NOAEL Studies Cosmetic Ingredient

CI 42053 NOAEL Studies

CAS: 2353-45-9

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

COSMOS_DB 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 1250 mg/kg bw/day rabbit oral 13 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 2000 mg/kg bw/day rat oral 540 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 2500 mg/kg bw/day rat oral 730 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 3000 mg/kg bw/day mouse oral 730 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 500 mg/kg bw/day dog oral 730 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 1000 mg/kg bw/day rat oral NA Multigeneration Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 3602 mg/kg bw/day rat oral 900 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 992 mg/kg bw/day mouse oral 735 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
IARC Monographs 3 endpoints
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":"16, Sup 7"}
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":"16, Sup 7"}
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":"16, Sup 7"}
NTP_ICE_acute_oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 >2000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_4360; row=5455; data_type=In Vivo; mixture=Chemical; chemical_name=FD&C Green No. 3; preferred_name=FD&C Green No. 3; dtxsid=DTXSID3020673; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3020673; source_file=acute_oral.xlsx
NTP_ICE_adme_parameters 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_adme_parameters Clint 0 uL/min/10^6 cells Human - - Measured; httk, Human Hepatic Intrinsic Clearance sheet=Data; excel_row=1158; Record_ID=adme_parameters_1014; Data_Type=Measured; DTXSID=DTXSID3020673; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=0.0; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3020673
NTP_ICE_adme_parameters Fu 0.0151 fraction Human - - Measured; httk, Human Plasma Fraction Unbound sheet=Data; excel_row=1159; Record_ID=adme_parameters_1014; Data_Type=Measured; DTXSID=DTXSID3020673; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.0151; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3020673
NTP_ICE_cancer 1 endpoint
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=3445; Record_ID=cancer_716; Data_Type=WOE; Formulation_Name=FD&C Green No. 3; Mixture=Chemical; DTXSID=DTXSID3020673; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/34; http://publications.iarc.fr/139; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3020673
NTP_ICE_endocrine 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_endocrine AC50 11.86188925 uM - - - ARPathway2016; AR Pathway Model, Agonist sheet=Integrated_approaches; excel_row=9306; RecordID=ARPathway2016_121; DatasetName=ARPathway2016; DTXSID=DTXSID3020673; Assay=AR Pathway Model, Agonist; Endpoint=AC50; Response=11.86188925; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3020673
NTP_ICE_endocrine ACC 7.982783792 uM - - - ARPathway2016; AR Pathway Model, Agonist sheet=Integrated_approaches; excel_row=9307; RecordID=ARPathway2016_121; DatasetName=ARPathway2016; DTXSID=DTXSID3020673; Assay=AR Pathway Model, Agonist; Endpoint=ACC; Response=7.982783792; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3020673
NTP_ICE_endocrine Model Score 0.209 unitless - - - ARPathway2016; AR Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=9308; RecordID=ARPathway2016_121; DatasetName=ARPathway2016; DTXSID=DTXSID3020673; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0.209; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3020673
NTP_ICE_endocrine Model Score 0 unitless - - - ARPathway2016; AR Pathway Model, Agonist sheet=Integrated_approaches; excel_row=9309; RecordID=ARPathway2016_121; DatasetName=ARPathway2016; DTXSID=DTXSID3020673; Assay=AR Pathway Model, Agonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3020673
ToxValDB_ECHA_IUCLID 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID LOAEL =48.75 mg/kg bw/day Rat oral - chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3bc7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17622/7/8?documentUUID=def235c3-2ee7-4de6-8e11-a7076fe3c277; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID:15817931: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_154f4507637e22ead35c62fed9effac5
ToxValDB_ECHA_IUCLID NOAEL =2500 mg/kg bw/day Rat oral - chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3bc3; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17622/7/8?documentUUID=def235c3-2ee7-4de6-8e11-a7076fe3c277; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID:15816921: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_f2b9cf1d0ecba7a830d9ef7da4d0d2d0
