis, organ weight, macroscopic and microscopic findings, and confirmed the conclusion of the initial study report (5b). Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation. Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidne","page":13,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_001"}
SCCS_vision_codex NOAEL =15 % - - Chronic NOAEL study {"citation":"Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation","dose":"Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidney weight (males, females 15%), the NOAEL in this study was set at 200 mg/kg bw/day.","effect":"ditional work on this study included an expert report which reviewed the urinalysis, organ weight, macroscopic and microscopic findings, and confirmed the conclusion of the initial study report (5b). Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation. Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidney weight (males, females 15%), the NOAEL in this study was set at 200 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":13,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_002"}
SCCS_vision_codex NOAEL =1000 mg/kg rat - developmental developmental toxicity {"dose":"In the submission the applicant concluded that the NOAEL for both maternal and developmental toxicity was 1000 mg/kg day.","effect":"yotoxic and 2 foetuses showed malformations (11a). According to an additional position paper in which the significance of the polydactyly was investigated, the presence of a polydactyly was not confirmed by the re-examination of the specimen by two reviewers. The changes noted in carpals were therefore considered an artefact and not to be test item related (11b). Comments Despite the deficiencies of this study (purity unknown) this study is useful for evaluation. In the submission the applicant concluded that the NOAEL for both maternal and developmental toxicity was 1000 mg/kg day. The applicant argued that the external astomia associated with the face and brain observed in a single foetus from the 1000 mg/kg/day group is unlikely to be related to administration of the test substance, given the isolated nature of this finding and because this malformation is known to occur spontaneously in rats of this strain at a low incidence. However, no historical control data on the occurrence of external astomia is provided. It can not be","page":21,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg/day rat - developmental developmental toxicity {"citation":"Ref: 11a and 11b 3","dose":"In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group.","effect":"eously in rats of this strain at a low incidence. However, no historical control data on the occurrence of external astomia is provided. It can not be ruled out that the observed teratogenic effect (external astomia) was related to the administration of the test substance. In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group. Therefore, the SCCP considers the NOAEL for developmental toxicity to be 100 mg/kg/day and the NOAEL for maternal toxicity 1000 mg/kg/day, which means that it can not be ruled out that teratogenic (external astomia) and embryotoxic (decreased number of live foetuses and increased post-implantation loss) effects occurred at dose levels which were not toxic to the pregnant dams. Ref: 11a and 11b 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigation","page":21,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_004"}
SCCS_vision_codex NOAEL =100 mg/kg rat oral developmental developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg System...","effect":"SCCP/1036/06 OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.096 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0128 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 7792","page":22,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_006"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat - 90-day NOAEL study {"dose":"Stability of 3-Nitro-p- hydroxyethylaminophenol in marketed products is not reported General toxicity A non-lethal dose of 3-nitro-p-hydroxethylaminophenol was 1000 mg/kg.","effect":"o-p-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. It should not be used in combination with nitrosating agents. Nitrosamine content in 3-nitro-p-hydroxyethylaminophenol is not reported. Stability of 3-Nitro-p- hydroxyethylaminophenol in marketed products is not reported General toxicity A non-lethal dose of 3-nitro-p-hydroxethylaminophenol was 1000 mg/kg. A lethal dose was 2000 mg/kg in rats. On the basis of significant increase in organ weights in the highest dose group, the NOAEL in the 90-day study was 200 mg/kg bw/day.","page":22,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_010"}
