Regulatory Status
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Safety Data
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Expert Verdict
CI 12120 (Toluidine Red / D&C Red 35) is an azo pigment with significant carcinogenicity concerns. NTP studies found increased adrenal pheochromocytomas in male rats and hepatocellular adenomas in female rats. IARC Group 3 (inadequate human evidence, limited animal evidence). FDA delisted D&C Red 35 in 1966; Health Canada lists it as prohibited. EU Annex IV permits it only in rinse-off products (Cat 4, brief contact). Prohibited in Canada. The combination of animal carcinogenicity data and US/Canada prohibition warrants a POOR safety rating despite IARC Group 3 classification.
Regulatory Flags
Frequently Asked Questions
Is CI 12120 (Pigment Red 3 / Toluidine Red) safe in cosmetics?
CI 12120 (Toluidine Red / D&C Red 35) is an azo pigment with significant carcinogenicity concerns. NTP studies found increased adrenal pheochromocytomas in male rats and hepatocellular adenomas in female rats. IARC Group 3 (inadequate human evidence, limited animal evidence). FDA delisted D&C Red 35 in 1966; Health Canada lists it as prohibited. EU Annex IV permits it only in rinse-off products (Cat 4, brief contact). Prohibited in Canada. The combination of animal carcinogenicity data and US/Canada prohibition warrants a POOR safety rating despite IARC Group 3 classification. The EU classifies CI 12120 (Pigment Red 3 / Toluidine Red) as "restricted". Safety rating: POOR.
Is CI 12120 (Pigment Red 3 / Toluidine Red) allowed in the EU?
CI 12120 (Pigment Red 3 / Toluidine Red) EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 12120 (Pigment Red 3 / Toluidine Red) do in cosmetics?
CI 12120 (Pigment Red 3 / Toluidine Red) functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 2425-85-6.
What is the Margin of Safety for CI 12120 (Pigment Red 3 / Toluidine Red)?
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
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Related Ingredients
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