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
2 study endpoints found for Bismuth Subnitrate. 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 | 1000 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 1000 mg/kg bw/day | oral | rat | oral | REACH |
Expert Verdict
Bismuth Subnitrate is permitted in the EU but lacks a dedicated SCCS opinion and carries GHS classifications for skin and eye irritation. It is not FDA-approved as a cosmetic color additive and requires concentration justification for cosmetic product safety reports.
Frequently Asked Questions
Is Bismuth Subnitrate safe in cosmetics?
Bismuth Subnitrate is permitted in the EU but lacks a dedicated SCCS opinion and carries GHS classifications for skin and eye irritation. It is not FDA-approved as a cosmetic color additive and requires concentration justification for cosmetic product safety reports. The EU classifies Bismuth Subnitrate as "permitted". Safety rating: MODERATE. 2 toxicological study endpoint(s) are available in our database.
Is Bismuth Subnitrate allowed in the EU?
Bismuth Subnitrate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Bismuth Subnitrate do in cosmetics?
Bismuth Subnitrate functions as: Absorbent, Opacifying. It is classified as a Cosmetic Ingredient in our database. CAS number: 1304-85-4.
What is the Margin of Safety for Bismuth Subnitrate?
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 Bismuth Subnitrate?
The NOAEL (No Observed Adverse Effect Level) for Bismuth Subnitrate is 1000 mg/kg bw/day based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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