# Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance), Division: Circumstances in which required

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

The acute dermal toxicity of the active substance shall be reported unless waiving is scientifically justified (for example where oral LD50 is greater than 2 000 mg/kg). Both local and systemic effects shall be investigated.
Findings of severe skin irritation (Grade 4 erythema or oedema) in the dermal study shall be used instead of performing a specific irritation study.

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Source: https://www.legislation.gov.uk/eur/2013/283/annex/section/5/division/5.2/division/5.2.2/division/1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.2/division-5.2.2/division-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.