SCCS_vision_codex NOAEL =1000 mg/kg/day rat oral - NOAEL study {"citation":"Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation","dose":"Conclusion The oral administration of the product Imexine FH to the rat for three months at doses of 40, 200 and 1000 mg/kg/day caused no modifications in organs with the exception of pigment deposition in thyroid follicles of most of the males treated at the high dose.","effect":"follicles. Conclusion The oral administration of the product Imexine FH to the rat for three months at doses of 40, 200 and 1000 mg/kg/day caused no modifications in organs with the exception of pigment deposition in thyroid follicles of most of the males treated at the high dose. According to the authors, this abnormality does not constitute a toxicological alteration and the dose of 1000 mg/kg/day administered under the conditions described can thus be considered as a dose without toxic effect. Accordingly, the NOAEL was set at 1000 mg/kg/day (5a). Additional work on this study included an expert report which reviewed the urinalysis, organ weight, macroscopic and microscopic findings, and confirmed the conclusion of the initial study report (5b). Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation. Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidne","page":13,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_001"}
SCCS_vision_codex NOAEL =15 % - - Chronic NOAEL study {"citation":"Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation","dose":"Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidney weight (males, females 15%), the NOAEL in this study was set at 200 mg/kg bw/day.","effect":"ditional work on this study included an expert report which reviewed the urinalysis, organ weight, macroscopic and microscopic findings, and confirmed the conclusion of the initial study report (5b). Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation. Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidney weight (males, females 15%), the NOAEL in this study was set at 200 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","page":13,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_002"}
SCCS_vision_codex NOAEL =1000 mg/kg rat - developmental developmental toxicity {"dose":"In the submission the applicant concluded that the NOAEL for both maternal and developmental toxicity was 1000 mg/kg day.","effect":"yotoxic and 2 foetuses showed malformations (11a). According to an additional position paper in which the significance of the polydactyly was investigated, the presence of a polydactyly was not confirmed by the re-examination of the specimen by two reviewers. The changes noted in carpals were therefore considered an artefact and not to be test item related (11b). Comments Despite the deficiencies of this study (purity unknown) this study is useful for evaluation. In the submission the applicant concluded that the NOAEL for both maternal and developmental toxicity was 1000 mg/kg day. The applicant argued that the external astomia associated with the face and brain observed in a single foetus from the 1000 mg/kg/day group is unlikely to be related to administration of the test substance, given the isolated nature of this finding and because this malformation is known to occur spontaneously in rats of this strain at a low incidence. However, no historical control data on the occurrence of external astomia is provided. It can not be","page":21,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_003"}
SCCS_vision_codex NOAEL =100 mg/kg/day rat - developmental developmental toxicity {"citation":"Ref: 11a and 11b 3","dose":"In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group.","effect":"eously in rats of this strain at a low incidence. However, no historical control data on the occurrence of external astomia is provided. It can not be ruled out that the observed teratogenic effect (external astomia) was related to the administration of the test substance. In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group. Therefore, the SCCP considers the NOAEL for developmental toxicity to be 100 mg/kg/day and the NOAEL for maternal toxicity 1000 mg/kg/day, which means that it can not be ruled out that teratogenic (external astomia) and embryotoxic (decreased number of live foetuses and increased post-implantation loss) effects occurred at dose levels which were not toxic to the pregnant dams. Ref: 11a and 11b 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigation","page":21,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_004"}
SCCS_vision_codex NOAEL =100 mg/kg rat oral developmental developmental toxicity {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg System...","effect":"SCCP/1036/06 OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.096 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0128 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 7792","page":22,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_006"}
