NOAEL Studies Cosmetic Ingredient

HC Orange No. 3 NOAEL Studies

INCI: HC ORANGE NO. 3

CAS: 81612-54-6

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 91 day Subchronic SCCNFP; Toxicol Labs Ltd, UK. Report No. LRL/34/94 (March 1995)
SCCNFP_vision_codex 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCNFP_vision_codex NOAEL =300 mg/kg bw/day rat - subchronic repeated dose toxicity {"dose":"Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day.","effect":"e of toxicological relevance because the weights were within the normal range. The only notable macroscopic findings related to the staining properties of the hair dye. The small number of histological findings recorded were reported to be within the normal range for this strain of rat. There was no evidence of toxicity in any organ, including the liver, spleen and kidney. Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day. The SCCNFP concluded that the NOAEL should be 100 mg/kg bw/day on the basis of the observed changes in organ weights. Fur and tail staining, observed in all treated animals during the treatment period as well as discoloration of the urine and staining of the urinary bladder, are indicative of absorption and distribution of the substance. The subchronic toxicity study lacks a recovery group which could give an answer to the question if the staining of the eyes observed in the high dose group i","page":7,"pdf":"out214_en.pdf","row_type":"noael_study","study_id":"out214_en_noael_001"}
SCCNFP_vision_codex NOAEL =100 mg/kg bw/day rat - subchronic repeated dose toxicity {"dose":"Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day.","effect":"in the normal range. The only notable macroscopic findings related to the staining properties of the hair dye. The small number of histological findings recorded were reported to be within the normal range for this strain of rat. There was no evidence of toxicity in any organ, including the liver, spleen and kidney. Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day. The SCCNFP concluded that the NOAEL should be 100 mg/kg bw/day on the basis of the observed changes in organ weights. Fur and tail staining, observed in all treated animals during the treatment period as well as discoloration of the urine and staining of the urinary bladder, are indicative of absorption and distribution of the substance. The subchronic toxicity study lacks a recovery group which could give an answer to the question if the staining of the eyes observed in the high dose group is persistent. In addition, no data are available for the d","page":7,"pdf":"out214_en.pdf","row_type":"noael_study","study_id":"out214_en_noael_002"}
SCCNFP_vision_codex NOAEL =300 mg/kg bw/day rat - subchronic repeated dose toxicity {"dose":"Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day.","effect":"e of toxicological relevance because the weights were within the normal range. The only notable macroscopic findings related to the staining properties of the hair dye. The small number of histological findings recorded were reported to be within the normal range for this strain of rat. There was no evidence of toxicity in any organ, including the liver, spleen and kidney. Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day. The SCCNFP concluded that the NOAEL should be 100 mg/kg bw/day on the basis of the observed changes in organ weights. Fur and tail staining, observed in all treated animals during the treatment period as well as discoloration of the urine and staining of the urinary bladder, are indicative of absorption and distribution of the substance. The subchronic toxicity study lacks a recovery group which could give an answer to the question if the staining of the eyes observed in the high dose group i","page":7,"pdf":"out214_en.pdf","row_type":"noael_study","study_id":"out214_en_noael_001"}
SCCNFP_vision_codex NOAEL =100 mg/kg bw/day rat - subchronic repeated dose toxicity {"dose":"Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day.","effect":"in the normal range. The only notable macroscopic findings related to the staining properties of the hair dye. The small number of histological findings recorded were reported to be within the normal range for this strain of rat. There was no evidence of toxicity in any organ, including the liver, spleen and kidney. Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day. The SCCNFP concluded that the NOAEL should be 100 mg/kg bw/day on the basis of the observed changes in organ weights. Fur and tail staining, observed in all treated animals during the treatment period as well as discoloration of the urine and staining of the urinary bladder, are indicative of absorption and distribution of the substance. The subchronic toxicity study lacks a recovery group which could give an answer to the question if the staining of the eyes observed in the high dose group is persistent. In addition, no data are available for the d","page":7,"pdf":"out214_en.pdf","row_type":"noael_study","study_id":"out214_en_noael_002"}
SCCNFP_vision_codex NOAEL =300 mg/kg bw/day rat - subchronic repeated dose toxicity {"dose":"Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day.","effect":"e of toxicological relevance because the weights were within the normal range. The only notable macroscopic findings related to the staining properties of the hair dye. The small number of histological findings recorded were reported to be within the normal range for this strain of rat. There was no evidence of toxicity in any organ, including the liver, spleen and kidney. Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day. The SCCNFP concluded that the NOAEL should be 100 mg/kg bw/day on the basis of the observed changes in organ weights. Fur and tail staining, observed in all treated animals during the treatment period as well as discoloration of the urine and staining of the urinary bladder, are indicative of absorption and distribution of the substance. The subchronic toxicity study lacks a recovery group which could give an answer to the question if the staining of the eyes observed in the high dose group i","page":7,"pdf":"out214_en.pdf","row_type":"noael_study","study_id":"out214_en_noael_001"}
