Poor Cosmetic Ingredient

CI 42640 (FD&C Violet No. 1)

INCI: CI 42640

CAS Number

1694-09-3

Function

Colorant. Formerly certified synthetic triphenylmethane violet dye. Once used as a food, drug, and cosmetic colorant. Now fully delisted and prohibited in the United States and not included in the EU Annex IV permitted colorants list.

Safety Rating

POOR

Regulatory Status

🇪🇺 EU Status prohibited

🇺🇸 US Status prohibited

US Notes Fully prohibited in the United States. FD&C Violet No. 1 was delisted by the FDA in 1973 (effective April 10, 1973) following Japanese studies linking the dye to carcinogenicity in female rats. The provisional listing for drug and cosmetic use was terminated. Delisted color additives are not permitted for any use in the US under 21 CFR 81.10. Any US cosmetic product containing CI 42640 would be considered adulterated under the FD&C Act.

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 42640 (FD&C Violet No. 1) is fully prohibited for cosmetic use in both the US and EU. The FDA delisted it in 1973 due to carcinogenicity demonstrated in rodent studies, and it is absent from the EU Annex IV permitted colorants list. No authorized cosmetic application exists in any major jurisdiction.

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Concern Level: High

Regulatory Flags

fda-delisted-1973 fda-prohibited not-in-eu-annex-iv eu-prohibited-by-omission carcinogenic-animal-studies no-cosmetic-authorization triphenylmethane-dye adulterated-if-used-us 21-cfr-81-10 prop65 eu_banned_cosmetics fda_food_additive eu_cosing_listed jecfa_concern

Frequently Asked Questions

Is CI 42640 (FD&C Violet No. 1) safe in cosmetics?

Is CI 42640 (FD&C Violet No. 1) allowed in the EU?

CI 42640 (FD&C Violet No. 1) EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 42640 (FD&C Violet No. 1) do in cosmetics?

CI 42640 (FD&C Violet No. 1) functions as: Colorant. Formerly certified synthetic triphenylmethane violet dye. Once used as a food, drug, and cosmetic colorant. Now fully delisted and prohibited in the United States and not included in the EU Annex IV permitted colorants list.. It is classified as a cosmetic ingredient in our database. CAS number: 1694-09-3.

What is the Margin of Safety for CI 42640 (FD&C Violet 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 42640 (FD&C Violet No. 1) compliance across multiple jurisdictions:

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Ingredient Decoder

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82 Allergen Checker

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Substance Compliance

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MoS Calculator

Calculate Margin of Safety using SCCS methodology

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Heavy Metal Limits

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