Acute Eye Irritation/Corrosion (OECD 405: 2020).
Test with the Certificate of Good Laboratory Practices (GLPs).
This Standard indicates the procedure to be followed to evaluate the degree of eye irritation / corrosion caused by a product using sequential tests. If there is strong evidence of irritation / corrosion of the structurally related substance or substances, the test should not be performed. In addition, when it is necessary to carry it out, a prior study of the skin corrosion of the substance in vitro / in vivo should be considered.
For new substances, which must be tested, the standard describes a sequential testing procedure. The initial test must be done on a single animal. Preferably healthy young adult albino rabbits should be used. The substance to be tested should be applied in a single dose in one of the eyes of the experimental animal, serving the untreated eye as a control. To test liquids, a dose of 0.1 ml is used. To analyze solids, the quantity used must have a volume of 0.1 ml or a weight of not more than 100 mg. Sprays and impulse sprays are recommended to be collected before application. The degree of ocular irritation / corrosion is evaluated by classifying the conjunctiva, cornea and iris lesions at specific intervals. The degree of eye reaction should be observed and recorded at the time, and after 24, 48 and 72 hours. Animals without lesions can be removed from the study 3 days after application. For animals with non-severe injuries, the usual observation period is 21 days after the application of the test substance, but if reversibility is observed earlier, the experiment may be terminated.
If the results of the initial test indicate that the substance is corrosive or a serious eye irritant, no further tests should be performed. If no corrosive or intense irritant effect is observed, the result should be confirmed using up to two additional animals sequentially. If the second animal shows corrosive or irritant effects, the test should not be continued. If the results of the second animal are sufficient to allow a hazard classification determination, no further tests should be conducted.