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EC number: 801-260-5 | CAS number: 96383-55-0
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil macroorganisms except arthropods: short-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Aug -07 Sep 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to GLP and to relevant OECD guideline (OECD 207) without any major deficiencies.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 6SFCT83018
- Expiration date of the lot/batch: 31 March 2020
- Purity test date: 2 Apr 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
- Stability under test conditions: not applicable
- Solubility and stability of the test substance in the solvent/vehicle: not reported
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: unknown - Analytical monitoring:
- no
- Details on sampling:
- no analytical sampling conducted
- Vehicle:
- yes
- Remarks:
- acetone
- Details on preparation and application of test substrate:
- - Method of mixing into soil (if used): C6SFCLA was dispersed in 100 mL acetone for each treatment rate, of which 40 mL was poured over 200 g dry soil and the solvent allowed to evaporate. The dry soil was then mixed into a 2000 g dry weight equivalent of moist soil.
- Controls: For the water control, 200 g dry soil was mixed into a 2000 g dry weight equivalent of moist soil. For the solvent control, 40 mL acetone was poured over 200 g dry soil and the solvent allowed to evaporate before mixing with a 2000 g equivalent of dry soil.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Evaporation of vehicle before use: yes - Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Earthworm
- Source: not specified, a reputable supplier.
- Age at test initiation (mean and range, SD): cocoons laid 9-23 Jan 2018; approx 7 months old
- Weight at test initiation (mean and range, SD): 377-380 mg
ACCLIMATION
- Acclimation period: at least 24 hours
- Acclimation conditions (same as test or not): 18.0-21.1oC, light levals between 520 and 560 lux.
- Health during acclimation (any mortality observed): not reported - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 14 d
- Test temperature:
- Desired range: 18.0 – 21.1 oC, Actual range: 18.8 – 21.1oC
- pH:
- Desire range: 6.0 ± 0.5, Actual Range: 6.0 ± 0.5
- Moisture:
- Desired: 35%, Actual: 33 - 35%
- Details on test conditions:
- TEST SYSTEM
- Test container (material, size): glass, 1-litre capacity
- Amount of soil or substrate: 2200 g dry weight between 4 containers (approx. 550g per container)
- No. of organisms per container (treatment): 10 per container, 40 per treatment
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- No. of replicates per vehicle control: 4
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): 70% quartz sand, 20% kaolin clay and 10% sphagnum peat. The pH was adjusted with calcium carbonate to 6.0 ± 0.5.
- Pretreatment of soil: adjustment to 18.69% moisture content.
- Storage (condition, duration): unknown
- Stability and homogeneity of test material in the medium: unknown
OTHER TEST CONDITIONS
- Photoperiod: not reported
- Light intensity: desired range (from OECD 207 guideline): 400-800 lux. light levels achieved were between 421 and 686 lux.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : behavioural observations daily, mortality observations, bodyweight at day 14
VEHICLE CONTROL PERFORMED: yes
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study
- Test concentrations: not performed
- Results used to determine the conditions for the definitive study: no - Nominal and measured concentrations:
- nominal concentrations only: 1000, 555.6, 308.6, 171.5, 95.3 mg/kg
- Reference substance (positive control):
- yes
- Remarks:
- Chloroacetamide at 60 mg/kg
- Key result
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- 332 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks on result:
- other: 95% CI: 295-374 mg/kg dw
- Duration:
- 14 d
- Dose descriptor:
- EC50
- Effect conc.:
- 170 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Remarks:
- bodyweight
- Remarks on result:
- other: 95% CI: 164-177 mg/kg dw
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 95.3 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 95.3 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Remarks:
- bodyweight
- Details on results:
- - Mortality at end of exposure period:
The C6SFCLA treated groups 95.3, 171.5, 308.6, 555.6 and 1000 mg a.i./kg dry soil resulted in mortality levels of 12.5, 32.5, 92.5, and 100%, respectively. Refer Table 1 also.
- Total mass of adults at beginning of test: Refer Table 2.
