Division 12.7

‘Non-regulatory Toxicology and Ecotoxicology’ refers to discovery toxicology and investigations to prepare for the regulatory submission and method development. This category does not include studies required for regulatory submissions (preliminary studies, MTD (Maximum Tolerated Dose)). Dose-range-finding (DRF) studies, when carried out with a view to satisfying legislative requirements, are also excluded and covered in ‘Regulatory use and routine production’ under ‘Other efficacy and tolerance testing’.