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| Content Provider | OECD iLibrary |
|---|---|
| Organization | OECD |
| Abstract | Cette Ligne directrice pour la reproduction sur deux générations est conçue pour fournir des informations générales concernant les effets d'une substance d'essai sur l'intégrité et la performance des systèmes reproducteurs mâle et femelle, et sur la croissance et le développement de la progéniture. La substance d’essai est administrée quotidiennement par dose graduée à plusieurs groupes de mâles et de femelles. Les mâles et les femelles (de 5-6 semaines) de la génération parentale doivent être dosés durant la croissance, l’accouplement, la gravidité et jusqu’au sevrage de la progéniture de la première génération. L'administration de la substance continue avec la progéniture de première génération pendant leur croissance jusqu’à l'âge adulte, l'accouplement et la production d'une deuxième génération (jusqu'au sevrage). Le rat est l’espèce préférée pour l’essai. Chaque groupe d’essai et de contrôle doit contenir un nombre suffisant d’animaux pour fournir de préférence, au moins 20 femelles gravides à terme ou presque. Au moins trois niveaux de dose et un contrôle concourant seront employés. Il est recommandé que la substance d'essai soit administrée oralement (par alimentation, eau potable ou gavage). Un essai limite peut être effectué si aucun effet n’est attendu à une dose de 1000 mg/kg poids corporel/j. Les résultats de l’étude comportent des mesures (poids, paramètres du sperme, du cycle ovarien et de la progéniture) et des observations cliniques quotidiennes, de même qu’une autopsie générale et de l’histopathologie. Les résultats de cette étude de toxicité de reproduction sur deux générations sont évalués en termes d'effets observés comprenant l'autopsie et les résultats microscopiques. Une étude de toxicité pour la reproduction correctement effectuée fournit une évaluation satisfaisante d'un niveau de sans effet et une compréhension des effets nuisibles sur la reproduction, la parturition, la lactation, le développement postnatal comprenant la croissance et le développement sexuel. |
| Page Count | 15 |
| ISSN | 20745842 |
| e-ISBN | 9789264070875 |
| Language | French |
| Publisher | OECD Publishing |
| Publisher Date | 2001-01-22 |
| Access Restriction | Open |
| Subject Keyword | Environment |
| Content Type | Text |
| Resource Type | Book |
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|---|---|---|---|
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