Hurley P M, Chambers W A, Green S, Gupta K C, Hill R N, Lambert L A, Lee C C, Lee J K, Liu P T, Lowther D K
US Environmental Protection Agency, Washington, DC 20460.
Food Chem Toxicol. 1993 Feb;31(2):87-94. doi: 10.1016/0278-6915(93)90119-j.
Screens aid in identifying some severe irritants or corrosives and eliminating them from consideration for in vivo eye irritation testing. Products may be evaluated for ocular irritation potential in a stepwise progression as follows: (1) products at pH extremes of 2 or below or of 11.5 or above may be considered to be ocular irritants; (2) based on chemical structure-activity considerations, some products may be judged to have ocular irritation potential; (3) validated and accepted in vitro systems may possibly be used as a screen in the future; (4) when a test material demonstrates severe acute dermal toxicity (lethality at < or = 200 mg/kg body weight), further testing for either dermal or ocular irritation may not need to be undertaken; (5) if a substance shows a primary dermal irritation index of 5 or above, it may be considered to be an ocular irritant; (6) materials that are not removed from consideration based on these proposed screens may then be considered for testing for ocular irritation in rabbits under accepted procedures. In a survey given to participants in the workshop, a high percentage believed that screens should be used. However, opinions on the use of the individual screens varied between the different interested groups attending, with the possible future use of in vitro screens for specific product lines having the highest percentage of agreement (57-100%).
筛选有助于识别一些严重的刺激物或腐蚀性物质,并将其排除在体内眼刺激试验的考虑范围之外。可按以下逐步流程评估产品的眼刺激可能性:(1) pH值在2或以下或11.5或以上的极端情况下的产品可被视为眼刺激物;(2) 根据化学结构-活性考虑,一些产品可能被判定具有眼刺激可能性;(3) 经过验证且被认可的体外系统将来可能用作筛选方法;(4) 当测试物质显示出严重的急性皮肤毒性(体重≤200 mg/kg时致死)时,可能无需进一步进行皮肤或眼刺激测试;(5) 如果一种物质的原发性皮肤刺激指数为5或以上,则可被视为眼刺激物;(6) 基于这些提议的筛选方法未被排除考虑的物质,随后可根据公认程序考虑在兔身上进行眼刺激测试。在对研讨会参与者进行的一项调查中,很大比例的人认为应该使用筛选方法。然而,参加会议的不同利益集团对使用个别筛选方法的意见各不相同,对特定产品线未来可能使用体外筛选方法的赞同比例最高(57%-100%)。