SCCS_vision_codex NOAEL =200 mg/kg bw/day rat - 90-day NOAEL study {"dose":"Stability of 3-Nitro-p- hydroxyethylaminophenol in marketed products is not reported General toxicity A non-lethal dose of 3-nitro-p-hydroxethylaminophenol was 1000 mg/kg.","effect":"o-p-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. It should not be used in combination with nitrosating agents. Nitrosamine content in 3-nitro-p-hydroxyethylaminophenol is not reported. Stability of 3-Nitro-p- hydroxyethylaminophenol in marketed products is not reported General toxicity A non-lethal dose of 3-nitro-p-hydroxethylaminophenol was 1000 mg/kg. A lethal dose was 2000 mg/kg in rats. On the basis of significant increase in organ weights in the highest dose group, the NOAEL in the 90-day study was 200 mg/kg bw/day.","page":22,"pdf":"sccp_o_083.pdf","row_type":"noael_study","study_id":"sccp_o_083_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 11 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1000 mg/kg/day rat oral - - SOURCE_SUBDIR=sccp_o_083; REPORT_TITLE=OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL COLIPA N° B54; OPINION_NUMBER=SCCP/1036/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=Conclusion The oral administration of the product Imexine FH to the rat for three months at doses of 40, 200 and 1000 mg/kg/day caused no modifications in organs with the exception of pigment deposition in thyroid follicles of most of the males treated at the high dose.; EFFECT=follicles. Conclusion The oral administration of the product Imexine FH to the rat for three months at doses of 40, 200 and 1000 mg/kg/day caused no modifications in organs with the exception of pigment deposition in thyroid follicles of most of the males treated at the high dose. According to the authors, this abnormality does not constitute a toxicological alteration and the dose of 1000 mg/kg/day administered under the conditions described can thus be considered as a dose without toxic effect. Accordingly, the NOAEL was set at 1000 mg/kg/day (5a). Additional work on this study included an expert report which reviewed the urinalysis, organ weight, macroscopic and microscopic findings, and confirmed the conclusion of the initial study report (5b). Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation. Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidne; CITATION=Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation; CITATION_NUMBERS=[5]; REFERENCE=Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation; DETAILS_JSON={"cas_number":"65235-31-6","citation":"Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation","dose":"Conclusion The oral administration of the product Imexine FH to the rat for three months at doses of 40, 200 and 1000 mg/kg/day caused no modifications in organs with the exception of pigment deposition in thyroid follicles of most of the males treated at the high dose.","duration":"","effect":"follicles. Conclusion The oral administration of the product Imexine FH to the rat for three months at doses of 40, 200 and 1000 mg/kg/day caused no modifications in organs with the exception of pigment deposition in thyroid follicles of most of the males treated at the high dose. According to the authors, this abnormality does not constitute a toxicological alteration and the dose of 1000 mg/kg/day administered under the conditions described can thus be considered as a dose without toxic effect. Accordingly, the NOAEL was set at 1000 mg/kg/day (5a). Additional work on this study included an expert report which reviewed the urinalysis, organ weight, macroscopic and microscopic findings, and confirmed the conclusion of the initial study report (5b). Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation. Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidne","endpoint":"","ingredient":"3-Nitro-p-hydroxyethylaminophenol (INCI)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"1000","page":13,"route":"oral","species":"rat","study_id":"sccp_o_083_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 15 % - - Chronic - SOURCE_SUBDIR=sccp_o_083; REPORT_TITLE=OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL COLIPA N° B54; OPINION_NUMBER=SCCP/1036/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=15; DOSE=Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidney weight (males, females 15%), the NOAEL in this study was set at 200 mg/kg bw/day.; EFFECT=ditional work on this study included an expert report which reviewed the urinalysis, organ weight, macroscopic and microscopic findings, and confirmed the conclusion of the initial study report (5b). Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation. Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidney weight (males, females 15%), the NOAEL in this study was set at 200 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted; CITATION=Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation; CITATION_NUMBERS=[5]; REFERENCE=Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation; DETAILS_JSON={"cas_number":"65235-31-6","citation":"Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation","dose":"Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidney weight (males, females 15%), the NOAEL in this study was set at 200 mg/kg bw/day.","duration":"Chronic","effect":"ditional work on this study included an expert report which reviewed the urinalysis, organ weight, macroscopic and microscopic findings, and confirmed the conclusion of the initial study report (5b). Ref.: 5a and 5b Comment Despite the deficiencies of this study (not according to a guideline) this study is useful for evaluation. Based on organ weight increase in the highest dose group (19% increase in relative liver weight (females, males 12%) and a 19% increase in relative kidney weight (males, females 15%), the NOAEL in this study was set at 200 mg/kg bw/day. