Registration Dossier

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Currently viewing:

Administrative data

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:
30 April 2013 to 18 January 2014
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: E00031-700
- Expiration date of the lot/batch: 1 October 2015
- Purity: 98%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature under nitrogen in the dark
- Stability under test conditions: Stable in container after opening and stable in water, light and soil.
Analytical monitoring:
no
Details on sampling:
- Concentrations: limit test (1000 mg/kg)
- Sampling method: artifical soil test
Vehicle:
no
Details on preparation and application of test substrate:
The test substance was accurately weighed (2.750 g) into a beaker and dissolved with the appropriate amount of acetone. It was then diluted to 50 mL to obtain the 55 mg/mL of test stock solution. 10 mL of test stock solution was withdrawn and mixed with 10 g of quartz sand. After drying, this was mixed with 740 g of wet artificial soil in the test container to prepare the 1000 mg/kg dry weight soil. 4 replicate test systems were prepared for each test group. Each earthworm was placed on the test medium surface, with each container being covered with plastic film to prevent the test medium from drying.
Test organisms (species):
other: Eisenia foetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Earthworm
- Source: Zhuhai Hongming Earthworm Breeding Park
- Age at test initiation (mean and range, SD): Older than 2 months
- Weight at test initiation (mean and range, SD): 334 mg - 385 mg

ACCLIMATION
- Acclimation period: At least 14 days
- Acclimation conditions (same as test or not): same as test
- Health during acclimation (any mortality observed): all healthy
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
yes
Total exposure duration:
14 d
Post exposure observation period:
Any behavioural or pathological symptoms were checked and recorded on Day 7 and Day 14. pH was measured at the beginning of the test, and humidity and body weights were measured at the beginning and end of the test.
Test temperature:
18.4-22 degrees Celsius
pH:
6.44
Moisture:
approxiamtely 26.2 - 30.7%
Details on test conditions:
TEST SYSTEM
- Test container (material, size): 1L glass beaker
- No. of organisms per container (treatment): 1
- No. of replicates per treatment group: 10 replicates per treatment group
- No. of replicates per control: 10 replicates
- No. of replicates per vehicle control: 10 replicates

OTHER TEST CONDITIONS
- Photoperiod: Continuous light intensity
- Light intensity: 548 lx at the beginning and 671 lx at the end of the test

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Behavioural or pathological observations, mortality, pH, humidity and weight.

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Range finding study
Test concentrations: 0 mg/kg, 10 mg/kg, 100 mg/kg, 1000 mg/kg
Results used to determine the conditions for the definitive study: preliminary study
Nominal and measured concentrations:
1000 mg/kg
Reference substance (positive control):
no
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:
- Mortality at end of exposure period: 0%
- Morphological abnormalities: no
- Behavioural abnormalities: no
Results with reference substance (positive control):
Not applicable
Validity criteria fulfilled:
yes
Conclusions:
Under the present test conditions, results indicated that the 14 Day LC50 of the test substance to earthworms by artificial soil test was greater than 1000 mg/kg dry soil.
Executive summary:

The purpose of this study was to evaluate the acute toxicity of the test substance to earthworm by observing the mortality and pathological symptoms.

The artificial test involves keeping earthworms in samples of precisely defined artificial soil to which a limit of concentration (1000 mg/kg) of the test substance has been applied. Mortality is assessed 7 and 14 days after application, and then the acute toxicity of the test substance is determined by the results of the mortality.

The results demonstrated the mortality in the controls, solvent and test group was 0%, which fulfilled the validity criteria of not exceeding 10%. The mean moisture content of the control group and treatment group’s artificial soil at the start and at the end of the test were 30.3% and 26.3% respectively.

Under the present test conditions, results indicated that the 14 Day LC50 of the test substance to earthworms by artificial soil test was greater than 1000 mg/kg dry soil.

Description of key information

The study was conducted to GLP in accordance with the OECD 207 guideline.

The results demonstrated the mortality in the controls solvent and test group was 0%, which fulfilled the valid criteria of not exceeding 10%.

Under the present test conditions, results indicated that the 14 Day LC50 of the test substance to earthworms by artificial soil test was greater than 1000 mg/kg dry soil.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:
1 000 mg/kg soil dw

Additional information