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

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

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)
3 Downloads (Pure)


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

Original languageEnglish
Pages (from-to)239-249
Number of pages11
JournalHuman and Experimental Toxicology
Issue number3
Early online date20 May 2010
Publication statusPublished - 1 Mar 2011
Externally publishedYes

Bibliographical note

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 3.0 License (http://www.creativecommons.org/licenses/by-nc/3.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (http://www.uk.sagepub.com/aboutus/openaccess.htm).


  • acute inhalation toxicity
  • fixed concentration procedure
  • gender differences
  • OECD Test Guidelines

ASJC Scopus subject areas

  • Toxicology
  • Health, Toxicology and Mutagenesis


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