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted","endpoint":"","ingredient":"3-Nitro-p-hydroxyethylaminophenol (INCI)","loael_value":"","noael_unit":"%","noael_value":"15","page":13,"route":"","species":"","study_id":"sccp_o_083_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 200 mg/kg bw/day rat - 90-day - SOURCE_SUBDIR=sccp_o_083; REPORT_TITLE=OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL COLIPA N° B54; OPINION_NUMBER=SCCP/1036/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=200; DOSE=Stability of 3-Nitro-p- hydroxyethylaminophenol in marketed products is not reported General toxicity A non-lethal dose of 3-nitro-p-hydroxethylaminophenol was 1000 mg/kg.; EFFECT=o-p-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. It should not be used in combination with nitrosating agents. Nitrosamine content in 3-nitro-p-hydroxyethylaminophenol is not reported. Stability of 3-Nitro-p- hydroxyethylaminophenol in marketed products is not reported General toxicity A non-lethal dose of 3-nitro-p-hydroxethylaminophenol was 1000 mg/kg. A lethal dose was 2000 mg/kg in rats. On the basis of significant increase in organ weights in the highest dose group, the NOAEL in the 90-day study was 200 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65235-31-6","citation":"","dose":"Stability of 3-Nitro-p- hydroxyethylaminophenol in marketed products is not reported General toxicity A non-lethal dose of 3-nitro-p-hydroxethylaminophenol was 1000 mg/kg.","duration":"90-day","effect":"o-p-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. It should not be used in combination with nitrosating agents. Nitrosamine content in 3-nitro-p-hydroxyethylaminophenol is not reported. Stability of 3-Nitro-p- hydroxyethylaminophenol in marketed products is not reported General toxicity A non-lethal dose of 3-nitro-p-hydroxethylaminophenol was 1000 mg/kg. A lethal dose was 2000 mg/kg in rats. On the basis of significant increase in organ weights in the highest dose group, the NOAEL in the 90-day study was 200 mg/kg bw/day.","endpoint":"","ingredient":"3-Nitro-p-hydroxyethylaminophenol (INCI)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":22,"route":"","species":"rat","study_id":"sccp_o_083_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 1000 mg/kg rat - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_083; REPORT_TITLE=OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL COLIPA N° B54; OPINION_NUMBER=SCCP/1036/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=1000; DOSE=In the submission the applicant concluded that the NOAEL for both maternal and developmental toxicity was 1000 mg/kg day.; EFFECT=yotoxic and 2 foetuses showed malformations (11a). According to an additional position paper in which the significance of the polydactyly was investigated, the presence of a polydactyly was not confirmed by the re-examination of the specimen by two reviewers. The changes noted in carpals were therefore considered an artefact and not to be test item related (11b). Comments Despite the deficiencies of this study (purity unknown) this study is useful for evaluation. In the submission the applicant concluded that the NOAEL for both maternal and developmental toxicity was 1000 mg/kg day. The applicant argued that the external astomia associated with the face and brain observed in a single foetus from the 1000 mg/kg/day group is unlikely to be related to administration of the test substance, given the isolated nature of this finding and because this malformation is known to occur spontaneously in rats of this strain at a low incidence. However, no historical control data on the occurrence of external astomia is provided. It can not be; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65235-31-6","citation":"","dose":"In the submission the applicant concluded that the NOAEL for both maternal and developmental toxicity was 1000 mg/kg day.","duration":"developmental","effect":"yotoxic and 2 foetuses showed malformations (11a). According to an additional position paper in which the significance of the polydactyly was investigated, the presence of a polydactyly was not confirmed by the re-examination of the specimen by two reviewers. The changes noted in carpals were therefore considered an artefact and not to be test item related (11b). Comments Despite the deficiencies of this study (purity unknown) this study is useful for evaluation. In the submission the applicant concluded that the NOAEL for both maternal and developmental toxicity was 1000 mg/kg day. The applicant argued that the external astomia associated with the face and brain observed in a single foetus from the 1000 mg/kg/day group is unlikely to be related to administration of the test substance, given the isolated nature of this finding and because this