# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division 5.1: Studies on absorption, distribution, excretion and metabolism in mammals

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

Quite limited data, as described below and restricted to one test species (normally the rat) may be all that is required in this area. These data can provide information useful in the design and interpretation of subsequent toxicity tests. However, it must be remembered that information on interspecies differences may be crucial in extrapolation of animal data to man and information on percutaneous penetration, absorption, distribution, excretion and metabolism may be useful in operator risk assessments. It is not possible to specify detailed data requirements in all areas, since the exact requirements will be dependent upon the results obtained for each particular test substance.
Aim of the test:
The tests shall provide sufficient data to permit:
an evaluation of the rate and extent of absorption,
an evaluation of the tissue distribution and the rate and extent of excretion of the test substance and the relevant metabolites,
the identification of metabolites and the metabolic pathway.
The effect of dose level on these parameters and whether the results are different after single versus repeated doses, shall also be investigated.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/A/division/5/division/5.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-A/division-5/division-5.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.