NOAEL Studies Emulsifier

Polysorbate 60 NOAEL Studies

INCI: POLYSORBATE 60

CAS: 9005-67-8

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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CIR Safety Assessment 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity 46, p.7
COSMOS DB 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB NOAEL 2500 mg/kg bw/day rat oral 720 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 5000 mg/kg bw/day rat oral 720 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 7500 mg/kg bw/day hamster oral 354 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 7693 mg/kg bw/day rat oral 8 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 15000 mg/kg bw/day mouse oral 120 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
ECHA 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA LOAEL =5000 ppm Mouse oral - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab87e4b0a7c65d1ba9ad; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/11403?documentUUID=bf7712db-97ed-41c7-a3d4-85e11bfea5c7; YEAR=2010; ORIGINAL_YEAR=2010; TOXICOLOGICAL_EFFECT=F1: viability; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ECHA IUCLID:15859911:M/F:F1-; 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_d4985cd93fe3e3f33f7bc02604feb150
ECHA NOAEL =52000 mg/kg bw/day Mouse oral - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac86e4b0a7c65d1bf9b1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/11403?documentUUID=bf7712db-97ed-41c7-a3d4-85e11bfea5c7; YEAR=2010; ORIGINAL_YEAR=2010; TOXICOLOGICAL_EFFECT=fetus: fetal/pup body weight changes|fetus: external malformations|fetus: skeletal malformations|fetus: visceral malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15825285:-:-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_8b807a1751ab52e35da14fc1944b0a88
ECHA NOAEL =7693 mg/kg bw/day Rat oral - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac86e4b0a7c65d1bf9bc; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/11403?documentUUID=bf7712db-97ed-41c7-a3d4-85e11bfea5c7; YEAR=2010; ORIGINAL_YEAR=2010; STUDY_GROUP=ECHA IUCLID:15825287: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_6c9df63fc515646c7b374da80555818c
ECHA NOAEL =960 mg/kg bw/day Rat oral - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac86e4b0a7c65d1bf9bc; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/11403?documentUUID=bf7712db-97ed-41c7-a3d4-85e11bfea5c7; YEAR=2010; ORIGINAL_YEAR=2010; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: dead fetuses|maternal: early or late resorptions|maternal: effects on pregnancy duration|maternal: food consumption and compound intake|maternal: maternal abnormalities|maternal: number of abortions|maternal: organ weights and organ / body weight ratios|maternal: pre and post implantation loss|maternal: total litter losses by resorption; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|development|food and/or water consumption|organ weight|other|reproduction; STUDY_GROUP=ECHA IUCLID:15825288: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_a1f3029257d5e06c1db24b67c67fccb0
ECHA NOAEL =5000 mg/kg bw/day Mouse oral chronic; 22 months chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf51e4b0a7c65d1cd748; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/11403?documentUUID=bf7712db-97ed-41c7-a3d4-85e11bfea5c7; YEAR=2010; ORIGINAL_YEAR=2010; STUDY_GROUP=ECHA IUCLID:15848570: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_747fcfd32ce112f3ff9cb91e800a0a90
ECHA NOAEL =1000 mg/kg bw/day Rat oral chronic; 2 years chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf51e4b0a7c65d1cd741; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/11403?documentUUID=bf7712db-97ed-41c7-a3d4-85e11bfea5c7; YEAR=2010; ORIGINAL_YEAR=2010; STUDY_GROUP=ECHA IUCLID:15849979:M/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_012301a8c3e9bb87eb91b8097c8aa5ec
ECHA NOAEL =10000000 ppm Rat oral - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab87e4b0a7c65d1ba9a5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/11403?documentUUID=bf7712db-97ed-41c7-a3d4-85e11bfea5c7; YEAR=2010; ORIGINAL_YEAR=2010; STUDY_GROUP=ECHA IUCLID:15856949: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_df176e137e1a6d53273bf1d2a16ea4ab
ToxValDB GESTIS DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB GESTIS DNEL DNEL systemic =98.7 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:15634905:-:--; 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_2583f40476bbf8620e54336c08bd1bbd
WHO/JECFA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
WHO/JECFA ADI <=25 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650b0339e4b0d99f5a8876c1; 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/397; YEAR=2014; ORIGINAL_YEAR=2014; STUDY_GROUP=WHO JECFA ADI:15715681:-:--; 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_18ebf022f166f62f8a790bdfd48cb1e7
openFDA substances 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 073G38N8GC UNII - - - polymer -
openFDA substances FDA UNII substance identifier 3453J8557N UNII - - - polymer -
openFDA substances FDA UNII substance identifier 90SOR12GHG UNII - - - chemical -
openFDA substances FDA UNII substance identifier CAL22UVI4M UNII - - - mixture -
openFDA substances FDA UNII substance identifier HD40WR33LC UNII - - - polymer -
openFDA substances FDA UNII substance identifier X61U1UH01B UNII - - - polymer -