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Ecotoxicological information

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:
2015-10-09 - 2015-12-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted to the appropriate OECD Test Guideline
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:
Details on properties of test surrogate or analogue material (migrated information):
not applicable
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Earthworm
- Source: Breeding stock culture maintained at the test facility
- Age at test initiation (mean and range, SD): 10 adult earthworms (with clitellum) aged 2-12 months were used per replicate
- Weight at test initiation (mean and range, SD): individual body weight between 0.36 and 0.53 g at the start of exposure

ACCLIMATION
- Acclimation period: Earthworms were adapted to untreated artificial soil two days prior to the test start.
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
8 wk
Test temperature:
20 +/-2 °C
pH:
6.0 +/-0.5
Moisture:
The humidity of the artificial soil was adjusted to a moisture of 54 % of the WHCmax (WHCmax = 53.3 g/100g dw).
Details on test conditions:
Test units containing about 600 g SDW were round plastic boxes with an inner diameter of 15.0 cm, corresponding to a bottom surface area of 177 cm2, and a height of 14 cm. Transparent and perforated lids enabled sufficient gas exchange, light input and prevented the test substrate from drying.

8 control replicates and 4 replicates per test item concentration
10 adult earthworms/replicate

Photoperiod: 16 h
Light intensity: 400 - 800 lx

The artificial soil consisted of the following components:
- 10 % peat, air-dried and finely ground
- 20 % kaolin, kaolinite content > 30 %
- 69 % air-dried quartz sand (sand with > 50 % particle size of 0.05 - 0.2 mm)
- 0.39 % calcium carbonate (CaCO3)

To ensure homogeneity before weighing, the test item was heated in a water bath (45 °C) for about one hour. The respective test item amount for each concentration was weighed out, dissolved in demineralised water (200 mL) and added to the artificial soil (2400 g DW). Additional demineralised water (155 mL) was added to adjust the humidity of the artificial soil to a moisture of 54 % of the WHCmax. Subsequently, the test medium was mixed thoroughly to ensure a homogenous distribution, and a soil amount corresponding to about 600 g DW was filled into each test vessel.


TEST SYSTEM
- Test container (material, size):
- Amount of soil or substrate:
- No. of organisms per container (treatment):
- No. of replicates per treatment group:
- No. of replicates per control:
- No. of replicates per vehicle control:

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographic location:
- Pesticide use history at the collection site:
- Collection procedures:
- Sampling depth (cm):
- Soil texture (if natural soil)
- % sand:
- % silt:
- % clay:
- Soil taxonomic classification:
- Soil classification system:
- Composition (if artificial substrate):
- Organic carbon (%):
- Maximum water holding capacity (in % dry weigth):
- CEC:
- Pretreatment of soil:
- Storage (condition, duration):
- Stability and homogeneity of test material in the medium:

OTHER TEST CONDITIONS
- Photoperiod:
- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

VEHICLE CONTROL PERFORMED: yes/no

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Key result
Duration:
56 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 280 mg/kg soil dw
Basis for effect:
other: mortality, growth and reproduction
Duration:
56 d
Dose descriptor:
LOEC
Effect conc.:
> 1 280 mg/kg soil dw
Basis for effect:
other: mortality, growth and reproduction

Summary of All Observed Effects in the Tested Application Rates after 56 days

 mg test item/kg SDW  80  160  320  640  1280
 Mortality of adult earthworms    No   No     No    No    No
 Body weight gain    No    No    No    No    No
 Reproduction rate    No    No   No     No    No
 Summary of all effects    No    No    No    No    No
Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of this study, POLYOL PX did not induce mortality, pathological symptoms or changes of the behaviour of adult earthworms after 28 days of exposure in any tested concentration. The adult earthworm biomass increased in the control and in all test item concentrations with no statistically significant difference in any treatment. After a further four weeks of exposure, the number of juvenile earthworms was not statistically significantly different in any test item concentration compared to the untreated control.

Thus, the No Observed Effect Concentration (NOEC) of POLYOL PX summarizing the endpoints mortality, growth and reproduction of Eisenia fetida after eight weeks of exposure in artificial soil was determined to be ≥ 1280 mg test item/SDW.
Executive summary:

Under the conditions of this study, POLYOL PX did not induce mortality, pathological symptoms or changes of the behaviour of adult earthworms after 28 days of exposure in any tested concentration. The adult earthworm biomass increased in the control and in all test item concentrations with no statistically significant difference in any treatment. After a further four weeks of exposure, the number of juvenile earthworms was not statistically significantly different in any test item concentration compared to the untreated control.

Thus, the No Observed Effect Concentration (NOEC) of POLYOL PX summarizing the endpoints mortality, growth and reproduction of Eisenia fetida after eight weeks of exposure in artificial soil was determined to be ≥ 1280 mg test item/SDW.

Description of key information

A reliable study (Klimisch 1)) is available. POLYOL PX did not induce mortality, pathological symptoms or changes of the behaviour of adult earthworms (Eisenia fetida) after 28 days of exposure in any tested concentration. The adult earthworm biomass increased in the control and in all test item concentrations with no statistically significant difference in any treatment. After a further four weeks of exposure, the number of juvenile earthworms was not statistically significantly different in any test item concentration compared to the untreated control.

Thus, the No Observed Effect Concentration (NOEC) of POLYOL PX summarizing the endpoints mortality, growth and reproduction of Eisenia fetida after eight weeks of exposure in artificial soil was determined to be ≥ 1280 mg test item/ soil dry weight

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for soil macroorganisms:
1 280 mg/kg soil dw

Additional information