Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione

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:

2017-09-05 - 2018-02-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione

EC Number:

700-064-6

Cas Number:

2105830-60-0

Molecular formula:

Not applicable as this is a UVCB substance

IUPAC Name:

Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione

Sampling and analysis

Analytical monitoring:

no

Test substrate

Vehicle:

yes

Remarks:

Acetone

Details on preparation and application of test substrate:

Based on the results of the range-finding test, a limit test was carried out. The nominal concentration was 1000 mg/kg. The blank control and the solvent control
were also canied out. 40 earthworms were exposed to each group, divided into four replicates of 10 earthworms each. The test duration was 14:days.
2520.1mg of the test substances was dissolved in 10mL acetone to give the solvent stock solution. The solvent stock solution was inverted several times to ensure adequate mixing and homogeneity. An aliquot solvent solution was separately added to a certain amount of silica sand and the solvent allowed to evaporate off prior to incorporation Into formulated artificial soil with deionised reverse osmosis water. These were mixed by a mixer to give the blank control, solvent control, 1000mg/kg respectively with a nominal moisture content of 40-60% by mass of the total water-holding capacity with the deionized water.

Test organisms

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

The study was performed with earthworms (Eisenia fetida). This species was recommended in "Ministry of environmental protection of the people's Republic of
China, The Guidelines for the Testing of Chemicals - Effects on Biotic Systems, 2013, 207 Earthworm, Acute Toxicity Test" and .. OECD, Gutd~lines for the ·Testing of Chemicals, 1984, 207 Earthworm, Acute Toxicity Test".

The earthworms used in the limit test were purchased from Jiang Su province Jurong Stock Farm. (ID: EF-MKT-171027). All newly acquired earthworms were quarantined and observed for 14 days prior to use in the test. Earthworms were bred on a substrate consisting of 50% by volume peat and 50% by volume cow manure and kept under 20 ± 2°C for 7 days prior to testing. The test organisms were with clitellum and were transferred into artificial soil (without test substance) approximately 24 hours prior to the start of the test. At the start of the test, tH'e used adult earthworms, which were originated from the same ·population, were with clitellum and wet weight of 300 to 600mg.

Study design

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Test conditions

Test temperature:

20.0 - 20.3 °C

pH:

6.01 - 6.07

Moisture:

29.51 - 31.64 (expressed as % dry weight)

Nominal and measured concentrations:

nominal 1000 mg/kg dry soil weight

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Key result

Duration:

14 d

Dose descriptor:

LC50

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 were 5.0% at the 7th day and 7.5% at the 14th day in the blank control group.
The mortalities were 5.0% at the th day and 5.0% at the 14th day in the solvent control group.
The mortalities were 5.0% at the 7th day and 10.0% at the 14th day in the 1000mglkg treatment group.
No adverse behavioural effects were observed at either 7 or 14 days exposure in any of the treatment groups

Results with reference substance (positive control):

The LC50 of the toxic reference substance chloroacetamide was determined once a year.The most recent test with chloroacetamide was performed from 8th Nov. 2017 to 22nd Nov. 2017 (14 days test).
In this study, the reference substance was tested at five concentrations of 3.75, 7.50, 15, 30 and 60mglkg dry artificial soil weight. The mortalities in chloroacetamide treatment groups were shown to be between 0% to 100%. The 14-days LC50 for chloroacetamide was 21.60 mg/kg dry soil weight.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Expressed as nominal concentration, the median lethal concentration of MULTIESTER P97-463 on Eisenia fetida are as follows:
The 7 day LC50 value was higher than 1000 mglkg dry soil weight.
The 14 day LC50 value was higher than 1000 mglkg dry soil weight.

Executive summary:

Expressed as nominal concentration, the median lethal concentration of MULTIESTER P97-463 on Eisenia fetida are as follows:

The 7 day LC50 value was higher than 1000 mglkg dry soil weight.

The 14 day LC50 value was higher than 1000 mglkg dry soil weight.