NOAEL Studies Cosmetic Ingredient

Hydroxyethyl-3,4-Methylenedioxyaniline HCl NOAEL Studies

INCI: HYDROXYETHYL-3,4-METHYLENEDIOXYANILINE HCL

CAS: 94158-14-2

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

Back to parent ingredient page
CIR Safety Assessment 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment NOAEL =20 mg/kg/d rat oral - developmental toxicity (350; 100; 20, p.9
CIR Safety Assessment NOAEL =26 mg/kg/d mouse - - developmental toxicity 688; 152; 2, p.9
COSMOS DB 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB LOAEL 100 mg/kg bw/day rat oral 90 day Subchronic SCCS; Braun, W. H.; Hydroxyethyl-3,4-methylene-dioxyaniline HCl (WR 23094): 13-weekoral toxicity (gavage) study in Wistar rats; RCC;
COSMOS DB NOAEL 20 mg/kg bw/day rat oral 90 day Subchronic SCCS; Braun, W. H.; Hydroxyethyl-3,4-methylene-dioxyaniline HCl (WR 23094): 13-weekoral toxicity (gavage) study in Wistar rats; RCC;
SCCS Opinion 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =20 mg/kg bw/day rat - Chronic genotoxicity p.16
SCCS Opinion NOAEL =20 mg/kg rabbit oral - NOAEL study p.31
SCCS Opinion NOAEL =25.7 mg/kg bw human - 7 days NOAEL study p.24
SCCS Opinion NOAEL =50 mg/kg bw - - 7 days NOAEL study p.24
ECHA 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA NOAEL =20 mg/kg bw/day Rat oral subchronic; 13 weeks subchronic QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf7fe4b0a7c65d1ce1d2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22545/7/6/2?documentUUID=60e60b89-1aac-4b41-a165-5643688e4133; YEAR=1985; ORIGINAL_YEAR=1985; TOXICOLOGICAL_EFFECT=liver: behaviour (functional findings)|clinical biochemistry|histopathology: non-neoplastic|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|neurobehavior|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID:15836630: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_7e6baf0b070a95da2843caae6b961261
ECHA NOAEL =26 mg/kg bw/day Rat oral - developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac93e4b0a7c65d1bfd02; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22545/7/9/3?documentUUID=60e60b89-1aac-4b41-a165-5643688e4133; YEAR=1985; ORIGINAL_YEAR=1985; TOXICOLOGICAL_EFFECT=fetus: fetal/pup body weight changes|fetus: skeletal malformations|fetus: visceral malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15821098:-:-fetal; 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_ba388a2707de8a64a912c847cf68599a
Regulatory source 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source developmental toxicity 20 mg/kg/d rat oral - developmental toxicity p.9
Regulatory source developmental toxicity 26 mg/kg/d mouse - - developmental toxicity p.9
Regulatory source - 20 mg/kg rabbit oral - - p.31
Regulatory source - =25.7 mg/kg bw human - 7 days - p.24
Regulatory source - 50 mg/kg bw - - 7 days - p.24
Regulatory source - 50 mg/kg bw human - 7 days - p.24
Regulatory source developmental toxicity 20 mg/kg bw/day rat - 90 day developmental toxicity p.28
Regulatory source genotoxicity 20 mg/kg bw/day rat - Chronic genotoxicity p.16
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 8IRK9YBY3K UNII - - - chemical -