ToxValDB_ECHA_IUCLID NOAEL =1321.43 mg/kg bw/day Mouse oral - chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ea9ffe4b0a7c65d1b3bc5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17622/7/8?documentUUID=def235c3-2ee7-4de6-8e11-a7076fe3c277; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID:15817625: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_ff8f60276b287231c89d2a2488b4f3c9
ToxValDB_ECHA_IUCLID NOAEL =1428.5 mg/kg bw/day Mouse dermal chronic; 19.5 months chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61e3be4b096bca8778cfe; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17622/7/6/4?documentUUID=def235c3-2ee7-4de6-8e11-a7076fe3c277; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID:15826433: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_46ab2b06ffefd797e606d3ecb8575c9f
ToxValDB_ECHA_IUCLID NOAEL =7142.85 mg/kg bw/day Mouse oral chronic; 24 months chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eade1e4b0a7c65d1c6674; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17622/7/6/2?documentUUID=def235c3-2ee7-4de6-8e11-a7076fe3c277; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID:15839570: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_7ad0b076651574c2763d318f50a413a0
ToxValDB_ECHA_IUCLID NOAEL =500 mg/kg bw/day Dog oral chronic; 2 years chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eade1e4b0a7c65d1c667c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17622/7/6/2?documentUUID=def235c3-2ee7-4de6-8e11-a7076fe3c277; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID:15840062: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_35463fa892c49c946ab9dd59e7b1adb5
ToxValDB_ECHA_IUCLID NOAEL =2857 mg/kg bw/day Mouse oral chronic; 2 years chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eade1e4b0a7c65d1c6682; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17622/7/6/2?documentUUID=def235c3-2ee7-4de6-8e11-a7076fe3c277; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID:15846447: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_d23a5ac7184fd88a0b784b708dc8564f
ToxValDB_ECHA_IUCLID NOAEL =1000 mg/kg bw/day Rat oral - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaad2e4b0a7c65d1b791f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17622/7/9/2?documentUUID=def235c3-2ee7-4de6-8e11-a7076fe3c277; YEAR=2015; ORIGINAL_YEAR=2015; STUDY_GROUP=ECHA IUCLID:15855499: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_d3f5199d4fa94bc6fabcc4e33128a98a
ToxValDB_ECOTOX 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECOTOX NOEL =2000 mg/kg bw/day Mouse oral acute; 1 days acute LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15597655:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=384391213e893778acfff3eb53a1dfe3
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =89.957 mg/m3 Human inhalation - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15631227:-:--; 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_f0e19a5b54ff6a4974d4f107c948d0a3
ToxValDB_WHO_JECFA_ADI 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_WHO_JECFA_ADI ADI <=25 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afe26e4b0d99f5a87f8c0; 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/502; YEAR=2017; ORIGINAL_YEAR=2017; STUDY_GROUP=WHO JECFA ADI:15715514:-:--; 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_dfb185db541d0cc3f1ad146e29e66d1b
openFDA substances 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 3P3ONR6O1S UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"3P3ONR6O1S"}
openFDA substances FDA UNII substance identifier 9J3VQ0Y6BV UNII - - - chemical {"approval_status":null,"molecular_formula":"C37H34N2O10S3.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9J3VQ0Y6BV"}
openFDA substances FDA UNII substance identifier 3P3ONR6O1S UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"3P3ONR6O1S"}
openFDA substances FDA UNII substance identifier 3P3ONR6O1S UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"3P3ONR6O1S"}
openFDA substances FDA UNII substance identifier 3P3ONR6O1S UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"3P3ONR6O1S"}
openFDA substances FDA UNII substance identifier 9J3VQ0Y6BV UNII - - - chemical {"approval_status":null,"molecular_formula":"C37H34N2O10S3.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9J3VQ0Y6BV"}
openFDA substances FDA UNII substance identifier 9J3VQ0Y6BV UNII - - - chemical {"approval_status":null,"molecular_formula":"C37H34N2O10S3.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9J3VQ0Y6BV"}
openFDA substances FDA UNII substance identifier 9J3VQ0Y6BV UNII - - - chemical {"approval_status":null,"molecular_formula":"C37H34N2O10S3.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"9J3VQ0Y6BV"}