# Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance), Division 3.2.2.1: Acute toxicity

Extent: E+W+S+N.I.

Acute toxicity studies are required to classify and to provide limited characterisation of the toxicity of the compound.
Acute toxicity studies shall be carried out in at least two mammalian species. One laboratory species may be replaced by a target species, if appropriate.
It will be not necessary to determine a precise LD50; an approximate determination of the minimum lethal dose is considered sufficient. The maximum dosage shall not exceed 2 000 mg/kg body weight.
In order to reduce the number and the suffering of the animals involved, new protocols for acute dose toxicity testing are continually being developed. Studies carried out by these new procedures will be accepted, when properly validated.
OECD Guidelines 402 (acute dermal toxicity), 420 (Fixed Dose Method), 423 (Acute Toxic Class Method) and 425 (Up-and-Down Procedure) should be followed.

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Source: https://www.legislation.gov.uk/eur/2008/429/annex/II/division/3/division/3.2/division/3.2.2/division/3.2.2.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.2/division-3.2.2/division-3.2.2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.