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A new sighting study for the fixed concentration procedure to allow for gender differences

By Nigel Stallard, Charlotte L Price, Stuart Creton, Ian Indans, Robert Guest, David Griffiths and Philippa Edwards


The fixed concentration procedure (FCP) has been proposed as an alternative to the median lethal\ud concentration (LC50) test (organisation for economic co-operation and development (OECD) test guideline\ud [TG] 403) for the assessment of acute inhalation toxicity. The FCP tests animals of a single gender (usually\ud females) at a number of fixed concentration levels in a sequential fashion. It begins with a sighting study that precedes\ud the main FCP study and is used to determine the main study starting concentration. In this paper, we propose\ud a modification to the sighting study and suggest that it should be conducted using both male and female\ud animals, rather than just animals of a single gender. Statistical analysis demonstrates that, when females are more\ud sensitive, the new procedure is likely to give the same classification as the original FCP, whereas, if males are more\ud sensitive, the new procedure is much less likely to lead to incorrect classification into a less toxic category. If\ud there is no difference in the LC50 for females and males, the new procedure is slightly more likely to classify into\ud a more stringent class than the original FCP. Overall, these results show that the revised sighting study ensures\ud gender differences in sensitivity do not significantly impact on the performance of the FCP, supporting its use as\ud an alternative test method for assessing acute inhalation toxicity

Topics: RC
Publisher: Sage Publications Ltd
Year: 2011
OAI identifier:

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