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
7 study endpoints found for Trehalose. 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 | >=250 mg/kg bw/day | dermal | code:3532 | dermal | REACH |
| NOAEL | >=2500 mg/kg bw/day | dermal | code:3543 | dermal | REACH |
| NOAEL | >=1000 mg/kg bw/day | intravenous | dog | other | REACH |
| NOAEL | >7500 mg/kg bw/day | oral | mouse | oral | REACH |
| NOAEL | >=5000 mg/kg bw/day | oral | dog | oral | REACH |
| NOAEL | >=1000 mg/kg bw/day | intravenous | mouse | other | REACH |
| NOAEL | >=5000 mg/kg bw/day | oral | mouse | oral | REACH |
Expert Verdict
CIR Expert Panel (2019) concluded safe as used at ≤2% leave-on and ≤1% rinse-off formulations. Genotoxicity studies negative (Ames, chromosomal aberration, micronucleus). Acute oral LD50 >16,000 mg/kg in rats. Non-irritating at 10% in rabbit eye irritation testing. Not listed in any EU restricted annex.
Regulatory Flags
Frequently Asked Questions
Is Trehalose safe in cosmetics?
CIR Expert Panel (2019) concluded safe as used at ≤2% leave-on and ≤1% rinse-off formulations. Genotoxicity studies negative (Ames, chromosomal aberration, micronucleus). Acute oral LD50 >16,000 mg/kg in rats. Non-irritating at 10% in rabbit eye irritation testing. Not listed in any EU restricted annex. The EU classifies Trehalose as "permitted". Safety rating: EXCELLENT. 7 toxicological study endpoint(s) are available in our database.
Is Trehalose allowed in the EU?
Trehalose EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Trehalose do in cosmetics?
Trehalose functions as: humectant, skin-conditioning, autophagy-inducer. It is classified as a Humectant in our database. CAS number: 99-20-7.
What is the Margin of Safety for Trehalose?
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 Trehalose?
The NOAEL (No Observed Adverse Effect Level) for Trehalose is >=250 mg/kg bw/day based on a dermal study via dermal route in code:3532. A total of 7 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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