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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 05 - November 23, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
The test medium (reconstituted water and test material) was prepared freshly. Therefore, the calibrated flask with test medium was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was stirred with a magnetic stirrer for further 23 hours. Afterwards, the formulation was passed through a membrane filter with a pore size of 0.2 µm. The filtrate was used for the study.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebrafish
- Strain: Dania rerio
- Source: in house
- Length at study initiation: 2.0 ± 1.0 cm
- Weight at study initiation: 7.8 g (test material group), 6.7 g (control group)
- Method of breeding: standard
- Feeding during test: tetra min diet during acclimatization, with daphnia or artemia, or frozen mosquito larva daily

ACCLIMATION
- Acclimation period: more than 14 days
- Acclimation conditions (same as test or not): same
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
250 mg/L CaCO3
Test temperature:
21 -23 °C
pH:
7-8
Dissolved oxygen:
> 60%
Nominal and measured concentrations:
100 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel: 10 L
- Type (delete if not applicable): open
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per vehicle control (replicates): 1

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12/12 hours

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Clinical Examination: daily
(loss of equilibrium, changes in swimming behavior, respiratory function, pigmentation, dead)

TEST CONCENTRATIONS
- Spacing factor for test concentrations: -
- Test concentrations: 100 mg/l
- Results used to determine the conditions for the definitive study: pretest
Reference substance (positive control):
no
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 (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: no
- Observations on body length and weight: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
Validity criteria fulfilled:
yes
Conclusions:
No aquatic toxicity was observed in this test system up to a nominal concentration of 100 mg/L test material. The 96h LC50 and the 96h NOEC were above the water solubility limit and larger than 100 mg/L (nominal).
Executive summary:

The objective of this study was to determine the acute fish toxicity of the test material using zebra fish (Danio rerio). For this purpose, 10 zebra fish were exposed to a nominal test material concentration of 100 mg/L for 96 hours in a limit test, under defined conditions. Additionally, one control group (10 fish) was used. The fish were observed for signs of toxicity or death for 96 hours. The GLP study was performed according to OECD TG 203. Due to the low water solubility of the test material (calculated: < 0.0007 mg/L), a limit test was performed.

During the course of this test no mortality was observed. Further no other signs of toxicity were seen.
No aquatic toxicity was observed in this test system up to a nominal concentration of 100 mg/L test material. The 96h LC50 and the 96 h NOEC were above the water solubility limit and larger than 100 mg/L (nominal).

Description of key information

The information for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 203.

During the course of this test no mortality was observed. Further no other signs of toxicity were seen.
No aquatic toxicity was observed in this test system up to a nominal concentration of 100 mg/L test material. The 96h LC50 and the 96 h NOEC were above the water solubility limit and larger than 100 mg/L (nominal).

Key value for chemical safety assessment

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