# Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance), Division 3.7.2.3.4

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

Data from animal studies ideally shall provide clear evidence of specific reproductive toxicity in the absence of other systemic toxic effects. However, if developmental toxicity occurs together with other toxic effects in the dam, the potential influence of the generalised adverse effects shall be assessed to the extent possible. The preferred approach is to consider adverse effects in the embryo/foetus first, and then evaluate maternal toxicity, along with any other factors which are likely to have influenced these effects, as part of the weight of evidence. In general, developmental effects that are observed at maternally toxic doses shall not be automatically discounted. Discounting developmental effects that are observed at maternally toxic doses can only be done on a case-by-case basis when a causal relationship is established or refuted.

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Source: https://www.legislation.gov.uk/eur/2008/1272/annex/I/division/3/division/3.7/division/3.7.2/division/3.7.2.3/division/3.7.2.3.4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2008-1272/annex-I/division-3/division-3.7/division-3.7.2/division-3.7.2.3/division-3.7.2.3.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.