- Changes in body weight of live adults (% of initial weight) at end of exposure period: Refer Table 2.
- Morphological abnormalities: none reported
- Behavioural abnormalities: none reportd - Results with reference substance (positive control):
- - Results with reference substance valid? reference substance not required by guideline
- Relevant effect levels: 67.5% mortality on Day 7 and 14 - Reported statistics and error estimates:
- For mortality each C6SFCLA treatment and the water control group were compared to the solvent control group, and the positive control group was compared to the water control group, using one-tailed (upper-tail) Fisher’s exact tests (Fisher 1973). The LC50 for mortality was estimated using logistic regression, not assuming zero control mortality; 95% confidence intervals could not be calculated.
For the bodyweights each group was compared to the solvent control group using a sequence of tests. - Validity criteria fulfilled:
- yes
- Conclusions:
- For the test to be considered valid, the mortality in the controls must not exceed 10% in the control. As the mortality in the control was 0%, the test was considered valid.
- Executive summary:
A study was performed according to OECD 207 to assess the effects of the test item on survival and growth of Eisenia fetida. Eisenia fetida were exposed to the test item at nominal concentrations of 95.3, 171.5, 308.6, 555.6 and 1000 mg/kg dry weight soil for a period of 14 days. As the test item is poorly soluble in water, acetone was used as a co-solvent to aid test solution preparation, and a solvent control group was included. Mortality was measured at Day 7 and 14; bodyweights were measured at the end of the test.
The day 14 mortality LC50 was calculated to be 332 mg/kg dw soil (95% CI: 295 -374 mg/kg dw soil).
Reference
Table 1 Summary of Eisenia fetida Mortality on Days 7 and 14
Treatment |
Concentration (mg a.i./kg dry soil) |
No. of earthworms |
Mortalities |
Day 14 Total as % |
|
Day 7 |
Day 14 |
||||
Water control |
0 |
40 |
0 |
0 |
0 |
Solvent control |
0 |
40 |
0 |
0 |
0 |
C6SFCLA |
95.3 |
40 |
0 |
0 |
0 |
171.5 |
40 |
5 |
5 |
12.5 |
|
308.6 |
40 |
13 |
13 |
32.5 |
|
555.6 |
40 |
33 |
37 |
92.5 |
|
1000 |
40 |
40 |
40 |
100 |
|
Chlorocetamide |
60 |
40 |
27 |
27 |
67.5 |
Table 2 Group Mean Bodyweights (mg)
Treatment |
Concentration (mg a.i./kg dry soil) |
Day of Study |
% Difference |
Adjusted Mean |
|
Day 7 |
Day 14 |
||||
Water control |
0 |
377 |
330 |
-12.5 |
331 |
Solvent control |
0 |
379 |
323 |
-14.8 |
322 |
C6SFCLA |
95.3 |
379 |
340 |
-10.3 |
340 |
171.5 |
380 |
281 |
-26.1 |
281 |
|
308.6 |
378 |
249 |
-34.1 |
249 |
|
555.6 |
379 |
218 |
-42.5 |
- |
|
1000 |
378 |
- |
- |
- |
|
Chlorocetamide |
60 |
377 |
306 |
-18.8 |
307 |
Description of key information
The day 14 LC50 was calculated to be 332 mg/kg dw soil.
Key value for chemical safety assessment
- Short-term EC50 or LC50 for soil macroorganisms:
- 332 mg/kg soil dw
Additional information
A study was performed according to OECD 207 to assess the effects of test item on survival and growth of Eisenia fetida. Eisenia fetida were exposed to the test item at nominal concentrations of 95.3, 171.5, 308.6, 555.6 and 1000 mg/kg dry weight soil for a period of 14 days. As the test substance is poorly soluble in water, acetone was used as a co-solvent to aid test solution preparation, and a solvent control group was included. Mortality was measured at Day 7 and 14; bodyweights were measured at the end of the test.
The day 14 mortality LC50 was calculated to be 332 mg/kg dw soil (95% CI: 295 -374 mg/kg dw soil).
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