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An evaluation of the fixed concentration procedure for assessment of acute inhalation toxicity

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Sewell, Fiona, Ragan, Ian, Indans, Ian, Marczylo, Tim, Stallard, Nigel, Griffiths, David, Holmes, Thomas, Smith, Paul and Horgan, Graham (2018) An evaluation of the fixed concentration procedure for assessment of acute inhalation toxicity. Regulatory Toxicology and Pharmacology, 94 . pp. 22-32. doi:10.1016/j.yrtph.2018.01.001

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Official URL: http://dx.doi.org/10.1016/j.yrtph.2018.01.001

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Abstract

Acute inhalation studies are conducted in animals as part of chemical hazard identification and for classification and labelling. Current methods employ death as an endpoint (OECD TG403 and TG436) while the recently approved fixed concentration procedure (FCP) (OECD TG433) uses fewer animals and replaces lethality as an endpoint with evident toxicity. Evident toxicity is the presence of clinical signs that predict that exposure to the next highest concentration will cause severe toxicity or death in most animals. Approval of TG433 was the result of an international initiative, led by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), which collected data from six laboratories on clinical signs recorded for inhalation studies on 172 substances. This paper summarises previously published data and describes the additional analyses of the dataset that were essential for approval of the TG.

Item Type: Journal Article
Subjects: R Medicine > RA Public aspects of medicine > RA1001 Forensic Medicine. Medical jurisprudence. Legal medicine
Divisions: Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Toxicity testing -- Standards, Alternative toxicity testing
Journal or Publication Title: Regulatory Toxicology and Pharmacology
Publisher: Elsevier
ISSN: 0273-2300
Official Date: April 2018
Dates:
DateEvent
April 2018Published
6 January 2018Available
3 January 2018Accepted
Volume: 94
Page Range: pp. 22-32
DOI: 10.1016/j.yrtph.2018.01.001
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access

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