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 Kaolin. 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 | ca.2500 mg/kg bw/day | oral | code:3544 | oral | REACH |
| NOAEL | >5000 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 10000 mg/kg bw/day | oral | code:3544 | oral | REACH |
| NOAEL | 1760 other | oral | rat | oral | REACH |
| NOAEL | 5270 other | oral | mouse | oral | REACH |
| NOAEL | 8980 mg/kg bw/day | oral | rat | oral | REACH |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Expert Verdict
Kaolin is concluded safe in cosmetics in present practices of use and concentration up to 53.2% with negligible dermal absorption confirmed via Franz diffusion cells. Cosmetic-grade Kaolin must contain less than 2% crystalline silica. Nanoparticle forms require separate safety assessment.
Regulatory Flags
Frequently Asked Questions
Is Kaolin safe in cosmetics?
Kaolin is concluded safe in cosmetics in present practices of use and concentration up to 53.2% with negligible dermal absorption confirmed via Franz diffusion cells. Cosmetic-grade Kaolin must contain less than 2% crystalline silica. Nanoparticle forms require separate safety assessment. The EU classifies Kaolin as "permitted". Safety rating: GOOD. 6 toxicological study endpoint(s) are available in our database.
Is Kaolin allowed in the EU?
Kaolin EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Kaolin do in cosmetics?
Kaolin functions as: absorbent, opacifier, viscosity-increasing, bulking. It is classified as a cosmetic ingredient in our database. CAS number: 1332-58-7.
What is the Margin of Safety for Kaolin?
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 Kaolin?
The NOAEL (No Observed Adverse Effect Level) for Kaolin is ca.2500 mg/kg bw/day based on a oral study via oral route in code:3544. A total of 6 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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