NOAEL Studies Cosmetic Ingredient

HC Red No. 7 NOAEL Studies

INCI: HC RED NO. 7

CAS: 24905-87-1

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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CIR Safety Assessment 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment NOAEL =50 mg/kg day rat oral subchronic repeated dose toxicity {"citation":"1; 7; 98","dose":"In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg.","effect":"ol- orant in one cosmetic product at 1%. Analytical studies found the relative purity of HC Red No. 7 to be >98.5%. Impurities may include 2-nitro-benzene-1,4-diamine; 3-(4-amino-3-nitro-phenyl)- oxazolin-2-one; 2-chloroethyl 4-amino-3-nitrophenylcarbamate; residual solvents ethanol, DMF, or isopropyl acetate; chloride ions; and heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day−1. HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moder- ate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was...","page":1,"pdf":"PRS362.pdf","row_type":"noael_study","study_id":"PRS362_noael_001"}
CIR Safety Assessment NOAEL =200 mg/kg/day rat oral subchronic repeated dose toxicity {"citation":"0; 10; 7","dose":"In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg.","effect":"d heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day−1. HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moder- ate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was mutagenic in several Salmonella typhimurium strains, was not ac- tive in an unscheduled DNA synthesis assay, and was unclear in a micronucleus assay in human lymphocyte cultures. No carcino- genicity studies were available, nor were any clinical tests reported. Available hair dye epidemiology studies are insufficient to conclu...","page":1,"pdf":"PRS362.pdf","row_type":"noael_study","study_id":"PRS362_noael_002"}
CIR Safety Assessment NOAEL =50 mg/kg day rat oral subchronic repeated dose toxicity {"citation":"1; 7; 98","dose":"In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg.","effect":"ol- orant in one cosmetic product at 1%. Analytical studies found the relative purity of HC Red No. 7 to be >98.5%. Impurities may include 2-nitro-benzene-1,4-diamine; 3-(4-amino-3-nitro-phenyl)- oxazolin-2-one; 2-chloroethyl 4-amino-3-nitrophenylcarbamate; residual solvents ethanol, DMF, or isopropyl acetate; chloride ions; and heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day−1. HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moder- ate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was...","page":1,"pdf":"PRS362.pdf","row_type":"noael_study","study_id":"PRS362_noael_001"}
CIR Safety Assessment NOAEL =200 mg/kg/day rat oral subchronic repeated dose toxicity {"citation":"0; 10; 7","dose":"In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg.","effect":"d heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day−1. HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moder- ate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was mutagenic in several Salmonella typhimurium strains, was not ac- tive in an unscheduled DNA synthesis assay, and was unclear in a micronucleus assay in human lymphocyte cultures. No carcino- genicity studies were available, nor were any clinical tests reported. Available hair dye epidemiology studies are insufficient to conclu...","page":1,"pdf":"PRS362.pdf","row_type":"noael_study","study_id":"PRS362_noael_002"}
CIR Safety Assessment NOAEL =50 mg/kg day rat oral subchronic repeated dose toxicity {"citation":"1; 7; 98","dose":"In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg.","effect":"ol- orant in one cosmetic product at 1%. Analytical studies found the relative purity of HC Red No. 7 to be >98.5%. Impurities may include 2-nitro-benzene-1,4-diamine; 3-(4-amino-3-nitro-phenyl)- oxazolin-2-one; 2-chloroethyl 4-amino-3-nitrophenylcarbamate; residual solvents ethanol, DMF, or isopropyl acetate; chloride ions; and heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day−1. HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moder- ate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was...","page":1,"pdf":"PRS362.pdf","row_type":"noael_study","study_id":"PRS362_noael_001"}
CIR Safety Assessment NOAEL =200 mg/kg/day rat oral subchronic repeated dose toxicity {"citation":"0; 10; 7","dose":"In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg.","effect":"d heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day−1. HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moder- ate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was mutagenic in several Salmonella typhimurium strains, was not ac- tive in an unscheduled DNA synthesis assay, and was unclear in a micronucleus assay in human lymphocyte cultures. No carcino- genicity studies were available, nor were any clinical tests reported. Available hair dye epidemiology studies are insufficient to conclu...","page":1,"pdf":"PRS362.pdf","row_type":"noael_study","study_id":"PRS362_noael_002"}
