Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-07-25 to 2007-01-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
adopted 1992-07-17
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
Official Journal No. L 383 A, 29 December 1992
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Content: 99.0 %

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L (Limit concentration)
- Sampling method: Samples were taken at 0 (start) and 96 h (end) of the experiment
- Sample storage conditions before analysis: Samples were directly analyzed after sampling

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item (reconstituted water and test item) was freshly prepared. The test item was weighed into a calibrated flask and filled with reconstituted water. After stirring of 10 minutes, the test item was completely dissolved and the flask filled to the mark with reconstituted water.
- Controls: reconstituted water
- Concentration of the test item in the test medium: 100 mg/L

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: The fish were breeded at the test facility
- Length at study initiation: 2.0 +/- 1.0 cm
- Weight at study initiation: 7.3 to 8.6 g per group (10 fish)

ACCLIMATION
- Acclimation period: > 14 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: TetraMin diet, daphnia, artemia
- Feeding frequency during acclimation: daily
- Health during acclimation (any mortality observed): no mortality observed (<5%)

FEEDING DURING TEST
Fish were not fed during the study.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
~15° dH
Test temperature:
Temperature was between 25 to 26°C
pH:
pH values were within the range of 7.84 - 7.97
Dissolved oxygen:
Dissolved oxygen was within 74.8 - 96.4% oxygen saturation
Nominal and measured concentrations:
The test item concentration in the test medium of nominal 100 mg/L was analyzed at the start and the end of the 96 hour exposure period. The mean analytical concentration was 102.6 and 95.9 mg/L at 0 and 96 hours, respectively and, thus, confirmed the correct preparation of the test medium.
Details on test conditions:
TEST SYSTEM
- Test vessel: all-glass 10-L aquarium per group
- Type: open
- Material, size, headspace, fill volume: approx. 9 L per aquarium
- Aeration:
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 h light - 12 h dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality, behavior and general condition of all fish (control and test group) were checked immediately after start of exposure and daily thereafter.

TEST CONCENTRATIONS
- Range finding study : In a pretest with 4 fish, no mortality was observed at the limit dose of 100 mg/L
- Test concentrations: 100 mg/L

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: No adverse effects observed
- Observations on body length and weight: No adverse effects observed
- Other biological observations:No adverse effects observed
- Mortality of control: no mortality observed
- Other adverse effects control: No adverse effects observed
- Abnormal responses: No adverse effects observed
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
Results with reference substance (positive control):
not applicable

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
OECD 203 validity criteria fulfilled
Conclusions:
An aqueous solution of the test material with a nominal and analytical concentration of 100 mg/L, revealed no aquatic toxicity in the test system. The 96 hours LC50 to Danio rerio was > 100 mg/L (limit test) and, thus, could not be determined in this test.
Executive summary:

The objective of this study was to determine the acute toxicity to fish of the test material using zebra fish, Danio rerio. For this purpose, 10 fish in a test material group and further 10 fish in a control group were exposed over 96 hours, under defined conditions in a limit test. The fish were observed for signs of toxicity or death. Zebra fish were exposed to an aqueous test material solution of nominal 100 mg/L (limit-test) in an open static system.

Zebra fish exposed to an aqueous solution, with a nominal concentration of 100 mg of the test item per liter, were not affected. At the start, the analytically determined concentration was about 103 % of the nominal concentration. At the end of the experimental part, the analytically determined test material concentration was 96 % of the nominal concentration. Thus the test material concentration could be maintained at > 80 % of the initial concentration and the nominal value was regarded as equivalent to the analytical value. For the test material, the following nominal and analytical LC50 values for zebra fish were determined:

24 h LC50 >100mg/L

48 h LC50 >100mg/L

72 h LC50 >100mg/L

96 h LC50 >100mg/L

An aqueous solution of the test material with a concentration of 100 mg/L revealed no aquatic toxicity in the test system. The 96 hours LC50 to Dania rerio was > 100 mg/L (limit test) and, thus, could not be determined in this test.