Possible effects on birds must be investigated except where the possibility that birds will be exposed, directly or indirectly, can be ruled out such as for use in enclosed spaces or wound healing treatments.
The acute toxicity/exposure ratio (TER a ), the short term dietary toxicity/exposure ratio (TER st ) and the long term dietary toxicity/exposure ratio (TER lt ) must be reported, where:
=
LD 50 (mg a.s./kg body weight) / ETE (mg a.s./kg body weight)
=
LC 50 (mg a.s./kg food) / ETE (mg a.s./kg food)
=
NOEC (mg a.s./kg food) / ETE (mg a.s./kg food)
where ETE = estimated theoretical exposure.
In the case of pellets, granules or treated seeds the amount of a.s. in each pellet, granule or seed must be reported as well as the proportion of the LD 50 for the a.s. in 100 particles and per gram of particles. The size and shape of pellets or granules must be reported.
In the case of baits the concentration of a.s. in the bait (mg/kg) must be reported.
The test should provide, where possible, LD 50 values, the lethal threshold dose, time courses of response and recovery, the NOEL, and must include relevant gross pathological findings.
The acute oral toxicity of preparations must be reported, where TER a or TER st for the active substance(s) in birds are between 10 and 100 or where results from mammal testing give evidence of a significantly higher toxicity of the prepration compared to the active substance unless it can be justified that it is not likely that birds are exposed to the plant protection product itself.
The study must be conducted on the most sensitive species identified in the studies provided for in Annex II, point 8.1.1 or 8.1.2.
The test will provide sufficient data to evaluate the nature and the extent of the risk in practical conditions of use.
Where the TER a and TER st are > 100 and when there is no evidence of risk from any further study on the active substance (e.g. reproduction study) no further testing is required. In the other cases, expert judgement is necessary to decide whether there is a need to carry out further studies. This expert judgement will take into account, where relevant, foraging behaviour, repellency, alternative food, actual residue content in the food, persistence of the compound in the vegetation, degradation of the formulated product or treated produce, the amount of predation of the food, acceptance of bait, granules or treated seed and the possibility for bioconcentration.
Where TER a and TER st ≤ 10 or TER lt ≤ 5, cage or field trials must be conducted and reported unless a final assessment is possible on the basis of studies according to point 10.1.3.
Before performing these studies the applicant should seek the agreement of the competent authorities on the type and conditions of the study to be performed.
The test will provide sufficient data to evaluate the possibility of consumption of the protection product or plant products treated with it.
In the case of seed dressings, pellets, baits and preparations which are granules and where TER a ≤ 10, acceptability (palatability) tests must be conducted.
Expert judgment is required to decide whether the effects of secondary poisoning should be investigated.]