SCCNFP_vision_codex NOAEL =100 mg/kg bw/day rat - subchronic repeated dose toxicity {"dose":"Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day.","effect":"in the normal range. The only notable macroscopic findings related to the staining properties of the hair dye. The small number of histological findings recorded were reported to be within the normal range for this strain of rat. There was no evidence of toxicity in any organ, including the liver, spleen and kidney. Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day. The SCCNFP concluded that the NOAEL should be 100 mg/kg bw/day on the basis of the observed changes in organ weights. Fur and tail staining, observed in all treated animals during the treatment period as well as discoloration of the urine and staining of the urinary bladder, are indicative of absorption and distribution of the substance. The subchronic toxicity study lacks a recovery group which could give an answer to the question if the staining of the eyes observed in the high dose group is persistent. In addition, no data are available for the d","page":7,"pdf":"out214_en.pdf","row_type":"noael_study","study_id":"out214_en_noael_002"}
SCCNFP_vision_codex NOAEL =300 mg/kg bw/day rat - subchronic repeated dose toxicity {"dose":"Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day.","effect":"e of toxicological relevance because the weights were within the normal range. The only notable macroscopic findings related to the staining properties of the hair dye. The small number of histological findings recorded were reported to be within the normal range for this strain of rat. There was no evidence of toxicity in any organ, including the liver, spleen and kidney. Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day. The SCCNFP concluded that the NOAEL should be 100 mg/kg bw/day on the basis of the observed changes in organ weights. Fur and tail staining, observed in all treated animals during the treatment period as well as discoloration of the urine and staining of the urinary bladder, are indicative of absorption and distribution of the substance. The subchronic toxicity study lacks a recovery group which could give an answer to the question if the staining of the eyes observed in the high dose group i","page":7,"pdf":"out214_en.pdf","row_type":"noael_study","study_id":"out214_en_noael_001"}
SCCNFP_vision_codex NOAEL =100 mg/kg bw/day rat - subchronic repeated dose toxicity {"dose":"Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day.","effect":"in the normal range. The only notable macroscopic findings related to the staining properties of the hair dye. The small number of histological findings recorded were reported to be within the normal range for this strain of rat. There was no evidence of toxicity in any organ, including the liver, spleen and kidney. Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day. The SCCNFP concluded that the NOAEL should be 100 mg/kg bw/day on the basis of the observed changes in organ weights. Fur and tail staining, observed in all treated animals during the treatment period as well as discoloration of the urine and staining of the urinary bladder, are indicative of absorption and distribution of the substance. The subchronic toxicity study lacks a recovery group which could give an answer to the question if the staining of the eyes observed in the high dose group is persistent. In addition, no data are available for the d","page":7,"pdf":"out214_en.pdf","row_type":"noael_study","study_id":"out214_en_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 300 mg/kg bw/day rat - subchronic repeated dose toxicity SOURCE_SUBDIR=out214_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC ORANGE NO. 3 COLIPA n° B68; OPINION_NUMBER=SCCNFP/0676/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=300; DOSE=Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day.; EFFECT=e of toxicological relevance because the weights were within the normal range. The only notable macroscopic findings related to the staining properties of the hair dye. The small number of histological findings recorded were reported to be within the normal range for this strain of rat. There was no evidence of toxicity in any organ, including the liver, spleen and kidney. Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day. The SCCNFP concluded that the NOAEL should be 100 mg/kg bw/day on the basis of the observed changes in organ weights. Fur and tail staining, observed in all treated animals during the treatment period as well as discoloration of the urine and staining of the urinary bladder, are indicative of absorption and distribution of the substance. The subchronic toxicity study lacks a recovery group which could give an answer to the question if the staining of the eyes observed in the high dose group i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"81612-54-6","citation":"","dose":"Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day.","duration":"subchronic","effect":"e of toxicological relevance because the weights were within the normal range. The only notable macroscopic findings related to the staining properties of the hair dye. The small number of histological findings recorded were reported to be within the normal range for this strain of rat. There was no evidence of toxicity in any organ, including the liver, spleen and kidney. Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day. The SCCNFP concluded that the NOAEL should be 100 mg/kg bw/day on the basis of the observed changes in organ weights. Fur and tail staining, observed in all treated animals during the treatment period as well as discoloration of the urine and staining of the urinary bladder, are indicative of absorption and distribution of the substance. The subchronic toxicity study lacks a recovery group which could give an answer to the question if the staining of the eyes observed in the high dose group i","endpoint":"repeated dose toxicity","ingredient":"1-(2,3-Dihydroxypropyloxy)-3-nitro-4-(2-hydroxyethylamino)-benzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":7,"route":"","species":"rat","study_id":"out214_en_noael_001"}
