methyl-bis[2-(4-methylalicyclyl)propyl]dihydro-heteropolycyle

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 2020-07-14

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

Test material information

Constituent 1

Sampling and analysis

Analytical monitoring:

no

Test substrate

Vehicle:

no

Details on preparation and application of test substrate:

Based on the predictive moisture content of artificial soil, approximately 30%, respectively 62 mg, 110 mg, 194 mg, 346 mg and 6 15 mg of test substance (purity was 93 .9%) 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 101 mg/kg dry weight, 179 mg/kg dry weight, 316 mg/kg dry weight, 563 mg/kg dry weight and 1001 mg/kg dry weight, respectively. Four replicates were prepared for each group. Blank control was prepared by mixing about 10 g of quartz sand and about 740 g wet artificial soil, with four replicates.

The above test media (750 g wet weight) was transferred into 1 L glass beakers. Ten healthy earthwonns (which had been washed and dried with filter paper) were placed randomly on the surface of artificial soil in each container. These earthwonns were placed on the surface and allowed to borrow into the test medium by themselves. The containers were covered with perforated plastic film to prevent the artificial soil from drying.

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, earthwomrs were acclimated to the study conditions for about 24 h in the artificial soil.

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:

start: 6.27
end: 6.14 - 6.40

Moisture:

30.6% dry weight at the beginning of the test, and 27.8% - 28.8% dry weight at the end of the test.

Details on test conditions:

During the test, the environment temperature was 18.1 °C - 19.6°C, the humidity was 80.0% - 97.0%, with continuous light. The light intensity was 640 Ix at the start of the test and 682 Ix at the end of the test. Moisture contents of artificial soil were 30.6% dry weight at the beginning of the test, and 27.8% - 28.8% dry weight at the end of the test. At the start of test, pH value of the artificial soil was detennined as 6.27 and not be adjusted. At the end of test, pH values of the artificial soil were detennined as 6.14 - 6.40.

Nominal and measured concentrations:

Nominal: 101 mg/kg dry weight, 179 mg/kg dry weight, 316 mg/kg dry weight, 563 mg/kg dry weight and 1001 mg/kg dry weight

Reference substance (positive control):

yes

Remarks:

chloroacetamide (C2H4ClNO)

Results and discussion

Effect concentrations

Key result

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

234 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

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 earthworms in blank control was 0% at the end of the test, 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 234 mg/kg dry weight, with the 95% confidence limit of 108 mg/kg dry weight - 508 mg/kg dry weight.

Executive summary:

Earthworms 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 101 mg/kg dry weight, 179 mg/kg dry weight , 316 mg/kg dry weight, 563 mg/kg dry weight and 1001 mg/kg dry weight test groups were respectively 0%, 0%, 0%, 0%, 17.5% and 5%, 10%, 85%, 100%, 100%.

Under the test conditions, the result for the 14 d median lethal concentration (LC50) was 234 mg/kg dry weight, with the 95% confidence limit of 108 mg/kg dry weight - 508 mg/kg dry weight·