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
1 study endpoint found for Subtilisin. 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 | 572 mg/kg bw/day | oral | rat | oral | REACH |
Expert Verdict
Known respiratory sensitizer (H334); skin/eye irritant; contraindicated in spray/aerosol products; requires strict concentration control; index number 647-012-00-8
Regulatory Flags
Frequently Asked Questions
Is Subtilisin safe in cosmetics?
Known respiratory sensitizer (H334); skin/eye irritant; contraindicated in spray/aerosol products; requires strict concentration control; index number 647-012-00-8 The EU classifies Subtilisin as "permitted". Safety rating: MODERATE. 1 toxicological study endpoint(s) are available in our database.
Is Subtilisin allowed in the EU?
Subtilisin EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Subtilisin do in cosmetics?
Subtilisin functions as: Skin conditioning agent (serine protease enzyme from *Bacillus* spp.). It is classified as a cosmetic ingredient in our database. CAS number: 9014-01-1.
What is the Margin of Safety for Subtilisin?
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 Subtilisin?
The NOAEL (No Observed Adverse Effect Level) for Subtilisin is 572 mg/kg bw/day based on a oral study via oral route in rat. Source: REACH.
Compliance Tools
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Related Ingredients
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