Skin sensitisation testing - new perspectives and recommendations

Various methodological aspects of skin sensitisation testing have been expl ored, particularly in the context of animal welfare considerations and reli ability and sensitivity of test methods. Recommendations are made for the c onduct of current and proposed OECD skin sensitisation tests with respect t o appropriate test configurations for the purposes of hazard identification and labelling, and the requirement for positive controls. Specifically, th e following aspects of guinea pig sensitisation test methods have been addr essed: (1) the number of test and control animals required; (2) the option of using joint positive controls between independent laboratories; (3) the choice of positive control chemicals; (3) the optimal conduct and interpret ation of rechallenge; and (5) the requirement for pretreatment with sodium lauryl sulfate. In addition, the use of the murine local lymph node assay ( LLNA) has been considered. A number of conclusions have been drawn and reco mmendations made as follows: In many instances, particularly with the conduct of the guinea pig maximisa tion test, it is acceptable to halve the number of test and control animals used, An optional scheme for the conduct of joint positive control studies within a co-ordinated group of laboratories is appropriate, Only one positive control chemical (cc-hexyl cinnamic aldehyde) is necessar y for the routine assessment of assay sensitivity. The proper conduct and interpretation of rechallenge can provide valuable i nformation and confirmation of results in guinea pig sensitisation tests. Sodium lauryl sulfate should no longer be used as a pretreatment in the gui nea pig maximisation test. The LLNA is a viable and complete alternative to traditional guinea pig test methods for the purposes of skin sensitisation hazard identification. These recommendations provide the opportunity for both animal welfare benef its and improved hazard identification. (C) 2001 Elsevier Science Ltd. All rights reserved.