NOAEL Studies
Cosmetic Ingredient
CURRY RED NOAEL Studies
CAS: 25956-17-6
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS DB 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS DB | LOAEL | 250 | mg/kg bw/day | dog | oral | 42 day | Subchronic | PAFA |
| COSMOS DB | NOAEL | 125 | mg/kg bw/day | dog | oral | 42 day | Subchronic | PAFA |
| COSMOS DB | NOAEL | 200 | mg/kg bw/day | rat | oral | 21 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 250 | mg/kg bw/day | dog | oral | 42 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 700 | mg/kg bw/day | rabbit | oral | 13 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 939.3 | mg/kg bw/day | rat | oral | 20 day | Reproductive-developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 1000 | mg/kg bw/day | rat | oral | 20 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 1500 | mg/kg bw/day | swine | oral | 76 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 2550 | mg/kg bw/day | mouse | oral | NA | Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 2595 | mg/kg bw/day | rat | oral | 847 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 3604 | mg/kg bw/day | rat | oral | 847 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 5000 | mg/kg bw/day | rat | oral | 14 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 5190 | mg/kg bw/day | rat | oral | 42 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 7318 | mg/kg bw/day | mouse | oral | 763 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 7422 | mg/kg bw/day | mouse | oral | 728 day | Carcinogenicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 7785 | mg/kg bw/day | mouse | oral | 728 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
EFSA 10 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA | LOAEL | =50 | mg/kg bw/day | Mouse | - | - | reproduction toxicity | EFSA AFC - 2008 - OutputID 295 - neurology - developmental - Safety of aluminium from dietary intake - doi:10.2903/j.efsa.2008.754 |
| EFSA | NOAEL | =10 | mg/kg bw/day | Mouse | oral: feed | - | reproduction toxicity | EFSA AFC - 2008 - OutputID 295 - neurology - reproductive - Safety of aluminium from dietary intake - doi:10.2903/j.efsa.2008.754 |
| EFSA | NOAEL | =695 | mg/kg bw/day | Rat | oral: unspecified | - | reproduction toxicity | EFSA ANS - 2009 - OutputID 391 - growth - developmental - Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive - doi:10.2903/j.efsa.2009.1327 |
| EFSA | NOAEL | =701 | mg/kg bw/day | Rat | oral: unspecified | - | chronic/long term toxicity | EFSA ANS - 2009 - OutputID 391 - body weight - systemic - Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive - doi:10.2903/j.efsa.2009.1327 |
| EFSA | NOAEL | =13900 | mg/kg | Rat | - | - | reproduction toxicity | EFSA FEEDAP - 2021 - OutputID 4068 - reproduction - reproductive - Safety and efficacy of a feed additive consisting of Allura Red AC for small non-food-producing mammals and ornamental birds (Versele-Laga) - doi:10.2903/j.efsa.2021.6987 |
| EFSA | ADI | =0.14 | mg/kg bw/day | Consumers | - | - | ADI | EFSA - 2018 - OutputID 3111 - Consumers - Peer review of the pesticide risk assessment of the active substance fosetyl - doi:10.2903/j.efsa.2018.5307 |
| EFSA | ADI | =7 | mg/kg bw/day | Consumers | - | - | ADI | EFSA ANS - 2009 - OutputID 391 - Consumers - Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive - doi:10.2903/j.efsa.2009.1327 |
| EFSA | ARfD | =0.14 | mg/kg bw | Consumers | - | - | ARfD | EFSA - 2018 - OutputID 3111 - Consumers - Peer review of the pesticide risk assessment of the active substance fosetyl - doi:10.2903/j.efsa.2018.5307 |
| EFSA | NOAEL | =695 | mg/kg bw/day | Rat | oral | - | reproduction developmental | LONG_REF=EFSA ANS (2009). Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. doi:10.2903/j.efsa.2009.1327.; TITLE=Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2009.1327; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=growth; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=EFSA:15614076: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_ab205ca464e4f57c37f757f3f6d89f17 |
| EFSA | NOAEL | =701 | mg/kg bw/day | Rat | oral | - | chronic | LONG_REF=EFSA ANS (2009). Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. doi:10.2903/j.efsa.2009.1327.; TITLE=Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2009.1327; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=EFSA:15614077: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_28b89b1a96c261f601c5bdbf337637f9 |
