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Toxicity to soil macroorganisms except arthropods

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Reference
Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 October 2017 to ****
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Appearance: Light yellow to tan solid
Purity: 100% UVCB substance
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Earthworms (Eisenia fetida)
- Source: Reputable supplier of laboratory livestock.
- Age at test initiation (mean and range, SD): Adult
- Weight at test initiation (mean and range, SD): Weight range of 300-600 mg
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
28 d
Test temperature:
18.1 - 21.7°C
pH:
7.1 - 7.6
Moisture:
55% of the maximum water holding capacity
Details on test conditions:
TEST SYSTEM
- Test container (material, size): Plastic containers measuring approximately 11 x 17 x 5 cm
- Amount of soil or substrate: 500 g dry soil at 55% of the maximum water holding capacity
- No. of organisms per container (treatment): 40
- No. of replicates per treatment group: 8 Groups
- No. of replicates per control: 80
- No. of replicates per vehicle control: 80

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
Artivicial soil:
Industrial quartz sand 70% w/w
Kaolin clay 20% w/w
Peat 10% w/w

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light: 8-hour dark
- Light intensity: 521 - 798 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
On Day 28 of the study the soild was removed with tweezers from the containers and the numbers and replicate weights of live adults were recorded. The number of surviving juvenile worms, unemerged cacoons and moisture content of the soiil were determined on Day 56.
Nominal and measured concentrations:
16.3, 29.4, 52.9, 95.3, 171.5, 308.6, 555.6 and 1000 a.i./kg dry soil
Reference substance (positive control):
yes
Remarks:
Treated with Ringer.
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:
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:
other: Body weight
Key result
Duration:
26 d
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: number of juvenile worms
Details on results:
- Mortality at end of exposure period: No adult mortality was recorded with the test material. No mortality was recorded in the water control or solve control. Mortality in the positive control group was 18.8%.
- Changes in body weight of live adults (% of initial weight) at end of exposure period: There were no statistically significatn adverse effects in mean bodyweights between the solvent control group and the test item treatment groups. The positive control group had significantly lower body weight than the water conrol group.
- No. of Juveniles: Water control 255, Solvent control 256, Test item 233-253 (range of the 8 groups)
- No. of unhatched cocoons: 1
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Relevant effect levels: 5 mg/kg dry soil
Reported statistics and error estimates:
Statistical analysis was carried out using SAS 9.1.3 (SAS Institute 2002). The IT systems listed below were used on this study:
Pristima: Test substance management
SAS 9.1.3: Statistics
Validity criteria fulfilled:
yes
Conclusions:
The NOEC for mortality and body weight on Day 28 was 1000 mg a.i./kg dry soil. The NOEC for the number of juvenile worms on Day 56 was 1000 mg a.i./kg dry soil.
Executive summary:

The method followed in this study was that described in OECD 222 Guideline for the Testing of Chemicals, Earthworm Reproduction Test (Eiseniafetida/Eisenia andrei), adopted 29 July 2016.

No adult mortality was recorded at any test item rate. No mortality was recorded in the water control or solvent control. Mortality in the positive control group (Ringer) was 18.8%.

As no mortality was observed in the treatment or control groups, no statistical analysis could be performed and the LC50was estimated to be >1000 mg a.i./kg dry soil. The NOEC for mortality on Day 28 was 1000 mg a.i./kg dry soil. 

There were no statistically significant adverse effects in mean bodyweights between the solvent control group and test item treatment groups. The 5 mg a.i./kg dry soil carbendazim treated group had significantly lower body weight than the water control group.

The EC50for the mean body weight of the adult earthworms at Day 28 could not be estimated because there was no dose-response relationship. The NOEC for the mean bodyweight at Day 28 was 1000 mg a.i./kg dry soil.

The coefficient of variation of the number of juveniles in the solvent control group was 5.64%.

No statistically significant differences in the number of juveniles were recorded on Day 56 between the test item treatment groups and the solvent control. The 5 mg a.i./kg dry soil carbendazim treated group had significantly fewer juveniles than the water control group.

The EC50for the number of juveniles on Day 56 could not be estimated because there was no dose-response relationship. The NOEC for the number of juvenile worms on Day 56 was 1000 mg a.i./kg dry soil.

Statistical analysis was not carried out on cocoons as only one unemerged cocoon was found.

The study was considered valid as mortality in the negative (water) and solvent control groups was ≤ 10% adult at four weeks and ≥30 juveniles had been produced in each water and solvent control replicate by the end of the test. The coefficients of variation of reproduction in the the controls was ≤ 30%. In addition, treatment with carbendazim at 5 mg a.i./kg dry soil resulted insubstantial and unequivocal toxic effects.

Description of key information

An OECD Guideline 222 study the NOEC for mortality and body weight on Day 28 was 1000 mg a.i./kg dry soil.  The NOEC for the number of juvenile worms on Day 56 was 1000 mg a.i./kg dry soil.

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for soil macroorganisms:
1 000 mg/kg soil dw

Additional information