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An evaluation of the fixed concentration procedure for assessment of acute inhalation toxicity.
Sewell, Fiona; Ragan, Ian; Indans, Ian; Marczylo, Tim; Stallard, Nigel; Griffiths, David; Holmes, Thomas; Smith, Paul; Horgan, Graham.
Afiliación
  • Sewell F; National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), UK. Electronic address: Fiona.Sewell@nc3rs.org.uk.
  • Ragan I; Board Member, NC3Rs, UK.
  • Indans I; Health and Safety Executive, UK.
  • Marczylo T; Public Heath England, UK.
  • Stallard N; University of Warwick, UK.
  • Griffiths D; Envigo, UK.
  • Holmes T; Exponent International Ltd., UK.
  • Smith P; Charles River Laboratories Edinburgh Ltd., UK.
  • Horgan G; Biomathematics & Statistics Scotland (BioSS), UK.
Regul Toxicol Pharmacol ; 94: 22-32, 2018 Apr.
Article en En | MEDLINE | ID: mdl-29309809
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 (Organisation for Economic Co-operation and Development (OECD) test guideline (TG) 403 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 & 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pruebas de Toxicidad Aguda Tipo de estudio: Guideline Límite: Animals Idioma: En Revista: Regul Toxicol Pharmacol Año: 2018 Tipo del documento: Article Pais de publicación: Países Bajos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pruebas de Toxicidad Aguda Tipo de estudio: Guideline Límite: Animals Idioma: En Revista: Regul Toxicol Pharmacol Año: 2018 Tipo del documento: Article Pais de publicación: Países Bajos