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_4744; row=7258; data_type=In Vivo; mixture=Chemical; chemical_name=Allura Red C.I.16035; preferred_name=Allura Red C.I.16035; dtxsid=DTXSID4024436; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4024436; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID4024436; 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=1732; Record_ID=adme_parameters_884; Data_Type=Measured; DTXSID=DTXSID4024436; 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/DTXSID4024436; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4024436 |
| NTP ICE adme parameters | Fu | 0.0137 | fraction | Human | - | - | Measured; httk, Human Plasma Fraction Unbound | sheet=Data; excel_row=1731; Record_ID=adme_parameters_884; Data_Type=Measured; DTXSID=DTXSID4024436; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.0137; 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/DTXSID4024436; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4024436 |
NTP ICE endocrine 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE endocrine | AC50 | 57.1229775240489 | uM | - | - | - | ERPathway2016; ER Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=4734; RecordID=ERPathway2016_110; DatasetName=ERPathway2016; DTXSID=DTXSID4024436; Assay=ER Pathway Model, Agonist; Endpoint=AC50; Response=57.1229775240489; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4024436; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4024436 |
| NTP ICE endocrine | ACC | 63.4118100206417 | uM | - | - | - | ERPathway2016; ER Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=4735; RecordID=ERPathway2016_110; DatasetName=ERPathway2016; DTXSID=DTXSID4024436; Assay=ER Pathway Model, Agonist; Endpoint=ACC; Response=63.4118100206417; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4024436; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4024436 |
| NTP ICE endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=4730; RecordID=ARPathway2016_1063; DatasetName=ARPathway2016; DTXSID=DTXSID4024436; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4024436; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4024436 |
| NTP ICE endocrine | Model Score | 0.0157 | unitless | - | - | - | ERPathway2016; ER Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=4737; RecordID=ERPathway2016_110; DatasetName=ERPathway2016; DTXSID=DTXSID4024436; Assay=ER Pathway Model, Antagonist; Endpoint=Model Score; Response=0.0157; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4024436; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID4024436 |
SCCNFP Opinion 10 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP Opinion | NOAEL | =1.39 | % | - | oral | - | carcinogenicity | p.19 |
| SCCNFP Opinion | NOAEL | =5.19 | % | dog | oral | 1 year | NOAEL study | p.7 |
| SCCNFP Opinion | NOAEL | =7 | mg/kg bw/day | - | oral | - | carcinogenicity | p.19 |
| SCCNFP Opinion | NOAEL | =50 | mg/kg bw/day | rat | oral | 6-week | repeated dose toxicity | p.6 |
| SCCNFP Opinion | NOAEL | =500 | mg/kg bw/day | dog | oral | 14 days | NOAEL study | p.6 |
| SCCNFP Opinion | NOAEL | =700 | mg/kg | dog | oral | - | NOAEL study | p.19 |
| SCCNFP Opinion | NOAEL | =700 | mg/kg bw/day | - | oral | - | NOAEL study | p.19 |
| SCCNFP Opinion | NOAEL | =1000 | mg/kg bw/day | rat | - | prenatal | developmental toxicity | p.12 |
| SCCNFP Opinion | NOAEL | =1500 | mg/kg bw/day | pig | oral | 21 days | repeated dose toxicity | p.7 |
| SCCNFP Opinion | NOAEL | =3750 | mg/kg bw/day | rat | oral | 14 days | NOAEL study | p.6 |
ECHA 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ECHA | NOAEL | =200 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac26e4b0a7c65d1bdaa4; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17284/7/9/3?documentUUID=4ef657bb-2068-4ffe-ae1d-0d0d195e59c0; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15823529:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_85663e4e89b28f76b90f934ded2ac524 |
| ECHA | NOAEL | =260.2 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac26e4b0a7c65d1bdaaa; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17284/7/9/3?documentUUID=4ef657bb-2068-4ffe-ae1d-0d0d195e59c0; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15823265:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_ce8d0b033fc53591e0682796393538ac |
| ECHA | NOAEL | =901 | mg/kg bw/day | Rat | oral | chronic; 121 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead10e4b0a7c65d1c2564; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/12236?documentUUID=99b7317c-4c1d-4b46-8d69-c269b8cd8271; YEAR=2019; ORIGINAL_YEAR=2019; TOXICOLOGICAL_EFFECT=body weight and weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECHA IUCLID:15847777: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_569b0c0e066c4924dcd7b695f383f204 |
| ECHA | NOAEL | =1000 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac0de4b0a7c65d1bd2db; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/11604/7/9/3?documentUUID=17a6d5cd-1cbd-41b3-b200-263e0a0215cb; YEAR=1980; ORIGINAL_YEAR=1980; STUDY_GROUP=ECHA IUCLID:15824706:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_ac3438077009d6b72a525a2c41367859 |
