NOAEL Studies
Cosmetic Ingredient
Acid Red 18 NOAEL Studies
INCI: CI 16255
CAS: 2611-82-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
EFSA 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA | NOAEL | =70 | mg/kg bw/day | Mouse | oral: feed | 574 days | chronic/long term toxicity | EFSA ANS - 2009 - OutputID 392 - neurology - nephrotoxicity - Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive - doi:10.2903/j.efsa.2009.1328 |
| EFSA | ADI | =0.7 | mg/kg bw/day | Consumers | - | - | ADI | EFSA ANS - 2009 - OutputID 392 - Consumers - Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive - doi:10.2903/j.efsa.2009.1328 |
| EFSA | NOAEL | =70 | mg/kg bw/day | Mouse | oral | chronic; 82 weeks | chronic | LONG_REF=EFSA ANS (2009). Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive. doi:10.2903/j.efsa.2009.1328.; TITLE=Scientific Opinion on the re-evaluation of Ponceau 4R (E 124) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2009.1328; 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=neurology; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=EFSA_dup_-_15614320_15614321: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_1074035a4a921898fec2148a5e00931d |
NTP ICE acute oral 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE acute oral | LD50 | >8000 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | record_id=acute_oral_4786; row=15377; data_type=In Vivo; mixture=Chemical; chemical_name=SX purple; preferred_name=C.I. Acid Red 18, trisodium salt; dtxsid=DTXSID9021213; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9021213; source_file=acute_oral.xlsx |
SCCNFP Opinion 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP Opinion | NOAEL | >1 | % | rat | oral | - | reproductive toxicity | p.10 |
| SCCNFP Opinion | NOAEL | =300 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | p.6 |
| SCCNFP Opinion | NOAEL | =500 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | p.6 |
| SCCNFP Opinion | NOAEL | =1000 | mg/kg | - | - | - | NOAEL study | p.15 |
| SCCNFP Opinion | NOAEL | =1250 | mg/kg bw/day | rat | - | - | dermal absorption | p.11 |
| SCCNFP Opinion | NOAEL | >8000 | mg/kg bw | rat | oral | - | irritation | p.15 |
ECHA 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ECHA | NOAEL | =1250 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaadfe4b0a7c65d1b7cf5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10401/7/9/2?documentUUID=0558263c-ce95-4c77-abea-8f5ed1a7ce72; YEAR=2013; ORIGINAL_YEAR=2013; TOXICOLOGICAL_EFFECT=P0: reproductive performance; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ECHA IUCLID:15857041:M/F:P0-; 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_c66fbe524894935bba53770a6f1024b9 |
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_15609031_15609032:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=c61bcccdae024ba16d0de474716385b4 |
| 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_15609031_15609032:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=d088d90d109ded5656a6faa056a91e7b |
ToxValDB GESTIS DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB GESTIS DNEL | DNEL systemic | =24.7 | 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:15635583:-:--; 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_28b96c649302208c4a70f18633ca7cef |
WHO/JECFA 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| WHO/JECFA | ADI | <=4 | mg/kg | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afcb9e4b0d99f5a87cc88; 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/393; YEAR=2011; ORIGINAL_YEAR=2011; STUDY_GROUP=WHO JECFA ADI:15715367:-:--; 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_9b11c5940bff80e98494d48b4f5c7bd6 |
Regulatory source 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 500 | mg/kg bw/day | - | - | - | - | p.7 |
| Regulatory source | - | 1000 | mg/kg | - | - | - | - | p.15 |
| Regulatory source | dermal absorption | 1250 | mg/kg bw/day | rat | - | - | dermal absorption | p.11 |
| Regulatory source | irritation | 500 | mg/kg bw/day | rat | oral | - | irritation | p.15 |
| Regulatory source | irritation | >8000 | mg/kg bw | rat | oral | - | irritation | p.15 |
| Regulatory source | repeated dose toxicity | 300 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | p.6 |
| Regulatory source | repeated dose toxicity | 500 | mg/kg bw/day | rat | oral | 90 days | repeated dose toxicity | p.6 |
| Regulatory source | reproductive toxicity | >1 | % | rat | oral | - | reproductive toxicity | p.10 |
openFDA substances 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | Z525CBK9PG | UNII | - | - | - | chemical | - |