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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
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Name of test material: Irgalube 211
- Source and lot/batch number of test material: 0018757720
- Expiration date of the lot/batch: 13 Feb 2021
- Purity: 100% UVCB

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage: at room temperature
- Stability under storage conditions: guaranteed by the sponsor
Analytical monitoring:
no
Vehicle:
yes
Details on preparation and application of test substrate:
The test substance is liquid and poorly soluble in water. Therefore, the test
substance was dissolved in acetone for application. Aliquots of the stock solution with
required amounts of test substance for each scheduled test concentration were carefully
mixed with quartz sand portions. The organic solvent was removed by evaporation and
subsequently blended with prepared test substrate. Thereafter, the water content of the soil was adjusted to about 50% WHCmax using deionized water and was mixed once again. The test mixtures were distributed to the test units.
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
Only adult worms (with clitellum) with a fresh weight between 300 and 600 mg were used.
The worms that were introduced into the test were bred in horse manure and had an age
from about 12 months.

Acclimatization:
Before starting the test, the worms selected were acclimatized in the test substrate in a
plastic box under test conditions through overnight under permanent light and without
feeding. For this, a plastic box was filled up with approx. 750.1 g test substrate (Dw) and
added with a sufficient number of adult worms that were sorted out from the breeding
boxes.
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
56 d
Test temperature:
20.3 °C – 21.3 °C
pH:
6.3 - 6.4 at start
6.7 - 6.8 at end of exposure
Moisture:
47.6 - 48.5 % WHCmax at start
50.7 - 58.9 % WHCmax at end of exposure
Details on test conditions:
TEST SYSTEM
- Test container (material, size): Bellaplast 1 L plastic containers were used as test vessels. The containers consist of inert and non-toxic plastic. The test vessels have a bottom area of 11 cm × 15.5 cm and a height of 6 cm and were covered with perforated transparent lids.
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- No. of replicates per vehicle control: 8

OTHER TEST CONDITIONS
- Photoperiod: 16h light: 8h dark

EFFECT PARAMETERS MEASURED: Reproduction was measured 56 days after application) and mortality and the body weight development of the parent animals were measured after 28 days after application.

VEHICLE CONTROL PERFORMED: yes
Nominal and measured concentrations:
0 (control), 0 (solvent control), 62.5, 125, 250, 500 and 1000 mg/kg Dw as nominal concentrations.
Reference substance (positive control):
yes
Remarks:
BAS 346 F (Carbendazim) was tested as reference substance in order to show the sensitivity of the test system.
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil ww
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
56 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil ww
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
No mortality occurred in the controls or any treatment.
Results with reference substance (positive control):
The reference substance BAS 346 F (Carbendazim) was tested by a non-GLP project
68E0902/00G027 (start of exposure 15 April 2019).
ECx values [mg/kg soil (dw)], reproduction by counting juvenile worms, conf. limits 95%
EC10: 0.56 LCL: 0.45 UCL: 0.71
EC50: 1.03 LCL: 0.91 UCL: 1.16
These observed effects show a high sensitivity of the test system and the derived EC50
value for reproduction toxicity by counting the number of juvenile worms is within the
expected range from the test guideline (1-5 mg/kg carbendazim/kg soil (dw)) and hence
acceptable sensitivity of the test system is assured.
Validity criteria fulfilled:
yes
Conclusions:
The test substance is not harmful to terrestrial macroorganisms.

Description of key information

NOEC(56h) >= 1000 mg/kg soil dw for reprodution of Eisenia fetida (OECD 222)

Key value for chemical safety assessment

Additional information

One study is available investigating the long-term toxicity of the test substance to terrestrial macroorganisms. The study was performed accoring to GLP and OECD guideline 222 using Eisenia fetida as test organism (BASF 2020). Concentrations between 62.5 and 1000 mg/kg soil dw were tested in artificial soil. Aceton was used as vehicle. No mortality occurred in the controls and any treatment throughout the test. No inhibition of reproduction was observed. Thus, the 56h-NOEC value is determined to be >= 1000 mg/kg soil dw based on nominal concentrations.

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