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Toxicity to soil macroorganisms except arthropods

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Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
weight of evidence
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:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Version / remarks:
April 04, 1984
Deviations:
no
GLP compliance:
yes (incl. certificate)
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).
Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
Experiment Start: July 20, 2017 - Experiment Completion: August 24, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Study was performed with C16 alkyl lactate, which can be considered as a valid analogue of C12-15 alkyl lactates.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Hexadecyl lactate: 83.33%; Hexadecanol: 15.4%

3. ANALOGUE APPROACH JUSTIFICATION
Results of a study with C14 alkyl lactate performed in the same period gave a similar result.

Qualifier:
according to
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Version / remarks:
April 04, 1984
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Test Item Name: Propanoic acid, 2-hydroxy-, hexadecyl ester (Ceraphyl®28)
Batch Number: 0001930625
Date of Analysis: August 08, 2017
Date of Re-Analysis:
Appearance : Viscous white liquid with faint fatty buttery odor
Storage Condition: Room temperature
CHEMICAL ANALYSIS
Method of Analysis: Gas Chromatograph equipped with Mass Spectrophotometer (GC-MS)
Purity: Hexadecanol : 15.4%
Hexadecyl Lactate: 83.33% (Sum of % area of two peaks)
Test Facility: Jai Research Foundation, Valvada, Gujarat, India
The analysis of the Propanoic acid, 2-hydroxy-, hexadecyl ester (Ceraphyl®28) was conducted in compliance with the OECD principles of Good Laboratory Practices 1998.
Analytical monitoring:
no
Vehicle:
yes
Details on preparation and application of test substrate:
A quantity of 1500.0 mg propanoic acid, 2-hydroxy-, hexadecyl ester (CERAPHYL® 28) 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. 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 11 months earthworms with well-developed clitellum and having body weights ranging between 317.6 and 576.3 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® 28/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 ± 0.3 °C
pH:
6.41
Moisture:
The moisture contents of the artificial soil on days 0 and 14 were 34.0 and 31.5%, 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-, hexadecyl ester (CERAPHYL® 28)/kg artificial soil. Statistically no significant difference was observed between the mean body weights of the control and treatment group on day 0, while a statistically significant difference in mean body weights was observed between these groups on day 14. However, statistically no significant difference was found in relative decrease of mean body weight of the treatment group, i.e. at the test concentration of 2000.0 mg propanoic acid, 2-hydroxy-, hexadecyl ester (CERAPHYL® 28)/kg artificial soil, when compared with 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 mg propanoic acid, 2-hydroxy-, hexadecyl ester (CERAPHYL® 28)/kg (dry weight of artificial soil).

Description of key information

No mortality or signs of toxicity were observed during the 14 -day test period at the test concentrations of 0.0 (control) and 2000.0 mg of either C14 or C16 alkyl lactate. For both C14 and C16 alkyl lactates, statistical comparison of relative decrease of mean body weight showed no significant difference between the treatment group and the control group. Studies were performed under GLP according to the OECD guideline for short-term earthworm test.

Key value for chemical safety assessment

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

Additional information