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
1 study endpoint found for CI 10316 (Ext. D&C Yellow No. 7). 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 |
|---|---|---|---|---|---|
| LOAEL | 30 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
Expert Verdict
Restricted synthetic colorant with defined but limited permitted use scope. EU Annex IV listed; FDA batch-certified. Must not be used near eyes or on lips. Nitro dye structural class raises theoretical concern, but regulatory genotoxicity testing is negative. Safe within approved applications at typical concentrations.
Regulatory Flags
Frequently Asked Questions
Is CI 10316 (Ext. D&C Yellow No. 7) safe in cosmetics?
Restricted synthetic colorant with defined but limited permitted use scope. EU Annex IV listed; FDA batch-certified. Must not be used near eyes or on lips. Nitro dye structural class raises theoretical concern, but regulatory genotoxicity testing is negative. Safe within approved applications at typical concentrations. The EU classifies CI 10316 (Ext. D&C Yellow No. 7) as "restricted". Safety rating: MODERATE. 1 toxicological study endpoint(s) are available in our database.
Is CI 10316 (Ext. D&C Yellow No. 7) allowed in the EU?
CI 10316 (Ext. D&C Yellow No. 7) EU regulatory status: restricted. Maximum allowed concentration: Permitted in all cosmetics except those applied in the vicinity of the eyes and lip products; no maximum concentration specified. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 10316 (Ext. D&C Yellow No. 7) do in cosmetics?
CI 10316 (Ext. D&C Yellow No. 7) functions as: Colorant. Synthetic nitro dye (Disodium 5,7-dinitro-8-oxidonaphthalene-2-sulphonate), also known as Naphthol Yellow S and Acid Yellow 1. Imparts yellow coloration to cosmetic products. Water-soluble anionic dye. Historically used as a food colorant but delisted from food use in the US in 1959. Now restricted to external-use cosmetics and drugs only.. It is classified as a cosmetic ingredient in our database. CAS number: 846-70-8.
What is the Margin of Safety for CI 10316 (Ext. D&C Yellow No. 7)?
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 CI 10316 (Ext. D&C Yellow No. 7)?
The NOAEL (No Observed Adverse Effect Level) for CI 10316 (Ext. D&C Yellow No. 7) is 30 mg/kg bw/day based on a Subchronic study via oral route in rat. Source: COSMOS_DB.
Compliance Tools
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Related Ingredients
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