anx_II__cpt_1__cpt_1__cpt_1__table_1__row_99

8.9.4. Further repeat dose studies Further repeat dose studies including testing on a second species (non-rodent), studies of longer duration or through a different route of administration shall be undertaken in case of: no other information on toxicity for a second non-rodent species is provided for, or failure to identify a no observed adverse effect level (NOAEL) in the 28- or the 90-day study, unless the reason is that no effects have been observed at the limit dose, or substances bearing positive structural alerts for effects for which the rat or mouse is an inappropriate or insensitive model, or toxicity of particular concern (e.g. serious/severe effects), or indications of an effect for which the available data is inadequate for toxicological and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity, hormonal activity), or concern regarding local effects for which a risk characterisation cannot be performed by route-to route extrapolation, or particular concern regarding exposure (e.g. use in biocidal products leading to exposure levels which are close to the toxicologically relevant dose levels), or effects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28- or the 90-day study, or the route of administration used in the initial repeated dose study was inappropriate in relation to the expected route of human exposure and route-to-route extrapolation cannot be made. ADS

← anx_II__cpt_1__cpt_1__cpt_1__table_1__row_98__cell_3 · All articles · anx_II__cpt_1__cpt_1__cpt_1__table_1__row_99__cell_1 →

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