| ECHA | NOAEL | =2829 | mg/kg bw/day | Rat | oral | chronic; 118 weeks | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead10e4b0a7c65d1c2564; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/12236?documentUUID=99b7317c-4c1d-4b46-8d69-c269b8cd8271; YEAR=2019; ORIGINAL_YEAR=2019; STUDY_GROUP=ECHA IUCLID:15850590: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_c3d6967638d07309d964cafb0ee729e6 |
ToxValDB ECOTOX 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB ECOTOX | LOEL | =10 | 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_dup_EPA ORD_15597275_15597276:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=f03ea79a82ef88eb18595d3e52aabf1e |
| ToxValDB ECOTOX | NOEL | =1 | 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_dup_EPA ORD_15597275_15597276:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=f2859d07d0110c4e3e70fb3be0e6267b |
ToxValDB GESTIS DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB GESTIS DNEL | DNEL systemic | =16.4 | 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:15631641:-:--; 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_1b60b2d366262f90a31ef05e9294233e |
ToxValDB HPVIS 9 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB HPVIS | LOAEL | =545.68 | mg/kg bw/day | Rat | oral | short-term; 20 days | reproduction developmental | LONG_REF=Collins T., Black T.N., Welsch J.J., and Brown L.H. (1989a) Study of the teratogenic potential of FD & C Red No. 40 when given in drinking water. Toxicology and Industrial Health 5, 937-948.Posting dates of the documents from the HPV Challenge Program website from which data have been entered into the HPVIS:Test Plan: Dec. 12, 2006; CBIC Received: Nov. 13, 2006Robust Summary: Dec. 12, 2006; CBIC Received: Nov. 13, 2006. Study is also summarized in the initial robust summary posted Dec. 17, 2003.; QUALITY=1; EXTERNAL_SOURCE_ID=58378; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480590; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=HPVIS:15642432:-:F1offspring; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_9e09b413a9ab9a829b4e78b3ceab64da |
| ToxValDB HPVIS | LOAEL | >2829 | mg/kg bw/day | Rat | oral | chronic; 118 weeks | reproduction developmental | LONG_REF=Borzelleca J.F., Olson J.W. and Reno F.E. (1991a) Lifetime toxicity/ carcinogenicity studies of FD&C Red No. 40 (Allura Red) in Sprague Dawley Rats. Food and Chemical Toxicology, 27, 701-705.Posting dates of the documents from the HPV Challenge Program website from which data have been entered into the HPVIS:Test Plan: Dec. 12, 2006; CBIC Received: Nov. 13, 2006Robust Summary: Dec. 12, 2006; CBIC Received: Nov. 13, 2006. Study is also summarized in the initial robust summary posted Dec. 17, 2003.; QUALITY=1; EXTERNAL_SOURCE_ID=61953; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Repeat Dose_15639253_15639304:M:-paternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_b3d44474749b38af6d1ca91b267b7ba3 |
| ToxValDB HPVIS | LOAEL | =3604 | mg/kg bw/day | Rat | oral | chronic; 118 weeks | chronic | LONG_REF=Borzelleca J.F., Olson J.W. and Reno F.E. (1991a) Lifetimetoxicity/ carcinogenicity studies of FD&C Red No. 40 (AlluraRed) in Sprague Dawley Rats. Food and Chemical Toxicology, 27, 701-705.Data extracted from the robust summary posted to the HPV Challenge Program website Dec. 22, 2006.; QUALITY=1; EXTERNAL_SOURCE_ID=62758; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Repeat Dose_15639334_15639335: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_ffbebc819aafec5e1b3518a88e35b887 |
| ToxValDB HPVIS | LOAEL | =51900 | ppm | Rat | oral | - | reproduction developmental | LONG_REF=Hazelton Laboratories Inc. (1969) Two-generation reproductive study in rats. Red Z4576 (FD&C Red 40). Unpublished report 165-125.Data extracted from the robust summary posted to the HPV Challenge Program website Dec. 22, 2006.; QUALITY=1; EXTERNAL_SOURCE_ID=65291; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480598; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1969; ORIGINAL_YEAR=1969; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Reprotox_15643168_15643169:-:--; 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_7aa59f81ab49a396a352ae7fd50725cd |
| ToxValDB HPVIS | NOAEL | >5.19 | % diet | Mouse | oral | chronic; 104 weeks | chronic | LONG_REF=Borzelleca J.F., Olson J.W. and Reno F.E. (1991b) Lifetime toxicity/ carcinogenicity studies of FD&C Red No. 40 (Allura Red) in mice. Food and Chemical Toxicology, 29, 313-319.Data extracted from the robust summary posted to the HPV Challenge Program website Dec. 22, 2006.; QUALITY=1; EXTERNAL_SOURCE_ID=60646; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Repeat Dose_15639083_15639185:-:--; 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_91fa6f06a7ad778e73bb5d1e8d5ab761 |
