Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03.09.2003 - 04.12.2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
No surrogate or analogue material was used.

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
at start and end of study(0 and 96h)

Test solutions

Vehicle:
no
Details on test solutions:
The diluting water was drinking water.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Danio rerio
- Strain: Hamilton-Buchanan
- Source: weiler's Pet's best (Turmstr. 6, 67433 Neustadt, Germany)
- Age at study initiation (mean and range, SD): sexually immatire young fish
- Length at study initiation (length definition, mean, range and SD): 2 +/- 1 cm
- Weight at study initiation (mean and range, SD): no information
- Method of breeding: none
- Maintenance of the brood fish: not applicable

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: -2% body weight per day
- Feeding frequency during acclimation: 3 times/day
- Health during acclimation (any mortality observed): no information available

QUARANTINE (wild caught): not applicable

FEEDING DURING TEST
- Food type: none
- Amount: not applicable
- Frequency: not applicable

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
not apllicable

Test conditions

Hardness:
not information available
Test temperature:
23 +/- 1 °C
pH:
6.7 - 8.6 (no adjustment)
Dissolved oxygen:
7.9 - 9.2 mg/L
Salinity:
Test was performed in freshwater.
Nominal and measured concentrations:
nominal = measured concentration: 1000 mg/L (limit test)
Details on test conditions:
TEST SYSTEM
- Test vessel: glass aquaria
- Type (delete if not applicable): no information available
- Material, size, headspace, fill volume: max. 10 L
- Aeration: yes (with glass tubes; 1 bubble/sec)
- Type of flow-through (e.g. peristaltic or proportional diluter): not applicable
- Renewal rate of test solution (frequency/flow rate): not applicable
- No. of organisms per vessel: 7 (main test); 3 (pre-test)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: not applicable

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12/12
- Light intensity: no information available

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and abnomal behaviour

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable
- Justification for using less concentrations than requested by guideline: Limit test sufficient based on pre-test results
- Range finding study: pre-test
- Test concentrations: 1000 mg/L
- Results used to determine the conditions for the definitive study:
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: none
- Observations on body length and weight: none
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
not applicable
Reported statistics and error estimates:
not applicable as a limit test was performed

Any other information on results incl. tables

Purpose

The purpose of this assay was to identify the aquatic toxicity potential of the test material in fish.

Study design

For this purpose, young fish were exposed to an aqueous test material preparation over 96 hours. The GLP study was performed as a limit test according to OECD TG 203.

Results

No mortality or any other effect was observed.

The following values for fish were determined:

96 h EC50 > 1000 mg/L 

NOEC = 1000 mg/L

Conclusions

Under the given experimental conditions, the 96 hours EC50 to fish was > 1000 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

In a GLP study performed as a limit test according to OECD TG 203, the 96 hours EC50 to fish was > 1000 mg/L.