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Commission Regulation (EU) No 544/2011 (repealed)Show full title
Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)
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8.1. Effects on birds
8.1.1. Acute oral toxicity
Aim of the test
The test shall provide, where possible, LD50 values, the lethal threshold dose, time courses of response and recovery and the NOEL, and must include relevant gross pathological findings.
Circumstances in which required
The possible effects of the active substance on birds must be investigated except where the active substance is intended solely to be included in preparations for exclusive use in enclosed spaces (e.g. in glasshouses or in food storage practice).
Test conditions
The acute oral toxicity of active substance to a quail species (Japanese quail (Coturnix coturnix japonica) or Bobwhite quail (Colinus virginianus)) or to mallard duck (Anas platyrhynchos) must be determined. The highest dose used in tests need not exceed 2 000 mg/kg body weight.
Test guideline
SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.
8.1.2. Short-term dietary toxicity
Aim of the test
The test shall provide the short-term dietary toxicity (LC50 values, lowest lethal concentration (LLC), where possible no observed effect concentrations (NOEC), time courses of response and recovery) and include relevant gross pathological findings.
Circumstances in which required
The dietary (5-day) toxicity of the active substance to birds must always be investigated on one species except where a study in accordance with point 8.1.3 is reported. Where its acute oral NOEL is ≤ 500 mg/kg body weight or where the short-term NOEC is < 500 mg/kg food the test must be performed on a second species.
Test conditions
The first species to be studied must be either a quail species or mallard duck. If a second species must be tested it shall not be related to the first species tested.
Test guideline
The test must be carried out in accordance with OECD Method 205.
8.1.3. Subchronic toxicity and reproduction
Aim of the test
The test shall provide the subchronic toxicity and reproductive toxicity of the active substance to birds.
Circumstances in which required
The subchronic and reproductive toxicity of the active substance to birds must be investigated, unless it can be justified that continued or repeated exposure of adults, or exposure of nest sites during the breeding season is unlikely to occur.
Test guideline
The test must be carried out in accordance with OECD Method 206.
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