Good Cosmetic Ingredient NOAEL Data

Poloxamer 231

INCI: POLOXAMER 231

CAS Number
9003-11-6
Function
Surfactant, emulsifying agent, cleansing agent, solubilizing agent
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA reported; CIR: safe as used (2008); no reported cosmetic uses in CTFA survey

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Poloxamer 231. 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

Residual EO/PO/1,4-dioxane impurities present; very low HLB with potential irritation at higher concentrations due to surfactant strength.

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Concern Level: Low

Regulatory Flags

epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Poloxamer 231 safe in cosmetics?

Residual EO/PO/1,4-dioxane impurities present; very low HLB with potential irritation at higher concentrations due to surfactant strength. The EU classifies Poloxamer 231 as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Poloxamer 231 allowed in the EU?

Poloxamer 231 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Poloxamer 231 do in cosmetics?

Poloxamer 231 functions as: Surfactant, emulsifying agent, cleansing agent, solubilizing agent. It is classified as a cosmetic ingredient in our database. CAS number: 9003-11-6.

What is the Margin of Safety for Poloxamer 231?

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 231?

The NOAEL (No Observed Adverse Effect Level) for Poloxamer 231 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.

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