Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
5 study endpoints found for Polysorbate 65. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 12500 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
| dose_tested | 12500 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| dose_tested | 1000 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
Expert Verdict
Safe emulsifier with long regulatory history in food and cosmetics; good skin tolerance
Regulatory Flags
Frequently Asked Questions
Is Polysorbate 65 safe in cosmetics?
Safe emulsifier with long regulatory history in food and cosmetics; good skin tolerance The EU classifies Polysorbate 65 as "permitted". Safety rating: GOOD. 5 toxicological study endpoint(s) are available in our database.
Is Polysorbate 65 allowed in the EU?
Polysorbate 65 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Polysorbate 65 do in cosmetics?
Polysorbate 65 functions as: Emulsifying, Surfactant. It is classified as a cosmetic ingredient in our database. CAS number: 9005-71-4.
What is the Margin of Safety for Polysorbate 65?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Polysorbate 65?
The NOAEL (No Observed Adverse Effect Level) for Polysorbate 65 is 12500 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 5 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
Check Polysorbate 65 compliance across multiple jurisdictions:
Related Ingredients
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