Registration Dossier

Diss Factsheets

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 August - 29 December 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study was conducted in accordance with International guidelines and in accordance with GLP. All guideline validity criteria were met.
Qualifier:
according to guideline
Guideline:
OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: N/A
- Specific activity: N/A
- Locations of the label: N/A
- Expiration date of radiochemical substance: N/A

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark and under nitrogen.
- Stability under test conditions: Asumed stable .
- Solubility and stability of the test substance in the solvent/vehicle: Acetone stock solution prepared at 300 mg/mL
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: N/A

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: N/A
- Preliminary purification step (if any): N/A
- Final dilution of a dissolved solid, stock liquid or gel: N/A
- Final preparation of a solid: N/A

FORM AS APPLIED IN THE TEST (if different from that of starting material): Solubilised in an acetone stock solution which was incorporated into quartz sand and mixed with the artificial soil.

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable): N/A

OTHER SPECIFICS: No
Analytical monitoring:
no
Details on sampling:
N/A
Vehicle:
yes
Details on preparation and application of test substrate:
- Method of application to filter paper (if used): N/A
- Method of mixing into soil (if used): An aliquot (16 mL) of an acetone stock solution was added to quartz sand and mixed. The sand was incorportated into the artificial soil and homgenised.
- Method of application to soil surface (if used): N/A
- Controls: Solvent control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Acetone
- Concentration of vehicle in test medium (stock solution and final test solution): 16 mL acetone added to 4720 g soil (dry weight) i.e. 0.003 % v/w.
- Evaporation of vehicle before use: Not reported
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Eisenia foetida (redworm)
- Source: Chenggong Earthworm Raising Farm, Dongli District, Tianjing, China.
- Age at test initiation (mean and range, SD): > 2 months old
- Weight at test initiation (mean and range, SD): 300 - 430 g

ACCLIMATION
- Acclimation period: Not reported
- Acclimation conditions (same as test or not): Not reported
- Health during acclimation (any mortality observed): Not reported
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
yes
Total exposure duration:
28 d
Test temperature:
18.16 - 19.50 ºC
pH:
5.53 - 5.62
Moisture:
35 %
Details on test conditions:
TEST SYSTEM
- Test container (material, size): Container measuring 19 cm x 12 cm x 9 cm (H x L x W)
- Amount of soil or substrate: 750 g wet weight
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 8
- No. of replicates per control: 0
- No. of replicates per vehicle control: 8

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Artificial soil prepared as per OECD guidance. Adjusted and maintained at 35 % moisture content with deionised water for the duration of the test.

OTHER TEST CONDITIONS
- Photoperiod: 16:8 light: dark
- Light intensity: 400-800 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Adult mortality, weight and sub-lethal effects, reproduction

VEHICLE CONTROL PERFORMED: Yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: N/A, limit test.
- Justification for using less concentrations than requested by guideline: Limit test
- Range finding study: No
- Test concentrations: N/A
- Results used to determine the conditions for the definitive study: N/A
Nominal and measured concentrations:
Nominal: 1000 mg/kg dry weight
Reference substance (positive control):
no
Key result
Duration:
28 d
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
- Mortality at end of exposure period: No adult mortality was observed during the test.
- Total mass of adults at beginning of test: 300-430 g
- Changes in body weight of live adults (% of initial weight) at end of exposure period: +12 % and +7 % in the control and 1000 mg/kg groups, respectively
- No. of offspring produced: 51.8 and 42.1 for the control and 1000 mg/kg groups, respectively (mean values).
- No. of unhatched cocoons: Not reported
- Morphological abnormalities: Some cocoons in the 1000 mg/kg test grup looked smaller vs the control group.
- Behavioural abnormalities: No
- Other biological observations: No

Table 1       Earthworm weights

 

Concentration

(mg/kg dry soil)

Mean weight of earthworms ± sd

(g)

% Increase

Day 0

Day 28

Control

338.0 ± 36.9

378.2 ± 62.6

+12

1000

343.9 ± 34.0

368.4 ± 46.3

+7

 

