NOAEL Studies Cosmetic Ingredient

N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE NOAEL Studies

CAS: 54381-16-7

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

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COSMOS DB 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB LOAEL 20 mg/kg bw/day rat oral 6-20 Gestation day Developmental SCCP; Oral (Gavage) Developmental Toxicity Study of GTS03849 in Rats, P&G Study # 2628- 54026, November 1, 2005
COSMOS DB NOAEL 5 mg/kg bw/day rat oral 6-20 Gestation day Developmental SCCP; Oral (Gavage) Developmental Toxicity Study of GTS03849 in Rats, P&G Study # 2628- 54026, November 1, 2005
SCCS Opinion 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =0.003 mg/kg rat oral - dermal absorption p.30
SCCS Opinion NOAEL =5 mg/kg bw/day - - - NOAEL study p.15
SCCS Opinion NOAEL =5 mg/kg/day human oral developmental developmental toxicity p.29
SCCS Opinion NOAEL =5 mg/kg rat oral - dermal absorption p.30
SCCS Opinion NOAEL =20 mg/kg bw/day - - 91 days carcinogenicity p.16
SCCS Opinion NOAEL =31 mg/kg bw - oral 14 day developmental toxicity p.30
SCCS Opinion NOAEL =50 mg/kg/day human oral developmental developmental toxicity p.29
ECHA 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA NOAEL =5 mg/kg bw/day Rat oral - reproduction developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac32e4b0a7c65d1bde3a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23320/7/9/3?documentUUID=39800027-eaeb-4fa6-8981-5ae87e9a1f79; YEAR=1979; ORIGINAL_YEAR=1979; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: food consumption and compound intake; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822220_15824924:F:-maternal; 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_176c069c5ffd3930dc4e89441a4e3098
ECHA NOAEL =20 mg/kg bw/day Rat oral - reproduction developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac32e4b0a7c65d1bde42; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23320/7/9/3?documentUUID=39800027-eaeb-4fa6-8981-5ae87e9a1f79; YEAR=1979; ORIGINAL_YEAR=1979; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822220_15824924: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_30633822a2eb672d35ee3a91a30cf75d
ECHA NOAEL =40 mg/kg bw/day Rat oral - chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa0ce4b0a7c65d1b403c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23320/7/8?documentUUID=39800027-eaeb-4fa6-8981-5ae87e9a1f79; YEAR=1979; ORIGINAL_YEAR=1979; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15818400_15820063:M:--; 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_53d206183a90d753f7251b1cfa99479f
ECHA NOAEL =48 mg/kg bw/day Rat oral - chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa0ce4b0a7c65d1b403c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23320/7/8?documentUUID=39800027-eaeb-4fa6-8981-5ae87e9a1f79; YEAR=1979; ORIGINAL_YEAR=1979; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15818401_15820082: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_e4b864364696c7143a200cd0bf7aed73
ECHA NOAEL >=50 mg/kg bw/day Rat oral - developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac32e4b0a7c65d1bde3a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23320/7/9/3?documentUUID=39800027-eaeb-4fa6-8981-5ae87e9a1f79; YEAR=1979; ORIGINAL_YEAR=1979; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15821406_15824923:-:-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_096edad2fce30ce98e0481985e1f77c9
ECHA NOAEL >=121 mg/kg bw/day Rat oral - chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa0ce4b0a7c65d1b403c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23320/7/8?documentUUID=39800027-eaeb-4fa6-8981-5ae87e9a1f79; YEAR=1979; ORIGINAL_YEAR=1979; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15818400_15820063: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_27c8ba9fa948ff841831ee2283ed84fe
ECHA NOAEL >=146 mg/kg bw/day Rat oral - chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa0ce4b0a7c65d1b403c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23320/7/8?documentUUID=39800027-eaeb-4fa6-8981-5ae87e9a1f79; YEAR=1979; ORIGINAL_YEAR=1979; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15818401_15820082: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_5520027d49a69541aa84ec524d0993d0
ToxValDB GESTIS DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB GESTIS DNEL DNEL systemic =0.176 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:15629796:-:--; 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_077eaa48df163558f36194848948a5e6
Regulatory source 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 5 mg/kg bw/day - - - - p.15
Regulatory source carcinogenicity 20 mg/kg bw/day - - 91 days carcinogenicity p.16
Regulatory source dermal absorption =0.003 mg/kg rat oral - dermal absorption p.30
Regulatory source dermal absorption =5 mg/kg rat oral - dermal absorption p.30
Regulatory source developmental toxicity 5 mg/kg/day human oral developmental developmental toxicity p.29
Regulatory source developmental toxicity 5 mg/kg/day human oral 14 day developmental toxicity p.30
Regulatory source developmental toxicity 31 mg/kg bw - oral 14 day developmental toxicity p.30
Regulatory source developmental toxicity 50 mg/kg/day human oral developmental developmental toxicity p.29
Regulatory source developmental toxicity 50 mg/kg/day human oral 14 day developmental toxicity p.30
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 3X5A8DP6HC UNII - - - chemical -