CIR Safety Assessment NOAEL =50 mg/kg day rat oral subchronic repeated dose toxicity {"citation":"1; 7; 98","dose":"In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg.","effect":"ol- orant in one cosmetic product at 1%. Analytical studies found the relative purity of HC Red No. 7 to be >98.5%. Impurities may include 2-nitro-benzene-1,4-diamine; 3-(4-amino-3-nitro-phenyl)- oxazolin-2-one; 2-chloroethyl 4-amino-3-nitrophenylcarbamate; residual solvents ethanol, DMF, or isopropyl acetate; chloride ions; and heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day−1. HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moder- ate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was...","page":1,"pdf":"PRS362.pdf","row_type":"noael_study","study_id":"PRS362_noael_001"}
CIR Safety Assessment NOAEL =200 mg/kg/day rat oral subchronic repeated dose toxicity {"citation":"0; 10; 7","dose":"In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg.","effect":"d heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day−1. HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moder- ate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was mutagenic in several Salmonella typhimurium strains, was not ac- tive in an unscheduled DNA synthesis assay, and was unclear in a micronucleus assay in human lymphocyte cultures. No carcino- genicity studies were available, nor were any clinical tests reported. Available hair dye epidemiology studies are insufficient to conclu...","page":1,"pdf":"PRS362.pdf","row_type":"noael_study","study_id":"PRS362_noael_002"}
COSMOS DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB LOAEL 50 mg/kg bw/day rat oral 90 day Subchronic SCCNFP; S.A. Brownlie. Imexine FZ: 13 Week oral (Gavage) Toxicity Study in the Rat. ToxicolLaboratories Limited Study No. LRL/25/93,
SCCNFP Opinion 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCNFP Opinion NOAEL =10 % rat oral 13-week NOAEL study {"dose":"Nevertheless, the studies are sufficient to demonstrate that the substance is minimally toxic by ingestion of a single dose.","effect":"alkanolamine, that may give rise to nitrosamine formation. Therefore, analytical data on the nitrosamine content on more than one sample as well as in hair dye formulations is considered essential. The acute toxicity studies are old and not conducted to GLP or current guidelines. Nevertheless, the studies are sufficient to demonstrate that the substance is minimally toxic by ingestion of a single dose. A 13-week oral repeat dose study in rats showed a dose-related increase in liver weight of male rats for which a NOAEL was not identified. The 10% increase seen at 50 mg/kg bw/day cannot be clearly defined as “adverse” in the absence of histopathological changes. Serum transaminases were significantly elevated at 500 mg/kg bw/day, but not at the lower doses. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administere","page":17,"pdf":"out209_en.pdf","row_type":"noael_study","study_id":"out209_en_noael_003"}
SCCNFP Opinion NOAEL =10 % rat oral 13-week NOAEL study {"dose":"Nevertheless, the studies are sufficient to demonstrate that the substance is minimally toxic by ingestion of a single dose.","effect":"alkanolamine, that may give rise to nitrosamine formation. Therefore, analytical data on the nitrosamine content on more than one sample as well as in hair dye formulations is considered essential. The acute toxicity studies are old and not conducted to GLP or current guidelines. Nevertheless, the studies are sufficient to demonstrate that the substance is minimally toxic by ingestion of a single dose. A 13-week oral repeat dose study in rats showed a dose-related increase in liver weight of male rats for which a NOAEL was not identified. The 10% increase seen at 50 mg/kg bw/day cannot be clearly defined as “adverse” in the absence of histopathological changes. Serum transaminases were significantly elevated at 500 mg/kg bw/day, but not at the lower doses. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administere","page":17,"pdf":"out209_en.pdf","row_type":"noael_study","study_id":"out209_en_noael_003"}
