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8.9. Repeated dose toxicity In general, only one route of administration is necessary and the oral route is the preferred route. However, in some cases it may be necessary to evaluate more than one route of exposure. For the evaluation of the safety of consumers in relation to active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route Testing by the dermal route shall be considered if: skin contact in production and/or use is likely, and inhalation of the substance is unlikely, and one of the following conditions is met: (i) toxicity is observed in an acute dermal toxicity test at lower doses than in the oral toxicity test, or (ii) information or test data indicate dermal absorption is comparable or higher than oral absorption, or (iii) dermal toxicity is recognised for structurally related substances and for example is observed at lower doses than in the oral toxicity test or dermal absorption is comparable or higher than oral absorption Testing by the inhalation route shall be considered if: exposure of humans via inhalation is likely taking into account the vapour pressure of the substance (volatile substances and gases have vapour pressure > 1 × 10^(–2) Pa at 20 °C), and/or there is the possibility of exposure to aerosols, particles or droplets of an inhalable size (MMAD < 50 micrometers) The repeated dose toxicity study (28 or 90 days) does not need to be conducted if: a substance undergoes immediate disintegration and there are sufficient data on the cleavage products for systemic and local effects and no synergistic effects are expected, or relevant human exposure can be excluded in accordance with Section 3 of Annex IV In order to reduce testing carried out on vertebrates and in particular the need for free-standing single-endpoint studies, the design of the repeated dose toxicity studies shall take account of the possibility to explore several endpoints within the framework of one study

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.