Acid Orange 3

Abstract

The Expert Panel for Cosmetic Ingredient Safety reviewed updated information that has become available since their original assessment from year 2000, along with updated information regarding product types, and frequency and concentrations of use, and reaffirmed their original conclusion that Acid Orange 3 is safe for use in hair dye formulations at concentrations <.2%.

The Expert Panel for Cosmetic Ingredient Safety first published the Final Report on the Safety Assessment of Acid Orange 3 in 2000. ¹ The Expert Panel concluded that this ingredient is safe for use in hair dye formulations at concentrations ≤ .2%.

Because it has been at least 15 years since the final report was published, in accordance with Cosmetic Ingredient Review Procedures, the Expert Panel determined whether the safety assessment should be reopened. At the September 2022 meeting, the Expert Panel considered updated 2022 information regarding product types and ingredient use frequencies as reported in the FDA Voluntary Cosmetic Registration Program (VCRP) database ² and maximum use concentrations provided by the Personal Care Products Council (Council). ³ According to 2022 VCRP data, Acid Orange 3 is used in 1 formulation; it is reported to be used in a nail polish and enamel. ² The results of the concentration of use survey provided by the Council in 2022 reported no uses for this ingredient. ³ When the original safety assessment was published in 2000, Acid Orange 3 was reported to be used in 4 hair dye formulations (data acquired in 1997). ¹ At that time, concentrations of use were no longer reported by the FDA; however, data available from the FDA in 1984 indicated that Acid Orange 3 was used in 1 hair dye formulation at a concentration between 10% and 25% and 33 hair dye formulations at < 1%.

An extensive search of the world’s literature was performed for studies dated 1997 forward, and new data were found.^4-7 The Expert Panel agreed that an updated search of the published literature did not reveal toxicity data that warrant re-evaluation of the safety of this ingredient in cosmetic products. The Expert Panel did note that the European Union has banned Acid Orange 3 for use in cosmetic products; however, this ban is due to a lack of safety test data and not because of any toxicological findings.

The Expert Panel remarked on the reported use in a non-coloring cosmetic product (nail polish and enamel). The Federal Food, Drug and Cosmetic Act (FD&C Act) mandates that color additives must be approved by FDA for their intended use before they are used. Acid Orange 3 is an unapproved color additive in cosmetics products, and thereby, such use is not permitted. This use is not within the purview of this Expert Panel.

However, due to the “coal-tar hair dye exemption” of the FD&C Act, hair dye products labeled with the following caution statement do not require FDA approval prior to use:

Caution - This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.

Thus, use of this ingredient in hair dye products is permitted and is within the purview of this Expert Panel.

Finally, Acid Orange 3 is a secondary amine; a concern is the conversion of secondary amines (R1-NH-R2) into N-nitrosamines that may be carcinogenic. ⁸ The Expert Panel cautions that this ingredient should not be used in cosmetic products in which N-nitroso compounds can be formed.

The Expert Panel reviewed 2022 frequency and concentration of use data, in addition to any new, available, relevant safety data, and reaffirmed the 2000 conclusion regarding the safety of Acid Orange 3 in hair dye formulations.