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Division 5.6.1 Generational studies

United Kingdom

Original text. Later amendments are not shown.

The generational studies reported, taken together with other relevant data and information on the active substance, shall be sufficient to permit the identification of effects for reproduction, following repeated exposure to the active substance, and in particular shall be sufficient:

  1. (a)

    to identify direct and indirect effects on reproduction resulting from exposure to the active substance;

  2. (b)

    to identify any non-reproductive adverse effects occurring at lower doses than in short-term and chronic toxicity testing;

  3. (c)

    to establish the NOAELs for parental toxicity, reproductive outcome and pup development.

  1. Circumstances in which required