SCCNFP Opinion NOAEL =10 % rat oral 13-week NOAEL study {"dose":"Nevertheless, the studies are sufficient to demonstrate that the substance is minimally toxic by ingestion of a single dose.","effect":"alkanolamine, that may give rise to nitrosamine formation. Therefore, analytical data on the nitrosamine content on more than one sample as well as in hair dye formulations is considered essential. The acute toxicity studies are old and not conducted to GLP or current guidelines. Nevertheless, the studies are sufficient to demonstrate that the substance is minimally toxic by ingestion of a single dose. A 13-week oral repeat dose study in rats showed a dose-related increase in liver weight of male rats for which a NOAEL was not identified. The 10% increase seen at 50 mg/kg bw/day cannot be clearly defined as “adverse” in the absence of histopathological changes. Serum transaminases were significantly elevated at 500 mg/kg bw/day, but not at the lower doses. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administere","page":17,"pdf":"out209_en.pdf","row_type":"noael_study","study_id":"out209_en_noael_003"}
SCCNFP Opinion NOAEL =10 % rat oral 13-week NOAEL study {"dose":"Nevertheless, the studies are sufficient to demonstrate that the substance is minimally toxic by ingestion of a single dose.","effect":"alkanolamine, that may give rise to nitrosamine formation. Therefore, analytical data on the nitrosamine content on more than one sample as well as in hair dye formulations is considered essential. The acute toxicity studies are old and not conducted to GLP or current guidelines. Nevertheless, the studies are sufficient to demonstrate that the substance is minimally toxic by ingestion of a single dose. A 13-week oral repeat dose study in rats showed a dose-related increase in liver weight of male rats for which a NOAEL was not identified. The 10% increase seen at 50 mg/kg bw/day cannot be clearly defined as “adverse” in the absence of histopathological changes. Serum transaminases were significantly elevated at 500 mg/kg bw/day, but not at the lower doses. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administere","page":17,"pdf":"out209_en.pdf","row_type":"noael_study","study_id":"out209_en_noael_003"}
SCCNFP Opinion NOAEL =50 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Histopathological examination revealed increased haemosiderin deposits in the spleen of 6/10 males and 9/10 females dosed at 500 mg/kg bw/day.","effect":"of toxicological significance. The only abnormalities observed at autopsy were related to the staining properties of the substance. Histopathological examination revealed increased haemosiderin deposits in the spleen of 6/10 males and 9/10 females dosed at 500 mg/kg bw/day. Only 2 of 10 slides were examined for the lower dose groups, which appeared normal. There were a small number of other observations which were considered to be within the normal range for the age and strain of rat. The author concluded that the NOAEL was 50 mg/kg bw/day and failed to mention the significant increase in relative liver weight in male animals treated at 50 mg/kg bw/day. This dose should be viewed as a LOAEL, although it cannot be definitely concluded that a 10% increase in liver weight is adverse. Effects on the spleen were observed in the high dose group, but it is not possible to draw conclusions on possible effects at 50 and 150 mg/kg bw/day, since insufficient slides were examined. Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data","page":7,"pdf":"out209_en.pdf","row_type":"noael_study","study_id":"out209_en_noael_001"}
SCCNFP Opinion NOAEL =50 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Histopathological examination revealed increased haemosiderin deposits in the spleen of 6/10 males and 9/10 females dosed at 500 mg/kg bw/day.","effect":"of toxicological significance. The only abnormalities observed at autopsy were related to the staining properties of the substance. Histopathological examination revealed increased haemosiderin deposits in the spleen of 6/10 males and 9/10 females dosed at 500 mg/kg bw/day. Only 2 of 10 slides were examined for the lower dose groups, which appeared normal. There were a small number of other observations which were considered to be within the normal range for the age and strain of rat. The author concluded that the NOAEL was 50 mg/kg bw/day and failed to mention the significant increase in relative liver weight in male animals treated at 50 mg/kg bw/day. This dose should be viewed as a LOAEL, although it cannot be definitely concluded that a 10% increase in liver weight is adverse. Effects on the spleen were observed in the high dose group, but it is not possible to draw conclusions on possible effects at 50 and 150 mg/kg bw/day, since insufficient slides were examined. Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data","page":7,"pdf":"out209_en.pdf","row_type":"noael_study","study_id":"out209_en_noael_001"}
