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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsors identification: ARAKAWA KE-604
Description: pale yellow blocks
Batch No.: R61132
Purity: no data

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
Preliminary solutions were prepared n dimethylformamide at a concentration of 100mg/10 ml solvent. An aliquot of this solution was then dispersed in reconstituted water to yield a 1 mg/l test concentration.

- Chemical name of vehicle: dimethylformamide
- Concentration of vehicle in test medium (stock solution and final test solution): Preliminary solutions were prepared at 100mg/10 ml solvent. An aliquot of this solution was then dispersed in reconstituted water to yield a 1 mg/l test concentration. The test concentralion of 1 .0 mg/I was the highest attainable test concentration due to the Iimited solubility of the test material in water and auxiliary solvent.
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 100 mg of the test material was dissolved in dimethylformamide and the volume was adjusted to 10 ml to give a 100 mg/10 ml solvent stock solution. An aliquot (500 µ1) of the solvent stock solution was dispersed in reconstituted water and the volume adjusted to 5 litres to give the 1.0 mg/l test concentration.

- Controls: duplicates negative controls, maintained under idential conditions but not exposed to the test material. Duplicate solvent controls were exposed to 100 mg/l of dimethylformamide.
- Chemical name of vehicle: dimethylformamide

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain: Daphnia Magna STRAUS
- Source: Institut National de Recherche Chimique Applique (IRCHA), France.
- Age at study initiation: <24h (1st instar)
- Method of breeding: Adult Daphnia were maintained in polypropylene vessels containing approximately 2 litres of reconstituted water in a temperature controlled room at 21 °C. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods. Each culture was fed daily with a suspension of mixed algae (predominantly Chlorella spp). Culture conditions ensured that reproduction was by parthenogenesis. Gravid adults were isolated 24 hours prior to the initiation of the test, the young daphnids produced overnight were then removed for testing. The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study.
- Feeding during test: no food received during exposure

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Remarks on exposure duration:
h

Test conditions

Hardness:
ca. 250 mg CaCO3 /l
Test temperature:
21°C
pH:
7.9 - 8.0
Dissolved oxygen:
7.9 - 8.2 mg O2 /l
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type : closed, 250 ml glass jars
- Material, fill volume: 250 ml glass jars, containing 200 ml of test water, covered with glass lids during the test
- Aeration: no
- Type of test: static
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Intervals of water quality measurement: Water temperature was recorded daily throughout the study.
- Adjustment of pH: no
- Photoperiod: 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: Based on the results of the range-finding study a “Limit test" was conducted for the definitive study at a test concentration of 1.0 mg/l to confirm that at the highest attainable test concentration of 1.0 mg/l, no immobilisation or adverse reactions to exposure were observed.


- Range finding study
- Test concentrations: 1.0 mg/l
- Results used to determine the conditions for the definitive study: 1.0 mg/l
Reference substance (positive control):
yes
Remarks:
100µl/l of Dimethylformamide

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility

Any other information on results incl. tables

The results of the 48 h EC50 for Arakawa KE 604 to Daphnia magna based on the nominal test concentration was greater than 1 mg/l, therefore no toxicity was observed within the range of water solubility. Hence the No Observed Effect concentration is also equal to 1 mg/l.

The test concentration of 1 mg/l was the highest attainable test concentration due to the limited water solubility of the test material in water and the auxiliary solvent, having due regard for the amount of auxiliary solvent permitted in the test under OECD Guidelines.

The results are based on the nominal concentrations as the chemical analysis carried out at 0 h and 48 h on the test solutions showed that all measured concentrations were in excess of the required 80 % of the nominal test concentrations.No immobilisation of daphnia were recorded during the study.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes