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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:
Nov 13, 2014 - May 15, 2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no OECD GLP
Justification for type of information:
This study was performed according OECD TG 207. The quality system applied was not OECD GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
GLP compliance:
no
Remarks:
no OECD GLP

Test material

Reference
Name:
Unnamed
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Art. 201386 (B-2O-O5) / EF14003086
- Expiration date of the lot/batch: 2016-04-30
- Purity test date: 2014-04-16


Sampling and analysis

Analytical monitoring:
no

Test substrate

Vehicle:
yes
Remarks:
Acetone
Details on preparation and application of test substrate:
A defined artificial soil of the following composition was used for this assay.

Sphagnum peat 10% (w/w)
Kaolinite clay(Sigma Aldrich) 20 % (w/w)
Silica sand(screened with 0.2mm sieve) 70 % (w/w)


Based on the results of preliminary test, the test substance was insoluble in water, but could be dissolved in acetone. The test substance was added into the test system by test substance solvent stock solution.
An aliquot solvent solution was separately added to certain amount of silica sand and the solvent was allowed to evaporate off prior to incorporation into formulated artificial soil with deionised reverse osmosis water. These were mixed by mixer to give blank control, solvent control, 10, 100 and 1000 mg/kg respectively with a nominal moisture content of 40-60% by mass of the total water-holding capacity with the deionized water. Test medium preparation process of blank control group was the same with other groups, but without organic solvent and test substance. Test medium preparation process of solvent control was the same with other groups, but without test substance.

Test organisms

Test organisms (species):
Eisenia fetida
Details on test organisms:
TEST ORGANISM
- Common name: Eisenia fetida
- Source: Shanghai Yinquan Agriculture Development Co., Ltd.
- Age at test initiation (mean and range, SD): no data
- Weight at test initiation (mean and range, SD): (391.8 +/- 15.1) mg

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): yes
- Health during acclimation (any mortality observed): no mortality, no other findings

Study design

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

Test conditions

Test temperature:
21.7 - 22 °C
pH:
6.30 & 6.38 (start)
6.17 & 6.30 (end)
Moisture:
25 %
Details on test conditions:
TEST SYSTEM
- Test container (material, size): 1 L glass vessel, closed
- Amount of soil or substrate: 750 g
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- No. of replicates per vehicle control: 4


- Composition (if artificial substrate):
- Organic carbon (%):
- Maximum water holding capacity (in % dry weigth):
- CEC:
- Pretreatment of soil:
- Storage (condition, duration):
- Stability and homogeneity of test material in the medium:

OTHER TEST CONDITIONS
- Photoperiod: 24 h/day
- Light intensity: 573 - 581 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
day 7 and 14,

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Nominal and measured concentrations:
1000 mg/kg soil
Reference substance (positive control):
yes
Remarks:
Chloroacetamide

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
7 d
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
14 d
Dose descriptor:
LD50
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
The mortalities of the blank control group, the solvent control group and the treatment group on day 7 were 0%. The mortality of the control group on day 14 was 2.5%. The mortality of the solvent control group on day 14 was 5%. No mortality occured in the treatment group at study termination (day 14).
Results with reference substance (positive control):
LD50 at about 15 mg/kg soil dw
Reported statistics and error estimates:
Standard statistical methods have been applied for data processing.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under conditions of the test, the 7 -day LD50 and the 14 -day LD50 for the test substance to earthworms (Eisenia fetida) based on nominal test concentrations were higher than 1000 mg/kg dry soil weight.