Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
toxicity to terrestrial arthropods: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
yes
Details on preparation and application of test substrate:
- Method of mixing into soil (if used): For preparation of the test assays of the control, the amount of about 2500 g dry test substrate (depend on the water content of the dry test substrate) was added to a bowl. The quartz sand aliquot, treated only with acetone was added after evaporation of the solvent and thoroughly mixed with the test substrate. Than the calculated volume of deionized water was added to the test substrate, respectively and mixed well again. Four portions of 750 g of wet substrate were distributed to preserving jars.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Acetone
- Evaporation of vehicle before use: yes
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Earthworm
- Source: ECT GmbH, Germany
- Age at test initiation: approx. 6 months
- Weight at test initiation: 336 mg – 415 mg (calculated values from the mean values of replicates) and a clear visible clitellum were used for the test

ACCLIMATION
- Acclimation period: Stored in test substrate at test conditions over night before start of exposure
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
14 d
Test temperature:
20 ± 2°C
pH:
pH value of the dry test substrate: 6.3 mean value of 2 single values (6.3 and 6.3, rounded to 2 significant digits)
Moisture:
Calculated water content of the test substrate at start of exposure: 30 % of dry weight
Water content of the test substrate at the end of the exposure period: 29.9 % of dry weight (single measurement)
Details on test conditions:
TEST SYSTEM
- Test container: Preserving jars, volume 1 L, covered with glass lids
- Amount of soil or substrate: 750 g ± 1 g artificial soil (wet weight)
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4 test vessels per concentration
- No. of replicates per control: 4

OTHER TEST CONDITIONS
- Photoperiod: Continuously, over the exposure period
- Light intensity: 546 Lux, mean value of 5 single values (717, 514, 483, 521, 494 [Lux]) at the start of exposure

EFFECT PARAMETERS MEASURED: Mortality

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
Nominal and measured concentrations:
Nominal concentration: 0 (control), 62.5, 125, 250, 500, 1000 mg/kg soil dry weight
Reference substance (positive control):
yes
Remarks:
2-Chloroacetamide
Duration:
14 d
Dose descriptor:
LC10
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
14 d
Dose descriptor:
LC100
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality at end of exposure period: 5% mortality at the highest test concentration of 1000 mg/kg dw.
- Any other observations: No abnormal behaviour or toxic symptoms of the worms were observed in the test substance groups or control group during the exposure.
Results with reference substance (positive control):
- Results with reference substance: The LC50 value of the reference substance for the earthworm Eisenia fetida after 14 days was not in the range of 20 mg/kg to 80 mg/kg with a value of 12.6 mg/kg. Although the LC50 is outside of the recommended range of 20-80 mg/kg the test system showed that it was sufficiently sensitive and was suitable to determine the acute toxicity of the test substance.
Validity criteria fulfilled:
yes

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion