Registration Dossier

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 16, 2013 - December 31, 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Version / remarks:
1984
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 850.6200 (Earthworm Subchronic Toxicity Test)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test substrate

Details on preparation and application of test substrate:
- Method of mixing into soil: directly added

Test organisms

Test organisms (species):
Eisenia fetida
Animal group:
nematods
Details on test organisms:
TEST ORGANISM
- Common name: Earthworm
- Source: Nanjing Earthworm Nursery, China
- Age at test initiation (mean and range, SD): adult
- Weight at test initiation: 394 - 400 mg

ACCLIMATION
- Acclimation period: 94 days

Study design

Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
yes
Total exposure duration:
14 d

Test conditions

Test temperature:
20 - 22°C
pH:
6.0 - 6.5
Moisture:
35%
Details on test conditions:
TEST SYSTEM
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4

OTHER TEST CONDITIONS
- Photoperiod: continuous light
- Light intensity: 400 - 800 lux

EFFECT PARAMETERS MEASURED:
mortality, reaction on mechanical stimulus, behavioural and pathological symptoms assessed at days 7 and 14

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0, 10, 100, 1000 mg/kg dw
Nominal and measured concentrations:
Nominal concentration 1000 mg/kg dw
Reference substance (positive control):
yes
Remarks:
2-Chloroacetamide, purity >=98.5%

Results and discussion

Effect concentrations
Key result
Duration:
14 d
Dose descriptor:
LC0
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Any other information on results incl. tables

Study design

In this GLP study performed according to OECD GL 207 the acute toxicity of the test item in earthworms was investigated. During this test, the artificial soils was used with the moisture content of the test medium controlled in range of 30 - 36 % with pH values of 6 - 6.5. The test conditions were maintained at 20 - 22°C, a humidity of 80 - 85 % and continuous light with intensity of 400 - 800 lux.

Results

No dead earthworms were observed in treatments and control. During test all animals remained in soil. Based on the result of range-finding test and the Limit Test, the 14 d-LC50 of the test item in the artificial soil was determined to be greater than 1000 mg/kg dry weight soil. The highest concentration causing no mortality (14 d-LC0) was 1000 mg/kg dry weight soil.

Conclusion

No mortality was observed within the test period. Therefore, the 14 d-LC50 was determined to be >1000 mg/kg dw.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
A limit test on the acute toxicity of the test item was conducted according to OECD 207. The earthworm Eisenia fetida was used for the test in artificial soil. No mortality was observed within the test period. Therefore, the 14 d-LC50 was determined to be >1000 mg/kg dw.