NOAEL Studies Cosmetic Ingredient

CI 14720 (Carmoisine / Azorubine) NOAEL Studies

INCI: CI 14720

CAS: 3567-69-9

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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EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =375 mg/kg bw/day Mouse - - chronic/long term toxicity EFSA FEEDAP - 2012 - OutputID 150 - haematology - hemopoietic - Scientific Opinion on the safety and efficacy of Carmoisine (E 122) in feed for cats and dogs - doi:10.2903/j.efsa.2012.2570
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =400 mg/kg bw/day Rat - - chronic/long term toxicity EFSA FEEDAP - 2012 - OutputID 150 - body weight - systemic - Scientific Opinion on the safety and efficacy of Carmoisine (E 122) in feed for cats and dogs - doi:10.2903/j.efsa.2012.2570
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =375 mg/kg bw/day Mouse - - chronic/long term toxicity EFSA FEEDAP - 2012 - OutputID 150 - haematology - hemopoietic - Scientific Opinion on the safety and efficacy of Carmoisine (E 122) in feed for cats and dogs - doi:10.2903/j.efsa.2012.2570
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =400 mg/kg bw/day Rat - - chronic/long term toxicity EFSA FEEDAP - 2012 - OutputID 150 - body weight - systemic - Scientific Opinion on the safety and efficacy of Carmoisine (E 122) in feed for cats and dogs - doi:10.2903/j.efsa.2012.2570
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI <=4 mg/kg bw/day Consumers - - ADI EFSA ANS - 2009 - OutputID 396 - Consumers - Scientific Opinion on the re-evaluationof Azorubine/Carmoisine (E 122) as a food additive - doi:10.2903/j.efsa.2009.1332
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI <=4 mg/kg bw/day Consumers - - ADI EFSA ANS - 2009 - OutputID 396 - Consumers - Scientific Opinion on the re-evaluationof Azorubine/Carmoisine (E 122) as a food additive - doi:10.2903/j.efsa.2009.1332
IARC Monographs 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
IARC Monographs IARC carcinogenicity classification 3 IARC group - - 1987 IARC Monographs {"additional_info":"volume_publication_year=1987","evaluation_year":1987,"source_table":"iarc_classifications","volume":"8, Sup 7"}
INCHEM_WHO_jecfa_jecmono_v18je03 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_jecfa_jecmono_v18je03 ADI range:0-4.04 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v18je03; title=556. Azorubine (WHO Food Additives Series 18); path=mirror/documents/jecfa/jecmono/v18je03.htm; row_hash=92e75ca9e3040da3; raw_unit=mg/kg bw.; context=Estimate of acceptable daily intake for man 0-4.0 mg/kg bw.
INCHEM_WHO_jecfa_jecmono_v18je03 ADI range:0-4.04 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v18je03; title=556. Azorubine (WHO Food Additives Series 18); path=mirror/documents/jecfa/jecmono/v18je03.htm; row_hash=92e75ca9e3040da3; raw_unit=mg/kg bw.; context=Estimate of acceptable daily intake for man 0-4.0 mg/kg bw.
NTP_ICE_acute_oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 >10000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_5894; row=5497; data_type=In Vivo; mixture=Chemical; chemical_name=C.I. Acid Red 14; preferred_name=Azorubine; dtxsid=DTXSID3021225; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3021225; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID3021225; source_file=acute_oral.xlsx
NTP_ICE_cancer 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_cancer IARC group 3 unitless - - - WOE; IARC Carcinogenicity sheet=Data; excel_row=3634; Record_ID=cancer_1402; Data_Type=WOE; Formulation_Name=C.I. Acid Red 14; Mixture=Chemical; DTXSID=DTXSID3021225; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/26; http://publications.iarc.fr/139; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3021225; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3021225
NTP_ICE_cancer Top dose 25000 ppm Rat Dosed feed - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=3629; Record_ID=cancer_1405; Data_Type=In Vivo; Formulation_Name=C.I. Acid red 14; Mixture=Chemical; DTXSID=DTXSID3021225; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=25000; Response_Unit=ppm; Species=Rat; Strain=F344/N; Sex=Female; Route=Dosed feed; Reference=TR-220; URL=https://ntp.niehs.nih.gov/publications/reports/tr/200s/tr220/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3021225; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3021225
NTP_ICE_cancer Top dose 6000 ppm Mouse Dosed feed - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=3633; Record_ID=cancer_1401; Data_Type=In Vivo; Formulation_Name=C.I. Acid red 14; Mixture=Chemical; DTXSID=DTXSID3021225; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=6000; Response_Unit=ppm; Species=Mouse; Strain=B6C3F1; Sex=Female; Route=Dosed feed; Reference=TR-220; URL=https://ntp.niehs.nih.gov/publications/reports/tr/200s/tr220/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3021225; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3021225
NTP_ICE_cancer Top dose 12500 ppm Rat Dosed feed - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=3636; Record_ID=cancer_1403; Data_Type=In Vivo; Formulation_Name=C.I. Acid red 14; Mixture=Chemical; DTXSID=DTXSID3021225; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=12500; Response_Unit=ppm; Species=Rat; Strain=F344/N; Sex=Male; Route=Dosed feed; Reference=TR-220; URL=https://ntp.niehs.nih.gov/publications/reports/tr/200s/tr220/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3021225; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3021225
