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
10 study endpoints found for Polysorbate 80. 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 | 5000 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | monkey | Subchronic | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 10000 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 7500 mg/kg bw/day | oral | mouse | Short Term Toxicity | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 7500 mg/kg bw/day | oral | mouse | Subchronic | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Polysorbate 80, relevant to systemic exposure and MoS calculations.
Source: CIR
Expert Verdict
Most widely used polysorbate in both pharmaceutical and cosmetic applications. Excellent solubilizer for fragrance, essential oils, and active ingredients in O/W systems. CIR confirmed safe. Ethoxylated (1,4-dioxane risk at manufacturing), PEG-derived (COSMOS ineligible), and penetration-enhancing for co-formulants. Polyglyceryl esters are emerging PEG-free COSMOS-eligible alternatives.
Regulatory Flags
Frequently Asked Questions
Is Polysorbate 80 safe in cosmetics?
Most widely used polysorbate in both pharmaceutical and cosmetic applications. Excellent solubilizer for fragrance, essential oils, and active ingredients in O/W systems. CIR confirmed safe. Ethoxylated (1,4-dioxane risk at manufacturing), PEG-derived (COSMOS ineligible), and penetration-enhancing for co-formulants. Polyglyceryl esters are emerging PEG-free COSMOS-eligible alternatives. The EU classifies Polysorbate 80 as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.
Is Polysorbate 80 allowed in the EU?
Polysorbate 80 EU regulatory status: permitted. Maximum allowed concentration: 1,4-dioxane process impurity ≤10 ppm per EU GMP guidance. This is based on EU Regulation 1223/2009 and its amendments.
What does Polysorbate 80 do in cosmetics?
Polysorbate 80 functions as: Emulsifier; solubilizer; surfactant. It is classified as a Emulsifier in our database. CAS number: 9005-65-6.
What is the Margin of Safety for Polysorbate 80?
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 80?
The NOAEL (No Observed Adverse Effect Level) for Polysorbate 80 is 5000 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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Related Ingredients
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