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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)
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Short-term toxicity studies shall be designed to provide information as to the amount of the active substance that can be tolerated without adverse effects under the conditions of the study and to elucidate health hazards occurring at higher dose levels. Such studies provide useful data on the risks for those handling and using plant protection products containing the active substance, among other possible exposed groups. In particular, short-term studies provide an essential insight into possible repeated actions of the active substance and the risks to humans who may be exposed. In addition short-term studies provide information useful in the design of chronic toxicity studies.
The studies, data and information to be provided and evaluated, shall be sufficient to permit the identification of effects following repeated exposure to the active substance, and in particular to further establish, or indicate:
the relationship between dose and adverse effects;
toxicity of the active substance including where possible the No Observed Adverse Effect Level (NOAEL);
target organs, where relevant (including immune, nervous and endocrine systems);
the time course and characteristics of adverse effects with full details of behavioural changes and possible pathological findings at post-mortem;
specific adverse effects and pathological changes produced;
where relevant the persistence and reversibility of certain adverse effects observed, following discontinuation of dosing;
where possible, the mode of toxic action;
the relative hazard associated with the different routes of exposure;
relevant critical endpoints at appropriate time points for setting reference values, where necessary.
Toxicokinetic data (that is to say blood concentration) shall be included in short term studies. In order to avoid increased animal use, the data may be derived in range finding studies.
If nervous system, immune system or endocrine system are specific targets in short term studies at dose levels not producing marked toxicity, supplementary studies, including functional testing, shall be carried out (see point 5.8.2).
Where available, 28-day studies shall be reported.
The short-term oral toxicity of the active substance to rodents (90-day), usually the rat, a different rodent species shall be justified, and non rodents (90-day toxicity study in dogs), shall always be reported.
In the 90-day study, potential neurotoxic and immunotoxic effects, genotoxicity by way of micronuclei formation and effects potentially related to changes in the hormonal system shall be carefully addressed.
For human risk assessment additional dermal studies shall be considered on a case by case basis, unless the active substance is a severe irritant.
For volatile active substances (vapour pressure >10–2 Pascal) expert judgement (for example based on route-specific kinetic data) shall be required to decide whether the short term studies have to be performed by inhalation exposure.
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