Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
2020-03-30 to 2020-06-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
liquid

Sampling and analysis

Analytical monitoring:
not specified

Test substrate

Vehicle:
no
Details on preparation and application of test substrate:
Based on the predictive moisture content of artificial soil, approximately 30%, respectively 58 mg, 99 mg, 171 mg, 294 mg, 505 mg and 868 mg of test substance (purity was 99.7%) were weighted and mixed well with quartz sand to a total of about 10 g by grinding. Each mixture was then be mixed with about 740 g wet artificial soil to obtain test substance concentrations of 100 mg/kg dry weight, 171 mg/kg dry weight, 296 mg/kg dry weight, 508 mg/kg dry weight 873 mg/kg dry weight and 1500 mg/kg dry weight, respectively.
Four replicates were prepared for each group. Blank control was prepared by mixing about 1O g of quartz sand and about 740 g wet artificial soil, with four replicates.

Test organisms

Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
The earthworms which were used in the test were purchased on February 20, 2020 and all earthworms have been raised in the laboratory for 57 days before used.
Before test, earthworms were acclimated to the study conditions for about 24 h in the artificial soil.

Weight: 528 mg - 589 mg per earthworm
Batch No. EEf20200220-1
Purchased from Fogang Wotu agricultural science and technology Co., Ltd., and raised in the test facility

Study design

Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
14 d

Test conditions

Test temperature:
18.1 °C - 19.6°C
pH:
6.28 (at the beginning of the test)
6.25 - 6.44 (at the end of the test)
Moisture:
30.6% ( dry weight, at the beginning of the test )
27.8% - 28.8% ( dry weight, at the end of the test)
Nominal and measured concentrations:
Nominal: 100 mg/kg dry weight, 171 mg/kg dry weight, 296 mg/kg dry weight, 508 mg/kg dry weight, 873 mg/kg dry weight and 1500 mg/kg dry weight
Reference substance (positive control):
yes
Remarks:
The sensitivity test was carried out with the reference substance chloroacetamide (C2H4ClNO). The 14 d-LC50 of chloroacetamide was 27.6 mg/kg (dry weight of artificial soil), 95% confidence limit was 25.7 mg/kg - 29.7 mg/kg.

Results and discussion

Effect concentrations
Key result
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
850 mg/kg soil ww
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
The 7d and 14d mortalities of earthwoms in the 100 mg/kg dry weight, 171 mg/kg dry weight, 296 mg/kg dry weight, 508 mg/kg dry weight, 873 mg/kg and 1500 mg/kg dry weight test groups were respectively 0%, 0%,
0%, 0%, 0%, 27.5% and 0%, 0%, 0%, 7.5%, 45%, 100%.
Results with reference substance (positive control):
The 14 d-LC50 of chloroacetamide was 27.6 mg/kg (dry weight of artificial soil), 95% confidence limit was 25.7 mg/kg - 29.7 mg/kg.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
The mortality of earthworm in blank control was 0% at the end of the rest, which fulfilled the criteria for the validity of not exceeding 10%.
Conclusions:
Under the test conditions, the result for the 14 d median lethal concentration (LC50) was 850 mg/kg dry weight, with the 95% confidence limit of 771 mg/kg dry weight - 936 mg/kg dry weight·
Executive summary:

Earthwoms were exposed to artificial soil containing different concentrations of the test substance. Mortality was assessed after 7 and 14 days of exposure. Acute toxicity of the test substance to earthwonns was determined by the results of mortality.

After 7 days and 14 days exposure, the 7d and 14d mortalities of earthworms in the blank control were both 0%. After 7 days and 14 days exposure, the 7d and 14d mortalities of earthworms in the 100 mg/kg dry weight, 171 mg/kg dry weight, 296 mg/kg dry weight, 508 mg/kg dry weight, 873 mg/kg dry weight and 1500 mg/kg dry weight test groups were respectively 0%, 0%, 0%, 0%, 0%, 27.5% and 0%, 0%, 0%, 7.5%, 45%, 100%.

Under the test conditions, the result for the 14 d median lethal concentration (LC50) was 850 mg/kg dry weight, with the 95% confidence limit of 771 mg/kg dry weight - 936 mg/kg dry weight.