title: Criteria for in vitro alternatives for the eye irritation test.
abstract: A proposal encompassing considerations and criteria for the development of in vitro alternatives to the eye irritation test has been developed and is presented here. Two factors need to be considered initially in developing an alternative test. The first is to determine whether the alternative assay is to be used as a screen or as a replacement for the eye irritation test. Less stringent acceptance criteria are required for an assay used as a screen than for that used as a replacement test. A screen is a preliminary test for the assessment of eye irritation. It is used for making preliminary decisions or establishing the direction for further testing. Screens answer fewer and less complex questions than a replacement test would, since the results from screens are usually confirmed by more definitive testing. A replacement test, however, must provide the same answers as in vivo methods for the assessment of eye irritation and must provide data for making a definitive toxicological assessment of eye irritation. The second factor to be considered is knowledge of the in vivo assay intended to be replaced. This knowledge should include the procedural aspects of the test and the regulatory information it provides. The following may be considered as criteria for in vitro tests used as screens or as replacements for the eye irritation test in rabbits: rationale (there should be a clear statement regarding the rationale for the use of a particular test in relation to the availability of other tests); relevance (the in vitro endpoint should have biological or physiological relevance to the effect to be detected in vivo); and validational (intralaboratory as well as interlaboratory validation must be conducted).
authors.affiliation: US Food and Drug Administration, Washington, DC 20204.
authors.forename: S
authors.initials: S
authors.lastname: Green
authors.forename: W A
authors.initials: WA
authors.lastname: Chambers
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: L A
authors.initials: LA
authors.lastname: Lambert
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; D005128:Eye Diseases / Q000139:chemically induced*; D066298:In Vitro Techniques; D007391:International Cooperation; D007509:Irritants / Q000633:toxicity*; D011817:Rabbits
chemical_list: D007509:Irritants