SCCNFP Opinion NOAEL =50 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Histopathological examination revealed increased haemosiderin deposits in the spleen of 6/10 males and 9/10 females dosed at 500 mg/kg bw/day.","effect":"of toxicological significance. The only abnormalities observed at autopsy were related to the staining properties of the substance. Histopathological examination revealed increased haemosiderin deposits in the spleen of 6/10 males and 9/10 females dosed at 500 mg/kg bw/day. Only 2 of 10 slides were examined for the lower dose groups, which appeared normal. There were a small number of other observations which were considered to be within the normal range for the age and strain of rat. The author concluded that the NOAEL was 50 mg/kg bw/day and failed to mention the significant increase in relative liver weight in male animals treated at 50 mg/kg bw/day. This dose should be viewed as a LOAEL, although it cannot be definitely concluded that a 10% increase in liver weight is adverse. Effects on the spleen were observed in the high dose group, but it is not possible to draw conclusions on possible effects at 50 and 150 mg/kg bw/day, since insufficient slides were examined. Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data","page":7,"pdf":"out209_en.pdf","row_type":"noael_study","study_id":"out209_en_noael_001"}
SCCNFP Opinion NOAEL =50 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity {"citation":"Ref. : 5 2","dose":"Histopathological examination revealed increased haemosiderin deposits in the spleen of 6/10 males and 9/10 females dosed at 500 mg/kg bw/day.","effect":"of toxicological significance. The only abnormalities observed at autopsy were related to the staining properties of the substance. Histopathological examination revealed increased haemosiderin deposits in the spleen of 6/10 males and 9/10 females dosed at 500 mg/kg bw/day. Only 2 of 10 slides were examined for the lower dose groups, which appeared normal. There were a small number of other observations which were considered to be within the normal range for the age and strain of rat. The author concluded that the NOAEL was 50 mg/kg bw/day and failed to mention the significant increase in relative liver weight in male animals treated at 50 mg/kg bw/day. This dose should be viewed as a LOAEL, although it cannot be definitely concluded that a 10% increase in liver weight is adverse. Effects on the spleen were observed in the high dose group, but it is not possible to draw conclusions on possible effects at 50 and 150 mg/kg bw/day, since insufficient slides were examined. Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data","page":7,"pdf":"out209_en.pdf","row_type":"noael_study","study_id":"out209_en_noael_001"}
SCCNFP Opinion NOAEL =200 mg/kg bw/day - - - NOAEL study {"dose":"The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day.","effect":"s. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administered during organogenesis, the substance adversely affected maternal food consumption and weight gain, with a NOAEL of 50 mg/kg bw/day. Foetotoxicity appeared to be a secondary effect of maternal toxicity, occurring at 800 mg/kg bw/day with a NOAEL of 200 mg/kg bw/day.","page":17,"pdf":"out209_en.pdf","row_type":"noael_study","study_id":"out209_en_noael_006"}
SCCNFP Opinion NOAEL =200 mg/kg bw/day - - - NOAEL study {"dose":"The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day.","effect":"s. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administered during organogenesis, the substance adversely affected maternal food consumption and weight gain, with a NOAEL of 50 mg/kg bw/day. Foetotoxicity appeared to be a secondary effect of maternal toxicity, occurring at 800 mg/kg bw/day with a NOAEL of 200 mg/kg bw/day.","page":17,"pdf":"out209_en.pdf","row_type":"noael_study","study_id":"out209_en_noael_006"}
SCCNFP Opinion NOAEL =200 mg/kg bw/day - - - NOAEL study {"dose":"The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day.","effect":"s. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administered during organogenesis, the substance adversely affected maternal food consumption and weight gain, with a NOAEL of 50 mg/kg bw/day. Foetotoxicity appeared to be a secondary effect of maternal toxicity, occurring at 800 mg/kg bw/day with a NOAEL of 200 mg/kg bw/day.","page":17,"pdf":"out209_en.pdf","row_type":"noael_study","study_id":"out209_en_noael_006"}
