HC Orange No. 1

Conclusion

In the 1998 safety assessment of HC Orange No. 1, the Cosmetic Ingredient Review Expert Panel concluded that this ingredient was safe as a cosmetic ingredient at concentrations ≤3%. ¹ The Expert Panel reviewed newly available studies since that assessment along with updated frequency and concentration of use information. ^{2 –4} The Expert Panel reaffirmed the original conclusion that HC Orange No. 1 is safe as a hair dye at concentrations ≤3%.

Discussion

This ingredient was used in 95 hair dyes and colors and no hair tints in 1996, based on the voluntary reports submitted to the US Food and Drug Administration by the industry, with concentrations of use up to 0.15% in semipermanent hair colors. ¹

In 2013, HC Orange No. 1 was reportedly used in 15 hair dyes and colors and 1 hair tint. ² Data from an industry survey in 2013 indicate that concentrations of use have increased from 0.15% in 1998 to 0.55% and that this ingredient is only used in hair dyes and colors up to 0.55%. ³ The Expert Panel noted that these hair dyes should be formulated to be nonirritating, although the increased concentration is still well below the maximum concentration of 3%.

The Expert Panel recognized that HC Orange No. 1 can be considered a coal tar hair dye. Accordingly, products containing this ingredient are exempt from certain adulteration and color additive provisions of the Federal Food, Drug, and Cosmetic Act, when the product label bears a caution statement and patch test instructions for determining whether the product causes skin irritation. The Expert Panel considered concerns about such self-testing but agreed that following this procedure enables consumers to determine, prospectively, whether they will have an irritation/sensitization reaction and allow them to avoid subsequent significant exposures. The results of ongoing studies to evaluate the risks and benefits of consumer self-testing will be considered in the future.