Good Cosmetic Ingredient NOAEL Data

Poloxamer 101

INCI: POLOXAMER 101

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

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes CIR Expert Panel: safe as used. FDA permits in cosmetics

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 101. 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

Ethoxylation by-product: confirm supplier purification keeps residual 1,4-dioxane below 10 ppm (EU expectation) and complies with NY State limits. Monitor residual ethylene oxide and propylene oxide.

⚠️
Concern Level: Low

Regulatory Flags

epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Poloxamer 101 safe in cosmetics?

Ethoxylation by-product: confirm supplier purification keeps residual 1,4-dioxane below 10 ppm (EU expectation) and complies with NY State limits. Monitor residual ethylene oxide and propylene oxide. The EU classifies Poloxamer 101 as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Poloxamer 101 allowed in the EU?

Poloxamer 101 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Poloxamer 101 do in cosmetics?

Poloxamer 101 functions as: Surfactant, cleansing agent. It is classified as a cosmetic ingredient in our database. CAS number: 9003-11-6.

What is the Margin of Safety for Poloxamer 101?

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 101?

The NOAEL (No Observed Adverse Effect Level) for Poloxamer 101 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 101 compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
 🧪
Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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