UnifiedCodex:SCCNFP:beta.noael_studies repeated dose toxicity 100 mg/kg bw/day rat - subchronic repeated dose toxicity SOURCE_SUBDIR=out214_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC ORANGE NO. 3 COLIPA n° B68; OPINION_NUMBER=SCCNFP/0676/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=100; DOSE=Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day.; EFFECT=in the normal range. The only notable macroscopic findings related to the staining properties of the hair dye. The small number of histological findings recorded were reported to be within the normal range for this strain of rat. There was no evidence of toxicity in any organ, including the liver, spleen and kidney. Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day. The SCCNFP concluded that the NOAEL should be 100 mg/kg bw/day on the basis of the observed changes in organ weights. Fur and tail staining, observed in all treated animals during the treatment period as well as discoloration of the urine and staining of the urinary bladder, are indicative of absorption and distribution of the substance. The subchronic toxicity study lacks a recovery group which could give an answer to the question if the staining of the eyes observed in the high dose group is persistent. In addition, no data are available for the d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"81612-54-6","citation":"","dose":"Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day.","duration":"subchronic","effect":"in the normal range. The only notable macroscopic findings related to the staining properties of the hair dye. The small number of histological findings recorded were reported to be within the normal range for this strain of rat. There was no evidence of toxicity in any organ, including the liver, spleen and kidney. Based upon the observations of elevated alanine aminotransferase and liver weight in males at 1000 mg/kg bw/day, the authors concluded that the NOAEL was 300 mg/kg bw/day. The SCCNFP concluded that the NOAEL should be 100 mg/kg bw/day on the basis of the observed changes in organ weights. Fur and tail staining, observed in all treated animals during the treatment period as well as discoloration of the urine and staining of the urinary bladder, are indicative of absorption and distribution of the substance. The subchronic toxicity study lacks a recovery group which could give an answer to the question if the staining of the eyes observed in the high dose group is persistent. In addition, no data are available for the d","endpoint":"repeated dose toxicity","ingredient":"1-(2,3-Dihydroxypropyloxy)-3-nitro-4-(2-hydroxyethylamino)-benzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":7,"route":"","species":"rat","study_id":"out214_en_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies sensitisation 100 mg/kg bw/day rat oral 13-week sensitisation SOURCE_SUBDIR=out214_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HC ORANGE NO. 3 COLIPA n° B68; OPINION_NUMBER=SCCNFP/0676/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=100; DOSE=3 was not toxic following acute administration to rats at 1000 mg/kg bw.; EFFECT=olamine, and thus, it is prone to nitrosation. No information on the nitrosamine content in the dye and dye formulations has been provided. No experimental data on stability are provided. Purity of the chemical reported for one batch only (Batch Op. 10) : it would be advisable to have an statement of the range of impurities that be may be present, based on the analysis of more than one batch. HC Orange No. 3 was not toxic following acute administration to rats at 1000 mg/kg bw. From a 13-week oral study in rats, a NOAEL of 100 mg/kg bw/day was concluded, based upon observed changes in various organ weights. The study also indicated staining of the eye by the dye. This may be a reversible staining effect. HC Orange No. 3 was not toxic to the pregnant rat and gave no evidence of embryotoxicity or teratogenicity at doses up to 1000 mg/kg bw/day. HC Orange n° 11 was non-irritating to rabbit skin and to the rabbit eye. Sensitisation potential has not been adequately tested. Under the experimental conditions described in the percutaneo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"81612-54-6","citation":"","dose":"3 was not toxic following acute administration to rats at 1000 mg/kg bw.","duration":"13-week","effect":"olamine, and thus, it is prone to nitrosation. No information on the nitrosamine content in the dye and dye formulations has been provided. No experimental data on stability are provided. Purity of the chemical reported for one batch only (Batch Op. 10) : it would be advisable to have an statement of the range of impurities that be may be present, based on the analysis of more than one batch. HC Orange No. 3 was not toxic following acute administration to rats at 1000 mg/kg bw. From a 13-week oral study in rats, a NOAEL of 100 mg/kg bw/day was concluded, based upon observed changes in various organ weights. The study also indicated staining of the eye by the dye. This may be a reversible staining effect. HC Orange No. 3 was not toxic to the pregnant rat and gave no evidence of embryotoxicity or teratogenicity at doses up to 1000 mg/kg bw/day. HC Orange n° 11 was non-irritating to rabbit skin and to the rabbit eye. Sensitisation potential has not been adequately tested. Under the experimental conditions described in the percutaneo","endpoint":"sensitisation","ingredient":"1-(2,3-Dihydroxypropyloxy)-3-nitro-4-(2-hydroxyethylamino)-benzene","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":15,"route":"oral","species":"rat","study_id":"out214_en_noael_003"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 428754S94Z UNII - - - chemical {"approval_status":null,"molecular_formula":"C11H16N2O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"428754S94Z"}
openFDA substances FDA UNII substance identifier 428754S94Z UNII - - - chemical {"approval_status":null,"molecular_formula":"C11H16N2O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"428754S94Z"}
openFDA substances FDA UNII substance identifier 428754S94Z UNII - - - chemical {"approval_status":null,"molecular_formula":"C11H16N2O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"428754S94Z"}
openFDA substances FDA UNII substance identifier 428754S94Z UNII - - - chemical {"approval_status":null,"molecular_formula":"C11H16N2O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"428754S94Z"}