TR 078 – Skin Sensitisation Testing: Methodological Considerations

TR 078 : Skin Sensitisation Testing: Methodological Considerations | December 1999

Skin sensitisation testing was considered last by ECETOC in Monograph No.14 (1990). Since then a revised OECD guideline (406) has been published and it was considered timely to review the most appropriate methods for hazard identification.

Various methodological aspects of guinea pig skin sensitisation testing have been considered in the present report, including the numbers of test and control animals required, the option of using joint positive controls between independent laboratories, the choice of positive control chemicals, the optimal conduct and interpretation of rechallenge and the requirement for pretreatment with sodium lauryl sulphate. The use of the local lymph assay has also been reviewed. Recommendations are made which provide the opportunity for both animal welfare benefits and improved hazard identification.