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
4 study endpoints found for Saccharin. 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 | 7500 other | oral | rat | oral | REACH |
| LOEL | 1000 mg/kg bw/day | oral | mouse | oral | REACH |
| NOAEL | 353 mg/kg bw/day | oral | hamster | oral | REACH |
| LOAEL | 1000 mg/kg bw/day | oral | rat | oral | REACH |
Expert Verdict
Historical bladder cancer concern in rats — definitively resolved as species-specific, not relevant to humans ; trace o-toluenesulfonamide impurity should be controlled depending on manufacturing process
Regulatory Flags
Frequently Asked Questions
Is Saccharin safe in cosmetics?
Historical bladder cancer concern in rats — definitively resolved as species-specific, not relevant to humans ; trace o-toluenesulfonamide impurity should be controlled depending on manufacturing process The EU classifies Saccharin as "permitted". Safety rating: GOOD. 4 toxicological study endpoint(s) are available in our database.
Is Saccharin allowed in the EU?
Saccharin EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Saccharin do in cosmetics?
Saccharin functions as: Flavouring; fragrance functional. It is classified as a cosmetic ingredient in our database. CAS number: 81-07-2.
What is the Margin of Safety for Saccharin?
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 Saccharin?
The NOAEL (No Observed Adverse Effect Level) for Saccharin is 7500 other based on a oral study via oral route in rat. A total of 4 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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