NOAEL Studies Cosmetic Ingredient

Polysorbate 65 NOAEL Studies

INCI: POLYSORBATE 65

CAS: 9005-71-4

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 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment DERMAL_ABSORPTION =4.74 % Hairless mouse dermal 5% Franz cells {"absorption_percent":"Enhancement ratio: 4.74±0.23 compared to control (saline buffer); 1.75±0.29 compared to vehicle (ethanol)","citation":"42","concentration_tested":"5%","page":6,"pdf":"FR696.pdf","row_type":"dermal_absorption_study"}
CIR Safety Assessment DERMAL_ABSORPTION =4.74 % Hairless mouse dermal 5% Franz cells {"absorption_percent":"Enhancement ratio: 4.74±0.23 compared to control (saline buffer); 1.75±0.29 compared to vehicle (ethanol)","citation":"42","concentration_tested":"5%","page":6,"pdf":"FR696.pdf","row_type":"dermal_absorption_study"}
CIR Safety Assessment DERMAL_ABSORPTION =4.74 % Hairless mouse dermal 5% Franz cells {"absorption_percent":"Enhancement ratio: 4.74±0.23 compared to control (saline buffer); 1.75±0.29 compared to vehicle (ethanol)","citation":"42","concentration_tested":"5%","page":6,"pdf":"FR696.pdf","row_type":"dermal_absorption_study"}
COSMOS DB 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB NOAEL 1000 mg/kg bw/day rat oral 730 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 5000 mg/kg bw/day rat oral NA Multigeneration Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 12500 mg/kg bw/day rat oral 728 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA ADI (group) =25 mg/kg bw/day Consumers - - ADI (group) CHEMASSESS_ID 1059481; HAZARD_ID 13296 - OP_ID 2782 - EFSA ANS - 2015 - Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives - doi:10.2903/j.efsa.2015.4152
EFSA NOAEL =2500 mg/kg bw/day Rat oral: unspecified 721 days chronic/long term toxicity ENDPOINTSTUDY_ID 698710; TOX_ID 9677 - OP_ID 2782 - EFSA ANS - 2015 - Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives - doi:10.2903/j.efsa.2015.4152
EFSA NOAEL =2500 mg/kg bw/day Rat oral: unspecified 721 days chronic/long term toxicity ENDPOINTSTUDY_ID 698710; TOX_ID 9677 - OP_ID 2782 - EFSA ANS - 2015 - Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives - doi:10.2903/j.efsa.2015.4152
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 14BGY2Y3MJ UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"14BGY2Y3MJ"}
openFDA substances FDA UNII substance identifier 14BGY2Y3MJ UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"14BGY2Y3MJ"}
openFDA substances FDA UNII substance identifier 14BGY2Y3MJ UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"14BGY2Y3MJ"}
openFDA substances FDA UNII substance identifier 14BGY2Y3MJ UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"14BGY2Y3MJ"}