Evaluation of the cumulative (repeated application) eye irritation and corneal staining potential of FD & C Yellow No. 5, FD & C Blue No. 1 and FD & C Blue No. 1 Aluminium Lake

Abstract A protocol to evaluate the ocular irritation, staining, and embedding potential of FD & C colours (Yellow No. 5, Blue No. 1, Blue No. 1 Aluminium Lake) produced by repeated topical application to rabbit eyes is described. Test materials (3%, w/v in aqueous vehicle) were administered once daily, for a total of 21 days, to the conjunctival sac of the right eye of New Zealand White Rabbits (6 of each sex per group) at a dose volume of 30 μl. Control animals (6 of each sex) received 30 μl of the vehicle daily. All animals survived and were free of significant clinical signs of toxicity throughout the study. Ophthalmoscopic examinations revealed that all animals were free of abnormalities considered to be of clinical importance; all animals were free of significant signs of ocular irritation, staining and particle embedment. The results of this study support the safe use of these materials in consumer products intended for use in the eye area.