Good Cosmetic Ingredient NOAEL Data

Poloxamer 183

INCI: POLOXAMER 183

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

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR: safe as used (2008)

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Poloxamer 183. 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

Impurity control; no concentration-of-use data or FDA-reported formulations โ€” essentially unused commercially.

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Concern Level: Low

Regulatory Flags

epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Poloxamer 183 safe in cosmetics?

Impurity control; no concentration-of-use data or FDA-reported formulations โ€” essentially unused commercially. The EU classifies Poloxamer 183 as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Poloxamer 183 allowed in the EU?

Poloxamer 183 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Poloxamer 183 do in cosmetics?

Poloxamer 183 functions as: Surfactant, emulsifying agent. It is classified as a cosmetic ingredient in our database. CAS number: 9003-11-6.

What is the Margin of Safety for Poloxamer 183?

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 183?

The NOAEL (No Observed Adverse Effect Level) for Poloxamer 183 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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