malformation is known to occur spontaneously in rats of this strain at a low incidence. However, no historical control data on the occurrence of external astomia is provided. It can not be","endpoint":"developmental toxicity","ingredient":"3-Nitro-p-hydroxyethylaminophenol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"1000","page":21,"route":"","species":"rat","study_id":"sccp_o_083_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg/day rat - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_083; REPORT_TITLE=OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL COLIPA N° B54; OPINION_NUMBER=SCCP/1036/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=100; DOSE=In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group.; EFFECT=eously in rats of this strain at a low incidence. However, no historical control data on the occurrence of external astomia is provided. It can not be ruled out that the observed teratogenic effect (external astomia) was related to the administration of the test substance. In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group. Therefore, the SCCP considers the NOAEL for developmental toxicity to be 100 mg/kg/day and the NOAEL for maternal toxicity 1000 mg/kg/day, which means that it can not be ruled out that teratogenic (external astomia) and embryotoxic (decreased number of live foetuses and increased post-implantation loss) effects occurred at dose levels which were not toxic to the pregnant dams. Ref: 11a and 11b 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigation; CITATION=Ref: 11a and 11b 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref: 11a and 11b 3; DETAILS_JSON={"cas_number":"65235-31-6","citation":"Ref: 11a and 11b 3","dose":"In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group.","duration":"developmental","effect":"eously in rats of this strain at a low incidence. However, no historical control data on the occurrence of external astomia is provided. It can not be ruled out that the observed teratogenic effect (external astomia) was related to the administration of the test substance. In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group. Therefore, the SCCP considers the NOAEL for developmental toxicity to be 100 mg/kg/day and the NOAEL for maternal toxicity 1000 mg/kg/day, which means that it can not be ruled out that teratogenic (external astomia) and embryotoxic (decreased number of live foetuses and increased post-implantation loss) effects occurred at dose levels which were not toxic to the pregnant dams. Ref: 11a and 11b 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigation","endpoint":"developmental toxicity","ingredient":"3-Nitro-p-hydroxyethylaminophenol (INCI)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":21,"route":"","species":"rat","study_id":"sccp_o_083_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg/day human - developmental developmental toxicity SOURCE_SUBDIR=sccp_o_083; REPORT_TITLE=OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL COLIPA N° B54; OPINION_NUMBER=SCCP/1036/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=100; DOSE=In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group.; EFFECT=historical control data on the occurrence of external astomia is provided. It can not be ruled out that the observed teratogenic effect (external astomia) was related to the administration of the test substance. In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group. Therefore, the SCCP considers the NOAEL for developmental toxicity to be 100 mg/kg/day and the NOAEL for maternal toxicity 1000 mg/kg/day, which means that it can not be ruled out that teratogenic (external astomia) and embryotoxic (decreased number of live foetuses and increased post-implantation loss) effects occurred at dose levels which were not toxic to the pregnant dams. Ref: 11a and 11b 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted; CITATION=Ref: 11a and 11b 3; CITATION_NUMBERS=[11,3]; REFERENCE=Ref: 11a and 11b 3; DETAILS_JSON={"cas_number":"65235-31-6","citation":"Ref: 11a and 11b 3","dose":"In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group.","duration":"developmental","effect":"historical control data on the occurrence of external astomia is provided. It can not be ruled out that the observed teratogenic effect (external astomia) was related to the administration of the test substance. In addition, embryotoxic effects (a statistically significant decrease in the number of live foetuses and a statistically significant increased post-implantation loss) were observed in the 1000 mg/kg/day group. Therefore, the SCCP considers the NOAEL for developmental toxicity to be 100 mg/kg/day and the NOAEL for maternal toxicity 1000 mg/kg/day, which means that it can not be ruled out that teratogenic (external astomia) and embryotoxic (decreased number of live foetuses and increased post-implantation loss) effects occurred at dose levels which were not toxic to the pregnant dams. Ref: 11a and 11b 3.3.9. Toxicokinetics No data submitted 3.3.10. Photo-induced toxicity No data submitted 3.3.11. Human