The use of low-volume dosing in the eye irritation test.
The Draize rabbit eye test was developed to provide a method for assessing the irritation potential of materials that might come in contact with human eyes. The method involves the instillation of 0.1 ml of a test liquid (100 mg solid) into the conjunctival sac of an animal's eye. A refinement of the Draize test is the low-volume eye test in which 0.01 ml of a substance is placed directly on the cornea of the eye. Studies indicate that the low-volume method provides a better correlation to human eye irritation experience for some substances. The Interagency Regulatory Alternatives Group (IRAG) proposes that the low-volume eye test can be used to substantiate the irritancy of suspect severe ocular irritants that have not been eliminated by various pre-eye test 'screens'. A substance testing positive by the low-volume method can be classified as an irritant; one that tests negative will require further testing by the use of the 0.1-ml volume procedure. For all other definitive testing, the Draize test (0.1 ml) should be used. Results from a questionnaire distributed at the IRAG workshop showed that many workshop participants thought that the low-volume test should be used as an eye irritation screening procedure.
Lambert
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US Food and Drug Administration, Washington, DC 20204.
Chambers
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Green
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Gupta
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Hill
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Hurley
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Lee
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Lee
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Liu
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Lowther
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D000826:Animal Testing Alternatives; D000818:Animals; D003315:Cornea; D005128:Eye Diseases / Q000139:chemically induced*; D006801:Humans; D007509:Irritants / Q000008:administration & dosage* / Q000633:toxicity; D011817:Rabbits
D007509:Irritants