Considerations for Applying Route-to-Route Extrapolation to Assess the Safety of Oral Exposure to Substances.
Biomolecules
; 13(1)2022 12 20.
Article
em En
| MEDLINE
| ID: mdl-36671390
ABSTRACT
The safety evaluation of oral exposure to substances, such as food ingredients, additives, and their constituents, relies primarily on a careful evaluation and analysis of data from oral toxicity studies. When relevant oral toxicity studies are unavailable or may have significant data gaps that make them inadequate for use in safety evaluations, data from non-oral toxicity studies in animals, such as studies on inhalation, dermal exposure, etc., might be used in support of or in place of oral toxicity studies through route-to-route (R-t-R) extrapolation. R-t-R extrapolation is applied on a case-by-case basis as it requires attention to and comparison of substance-specific toxicokinetic (TK) and toxicodynamic (TD) data for oral and non-oral exposure routes. This article provides a commentary on the utility of R-t-R extrapolation to assess the safety of oral exposure to substances, with an emphasis on the relevance of TK and systemic toxicity data.
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Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Segurança
/
Administração por Inalação
Limite:
Animals
Idioma:
En
Revista:
Biomolecules
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Estados Unidos