Tetradecyl lactate

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:

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