| ToxValDB HPVIS | NOAEL | =273.58 | mg/kg bw/day | Rat | oral | short-term; 20 days | developmental | LONG_REF=Collins T., Black T.N., Welsch J.J., and Brown L.H. (1989a) Study of the teratogenic potential of FD & C Red No. 40 when given in drinking water. Toxicology and Industrial Health 5, 937-948.Data extracted from the robust summary posted to the HPV Challenge Program website Dec. 22, 2006.; QUALITY=1; EXTERNAL_SOURCE_ID=59595; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480590; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Devtox_15642798_15642927:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_e03112f87a55b9b3bfbc6b5a9d2cf7bf |
| ToxValDB HPVIS | NOAEL | =901 | mg/kg bw/day | Rat | oral | chronic; 118 weeks | reproduction developmental | LONG_REF=Borzelleca J.F., Olson J.W. and Reno F.E. (1991a) Lifetime toxicity/ carcinogenicity studies of FD&C Red No. 40 (Allura Red) in Sprague Dawley Rats. Food and Chemical Toxicology, 27, 701-705.Posting dates of the documents from the HPV Challenge Program website from which data have been entered into the HPVIS:Test Plan: Dec. 12, 2006; CBIC Received: Nov. 13, 2006Robust Summary: Dec. 12, 2006; CBIC Received: Nov. 13, 2006. Study is also summarized in the initial robust summary posted Dec. 17, 2003.; QUALITY=1; EXTERNAL_SOURCE_ID=63269; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Repeat Dose_15639388_15639416:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_a4ca51ab75224de5cc8a44f211bf1c54 |
| ToxValDB HPVIS | NOAEL | =939.29 | mg/kg bw/day | Rat | oral | short-term; 20 days | reproduction developmental | LONG_REF=Collins T., Black T.N., Welsch J.J., and Brown L.H. (1989a) Study of the teratogenic potential of FD & C Red No. 40 when given in drinking water. Toxicology and Industrial Health 5, 937-948.Posting dates of the documents from the HPV Challenge Program website from which data have been entered into the HPVIS:Test Plan: Dec. 12, 2006; CBIC Received: Nov. 13, 2006Robust Summary: Dec. 12, 2006; CBIC Received: Nov. 13, 2006. Study is also summarized in the initial robust summary posted Dec. 17, 2003.; QUALITY=1; EXTERNAL_SOURCE_ID=58377; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480590; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1989; ORIGINAL_YEAR=1989; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Devtox_15642431_15642689:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_1bfba8bdabfad08e294c357beb38279a |
| ToxValDB HPVIS | NOAEL | =13900 | ppm | Rat | oral | - | reproduction developmental | LONG_REF=Hazelton Laboratories Inc. (1969) Two-generation reproductive study in rats. Red Z4576 (FD&C Red 40). Unpublished report 165-125.Data extracted from the robust summary posted to the HPV Challenge Program website Dec. 22, 2006.; QUALITY=1; EXTERNAL_SOURCE_ID=65290; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480598; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1969; ORIGINAL_YEAR=1969; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Reprotox_15643168_15643169:-:--; 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_0138e572caeedbcc487fb65df8119910 |
WHO/JECFA 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| WHO/JECFA | ADI | <=7 | mg/kg | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650af6c4e4b0d99f5a875bc9; 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/2361; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=WHO JECFA ADI:15715299:-:--; 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_8d79c69f96873097eddcb2b00ccfe4e9 |
Regulatory source 11 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 5.19 | % | dog | oral | 1 year | - | p.7 |
| Regulatory source | - | 500 | mg/kg bw/day | dog | oral | 14 days | - | p.6 |
| Regulatory source | - | =700 | mg/kg | dog | oral | - | - | p.19 |
| Regulatory source | - | 700 | mg/kg bw/day | - | oral | - | - | p.19 |
| Regulatory source | - | 700 | mg/kg | - | - | - | - | p.19 |
| Regulatory source | - | 3750 | mg/kg bw/day | rat | oral | 14 days | - | p.6 |
| Regulatory source | carcinogenicity | 1.39 | % | - | oral | - | carcinogenicity | p.19 |
| Regulatory source | carcinogenicity | 7 | mg/kg bw/day | - | oral | - | carcinogenicity | p.19 |
| Regulatory source | developmental toxicity | 1000 | mg/kg bw/day | rat | - | prenatal | developmental toxicity | p.12 |
| Regulatory source | repeated dose toxicity | 50 | mg/kg bw/day | rat | oral | 6-week | repeated dose toxicity | p.6 |
| Regulatory source | repeated dose toxicity | 1500 | mg/kg bw/day | pig | oral | 21 days | repeated dose toxicity | p.7 |
openFDA substances 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | WZB9127XOA | UNII | - | - | - | chemical | - |