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Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

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Reference
Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experiment Start: July 20, 2017 - Experiment Completion: September 29, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Version / remarks:
April 04, 1984
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Test Item Name : Propanoic Acid, 2-Hydroxy-, Tetradecyl Ester (CERAPHYL® 50)
IBatch/Lot Number : 0001977717
Storage Conditions :
- Storage Temperature: Room temperature
- Storage Container: In original container as supplied by the Sponsor
- Storage Location:Test Item Control Office, JRF
Analytical monitoring:
no
Vehicle:
yes
Details on preparation and application of test substrate:
A quantity of 1500.0 mg propanoic acid, 2-hydroxy-, tetradecyl ester (CERAPHYL® 50) was weighed individually for each replicate and mixed with 10 g of industrial sand. A mixture of test item and industrial sand was mixed with pre-weighed 740 g of artificial soil. Approximately 270 mL distilled water was mixed with 850 g artificial soil for the control (4 replicates per test concentration) and 238 mL distilled water was mixed with 750 g artificial soil for the treatment group (4 replicates per test concentration) to achieve the required moisture content. 100 g of artificial soil was collected from three replicate of control group to measure moisture content and 100 g of artificial soil was disposed.
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
Adult earthworms (Eisenia fetida) were obtained from approved supplier.
They were subcultured and maintained in recommended breeding/rearing medium (farmyard manure) at the Section - Ecotoxicology, Jai Research Foundation.
Approximately 8 months earthworms with well-developed clitellum and having body weights ranging between 320.3 and 560.4 mg were selected for the study.
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
yes
Total exposure duration:
14 d
Remarks:
Preliminary range finding study with test concentrations of 0.0, 100, 250, 500, 1000 and 2000 mg CERAPHYL® 50/kg (dry weight of artificial soil) for a period of 14 days with twenty earthworms in each group (two replicates, each with ten earthworms).
Test temperature:
19.2 ± 0.2 °C
pH:
6.38
Moisture:
The moisture contents of the artificial soil on days 0 and 14 were 37.5 and 35.4%, respectively.
Details on test conditions:
Ingredient of Artificial Soil For Control Group and Acclimatisation For Treatment Group
Sphagnum peat (10%)
(Finely ground with no visible plant remains) 0.45 0.3 kg
Kaoline clay (20%) 0.9 0.6 kg
Industrial sand (70%) 3.15 2.1 kg
Total weight of artificial soil 4.5 3.0 kg

The above ingredients were dried at 105 ºC for 5 ± 1 hours and mixed thoroughly with sufficient distilled water to provide adequate moisture without necessarily making the artificial soil wet. Moisture content was then determined by drying approximately 100 g artificial soil at 105 ± 5 °C and reweighing after 24 h.


Nominal and measured concentrations:
2000 mg/kg dry weight
Reference substance (positive control):
yes
Remarks:
chloroacetamide
Key result
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
> 2 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
14 d
Dose descriptor:
LC0
Effect conc.:
2 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
No mortality or signs of toxicity were observed on days 7 and 14 at the test concentrations of 0.0 (control) and 2000.0 mg propanoic acid, 2-hydroxy-, tetradecyl ester (CERAPHYL® 50)/kg artificial soil. Statistically no significant difference was observed between the mean body weights of the control and treatment group on day 0 and 14. Also, statistical comparison of relative decrease of mean body weight showed no significant difference between the treatment group, i.e. at the test concentration of 2000.0 mg propanoic acid, 2-hydroxy-, tetradecyl ester (CERAPHYL® 50)/kg artificial soil, and the control group.
Results with reference substance (positive control):
The highest concentration of chloroacetamide causing no mortality was 9.0 mg/kg artificial soil and the lowest concentration of chloroacetamide causing 100 percent mortality was 52.5 mg/kg artificial soil.
The moisture contents of the artificial soil on days 0 and 14 were 33.6% and 31.9%, respectively.
The 14 days LC50 of chloroacetamide was determined as 27.3 mg/kg artificial soil.
Validity criteria fulfilled:
yes
Conclusions:
LC50 (14 day): Greater than 2000.0 mg propanoic acid, 2-hydroxy-, tetradecyl ester (CERAPHYL® 50)/kg (dry weight of artificial soil).

Description of key information

Statistically no significant difference was observed between the mean body weights of the control and treatment group on day 0 and 14. Also, statistical comparison of relative decrease of mean body weight showed no significant difference between the treatment group, i.e. at the test concentration of 2000.0 mg propanoic acid, 2-hydroxy-, tetradecyl ester (CERAPHYL® 50)/kg artificial soil, and the control group.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:
2 000 mg/kg soil dw

Additional information