Registration Dossier

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1990-02-14 to 1990-06-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)
Principles of method if other than guideline:
Toxizitaetstest fuer Regenwuermer nach 88/302 EWG
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Marlotherm S
- Substance type: pure active substance
- Physical state: yellow liquid
- Lot/batch No.: 200 l barrel from August 21, 1991
- Stability under test conditions: unlimited
- Storage condition of test material: no data
Specific details on test material used for the study:
The purity of the material used for the test was lower than the purity of the actual material. It contained ca. 26% of isomers of dimethyl tribenzenes. However, based on comparable basic structure of the impurities and the assumption that any toxic effects would increase with higher molecular weight and lipophilicity, we regard that the studies conducted with the lower purity material being "worst case" and can be used for the evaluation of the actual product.

Sampling and analysis

Analytical monitoring:
no

Test substrate

Vehicle:
no
Details on preparation and application of test substrate:
- Method of mixing into soil: The test substance was mixed with silica sand and afterwards added to soil substrate in a plastic bag. Water was added to a theoretical water content of approx. 40% and the substrate was thoroughly mixed.

Test organisms

Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: earthworm
- Source: Eisenia GmbH&Co. Produktions- und Vertrieb KG, Kapellenstraße 25, Wiesbaden, Germany
- Age at test initiation: at least 2 months
- Weight at test initiation: 300-432 mg

ACCLIMATION
- Acclimation period: not mentioned

Study design

Study type:
laboratory study
Substrate type:
other: mixture of peat and horse dung (1:1)
Limit test:
yes
Total exposure duration:
14 d
Post exposure observation period:
no

Test conditions

Test temperature:
not mentioned
pH:
7.4
Moisture:
42.9 - 45.6 %
Details on test conditions:
TEST SYSTEM
- Test container (material, size): Makrolon cages with perforated plexiglass covers, size not mentioned
- Amount of soil or substrate: not mentioned
- 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: not applicable

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): mixture of peat and horse dung (1:1)
- Organic carbon (%): not mentioned
- Maximum water holding capacity (in % dry weigth): not mentioned
- CEC: not mentioned
- Pretreatment of soil: not mentioned
- Storage (condition, duration): fresh prepared
- Stability and homogeneity of test material in the medium: not mentioned

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Range finding study: not performed
Nominal and measured concentrations:
nominal concentration, not measured: 300 / 550 / 1000 mg/kg dry soil
Reference substance (positive control):
yes
Remarks:
chloracetamide, historical data

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
7 d
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
850 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: 0/40 (0%) all concentrations after 7 days; 300 mg/kg: 0/40 (0%), 550 mg/kg 3/40 (7.5%), 1000 mg/kg 29/40 (72.5%) after 14 days
- Total mass of adults at beginning of test: 300 mg/kg = 324 mg; 550 mg/kg = 321 mg; 1000 mg/kg = 320 mg (mean)
- Changes in body weigth of live adults (% of initial weight) at end of exposure period: not mentioned
- No. of offspring produced: not mentioned
- No. of unhatched cocoons: not mentioned
- Morphological abnormalities: not mentioned
- Behavioural abnormalities: not mentioned
- Other biological observations: not mentioned
Results with reference substance (positive control):
RESULTS: TEST WITH REFERENCE SUBSTANCE (historical data, 1990-05-11)
- Concentrations: 0, 10, 30 and 100 mg 2-chloroacetamide/kg dry soil
- Results (mortality):
after 7 days: 0 mg/kg: 0/20 (0%); 10 mg/kg: 0/20 (0%) after 7 days; 30 mg/kg: 0/20 (0%) 100 mg/kg: 0/20 (100%)
after 14 days: 0 mg/kg: 1/20 (5); 10 mg/kg: 2/20 (10%) after 7 days; 30 mg/kg: 0/20 (0%) 100 mg/kg: 0/20 (100%)
Reported statistics and error estimates:
no statistics performed

Any other information on results incl. tables

RESULTS: EXPOSED

- Nominal concentrations: 300 / 550 / 1000 mg/kg dry soil

- Effect data (Mortality): 0 / 0 / 0% after 7 days; 0 / 7.5 / 72.5% after 14 days

RESULTS: CONTROL

- Effect data (Mortality): 0/40 (0%) after 7 and 14 days

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
LC 50 (14d) = 850 mg/kg dry soil.
Executive summary:

The acute toxicity of Marlotherm S to the earthworm eisenia foetida was determined during a 14 day exposure period according to EEC Methods for Determination of Ecotoxicity, Directive 88/302/EEC. Three concentrations 300, 550 and 1000 mg/kg dry soil, the test substance was mixed with silica sand and afterwards added to soil substrate. After 7 and 14 days the effects of the test substance on the earthworms' survival were examined. The 7 day LC 50 is > 1000 mg/kg.

The 14 day LC50 of Marlotherm S to Eisenia foetida was observed to be 850 mg/kg dry soil.