SCCNFP Opinion NOAEL =200 mg/kg bw/day - - - NOAEL study {"dose":"The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day.","effect":"s. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administered during organogenesis, the substance adversely affected maternal food consumption and weight gain, with a NOAEL of 50 mg/kg bw/day. Foetotoxicity appeared to be a secondary effect of maternal toxicity, occurring at 800 mg/kg bw/day with a NOAEL of 200 mg/kg bw/day.","page":17,"pdf":"out209_en.pdf","row_type":"noael_study","study_id":"out209_en_noael_006"}
Regulatory source 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source repeated dose toxicity 50 mg/kg day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=PRS362; REPORT_TITLE=Final Report on the Safety Assessment of HC Red No. 7; OPINION_NUMBER=PRS362; COMMITTEE=safe as a hair dye ingredient in the practices of use and concentrations as described in this safety assessment; REPORT_DATE=2008; VALUE_TEXT=50; DOSE=In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg.; EFFECT=ol- orant in one cosmetic product at 1%. Analytical studies found the relative purity of HC Red No. 7 to be >98.5%. Impurities may include 2-nitro-benzene-1,4-diamine; 3-(4-amino-3-nitro-phenyl)- oxazolin-2-one; 2-chloroethyl 4-amino-3-nitrophenylcarbamate; residual solvents ethanol, DMF, or isopropyl acetate; chloride ions; and heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day−1. HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moder- ate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was...; CITATION=1; 7; 98; CITATION_NUMBERS=[1,7,98]; REFERENCE=1; 7; 98; DETAILS_JSON={"cas_number":"24905-87-1","citation":"1; 7; 98","dose":"In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg.","duration":"subchronic","effect":"ol- orant in one cosmetic product at 1%. Analytical studies found the relative purity of HC Red No. 7 to be >98.5%. Impurities may include 2-nitro-benzene-1,4-diamine; 3-(4-amino-3-nitro-phenyl)- oxazolin-2-one; 2-chloroethyl 4-amino-3-nitrophenylcarbamate; residual solvents ethanol, DMF, or isopropyl acetate; chloride ions; and heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day−1. HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moder- ate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was...","endpoint":"repeated dose toxicity","ingredient":"HC Red No. 7","loael_value":"","noael_unit":"mg/kg day","noael_value":"50","page":1,"route":"oral","species":"rat","study_id":"PRS362_noael_001"}
Regulatory source repeated dose toxicity 200 mg/kg/day rat oral subchronic repeated dose toxicity SOURCE_SUBDIR=PRS362; REPORT_TITLE=Final Report on the Safety Assessment of HC Red No. 7; OPINION_NUMBER=PRS362; COMMITTEE=safe as a hair dye ingredient in the practices of use and concentrations as described in this safety assessment; REPORT_DATE=2008; VALUE_TEXT=200; DOSE=In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg.; EFFECT=d heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day−1. HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moder- ate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was mutagenic in several Salmonella typhimurium strains, was not ac- tive in an unscheduled DNA synthesis assay, and was unclear in a micronucleus assay in human lymphocyte cultures. No carcino- genicity studies were available, nor were any clinical tests reported. Available hair dye epidemiology studies are insufficient to conclu...; CITATION=0; 10; 7; CITATION_NUMBERS=[10,7]; REFERENCE=0; 10; 7; DETAILS_JSON={"cas_number":"24905-87-1","citation":"0; 10; 7","dose":"In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg.","duration":"subchronic","effect":"d heavy metals. Around 0.10% of the applied HC Red No. 7 was absorbed in human dermatomed skin samples. In an acute oral toxicity study in rats, the maximum nonlethal dose was 300 mg/kg. The no observed effect level (NOEL) in a subchronic oral toxicity study in rats was 50 mg/kg day−1. HC Red No. 7 was not a dermal or ocular irritant in rabbits, but lymphoproliferative responses in mice indicated that HC Red No. 7 should be considered a moder- ate sensitizer. The NOEL for maternal toxicity was 50 mg/kg/day and the no observed adverse effect level (NOAEL) for embryonic development was 200 mg/kg/day in a prenatal toxicity study of HC Red No. 7 using rats. HC Red No. 7 was nonmutagenic at the hprt locus but mutagenic at the TK locus in mouse lymphoma cells, was mutagenic in several Salmonella typhimurium strains, was not ac- tive in an unscheduled DNA synthesis assay, and was unclear in a micronucleus assay in human lymphocyte cultures. No carcino- genicity studies were available, nor were any clinical tests reported. Available hair dye epidemiology studies are insufficient to conclu...","endpoint":"repeated dose toxicity","ingredient":"HC Red No. 7","loael_value":"","noael_unit":"mg/kg/day","noael_value":"200","page":1,"route":"oral","species":"rat","study_id":"PRS362_noael_002"}
