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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:
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.

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

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).

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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