ToxValDB_ECHA_IUCLID 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =486 mg/kg bw/day Mouse dermal - chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c823e4b0a7c65d216dbe; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17281/7/8?documentUUID=5a017844-78fd-4fc3-9bc3-284a8276cdf0; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15816816_15819754:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_11612163c132b39d20e2407e7f5b1ee9
ToxValDB_ECHA_IUCLID NOAEL =1250 mg/kg bw/day Rat oral - chronic QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3ca9; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17281/7/8?documentUUID=5a017844-78fd-4fc3-9bc3-284a8276cdf0; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15820447_15820448:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_52271edce85929c0dd5b4bd92021e0aa
ToxValDB_ECHA_IUCLID NOAEL =625 mg/kg bw/day Rat oral - chronic QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3ca9; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17281/7/8?documentUUID=5a017844-78fd-4fc3-9bc3-284a8276cdf0; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15820449_15820450:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_14bd34594efb11866b614b6c4d678234
ToxValDB_ECHA_IUCLID NOAEL =1000 mg/kg bw/day Mouse oral - chronic QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3c99; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17281/7/8?documentUUID=5a017844-78fd-4fc3-9bc3-284a8276cdf0; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15820451_15820452:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_33d592ec62435bbe67be19c0a3e58f2d
ToxValDB_ECHA_IUCLID NOAEL =1785.7 mg/kg bw/day Mouse oral - chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3cad; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17281/7/8?documentUUID=5a017844-78fd-4fc3-9bc3-284a8276cdf0; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15820453_15820454:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_2b95e09125c9aa5c00b2982167dd82bd
ToxValDB_ECHA_IUCLID NOAEL =1200 mg/kg bw/day Rat oral - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab5ae4b0a7c65d1b9d5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22371/7/9/2?documentUUID=31fe9521-f090-4bec-a287-b660ae8bde2f; YEAR=2018; ORIGINAL_YEAR=2018; TOXICOLOGICAL_EFFECT=P0: clinical signs|P0: mortality|P0: reproductive performance; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs|mortality/survival|reproduction; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15860577_15862811:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_12bd8984a5a67a576ef8f02eff41010a
ToxValDB_ECHA_IUCLID NOAEL =400 mg/kg bw/day Rat oral - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab5ae4b0a7c65d1b9d5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22371/7/9/2?documentUUID=31fe9521-f090-4bec-a287-b660ae8bde2f; YEAR=2018; ORIGINAL_YEAR=2018; TOXICOLOGICAL_EFFECT=F1: viability|F1: histopathology: non-neoplastic|F1: histopathology: neoplastic|F1: clinical signs|F1: mortality|F1: body weight and weight gain|F1: food consumption and compound intake|F1: water consumption and compound intake|F1: haematology|F1: clinical biochemistry|F1: urinalysis|F1: gross pathology; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical chemistry|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|nonneoplastic histopathology|reproduction|urinalysis; STUDY_GROUP=ECHA IUCLID:15860607:M/F:F1-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_1367de420efdcb75d3a918e76abb06c5
ToxValDB_EFSA 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL =400 mg/kg bw/day Rat oral - chronic LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of Carmoisine (E 122) in feed for cats and dogs. doi:10.2903/j.efsa.2012.2570.; TITLE=Scientific Opinion on the safety and efficacy of Carmoisine (E 122) in feed for cats and dogs; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2570; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=EFSA:15614068:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_13fd69f17feee22279342cc81f59f636
ToxValDB_EFSA NOAEL =375 mg/kg bw/day Mouse oral - chronic LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of Carmoisine (E 122) in feed for cats and dogs. doi:10.2903/j.efsa.2012.2570.; TITLE=Scientific Opinion on the safety and efficacy of Carmoisine (E 122) in feed for cats and dogs; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2570; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=hematological; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=EFSA:15614069:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4c86b6a87b341844c8c762c5d044054e
ToxValDB_WHO_JECFA_ADI 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_WHO_JECFA_ADI ADI <=4 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afa11e4b0d99f5a878ed5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/; SUBSOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/1704; YEAR=1983; ORIGINAL_YEAR=1983; STUDY_GROUP=WHO JECFA ADI:15715293:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_fd2dc8bf4a95a34129819271e13bdf3f
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier DR4641L47F UNII - - - chemical {"approval_status":null,"molecular_formula":"C20H12N2O7S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"DR4641L47F"}
openFDA substances FDA UNII substance identifier DR4641L47F UNII - - - chemical {"approval_status":null,"molecular_formula":"C20H12N2O7S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"DR4641L47F"}
openFDA substances FDA UNII substance identifier DR4641L47F UNII - - - chemical {"approval_status":null,"molecular_formula":"C20H12N2O7S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"DR4641L47F"}
openFDA substances FDA UNII substance identifier DR4641L47F UNII - - - chemical {"approval_status":null,"molecular_formula":"C20H12N2O7S2.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"DR4641L47F"}