Chambers W A, Green S, Gupta K C, Hill R N, Huntley K, Hurley P M, Lambert L A, Lee C C, Lee J K, Liu P T
US Food and Drug Administration, Washington, DC 20204.
Food Chem Toxicol. 1993 Feb;31(2):111-5. doi: 10.1016/0278-6915(93)90123-g.
Scoring of the rabbit eye test and the resulting evaluation and classification should provide useful information about the likelihood that a test material may cause injury on contact with the human eye. When an animal test is necessary, a rabbit eye test based on the following characteristics is proposed for deriving the maximum information from the fewest animals. The ocular effects of interest should include corneal opacity, iritis and conjunctival redness. Animals should be scored for each ocular effect at 24, 48 and 72 hr after the test substance is administered. If an animal is negative at all three scoring times, it can be removed from the test at 72 hr. If it shows a positive effect at a scoring time but the lesion clears at 72 hr, it can be removed at 72 hr. If it shows a positive effect that does not clear at 72 hr, it should be scored again on day 7 when the test ends. However, if an animal shows severe effects at one or more scoring times, it can be removed from the test at 72 hr. An animal is positive if any one of the following criteria is observed at 24, 48 or 72 hr: corneal opacity of 1 or above, iritis of 1 or above, or conjunctival redness of 2 or above. Severe ocular effects (noted at 24, 48 or 72 hr) that may endanger sight deserve special recognition for the classification of chemicals and include corneal opacity of 3 or above, or iritis of 2. This proposal is consistent with the opinions of the majority of respondents who attended the Workshop on Updating Eye Irritation Test Methods, Proposals for Regulatory Consensus. The most notable exception was the suggestion by respondents to add conjunctival chemosis as one of the scoring parameters.
兔眼试验的评分以及由此得出的评估和分类应能提供有关受试物质接触人眼时可能造成损伤的可能性的有用信息。当有必要进行动物试验时，建议基于以下特征进行兔眼试验，以便用最少的动物获得最大量的信息。感兴趣的眼部效应应包括角膜混浊、虹膜炎和结膜发红。在给予受试物质后24、48和72小时应对每只动物的每种眼部效应进行评分。如果一只动物在所有三个评分时间均为阴性，则可在72小时时将其从试验中剔除。如果它在某个评分时间显示出阳性效应，但损伤在72小时时消退，则可在72小时时将其剔除。如果它显示出阳性效应且在72小时时未消退，则应在试验结束的第7天再次评分。然而，如果一只动物在一个或多个评分时间显示出严重效应，则可在72小时时将其从试验中剔除。如果在24、48或72小时观察到以下任何一项标准，则动物为阳性：角膜混浊为1级或以上、虹膜炎为1级或以上、或结膜发红为2级或以上。可能危及视力的严重眼部效应（在24、48或72小时时观察到）在化学品分类时值得特别关注，包括角膜混浊为3级或以上、或虹膜炎为2级。本提议与参加更新眼刺激试验方法研讨会（监管共识提案）的大多数受访者的意见一致。最显著的例外是受访者建议将结膜水肿作为评分参数之一。
