lexiara

anx_II__cpt_1__cpt_1__cpt_1__table_1__row_89

8.7. Acute toxicity In addition to the oral route of administration (8.7.1), for substances other than gases, the information mentioned under 8.7.2 to 8.7.3 shall be provided for at least one other route of administration The choice for the second route will depend on the nature of the substance and the likely route of human exposure Gases and volatile liquids should be administered by the inhalation route If the only route of exposure is the oral route, then information for only that route need be provided. If either the dermal or inhalation route is the only route of exposure to humans then an oral test may be considered. Before a new dermal acute toxicity study is carried out, an in vitro dermal penetration study (OECD 428) should be conducted to assess the likely magnitude and rate of dermal bioavailability There may be exceptional circumstances where all routes of administration are deemed necessary The study/ies do(es) not generally need to be conducted if: the substance is classified as corrosive to the skin

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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.