title: The use of low-volume dosing in the eye irritation test.
abstract: 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.
authors.affiliation: US Food and Drug Administration, Washington, DC 20204.
authors.forename: L A
authors.initials: LA
authors.lastname: Lambert
authors.forename: W A
authors.initials: WA
authors.lastname: Chambers
authors.forename: S
authors.initials: S
authors.lastname: Green
authors.forename: K C
authors.initials: KC
authors.lastname: Gupta
authors.forename: R N
authors.initials: RN
authors.lastname: Hill
authors.forename: P M
authors.initials: PM
authors.lastname: Hurley
authors.forename: C C
authors.initials: CC
authors.lastname: Lee
authors.forename: J K
authors.initials: JK
authors.lastname: Lee
authors.forename: P T
authors.initials: PT
authors.lastname: Liu
authors.forename: D K
authors.initials: DK
authors.lastname: Lowther
mesh_terms: 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
chemical_list: D007509:Irritants