HC Red No. 1

The safety of HC Red No. 1 has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel reviewed the scientific data and concluded that HC Red No. 1 was safe as used in hair dye formulations at concentrations of 0.5% or less. In 2011, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on HC Red No. 1 and reaffirmed the above conclusion.

CIR Safety Review:

In a study performed using human cadaver skin, the percutaneous absorption of HC Red No. 1 was poor. Short-term oral feeding of HC Red No. 1 had effects on several organ weights and resulted in liver and splenic lesions. Dermal exposure to almost twice the oral doses produced no evidence of toxicity. In laboratory studies, HC Red No. 1 was not a dermal irritant, but it was a mild ocular irritant. HC Red No. 1 was a contact sensitizer, but not a photosensitizer.

No reproductive or developmental toxicity was observed when a formulation containing 0.15% HC Red No. 1 was applied dermally, and neither fetotoxic nor developmental effects were observed after exposure to 0.1% or less HC Red No. 1. No evidence of mutagenic potential was seen in most assays.

No carcinogenic effects were reported after dermal dosing with HC Red No. 1, but several possible effects were seen in a skin-painting study with 0.15% HC Red No. 1. Whether these effects were compound-related was unclear. A repeated-insult patch test of a 3% slurry of HC Red No. 1 completed on 103 individuals with normal skin produced one possible and one definite sensitization reaction. Because the ingredient is used at a low concentration and very little is actually absorbed, the oral exposure data using concentrations of 0.1% or less represent a much higher exposure than would occur through the skin. The general absence of toxicity in such oral studies supports the safety of use of HC Red No. 1 in hair dye formulations at concentrations of 0.5% or less.

More information about the safety of hair dyes

In the European Union, HC Red No. 1 is permitted for use in non-oxidative hair dye products at concentrations up to 1%. See Annex III for additional information about the use of HC Red No. 1 in hair dye products in Europe.

Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm