Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Sampling and analysis

Analytical monitoring:
no

Test solutions

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

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

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
no

Test conditions

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

Results and discussion

Effect concentrationsopen allclose all
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
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
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

Applicant's summary and conclusion

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).