Stallard, Nigel, Price, Charlotte L, Creton, Stuart, Indans, Ian, Guest, Robert, Griffiths, David and Edwards, Philippa (2011) A new sighting study for the fixed concentration procedure to allow for gender differences. Human & Experimental Toxicology, Vol.30 (No.3). pp. 239-249. doi:10.1177/0960327110370983 ISSN 0960-3271.

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Abstract

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.

Item Type:	Journal Article
Subjects:	R Medicine > RC Internal medicine
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Pulmonary toxicology -- Sex differences, Toxicity testing
Journal or Publication Title:	Human & Experimental Toxicology
Publisher:	Sage Publications Ltd
ISSN:	0960-3271
Official Date:	March 2011
Dates:	Date Event March 2011 Published
Volume:	Vol.30
Number:	No.3
Page Range:	pp. 239-249
DOI:	10.1177/0960327110370983
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Funder:	National Centre for the Replacement, Refinement, and Reduction of Animals in Research (Great Britain) (NC3R)

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