Registration Dossier

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Administrative data

toxicity to soil macroorganisms except arthropods: long-term
Type of information:
experimental study planned
Study period:
From Dec.1,2011 to May.1,2012

Data source

Materials and methods

GLP compliance:

Test material

Details on test material:
Same with the substance notified in the section 1 of the dossier

Sampling and analysis

Analytical monitoring:

Test substrate

Details on preparation and application of test substrate:
A mixture comprised of 10 g of finely ground industrial quartz sand with a quantity of the test substance necessary to achieve the test concentration in the soil is prepared. The mixture is then mixed thoroughly with the pre-moistened artificial soil. De-ionised water is then added to an amount required to achieve a final moisture content of 40 to 60% of the maximum water holding capacity is then added and mixed in. The soil is then ready for placing to the test containers.

Test organisms

Test organisms (species):
Eisenia fetida
Animal group:
Details on test organisms:
The species used in the test is Eisenia fetida. Adult worms between two months and one year old and with a clitellum are required to start the test. The worms were selected from a synchronised culture with a relatively homogeneous age structure. Individuals in a test group did not differ in age by more than 4 weeks.

Study design

Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
Total exposure duration:
8 wk

Test conditions

Test temperature:
in accordance with the OECD guideline 222
The moisture content was 40 to 60% of the maximum water holding capacity. Losses are replenished as necessary with de-ionised water. The water content should not vary by more than 10 % from that at the start of the test.
Details on test conditions:
in accordance with the OECD guideline 222
Nominal and measured concentrations:
The range of test concentrations is selected to encompass those likely to cause both sub-lethal and lethal effects over a period of eight weeks.

7 2.5 0 5 0 2.5 0 7.5
14 5 0 7.5 5 5 2.5 10
Reference substance (positive control):

Results and discussion

Applicant's summary and conclusion

Executive summary:

Taking account of the results of initial CSA (see section 10) and the intrinsic properties of BDP, EPM estimation together with a confirmatory long-term toxicity test is enough to evaluate the potential risk in use of test substance. Here we choose the long-term toxicity test on earthworms as the confirmatory test.