NOAEL Studies Colorant

Acid Red 92 (Phloxine B) NOAEL Studies

INCI: CI 45410

CAS: 18472-87-2

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

COSMOS DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB LOAEL 10 mg/kg bw/day rat oral 90 day Subchronic SCCNFP; Braun W.H. et al.. Acid Red 92: 13-week oral toxicity (gavage) study in Wistar Rats; RCC
NTP ICE eye irritation 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE eye irritation Draize rabbit irritation score 71 unitless Rabbit Ocular - In Vivo; Draize Eye Irritation/Corrosion Test sheet=Data; excel_row=632; Record_ID=eye_irritation_164; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID1031090; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=71; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1031090; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1031090
NTP ICE eye irritation EPA Classification 1 unitless Rabbit Ocular - In Vivo; Draize Eye Irritation/Corrosion Test sheet=Data; excel_row=630; Record_ID=eye_irritation_164; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID1031090; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=1; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1031090; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1031090
NTP ICE eye irritation GHS Classification 2 unitless Rabbit Ocular - In Vivo; Draize Eye Irritation/Corrosion Test sheet=Data; excel_row=631; Record_ID=eye_irritation_164; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID1031090; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=GHS Classification; Response=2; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1031090; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1031090
NTP ICE eye irritation Intensity 0.74 %/sec - Ocular - In Vitro; Vitrigel sheet=Data; excel_row=628; Record_ID=eye_irritation_1300; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1031090; Assay=Vitrigel; Endpoint=Intensity; Response=0.74; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1031090; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1031090
NTP ICE eye irritation Lag time 0 s - Ocular - In Vitro; Vitrigel sheet=Data; excel_row=629; Record_ID=eye_irritation_1300; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1031090; Assay=Vitrigel; Endpoint=Lag time; Response=0; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1031090; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1031090
NTP ICE eye irritation Plateau level 82 % - Ocular - In Vitro; Vitrigel sheet=Data; excel_row=627; Record_ID=eye_irritation_1300; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1031090; Assay=Vitrigel; Endpoint=Plateau level; Response=82; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1031090; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1031090
SCCNFP Opinion 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCNFP Opinion NOAEL =50 mg/kg bw/day - dermal Sub-chronic repeated dose toxicity p.8
SCCS Opinion 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =0.14 mg/kg bw/day rat oral sub-chronic repeated dose toxicity p.21
SCCS Opinion NOAEL =50 mg/kg bw/d - - Chronic genotoxicity p.15
SCCS Opinion NOAEL =50 mg/kg bw/day - - - reproductive toxicity p.20
ECHA 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA LOAEL =2000 mg/kg bw/day Mouse oral - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabf4e4b0a7c65d1bc9f2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17373/7/9/3?documentUUID=5d95f378-85f2-4f18-8e15-f30ab1991803; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15824425:-:-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_66f18082c45b22a87f491b462efc9d27
ECHA NOAEL =50 mg/kg bw/day Rat oral - reproduction developmental QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabf4e4b0a7c65d1bcafc; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17402/7/9/3?documentUUID=25c76c54-1448-448b-93ac-423023ff25f8; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: clinical signs|maternal: food consumption and compound intake|maternal: gross pathology|maternal: mortality; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|gross pathology|mortality/survival; STUDY_GROUP=ECHA IUCLID:15823855: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_477b84cbbcbca4f7cbdf2f9164da0af6
ECHA NOAEL =250 mg/kg bw/day Rat oral - developmental QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabf4e4b0a7c65d1bcafc; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17402/7/9/3?documentUUID=25c76c54-1448-448b-93ac-423023ff25f8; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15823695:M/F:-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_b7014b083a7908ee726971f9d6c625e8
ECHA NOAEL =500 mg/kg bw/day Rat oral short-term; 14 days short-term QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cbfee4b0a7c65d228660; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/19796/7/6/2?documentUUID=cd2173fe-e97a-4c02-a634-cb93088728c5; YEAR=2017; ORIGINAL_YEAR=2017; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15848690_15849229: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_e22083a21a8ea03c20ab5167dca3f4db
ECHA NOAEL =920 mg/kg bw/day Rat oral - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabf4e4b0a7c65d1bcb00; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17402/7/9/3?documentUUID=25c76c54-1448-448b-93ac-423023ff25f8; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15824555:M/F:-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_b52d00ca437bcb5c3b78c42d51cb4d55
ECHA NOAEL =2000 mg/kg bw/day Mouse oral - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabf4e4b0a7c65d1bc9f2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17373/7/9/3?documentUUID=5d95f378-85f2-4f18-8e15-f30ab1991803; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15824426: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_3fc5224011a1d7844c71869a10b3c70d
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_15604110_15604111:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=8ba6c4e6baf95db1ae82cf55a6d5162a
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_15604110_15604111:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=041bc63ebdccaeedafd5259c08c6159e
ToxValDB GESTIS DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB GESTIS DNEL DNEL systemic =15.1 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:15635085:-:--; 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_7a17b86f6fe3dae23b0c63972f56d950
Regulatory source 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source developmental toxicity 50 mg/kg bw/day - - - developmental toxicity p.17
Regulatory source irritation 50 mg/kg bw/day human - - irritation p.17
Regulatory source repeated dose toxicity 50 mg/kg bw/day - dermal Sub-chronic repeated dose toxicity p.8
Regulatory source repeated dose toxicity 50 mg/kg bw/day rabbit dermal Sub-chronic repeated dose toxicity p.8
Regulatory source reproductive toxicity 50 mg/kg bw/day pig - - reproductive toxicity p.12
Regulatory source genotoxicity 50 mg/kg bw/d - - Chronic genotoxicity p.15
Regulatory source repeated dose toxicity =0.14 mg/kg bw/day rat oral sub-chronic repeated dose toxicity p.21
Regulatory source repeated dose toxicity =50 mg/kg bw/day rat oral sub-chronic repeated dose toxicity p.21
Regulatory source reproductive toxicity 50 mg/kg bw/day - - - reproductive toxicity p.20
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 767IP0Y5NH UNII - - - chemical -