Regulatory source - 10 % rat oral 13-week - SOURCE_SUBDIR=out209_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC RED Nº 7 COLIPA n° B36; OPINION_NUMBER=SCCNFP/0678/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=10; DOSE=Nevertheless, the studies are sufficient to demonstrate that the substance is minimally toxic by ingestion of a single dose.; EFFECT=alkanolamine, that may give rise to nitrosamine formation. Therefore, analytical data on the nitrosamine content on more than one sample as well as in hair dye formulations is considered essential. The acute toxicity studies are old and not conducted to GLP or current guidelines. Nevertheless, the studies are sufficient to demonstrate that the substance is minimally toxic by ingestion of a single dose. A 13-week oral repeat dose study in rats showed a dose-related increase in liver weight of male rats for which a NOAEL was not identified. The 10% increase seen at 50 mg/kg bw/day cannot be clearly defined as “adverse” in the absence of histopathological changes. Serum transaminases were significantly elevated at 500 mg/kg bw/day, but not at the lower doses. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administere; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"24905-87-1","citation":"","dose":"Nevertheless, the studies are sufficient to demonstrate that the substance is minimally toxic by ingestion of a single dose.","duration":"13-week","effect":"alkanolamine, that may give rise to nitrosamine formation. Therefore, analytical data on the nitrosamine content on more than one sample as well as in hair dye formulations is considered essential. The acute toxicity studies are old and not conducted to GLP or current guidelines. Nevertheless, the studies are sufficient to demonstrate that the substance is minimally toxic by ingestion of a single dose. A 13-week oral repeat dose study in rats showed a dose-related increase in liver weight of male rats for which a NOAEL was not identified. The 10% increase seen at 50 mg/kg bw/day cannot be clearly defined as “adverse” in the absence of histopathological changes. Serum transaminases were significantly elevated at 500 mg/kg bw/day, but not at the lower doses. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administere","endpoint":"","ingredient":"1-Amino-2-nitro-4-[(\u0001-hydroxyethyl)-aminobenzene]","loael_value":"","noael_unit":"%","noael_value":"10","page":17,"route":"oral","species":"rat","study_id":"out209_en_noael_003"}
Regulatory source - 50 mg/kg bw/day - - - - SOURCE_SUBDIR=out209_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC RED Nº 7 COLIPA n° B36; OPINION_NUMBER=SCCNFP/0678/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=50; DOSE=Incidences of minor abnormalities in the 50 and 200 mg/kg bw/day dose groups were similar to or lower than controls.; EFFECT=ral arches. Incidences of minor abnormalities in the 50 and 200 mg/kg bw/day dose groups were similar to or lower than controls. The test substance elicited dose-related maternal toxicity at 200 and 500 mg/kg bw/day. Delayed ossification was possibly related to lower foetal weight for larger litter sizes. However the incidence of 7 lumbar vertebrae and vestigial 14th ribs were considered to be indicative of an effect on foetal development, possibly resulting from the effect of treatment on maternal bodyweight. The NOAEL was 50 mg/kg bw/day for the dams and 200 mg/kg bw/day for the foetuses. Ref. : 11; CITATION=Ref. : 11; CITATION_NUMBERS=[11]; REFERENCE=Ref. : 11; DETAILS_JSON={"cas_number":"24905-87-1","citation":"Ref. : 11","dose":"Incidences of minor abnormalities in the 50 and 200 mg/kg bw/day dose groups were similar to or lower than controls.","duration":"","effect":"ral arches. Incidences of minor abnormalities in the 50 and 200 mg/kg bw/day dose groups were similar to or lower than controls. The test substance elicited dose-related maternal toxicity at 200 and 500 mg/kg bw/day. Delayed ossification was possibly related to lower foetal weight for larger litter sizes. However the incidence of 7 lumbar vertebrae and vestigial 14th ribs were considered to be indicative of an effect on foetal development, possibly resulting from the effect of treatment on maternal bodyweight. The NOAEL was 50 mg/kg bw/day for the dams and 200 mg/kg bw/day for the foetuses. Ref. : 11","endpoint":"","ingredient":"1-Amino-2-nitro-4-[(\u0001-hydroxyethyl)-aminobenzene]","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":10,"route":"","species":"","study_id":"out209_en_noael_002"}
