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Chapter Toxicological studies

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

The test programme shall cover the following aspects unless there are strong reasons to the contrary, supported by evidence, that it should not be followed:

  • Chronic toxicity study.

  • Carcinogenicity study.

  • Fertility study (e. g. three-generation study): only if an effect on fertility has been established at level 1.

  • Developmental toxicity study on perinatal and postnatal effects.

  • Teratology study (species not employed in the respective level 1).

  • Additional toxicokinetic studies which cover biotransformation, pharmokinetics.

  • Additional tests to investigate organ or system toxicity.