Moderate Cosmetic Ingredient NOAEL Data

Poloxamer 188

INCI: POLOXAMER 188

CAS Number
9003-11-6
Function
Insufficient Data
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
EU Max Conc. 5%
🇺🇸 US Status permitted
US Notes OTC drug ingredient

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Poloxamer 188. 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 188 is permitted in cosmetics with restrictions (5% max in EU); insufficient safety data available and further assessment recommended.

⚠️
Concern Level: Moderate

Regulatory Flags

epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Poloxamer 188 safe in cosmetics?

Poloxamer 188 is permitted in cosmetics with restrictions (5% max in EU); insufficient safety data available and further assessment recommended. The EU classifies Poloxamer 188 as "permitted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is Poloxamer 188 allowed in the EU?

Poloxamer 188 EU regulatory status: permitted. Maximum allowed concentration: 5%. This is based on EU Regulation 1223/2009 and its amendments.

What does Poloxamer 188 do in cosmetics?

Poloxamer 188 functions as: Insufficient Data. It is classified as a Cosmetic Ingredient in our database. CAS number: 9003-11-6.

What is the Margin of Safety for Poloxamer 188?

not established 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 188?

The NOAEL (No Observed Adverse Effect Level) for Poloxamer 188 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

Check Poloxamer 188 compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
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