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 Poloxamer 338. 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 | 25000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 30000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 480 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 3000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 200 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 500 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | dog | Subchronic | COSMOS_DB |
| NOAEL | 40 mg/kg bw/day | oral | dog | Subchronic | COSMOS_DB |
Expert Verdict
Poloxamer 338 is permitted for use in cosmetics with adequate margin of safety, though residual impurities of 1,4-dioxane, ethylene oxide, and propylene oxide should be verified with suppliers; higher ethylene oxide content than Poloxamer 184 may correlate with increased dioxane risk.
Regulatory Flags
Frequently Asked Questions
Is Poloxamer 338 safe in cosmetics?
Poloxamer 338 is permitted for use in cosmetics with adequate margin of safety, though residual impurities of 1,4-dioxane, ethylene oxide, and propylene oxide should be verified with suppliers; higher ethylene oxide content than Poloxamer 184 may correlate with increased dioxane risk. The EU classifies Poloxamer 338 as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.
Is Poloxamer 338 allowed in the EU?
Poloxamer 338 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Poloxamer 338 do in cosmetics?
Poloxamer 338 functions as: Emulsifying, Surfactant, Cleansing, Solubilizing. It is classified as a cosmetic ingredient in our database. CAS number: 9003-11-6.
What is the Margin of Safety for Poloxamer 338?
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 Poloxamer 338?
The NOAEL (No Observed Adverse Effect Level) for Poloxamer 338 is 25000 mg/kg bw/day based on a Short Term Toxicity 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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