Table 1.
Data requirement of pesticidal active substances according to EU Regulation 283/2013a – Setting data requirements for active substances. These data must be submitted, unless the substance is a low risk substance or a biopesticide
| Data requirements – pesticidal active substances |
|---|
| Toxicokinetics – absorption, distribution, excretion, metabolism – single and repeated dose rat |
| Acute exposure – oral, dermal, inhalation rat |
| Irritation – eye, skin rabbit |
| Sensitisation mouse |
| Subchronic toxicity (28–90 days) rat |
| Subchronic toxicity (28 days – 1 year) dog |
| Genotoxicity – in vitro (mutagenicity, chromosome aberrations, aneugenicity) |
| Genotoxicity – in vivo (chromosome aberrations – possibly others) mouse |
| Chronic toxicity (2 year) rat |
| Carcinogenicity (2 year) rat |
| Carcinogenicity mouse |
| Teratogenicity rat |
| Teratogenicity rabbit |
| Reproduction – 1 or 2 generations rat |
| Neurotoxicity (acute and/or chronic exposure) rat, developmental neurotoxicity rat |
| All relevant data from open literature (systematic review) |
| Others – e.g. studies on endocrine modes of actions |
a
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. OJ L 93, 3.4.2013, p. 1–84.