data No data submitted 3.3.12. Special investigations No data submitted","endpoint":"developmental toxicity","ingredient":"3-Nitro-p-hydroxyethylaminophenol (INCI)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":21,"route":"","species":"human","study_id":"sccp_o_083_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =100 mg/kg rat oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_083; REPORT_TITLE=OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL COLIPA N° B54; OPINION_NUMBER=SCCP/1036/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg System...; EFFECT=SCCP/1036/06 OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.096 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0128 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 7792; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65235-31-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg System...","duration":"developmental","effect":"SCCP/1036/06 OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.096 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0128 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 7792","endpoint":"developmental toxicity","ingredient":"3-Nitro-p-hydroxyethylaminophenol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 100","page":22,"route":"oral","species":"rat","study_id":"sccp_o_083_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =100 mg/kg rat oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_083; REPORT_TITLE=OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL COLIPA N° B54; OPINION_NUMBER=SCCP/1036/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg System...; EFFECT=NOL 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.096 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0128 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 7792 3.3.14. Discussion Physico-chemical specifications The ing; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65235-31-6","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg System...","duration":"developmental","effect":"NOL 22 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY (3-nitro-p-hydroxyethylaminophenol) (Oxidative/permanent) Maximum absorption through the skin A (µg/cm2) = 8.21 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 5.75 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.096 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0128 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 7792 3.3.14. Discussion Physico-chemical specifications The ing","endpoint":"developmental toxicity","ingredient":"3-Nitro-p-hydroxyethylaminophenol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 100","page":22,"route":"oral","species":"rat","study_id":"sccp_o_083_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =100 mg/kg rat oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_083; REPORT_TITLE=OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL COLIPA N° B54; OPINION_NUMBER=SCCP/1036/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 100; DOSE=ose (SED) SAS x A x 0.001/60 = 0.096 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per tr...; EFFECT=ose (SED) SAS x A x 0.001/60 = 0.096 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0128 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 7792 3.3.14. Discussion Physico-chemical specifications The ingredient 3-nitro-p-hydroxethylaminophenol is used in oxidative hair colouring products at a maximum on-head concentration of 3%, after mixing the hair dye formulation with hydrogen peroxide typically in 1:1 proportions. 3-Nitro-p-hydroxethylaminophenol is also used in semi-permanent hair colouring products at a maximum concentration of 1.85%. 3-Nitro-p-hydroxyethylaminophenol is; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65235-31-6","citation":"","dose":"ose (SED) SAS x A x 0.001/60 = 0.096 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per tr...","duration":"developmental","effect":"ose (SED) SAS x A x 0.001/60 = 0.096 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0128 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 7792 3.3.14. Discussion Physico-chemical specifications The ingredient 3-nitro-p-hydroxethylaminophenol is used in oxidative hair colouring products at a maximum on-head concentration of 3%, after mixing the hair dye formulation with hydrogen peroxide typically in 1:1 proportions. 3-Nitro-p-hydroxethylaminophenol is also used in semi-permanent hair colouring products at a maximum concentration of 1.85%. 3-Nitro-p-hydroxyethylaminophenol is","endpoint":"developmental toxicity","ingredient":"3-Nitro-p-hydroxyethylaminophenol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 100","page":22,"route":"oral","species":"rat","study_id":"sccp_o_083_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity =100 mg/kg rat oral developmental developmental toxicity SOURCE_SUBDIR=sccp_o_083; REPORT_TITLE=OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL COLIPA N° B54; OPINION_NUMBER=SCCP/1036/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT== 100; DOSE=evel (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human...; EFFECT=evel (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0128 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 7792 3.3.14. Discussion Physico-chemical specifications The ingredient 3-nitro-p-hydroxethylaminophenol is used in oxidative hair colouring products at a maximum on-head concentration of 3%, after mixing the hair dye formulation with hydrogen peroxide typically in 1:1 proportions. 