Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Dimethicone. 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 | 500 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 300 mg/kg bw/day | oral | dog | Subchronic | COSMOS_DB |
| NOAEL | 300 mg/kg bw/day | oral | dog | Subchronic | COSMOS_DB |
| NOAEL | 1250 mg/kg bw/day | oral | mouse | Chronic | COSMOS_DB |
| NOAEL | 1250 mg/kg bw/day | oral | mouse | Chronic | COSMOS_DB |
| NOAEL | 1250 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 500 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 500 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Dimethicone, relevant to systemic exposure and MoS calculations.
Source: SCCS/1241/10, CIR
Expert Verdict
One of the most extensively safety-tested cosmetic ingredients. CIR Final Amended Report (March 2022) covers 30 polymers and concludes safe as used except in airbrush delivery (insufficient data). FDA OTC-approved skin protectant at 1–30%. Creates occlusive but breathable barrier; does not disrupt stratum corneum lipid microstructure. Non-comedogenic per FDA classification. Medical-grade silicone for scar management regulated as FDA Class I device. Not PBT/vPvB — not subject to D4/D5/D6 EU restrictions. Avoid only in airbrush applications pending further safety data.
Regulatory Flags
Frequently Asked Questions
Is Dimethicone safe in cosmetics?
One of the most extensively safety-tested cosmetic ingredients. CIR Final Amended Report (March 2022) covers 30 polymers and concludes safe as used except in airbrush delivery (insufficient data). FDA OTC-approved skin protectant at 1–30%. Creates occlusive but breathable barrier; does not disrupt stratum corneum lipid microstructure. Non-comedogenic per FDA classification. Medical-grade silicone for scar management regulated as FDA Class I device. Not PBT/vPvB — not subject to D4/D5/D6 EU restrictions. Avoid only in airbrush applications pending further safety data. The EU classifies Dimethicone as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.
Is Dimethicone allowed in the EU?
Dimethicone EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Dimethicone do in cosmetics?
Dimethicone functions as: emollient, skin-conditioning, film-forming, skin protectant, occlusive. It is classified as a Emollient in our database. CAS number: 9006-65-9.
What is the Margin of Safety for Dimethicone?
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 Dimethicone?
The NOAEL (No Observed Adverse Effect Level) for Dimethicone is 500 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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