Poor Cosmetic Ingredient

CI 13065 (Acid Yellow 36 / Metanil Yellow / Ext. D&C Yellow No. 1)

INCI: CI 13065

CAS Number
587-98-4
Function
Colorant
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status prohibited
🇺🇸 US Status prohibited
US Notes Delisted by FDA on December 13, 1977 (21 CFR 81.10, 81.30). Originally approved in 1939 as Ext. D&C Yellow No. 1 for external drugs and cosmetics; delisted due to contamination with 4-aminobiphenyl (a known human carcinogen) and inability to produce the dye without benzidine-related impurities. No longer permitted in any FDA-regulated cosmetic or drug product in the United States.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

CI 13065 is prohibited in the EU (not listed in Annex IV of EC 1223/2009) and delisted by the FDA in 1977 due to unavoidable contamination with 4-aminobiphenyl and benzidine precursors. Animal studies document neurotoxic effects including cerebellar degeneration. No safe use scenario exists for cosmetic applications in EU or US jurisdictions.

⚠️
Concern Level: High

Regulatory Flags

eu-not-in-annex-iv not-fda-approved fda-delisted-1977 4-aminobiphenyl-contamination benzidine-precursor neurotoxic hepatotoxic genotoxic azo-dye aromatic-amine-precursor carcinogenic-impurities eu_banned_cosmetics eu_cosing_listed

Frequently Asked Questions

Is CI 13065 (Acid Yellow 36 / Metanil Yellow / Ext. D&C Yellow No. 1) safe in cosmetics?

CI 13065 is prohibited in the EU (not listed in Annex IV of EC 1223/2009) and delisted by the FDA in 1977 due to unavoidable contamination with 4-aminobiphenyl and benzidine precursors. Animal studies document neurotoxic effects including cerebellar degeneration. No safe use scenario exists for cosmetic applications in EU or US jurisdictions. The EU classifies CI 13065 (Acid Yellow 36 / Metanil Yellow / Ext. D&C Yellow No. 1) as "prohibited". Safety rating: POOR.

Is CI 13065 (Acid Yellow 36 / Metanil Yellow / Ext. D&C Yellow No. 1) allowed in the EU?

CI 13065 (Acid Yellow 36 / Metanil Yellow / Ext. D&C Yellow No. 1) EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 13065 (Acid Yellow 36 / Metanil Yellow / Ext. D&C Yellow No. 1) do in cosmetics?

CI 13065 (Acid Yellow 36 / Metanil Yellow / Ext. D&C Yellow No. 1) functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 587-98-4.

What is the Margin of Safety for CI 13065 (Acid Yellow 36 / Metanil Yellow / Ext. D&C Yellow No. 1)?

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.

Compliance Tools

Check CI 13065 (Acid Yellow 36 / Metanil Yellow / Ext. D&C Yellow No. 1) compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
 🧪
Substance Compliance
Check compliance across 55 jurisdictions
 🧮
MoS Calculator
Calculate Margin of Safety using SCCS methodology
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

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