3-Nitro-p-hydroxethylaminophenol is also used in semi-permanent hair colouring products at a maximum concentration of 1.85%. 3-Nitro-p-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. It sho; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65235-31-6","citation":"","dose":"evel (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human...","duration":"developmental","effect":"evel (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 1042 (3-nitro-p-hydroxyethylaminophenol) (Non-oxidative/semi-permanent) Maximum absorption through the skin A (µg/cm2) = 1.10 µg/cm² Skin Area surface SAS (cm2) = 700 cm2 Dermal absorption per treatment SAS x A x 0.001 = 0.71 mg Typical body weight of human = 60 kg Systemic exposure dose (SED) SAS x A x 0.001/60 = 0.0128 mg/kg No observed effect level (mg/kg) NOAEL = 100 mg/kg (developmental, oral, rat) Margin of Safety NOAEL / SED = 7792 3.3.14. Discussion Physico-chemical specifications The ingredient 3-nitro-p-hydroxethylaminophenol is used in oxidative hair colouring products at a maximum on-head concentration of 3%, after mixing the hair dye formulation with hydrogen peroxide typically in 1:1 proportions. 3-Nitro-p-hydroxethylaminophenol is also used in semi-permanent hair colouring products at a maximum concentration of 1.85%. 3-Nitro-p-hydroxyethylaminophenol is a secondary amine, and thus, it is prone to nitrosation. It sho","endpoint":"developmental toxicity","ingredient":"3-Nitro-p-hydroxyethylaminophenol (INCI)","loael_value":"","noael_unit":"mg/kg","noael_value":"= 100","page":22,"route":"oral","species":"rat","study_id":"sccp_o_083_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies developmental toxicity 100 mg/kg/day rabbit dermal developmental developmental toxicity SOURCE_SUBDIR=sccp_o_083; REPORT_TITLE=OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL COLIPA N° B54; OPINION_NUMBER=SCCP/1036/06; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=19 December 2006; VALUE_TEXT=100; DOSE=SCCP/1036/06 OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL 23 The NOAEL for developmental toxicity was set at 100 mg/kg/day and the NOAEL for maternal toxicity 1000 mg/kg/day.; EFFECT=SCCP/1036/06 OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL 23 The NOAEL for developmental toxicity was set at 100 mg/kg/day and the NOAEL for maternal toxicity 1000 mg/kg/day. Irritation / sensitisation 6% 3-nitro-p-hydroxyethylaminophenol was not irritant to rabbit skin. It was irritant to rabbit eyes. 3-nitro-p-hydroxyethylaminophenol was an extreme sensitiser in the murine Local Lymph Node Assay. Dermal absorption The maximum absorption values of 8.21 µgeq/cm² in oxidative and of 1.10 µgeq/cm² in semi-permanent conditions will be used for the calculation of the MoS. Mutagenic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65235-31-6","citation":"","dose":"SCCP/1036/06 OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL 23 The NOAEL for developmental toxicity was set at 100 mg/kg/day and the NOAEL for maternal toxicity 1000 mg/kg/day.","duration":"developmental","effect":"SCCP/1036/06 OPINION ON 3-NITRO-P-HYDROXYETHYLAMINOPHENOL 23 The NOAEL for developmental toxicity was set at 100 mg/kg/day and the NOAEL for maternal toxicity 1000 mg/kg/day. Irritation / sensitisation 6% 3-nitro-p-hydroxyethylaminophenol was not irritant to rabbit skin. It was irritant to rabbit eyes. 3-nitro-p-hydroxyethylaminophenol was an extreme sensitiser in the murine Local Lymph Node Assay. Dermal absorption The maximum absorption values of 8.21 µgeq/cm² in oxidative and of 1.10 µgeq/cm² in semi-permanent conditions will be used for the calculation of the MoS. Mutagenic","endpoint":"developmental toxicity","ingredient":"3-Nitro-p-hydroxyethylaminophenol (INCI)","loael_value":"","noael_unit":"mg/kg/day","noael_value":"100","page":23,"route":"dermal","species":"rabbit","study_id":"sccp_o_083_noael_011"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier AIP2J155AN UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H10N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"AIP2J155AN"}
openFDA substances FDA UNII substance identifier AIP2J155AN UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H10N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"AIP2J155AN"}
openFDA substances FDA UNII substance identifier AIP2J155AN UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H10N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"AIP2J155AN"}
openFDA substances FDA UNII substance identifier AIP2J155AN UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H10N2O4","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"AIP2J155AN"}