Regulatory source - 50 mg/kg bw/day rat - - - SOURCE_SUBDIR=out209_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC RED Nº 7 COLIPA n° B36; OPINION_NUMBER=SCCNFP/0678/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=50; DOSE=The 10% increase seen at 50 mg/kg bw/day cannot be clearly defined as “adverse” in the absence of histopathological changes.; EFFECT=r weight of male rats for which a NOAEL was not identified. The 10% increase seen at 50 mg/kg bw/day cannot be clearly defined as “adverse” in the absence of histopathological changes. Serum transaminases were significantly elevated at 500 mg/kg bw/day, but not at the lower doses. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administered during organogenesis, the substance adversely affected maternal food consumption and weight gain, with a NOAEL of 50 mg/kg bw/day. Foetotoxicity appeared to be a secondary effect of maternal toxicity, occurring at 800 mg/kg bw/day with a NOAEL of 200 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"24905-87-1","citation":"","dose":"The 10% increase seen at 50 mg/kg bw/day cannot be clearly defined as “adverse” in the absence of histopathological changes.","duration":"","effect":"r weight of male rats for which a NOAEL was not identified. The 10% increase seen at 50 mg/kg bw/day cannot be clearly defined as “adverse” in the absence of histopathological changes. Serum transaminases were significantly elevated at 500 mg/kg bw/day, but not at the lower doses. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administered during organogenesis, the substance adversely affected maternal food consumption and weight gain, with a NOAEL of 50 mg/kg bw/day. Foetotoxicity appeared to be a secondary effect of maternal toxicity, occurring at 800 mg/kg bw/day with a NOAEL of 200 mg/kg bw/day.","endpoint":"","ingredient":"1-Amino-2-nitro-4-[(\u0001-hydroxyethyl)-aminobenzene]","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":17,"route":"","species":"rat","study_id":"out209_en_noael_004"}
Regulatory source - 50 mg/kg bw/day - - - - SOURCE_SUBDIR=out209_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC RED Nº 7 COLIPA n° B36; OPINION_NUMBER=SCCNFP/0678/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=50; DOSE=Serum transaminases were significantly elevated at 500 mg/kg bw/day, but not at the lower doses.; EFFECT=absence of histopathological changes. Serum transaminases were significantly elevated at 500 mg/kg bw/day, but not at the lower doses. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administered during organogenesis, the substance adversely affected maternal food consumption and weight gain, with a NOAEL of 50 mg/kg bw/day. Foetotoxicity appeared to be a secondary effect of maternal toxicity, occurring at 800 mg/kg bw/day with a NOAEL of 200 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"24905-87-1","citation":"","dose":"Serum transaminases were significantly elevated at 500 mg/kg bw/day, but not at the lower doses.","duration":"","effect":"absence of histopathological changes. Serum transaminases were significantly elevated at 500 mg/kg bw/day, but not at the lower doses. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administered during organogenesis, the substance adversely affected maternal food consumption and weight gain, with a NOAEL of 50 mg/kg bw/day. Foetotoxicity appeared to be a secondary effect of maternal toxicity, occurring at 800 mg/kg bw/day with a NOAEL of 200 mg/kg bw/day.","endpoint":"","ingredient":"1-Amino-2-nitro-4-[(\u0001-hydroxyethyl)-aminobenzene]","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":17,"route":"","species":"","study_id":"out209_en_noael_005"}
Regulatory source - 200 mg/kg bw/day - - - - SOURCE_SUBDIR=out209_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC RED Nº 7 COLIPA n° B36; OPINION_NUMBER=SCCNFP/0678/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=200; DOSE=The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day.; EFFECT=s. