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 Polydextrose. 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 | 10000 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 10000 mg/kg bw/day | oral | monkey | Subchronic | COSMOS_DB |
| NOAEL | 19200 mg/kg bw/day | oral | dog | Subchronic | COSMOS_DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
| NOAEL | 5000 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
| NOAEL | 15000 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS_DB |
| NOAEL | 4000 mg/kg bw/day | oral | dog | Chronic | COSMOS_DB |
| NOAEL | 11250 mg/kg bw/day | oral | dog | Chronic | COSMOS_DB |
| NOAEL | 10000 mg/kg bw/day | oral | dog | Subchronic | COSMOS_DB |
Expert Verdict
EFSA recommended lowering the maximum limit for lead and introducing limits for arsenic, cadmium, and mercury in EU specifications.
Regulatory Flags
Frequently Asked Questions
Is Polydextrose safe in cosmetics?
EFSA recommended lowering the maximum limit for lead and introducing limits for arsenic, cadmium, and mercury in EU specifications. The EU classifies Polydextrose as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.
Is Polydextrose allowed in the EU?
Polydextrose EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Polydextrose do in cosmetics?
Polydextrose functions as: Humectant, skin conditioning, bulking agent. It is classified as a cosmetic ingredient in our database. CAS number: 68424-04-4.
What is the Margin of Safety for Polydextrose?
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 Polydextrose?
The NOAEL (No Observed Adverse Effect Level) for Polydextrose is 10000 mg/kg bw/day based on a Subchronic 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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