Excellent Emollient NOAEL Data

Methicone

INCI: METHICONE

CAS Number
9004-73-3
Function
emollient, skin-conditioning, film-forming
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Included in CIR Final Amended Report March 2022 for 30 methicone/dimethicone polymers; concluded safe as used

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

2 study endpoints found for Methicone. 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 300 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 150 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB

Expert Verdict

Linear silicone with one methyl and one hydrogen substituent per silicon. Included in CIR Final Amended Report March 2022 covering 30 methicone/dimethicone polymers, all concluded safe as used. Not subject to EU cyclic siloxane restrictions. Provides good emollient and conditioning properties with negligible skin penetration and no sensitization concerns.

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Concern Level: None

Regulatory Flags

cir-approved non-volatile-silicone high-molecular-weight cosmos-prohibited fda_food_additive

Frequently Asked Questions

Is Methicone safe in cosmetics?

Linear silicone with one methyl and one hydrogen substituent per silicon. Included in CIR Final Amended Report March 2022 covering 30 methicone/dimethicone polymers, all concluded safe as used. Not subject to EU cyclic siloxane restrictions. Provides good emollient and conditioning properties with negligible skin penetration and no sensitization concerns. The EU classifies Methicone as "permitted". Safety rating: EXCELLENT. 2 toxicological study endpoint(s) are available in our database.

Is Methicone allowed in the EU?

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

What does Methicone do in cosmetics?

Methicone functions as: emollient, skin-conditioning, film-forming. It is classified as a Emollient in our database. CAS number: 9004-73-3.

What is the Margin of Safety for Methicone?

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 Methicone?

The NOAEL (No Observed Adverse Effect Level) for Methicone is 300 mg/kg bw/day based on a Chronic study via oral route in dog. A total of 2 study endpoints are available. Source: COSMOS_DB.

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