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administered during organogenesis, the substance adversely affected maternal food consumption and weight gain, with a NOAEL of 50 mg/kg bw/day. Foetotoxicity appeared to be a secondary effect of maternal toxicity, occurring at 800 mg/kg bw/day with a NOAEL of 200 mg/kg bw/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"24905-87-1","citation":"","dose":"The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day.","duration":"","effect":"s. The other most notable observation was deposits of haemosiderin in the spleens of both sexes at 500 mg/kg bw/day. The spleens of animals of the intermediate dose groups were not all examined and therefore it is not possible to identify a NOAEL for this effect. When administered during organogenesis, the substance adversely affected maternal food consumption and weight gain, with a NOAEL of 50 mg/kg bw/day. Foetotoxicity appeared to be a secondary effect of maternal toxicity, occurring at 800 mg/kg bw/day with a NOAEL of 200 mg/kg bw/day.","endpoint":"","ingredient":"1-Amino-2-nitro-4-[(\u0001-hydroxyethyl)-aminobenzene]","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"200","page":17,"route":"","species":"","study_id":"out209_en_noael_006"}
Regulatory source repeated dose toxicity 50 mg/kg bw/day rat dermal Sub-chronic repeated dose toxicity SOURCE_SUBDIR=out209_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC RED Nº 7 COLIPA n° B36; OPINION_NUMBER=SCCNFP/0678/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=50; DOSE=Histopathological examination revealed increased haemosiderin deposits in the spleen of 6/10 males and 9/10 females dosed at 500 mg/kg bw/day.; EFFECT=of toxicological significance. The only abnormalities observed at autopsy were related to the staining properties of the substance. Histopathological examination revealed increased haemosiderin deposits in the spleen of 6/10 males and 9/10 females dosed at 500 mg/kg bw/day. Only 2 of 10 slides were examined for the lower dose groups, which appeared normal. There were a small number of other observations which were considered to be within the normal range for the age and strain of rat. The author concluded that the NOAEL was 50 mg/kg bw/day and failed to mention the significant increase in relative liver weight in male animals treated at 50 mg/kg bw/day. This dose should be viewed as a LOAEL, although it cannot be definitely concluded that a 10% increase in liver weight is adverse. Effects on the spleen were observed in the high dose group, but it is not possible to draw conclusions on possible effects at 50 and 150 mg/kg bw/day, since insufficient slides were examined. Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data; CITATION=Ref. : 5 2; CITATION_NUMBERS=[5,2]; REFERENCE=Ref. : 5 2; DETAILS_JSON={"cas_number":"24905-87-1","citation":"Ref. : 5 2","dose":"Histopathological examination revealed increased haemosiderin deposits in the spleen of 6/10 males and 9/10 females dosed at 500 mg/kg bw/day.","duration":"Sub-chronic","effect":"of toxicological significance. The only abnormalities observed at autopsy were related to the staining properties of the substance. Histopathological examination revealed increased haemosiderin deposits in the spleen of 6/10 males and 9/10 females dosed at 500 mg/kg bw/day. Only 2 of 10 slides were examined for the lower dose groups, which appeared normal. There were a small number of other observations which were considered to be within the normal range for the age and strain of rat. The author concluded that the NOAEL was 50 mg/kg bw/day and failed to mention the significant increase in relative liver weight in male animals treated at 50 mg/kg bw/day. This dose should be viewed as a LOAEL, although it cannot be definitely concluded that a 10% increase in liver weight is adverse. Effects on the spleen were observed in the high dose group, but it is not possible to draw conclusions on possible effects at 50 and 150 mg/kg bw/day, since insufficient slides were examined. Ref. : 5 2.3.8. Sub-chronic dermal toxicity No data","endpoint":"repeated dose toxicity","ingredient":"1-Amino-2-nitro-4-[(\u0001-hydroxyethyl)-aminobenzene]","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":7,"route":"dermal","species":"rat","study_id":"out209_en_noael_001"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 5WRI22G12X UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11N3O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5WRI22G12X"}
openFDA substances FDA UNII substance identifier 5WRI22G12X UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11N3O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5WRI22G12X"}
openFDA substances FDA UNII substance identifier 5WRI22G12X UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11N3O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5WRI22G12X"}
openFDA substances FDA UNII substance identifier 5WRI22G12X UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H11N3O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5WRI22G12X"}