Good Cosmetic Ingredient NOAEL Data

Ceteareth-20

INCI: CETEARETH-20

CAS Number

68439-49-6

Function

Emulsifier (O/W)

Safety Rating

GOOD

Regulatory Status

🇪🇺 EU Status permitted

EU Max Conc. 10%

🇺🇸 US Status permitted

US Notes Not listed among prohibited or restricted ingredients under 21 CFR 700. Permitted for cosmetic use based on manufacturer safety substantiation. No GRAS determination applicable — Ceteareth-20 is an inactive ingredient/excipient. May be used as an inactive ingredient in OTC drug products when appropriately formulated. Subject to general safety requirements under 21 CFR 700.13. FDA does not require premarket approval for cosmetic ingredients other than color additives.

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

Safety Data

Margin of Safety (MoS)

adequate

Dermal Absorption

low

Sensitization

low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for Ceteareth-20. 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	800 mg/kg bw/day	oral	rat	oral	REACH
NOAEL	800 mg/kg bw/day	oral	rat	oral	REACH

Expert Verdict

Ceteareth-20 is a PEG-20 ether of cetearyl alcohol permitted for general use in EU and US cosmetics without concentration restrictions. The CIR Expert Panel concluded it is safe as used in cosmetic formulations, though it should not be used on damaged or compromised skin due to historical PEG-related nephrotoxicity concerns in burn patients. Formulators must ensure 1,4-dioxane impurity levels remain ≤10 ppm per SCCS guidance.

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Concern Level: Low

Regulatory Flags

avoid-damaged-skin 1,4-dioxane-impurity-risk penetration-enhancer PEG-derived eu_children_restricted epa_safer_alternative

Frequently Asked Questions

Is Ceteareth-20 safe in cosmetics?

Is Ceteareth-20 allowed in the EU?

Ceteareth-20 EU regulatory status: permitted. Maximum allowed concentration: 10%. This is based on EU Regulation 1223/2009 and its amendments.

What does Ceteareth-20 do in cosmetics?

Ceteareth-20 functions as: Emulsifier (O/W). It is classified as a Cosmetic Ingredient in our database. CAS number: 68439-49-6.

What is the Margin of Safety for Ceteareth-20?

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 Ceteareth-20?

The NOAEL (No Observed Adverse Effect Level) for Ceteareth-20 is 800 mg/kg bw/day based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.

Compliance Tools

Check Ceteareth-20 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

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Heavy Metal Limits

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