Table 2       Adult earthworm mortality

 

Concentration

(mg/kg dry soil)

Mean surviving adults

Mean % mortality

Sub-lethal effects

Control

10

0

None

1000

10

0

None

 

Table 3       Juvenile worms

 

Concentration

(mg/kg dry soil)

Rep

Adult worm number

Cocoon number

Total juvenile worms

Mean number of juvenile worms ± sd

Reproductive abnormalities

Control

1

10

16

47

51.8 ± 14.6

None

2

10

17

50

3

10

15

42

4

10

13

37

5

10

13

42

6

10

23

73

7

10

24

76

8

10

14

47

1000

1

10

15

44

42.1 ± 7.2

Some cocoons looked smaller vs control

2

10

16

46

3

10

19

55

4

10

11

30

5

10

13

42

6

10

14

43

7

10

14

39

8

10

13

38

Validity criteria fulfilled:
yes
Conclusions:
The 28 day LC50 was > 1000 mg/kg dry soil weight. The 28 day NOEC for reproduction was 1000 mg/kg dry soil weight.
Executive summary:

OECD 222 (2012) - In a 28-day reproduction toxicity study, earthworms (Eisenia foetida) were exposed to Tetraesters of pentaerythritol with 2-methylpropanoic acid and 3,5,5-trimethyl-hexanoic acid at a nominal concentration of 1000 mg a.i./kg dry weight of artificial soil in a limit test. The experiment was carried out in accordance with the OECD 222 testing guideline. 

 

The test item was solubilized in acetone, an aliquot of which was mixed with quartz sand and incorporated in the artificial soil, prepared in accordance with the testing guideline. The soil was adjusted and maintained at 35 % moisture content throughout the testing period using deionized water. A solvent control was also prepared and run in parallel with the treated soil group.

 

At Day 28, the number of surviving adults was determined. It was noted that there was no mortality observed in any of the control or test replicates. The LC50 was therefore estimated to be >1000 mg/kg dry weight soil. No sub-lethal effects or significant weight gain changes were observed in the treated group versus the control.

 

The number of cocoons and juveniles produced in the control and test group was counted. No adverse effects on reproduction was observed and the NOEC was concluded to be 1000 mg/kg dry soil.

 

This study is classified as acceptable and satisfies the guideline requirements for a chronic reproduction toxicity study with earthworms.

Description of key information

28 d LC50: >1000 mg/kg dw soil; OECD 222; Hairong, Y. (2012)

28 d NOEC (reproduction): => 1000 mg/kg dw soil; OECD 222; Hairong, Y. (2012)

Key value for chemical safety assessment

Additional information

OECD 222 (2012) - In a 28-day reproduction toxicity study, earthworms (Eisenia foetida) were exposed to Tetraesters of pentaerythritol with 2-methylpropanoic acid and 3,5,5-trimethyl-hexanoic acid at a nominal concentration of 1000 mg a.i./kg dry weight of artificial soil in a limit test. The experiment was carried out in accordance with the OECD 222 testing guideline. 

 

The test item was solubilized in acetone, an aliquot of which was mixed with quartz sand and incorporated in the artificial soil, prepared in accordance with the testing guideline. The soil was adjusted and maintained at 35 % moisture content throughout the testing period using deionized water. A solvent control was also prepared and run in parallel with the treated soil group.

 

At Day 28, the number of surviving adults was determined. It was noted that there was no mortality observed in any of the control or test replicates. The LC50 was therefore estimated to be >1000 mg/kg dry weight soil. No sub-lethal effects or significant weight gain changes were observed in the treated group versus the control.

 

The number of cocoons and juveniles produced in the control and test group was counted. No adverse effects on reproduction was observed and the NOEC was concluded to be 1000 mg/kg dry soil.

 

This study is classified as acceptable and satisfies the guideline requirements for a chronic reproduction toxicity study with earthworms.

Categories Display