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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 ISSN 0273-2300.
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Official URL: http://dx.doi.org/10.1016/j.yrtph.2018.01.001
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 | ||||||||
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| Subjects: | R Medicine > RA Public aspects of medicine > RA1001 Forensic Medicine. Medical jurisprudence. Legal medicine | ||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > 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: |
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| 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 (Creative Commons) | ||||||||
| Date of first compliant deposit: | 12 January 2018 | ||||||||
| Date of first compliant Open Access: | 6 January 2019 |
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