Reaction mass of (9-acetoxy-3,8,10-triethyl-7,8,10-trimethyl-1,5-dioxa-9-azaspiro[5.5]undec-3-yl)methyl palmitate and (9-acetoxy-3,8,10-triethyl-7,8,10-trimethyl-1,5-dioxa-9-azaspiro[5.5]undec-3-yl)methyl stearate

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 DECEMBER 2015 - 16 DECEMBER 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

yes

Remarks:

Acetone, a solvent control was run in addition. It was evaporated before the test started.

Details on preparation and application of test substrate:

2.778 g test substance were accurately weighted into the beaker and dissolved with an appropriate amount of acetone. Then it was diluted to 50mL to obtain the 55.56mg/mL of test stock solution for test. 10 mL of the test stock solution were mixed with a total of 10g quartz sand. The solvent was dried and then the sand was mixed with 740g wet artificial soil in the test container to prepare the test system of 1000 mg/kg dried soil. Solvent control was prepared by taking 10 mL of solvent and mixing it with a total of 10g quartz sand firstly. Then the solvent was dried and was mixed with 740g wet artificial soil in the test container to prepare the solvent control. Blank control was prepared by mixing about 10g of quartz sand and 740g wet artificial soil. Four replicates were prepared for each test group.

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

Species Eisenia foetida
Batch No.: EEf20150527-1
Age: Older than 2 months
Weight: 306mg - 321 mg
Amount: 120 individuals
Source: Zhuhai Hongmning Earthworm Breeding Park
Holding: All earthwormns were obtained and held in the laboratory for 14 days and more under the same conditions before
use. During the holding period, all the earthworms were healthy. They were kept for 24h in the artificial soil before start of the artificial soil test.

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Test temperature:

18.1 °C - 21.7 °C

pH:

6.42

Moisture:

Start: 25.1-25.3 % by adding deionised water
End: 24.1 - 24.6 % in the control and treatment group

Details on test conditions:

TEST SYSTEM
- Test container (material, size): glass beaker (1L), covered with perforated plastic film
- Amount of soil or substrate:
- 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

OTHER TEST CONDITIONS
- Photoperiod: continuous light
- Light intensity: 712 lx - 656 lx

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, pathological sympotms and abnormal behavior, average weight

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: no as it is a limit test
- Justification for using less concentrations than requested by guideline: limit test due to results from range finding test
- Range finding study: yes
- Test concentrations in range finder: blank control, solvent control, 30, 100, 310 and 1000 mg/kg dw
- Results used to determine the conditions for the definitive study: no mortality was observed in the range finding study.

Nominal and measured concentrations:

1000 mg/kg dw

Reference substance (positive control):

yes

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

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

>= 1 000 mg/kg soil ww

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth

Details on results:

The mean moisture content of control group and treatment group at start and at the end of test were 25.2% and 24.3 %, respectively. The results demonstrate that the mortalities in the blank controls and the solvent group all were 0% , which did not exceed 10% at the end of the test and fulfilled the criteria for a valid test. The mortality in the test group was 0%. No obvious physical or pathological symptoms or distinct changes in behavior observed in the test organisms on day 7 and 14 day .Under the conditions of the present test, the 14d-LC50 of the test substance to earthworm was >1000 mg/kg dw.

Results with reference substance (positive control):

After domestication, the 14d-LC50 of reference substance chloracetarnide (C2H4C1NO) was tested for Eisenia foetoda. It was 28 mg/kg dry weight, and the 95% confidence limit was between 26 mg/kg dry weight and 30 mg/kg dry weight.

Validity criteria fulfilled:

yes

Conclusions:

Under the present test conditions, results indicate that the 14d-LC50 of the test substance to earthworn by artificial soil test was >1000mg/kg dw.

Description of key information

In the key study according to OECD TG 207, acute toxicity to earthworm, the test item did not show any negative effects corresponding to a 14 day LC50 of >= 1000 mg/kg dw. 

 

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

1 000 mg/kg soil dw