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
6 study endpoints found for Montmorillonite. 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 | 400 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 75000 mg/kg bw/day | oral | mouse | Short Term Toxicity | COSMOS_DB |
| NOAEL | 400 mg/kg bw/day | oral | swine | Short Term Toxicity | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| dose_tested | 400 mg/kg bw/day | oral | swine | Short Term Toxicity | COSMOS_DB |
| dose_tested | 1000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Expert Verdict
Montmorillonite is permitted in EU cosmetics without concentration limits for dermal applications. CIR affirms safety at current use concentrations (up to 3% leave-on) with negative sensitization and negligible dermal absorption; however, insufficient data exists for products that may be incidentally inhaled due to crystalline silica content.
Regulatory Flags
Frequently Asked Questions
Is Montmorillonite safe in cosmetics?
Montmorillonite is permitted in EU cosmetics without concentration limits for dermal applications. CIR affirms safety at current use concentrations (up to 3% leave-on) with negative sensitization and negligible dermal absorption; however, insufficient data exists for products that may be incidentally inhaled due to crystalline silica content. The EU classifies Montmorillonite as "permitted". Safety rating: GOOD. 6 toxicological study endpoint(s) are available in our database.
Is Montmorillonite allowed in the EU?
Montmorillonite EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Montmorillonite do in cosmetics?
Montmorillonite functions as: Rheology modifier, thickener, suspending agent, absorbent. It is classified as a cosmetic ingredient in our database. CAS number: 1302-78-9.
What is the Margin of Safety for Montmorillonite?
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 Montmorillonite?
The NOAEL (No Observed Adverse Effect Level) for Montmorillonite is 400 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 6 study endpoints are available. Source: COSMOS_DB.
Is Montmorillonite classified as hazardous under GHS?
Montmorillonite carries a GHS signal word of "DANGER". Hazard statements: Causes damage to the lungs through prolonged or repeated exposure if inhaled. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.
Compliance Tools
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Related Ingredients
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