3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione

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:

Mar 20 2019 to May 10, 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione

EC Number:

701-350-3

Molecular formula:

Not possible to assign, UVCB

IUPAC Name:

3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione

Test material form:

liquid

Details on test material:

- Appearance: brown liquid
- Storage: room temperature, in the dark

Specific details on test material used for the study:

Test substance is a UVCB

Test organisms

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

The organism used was Eisenia foetida with obvious clitellum which was older than 2 months with batch no. EEf20181018-l weighing between 385 mg - 414 mg mg per earthworm. A total of 80 eartworms were used, purchased from Purchased from Fogang Wotu Agricultural Technology
Co. Ltd. and raised in the test facility.

Study design

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

7 d

Test conditions

Test temperature:

20°C ± 2°C

pH:

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 6.29 - 6.34.

Moisture:

27.7% (mean value)

Details on test conditions:

During the test, the environment temperature was 19.5 °C - 20.6 °C, the humidity was 70.0% - 90.0%. Continuous light, light intensity was 691 lx at the start of the test and 589 lx at the end of the test. Moisture content of artificial soil was 29.0% dry weight at the beginning of the test, and were 27.7% - 28.4% 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 6.29 - 6.34.

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Key result

Duration:

7 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Conc. based on:

test mat.

Basis for effect:

mortality

Results with reference substance (positive control):

The sensitivity test was carried out with the reference substance chloroacetamide (C2H4ClNO) based on the artificial soil test of the same batch Eisenia foetida.
The 14 d-LC50 of chloroacetamide was 20.7 mg/kg (dry weight of artificial soil), 95% confidence limit was 18.4 mg/kg - 23.2 mg/kg. The test report number of sensitivity test was 2018GST0018R.

Any other information on results incl. tables

Deaths and Mortality of earthworm

Groups	No. of earthworms	7d		14 d
		Deaths of earthworm	Mortality %	Deaths of earthworm	Mortality %
Blank control	40	0	0	0	0
test substance group (1000 mg/kg dry weight)	40	0	0	0	0

All earthworms were healthy on day 7 and day 14.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions, the result for the 14 d median lethal concentration (LC50) was greater than 1000 mg/kg (dry weight of artificial soil).

Executive summary:

The acute toxicity to earthworm of the test substance was determined in accordance with OECD 207 guidelines , Artificial soil test. The study was conducted in complaince with GLP. The duration of the test lasted for 14days, one test group of 1000 mg/kg ( dry weight of artificial soil) was designed and a blank control without test substance . 4 replicates per group having 10 earth worms per replicate was used for the study. Based on the predicted moisture content of artificial soil,

approximately 30%, respectively 577 mg of test ssubstance (purity was 100 %) was weighed and mixed well with quartz sand to a total weight of about 10 g by grinding. Each mixture was then mixed with about 740 g wet artificial soil to obtain test substance concentrations of 1000 mg/kg (dry weight of artificial soil). Four replicates were prepared. Blank control was prepared by mixing about 10 g of quartz sand and about 740 g wet artificial soil, with four replicates. Incubator temparture was in the range of 19.5 °C - 20.6 °C having ambient humidity of 70% -90%. Continuous light, the light intensity was 691 Ix at the beginning of the test and 589 Ix at the end of the test.

Based on the results of range-finding test (Annex A), a limit test was conducted to evaluate the acute toxicity of the test substance to earthwonn (Eisenia foetida). After 7 days and 14 days exposure, the mortalities of earthworms in the blank control were 0% and 0%, and were 0% and 0% in the 1000 mg/kg ( dry weight of artificial soil) test group. Under the test conditions, the result for the 14 d median lethal concentration (LC50) was > 1000 mg/kg ( dry weight of artificial soil).