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 Sucralose. 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 | 1500 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 2000 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 4000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 3000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 700 mg/kg bw/day | oral | rabbit | Developmental | COSMOS_DB |
| NOAEL | 750 mg/kg bw/day | oral | rabbit | Developmental | COSMOS_DB |
| NOAEL | 500 mg/kg bw/day | oral | rat | Special Toxicology Study | COSMOS_DB |
| NOAEL | 2965 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS_DB |
| NOAEL | 2000 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | monkey | Neurotoxicity | COSMOS_DB |
Expert Verdict
Sucralose is generally considered safe for cosmetic use with a maximum concentration of 1%.
Regulatory Flags
Frequently Asked Questions
Is Sucralose safe in cosmetics?
Sucralose is generally considered safe for cosmetic use with a maximum concentration of 1%. The EU classifies Sucralose as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.
Is Sucralose allowed in the EU?
Sucralose EU regulatory status: permitted. Maximum allowed concentration: 1%. This is based on EU Regulation 1223/2009 and its amendments.
What does Sucralose do in cosmetics?
Sucralose functions as: Sweetening agent. It is classified as a Cosmetic Ingredient in our database. CAS number: 56038-13-2.
What is the Margin of Safety for Sucralose?
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 Sucralose?
The NOAEL (No Observed Adverse Effect Level) for Sucralose is 1500 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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Related Ingredients
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