Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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: short-term
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test was conducted by keeping the earthworms in samples of a precisely defined artificial soil to which a range of concentrations of the test substance was applied. Mortality was assessed 7 and 14 days after application.
GLP compliance:
yes
Specific details on test material used for the study:
- Substance ID: TSN 100010
- Name of substance: XDE-795 Fungicide
- Purity: 99.19%
Analytical monitoring:
yes
Details on sampling:
- Sampling method: The test substance was extracted from soil by combining a 10 g subsample of soil and 10 ml acetonitrile in a glass vial and sonicating the vial for approximately 10 minutes. The supernatant was removed from the vial, and the procedure was repeated twice more with 5 ml volumes of acetonitrile. The supernatants were combined and approximately 2 ml was filtered through a 0.45 micron filter into an HPLC vial.
- Sample storage conditions before analysis: Refrigerated
Vehicle:
yes
Remarks:
dilution water
Details on preparation and application of test substrate:
- Method of mixing into soil: Appropriate amounts of test substance were added to dry soil in each test vessel and thoroughly mixed. Deionized water was then added to each vessel to achieve a final moisture content of approximately 30% and the media was mixed.
- Controls: Untreated soil
- Chemical name of vehicle: Dilution water
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Earthworm
- Source: Carolina Biological Supply Company, Burlington, North Carolina

ACCLIMATION
- Acclimation period: 96 hours
- Health during acclimation: During acclimation worms were not treated for disease and they were free of apparent sickness, injuries, and abnormalities at the beginning of the test
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
14 d
Test temperature:
20 ± 2°C
Moisture:
Approximately 30%
Details on test conditions:
TEST SYSTEM
- Test container (material, size): 3.78 liter glass jars with ventilated caps
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4

PROPERTIES OF SUBSTRATE
- Soil was formulated by combining industrial sand, kaolin clay, and finely ground sphagnum peat in a 70:20:10 ratio by weight. At the beginning of the test the soil had a moisture content of 34.7% and a pH of 5.8. At the end of the test the soil moisture was 34.4%.

OTHER TEST CONDITIONS
- Photoperiod: 24 hour light and 0 hour dark
- Light intensity: 520 lux

EFFECT PARAMETERS MEASURED: The number of surviving organisms and the occurrence of sublethal effects were determined visually and recorded initially and after 7 and 14 days. The time required to burrow was recorded after 0 and 7 days, and the average wet weight of surviving worms was determined at the beginning of the test and after 14 days. Soil temperature was measured and recorded daily in each test vessel and the temperature in one test vessel was recorded continuously during the test.

TEST CONCENTRATIONS
Range finding study
- Test concentrations: 0, 10, 100, 500, and 1000 mg/kg
- Results used to determine the conditions for the definitive study: After 14 days there was at least 90% survival at 0, 10, and 100 mg/kg, 80% survival at 500 mg/kg, and 20% survival at 1000 mg/kg
Nominal and measured concentrations:
Nominal concentrations: 150, 250, 400, 600, 1000 mg/kg
Measured concentrations: 117, 233, 402, 619, 923 mg/kg
Reference substance (positive control):
no
Key result
Duration:
7 d
Dose descriptor:
LC50
Effect conc.:
> 923 other: mg/kg
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: highest concentration tested
Key result
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
> 923 other: mg/kg
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: highest concentration tested
Key result
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
923 other: mg/kg
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: highest concentration tested
Validity criteria fulfilled:
yes
Conclusions:
7 and 14 day LC50 (earthworms): >923 mg/kg (highest concentration tested)
14 day NOEC (earthworms): 923 mg/kg (highest concentration tested)
Executive summary:

The acute toxicity of the test substance to the earthworm was perfomed with five concentrations of the test substance and a control at a temperature of 20 ± 2°C. The test media was artificial soil comprised of 70% sand, 20% kaolin clay, and 10% finely ground sphagnum peat moss. Test substance was added to dry artificial soil in the test vessel and thoroughly mixed. Deionized water was then added to each vessel to achieve a final moisture content of approximately 30% and the media was mixed.

The test vessels were 3.87 liter glass jars capped with a ventilated closure. Forty worms (10 per replicate) were exposed to the following nominal concentrations: 0 (control), 150, 250, 400, 600, and 1000 mg/kg. Measured soil concentrations were analytically determined on day 0, 7, and 14. Mean measured concentrations were: ND (none detected at or below the analytical detection limit of 10 mg/kg; control), 117, 233, 402, 619, and 923 mg/kg. Measured concentrations were used for all calculations. Temperature was within acceptable limits throughout the test.

Exposure of worms to the test substance resulted in 7- and 14-day median lethal concentrations (LC50) greater than 923 mg/kg (the highest tested concentration). The 14 day no observed effect concentration (NOEC) in this test was 923 mg/kg.

Description of key information

14-day LC50 (Eisenia fetida): > 923 mg/kg (the highest concentration tested); no guideline followed; Reliability = 2

14-day NOEC (Eisenia fetida): 923 mg/kg (the highest concentration tested); no guideline followed; Reliability = 2

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:
923 mg/kg soil dw

Additional information