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 Menthol. 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.375 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | ca.667 mg/kg bw/day | oral | mouse | oral | REACH |
| NOEL | 200 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | ca.1000 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | ca.2143 mg/kg bw/day | oral | mouse | oral | REACH |
| NOAEL | ca.375 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | ca.667 mg/kg bw/day | oral | mouse | oral | REACH |
| NOEL | 200 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | ca.1000 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | ca.2143 mg/kg bw/day | oral | mouse | oral | REACH |
Sensitization Profile
Contact sensitization data for Menthol based on clinical patch test studies and IFRA standards.
Source: EU 2023/1545; SCCS/1459/11
Dermal Penetration Profile
Skin absorption and penetration characteristics of Menthol, relevant to systemic exposure and MoS calculations.
Source: J Pharm Sci 1996
Expert Verdict
Primary scalp cooling active via TRPM8 ion channel activation. Provides documented anti-pruritic (itch relief) and vasodilatory effects on the scalp. Well-understood sensory mechanism. FDA M032 allows 1.5% in combination dandruff shampoos with coal tar. Effective at 0.1–1% for scalp freshness and itch relief in cosmetic formulations without drug claims.
Regulatory Flags
Frequently Asked Questions
Is Menthol safe in cosmetics?
Primary scalp cooling active via TRPM8 ion channel activation. Provides documented anti-pruritic (itch relief) and vasodilatory effects on the scalp. Well-understood sensory mechanism. FDA M032 allows 1.5% in combination dandruff shampoos with coal tar. Effective at 0.1–1% for scalp freshness and itch relief in cosmetic formulations without drug claims. The EU classifies Menthol as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.
Is Menthol allowed in the EU?
Menthol EU regulatory status: permitted. Maximum allowed concentration: No specific Annex III limit for scalp/shampoo use at standard concentrations (typically ≤1%); higher concentrations require safety assessment. This is based on EU Regulation 1223/2009 and its amendments.
What does Menthol do in cosmetics?
Menthol functions as: Cooling agent; antipruritic; sensory modifier; scalp vasodilator. It is classified as a Active Ingredient in our database. CAS number: 89-78-1.
What is the Margin of Safety for Menthol?
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 Menthol?
The NOAEL (No Observed Adverse Effect Level) for Menthol is ca.375 mg/kg bw/day based on a oral study via oral route in rat. A total of 10 study endpoints are available. Source: REACH.
Compliance Tools
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