Moderate Cosmetic Ingredient NOAEL Data

PEG-2 Stearamine

INCI: PEG-2 STEARAMINE

CAS Number
10213-78-2
Function
Emulsifying, antistatic
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted โ€” no specific FDA restriction

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

8 study endpoints found for PEG-2 Stearamine. 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
NOEL 500 ppm oral rat oral REACH
NOAEL 13 mg/kg bw/day oral dog oral REACH
NOAEL >100 mg/kg bw/day oral rat oral REACH
NOEL 500 ppm oral rat oral REACH
NOAEL 13 mg/kg bw/day oral dog oral REACH
NOAEL >100 mg/kg bw/day oral rat oral REACH
NOEL 5 mg/kg bw/day oral rat oral REACH
NOEL 5 mg/kg bw/day oral rat oral REACH

Expert Verdict

Low MW PEG with plausible dermal penetration; 1,4-dioxane and ethylene oxide residuals present; amine functionality may form nitrosamines under specific conditions; avoid contact with nitrosating agents and use on compromised skin is not recommended.

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Concern Level: Moderate

Regulatory Flags

peg-ingredient

Frequently Asked Questions

Is PEG-2 Stearamine safe in cosmetics?

Low MW PEG with plausible dermal penetration; 1,4-dioxane and ethylene oxide residuals present; amine functionality may form nitrosamines under specific conditions; avoid contact with nitrosating agents and use on compromised skin is not recommended. The EU classifies PEG-2 Stearamine as "permitted". Safety rating: MODERATE. 8 toxicological study endpoint(s) are available in our database.

Is PEG-2 Stearamine allowed in the EU?

PEG-2 Stearamine EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does PEG-2 Stearamine do in cosmetics?

PEG-2 Stearamine functions as: Emulsifying, antistatic. It is classified as a cosmetic ingredient in our database. CAS number: 10213-78-2.

What is the Margin of Safety for PEG-2 Stearamine?

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 PEG-2 Stearamine?

The NOAEL (No Observed Adverse Effect Level) for PEG-2 Stearamine is 500 ppm based on a oral study via oral route in rat. A total of 8 study endpoints are available. Source: REACH.

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