This test is found in an informative annex of the document.
The rabbit is the preferred model.
There is an exemption statement that test articles are excluded when the pH is less than or equal to 2 or greater than or equal to 11.5 or if it is already known as an irritant in other tissues.
Liquid samples should be tested undiluted and solid samples should be ground to a fine powder. If the test article needs to be extracted, the method is provided according to an associated annex and should include both polar and nonpolar vehicles.
Rabbits of either sex can be used and should weigh 2 to 3 kilograms.
Only one initial animal should be dosed in order to assess the potential effect of the test article. If there is not a well defined reaction observed in the initial animal, two more animals should be dosed if the test article is directly applied or two more animals per extract if not direct.
Not more than 24 hours prior to test, the eyes should be examined for signs of pre-existing conditions. The test article is applied to one eye and the contralateral eye is used as an untreated control. The dose applied to each animal is 0.1 mL but is not to weigh more than 100 mg. If the test article is applied using a pump spray, accumulate 0.1 mL in a vessel to measure each dose. If the test article is applied using an aerosol, spray a 1 second burst from 10 cm away from the eye or accumulate 0.1 mL in a vessel to measure each dose. After dosing, hold the eyelids together for 1 second to ensure dose application to the eye. If the test article is applied repeated in clinical exposure, a repeated dose study may be conducted mimicking clinical exposure.
An eye exam is performed at 1, 24, 48, and 72 hours after dosing. Observations may be extended to, but not exceed, 21 days for the purpose of assessing reversal of scoring. This is not to be done with animals with severe lesions. In repeat dose studies, the eyes should be examined prior to and 1 hour following each dose.
If any observations occur in the cornea or iris, the conjuntiva appears red, or if obvious swelling is present, these findings would be sufficient to label the test article as an irritant. A scoring scale for the cornea, iris, conjuctiva, chemosis, and discharge is provided and is used for each of the eye examinations.
The rabbit is the preferred model.
There is an exemption statement that test articles are excluded when the pH is less than or equal to 2 or greater than or equal to 11.5 or if it is already known as an irritant in other tissues.
Liquid samples should be tested undiluted and solid samples should be ground to a fine powder. If the test article needs to be extracted, the method is provided according to an associated annex and should include both polar and nonpolar vehicles.
Rabbits of either sex can be used and should weigh 2 to 3 kilograms.
Only one initial animal should be dosed in order to assess the potential effect of the test article. If there is not a well defined reaction observed in the initial animal, two more animals should be dosed if the test article is directly applied or two more animals per extract if not direct.
Not more than 24 hours prior to test, the eyes should be examined for signs of pre-existing conditions. The test article is applied to one eye and the contralateral eye is used as an untreated control. The dose applied to each animal is 0.1 mL but is not to weigh more than 100 mg. If the test article is applied using a pump spray, accumulate 0.1 mL in a vessel to measure each dose. If the test article is applied using an aerosol, spray a 1 second burst from 10 cm away from the eye or accumulate 0.1 mL in a vessel to measure each dose. After dosing, hold the eyelids together for 1 second to ensure dose application to the eye. If the test article is applied repeated in clinical exposure, a repeated dose study may be conducted mimicking clinical exposure.
An eye exam is performed at 1, 24, 48, and 72 hours after dosing. Observations may be extended to, but not exceed, 21 days for the purpose of assessing reversal of scoring. This is not to be done with animals with severe lesions. In repeat dose studies, the eyes should be examined prior to and 1 hour following each dose.
If any observations occur in the cornea or iris, the conjuntiva appears red, or if obvious swelling is present, these findings would be sufficient to label the test article as an irritant. A scoring scale for the cornea, iris, conjuctiva, chemosis, and discharge is provided and is used for each of the eye examinations.
