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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-04-14 to 2006-04-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
other: "Method concerning tests relating to new chemical substances"
Version / remarks:
No.1121002 by the Pharmaceutical and Food Safety Bureau, 2003; No.2 by the Manufacturing Bureau directive, 2003; No. 021121002 Environmental Protection Agency Planning Directive
Principles of method if other than guideline:
method similar to OECD203 performed under GLP; with analytical verification of test substance
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: The freshly prepared test solutions at test start and water renewal and the old solutions at water renewal were sampled for analysis.
- Sampling method: The analytical samples were collected 10 mL each with graduation of the test tube in the glass-stoppered 10mL capacity test tubes from the middle layer of the test liquid in the test container using 10 mL capacity Komagome pipettes.
- Sample storage conditions before analysis: Samples were stored at 4 °C until analysis.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 500 mg of test substance were added to dilution water and the mixture was placed in an ultrasonic bath at 24 °C for 10 min. Afterwards, the volume was adjusted to 5 L.

Test organisms

Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Source: In-house rearing within the institute of environmental ecology
- Age at study initiation (mean and range, SD): 6 months
- Length at study initiation (length definition, mean, range and SD): 2.9 cm (2.7 to 3.0 cm)
- Weight at study initiation (mean and range, SD): 0.23 g (0.20 to 0.26 g)
- Feeding during test: None

ACCLIMATION
- Acclimation period: 7 days in a flow water system, 24 h at the same conditions as the test
- Type and amount of food: Tetramine, ca. 2% of fish bodyweight/day

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Remarks on exposure duration:
prolongation to 120 h

Test conditions

Hardness:
59 mg/L as CaCO3
Test temperature:
23.7 - 24.1° C (control group), 23.5 - 24.8° C (concentration groups)
pH:
7.5 - 7.9 (control group), 6.1 - 6.8 (concentration groups)
Dissolved oxygen:
7.0 - 8.5 mg/L (control group), 7.1 - 8.8 mg/L (concentration groups)
Nominal and measured concentrations:
Nominal: control, 100 mg/L
Measured: 102.4 mg/L (geometric mean)
Details on test conditions:
TEST SYSTEM
- Test vessel: Container
- Type (delete if not applicable): covered with glass
- Material, size, fill volume: Glass, 12 L, 5 L
- Aeration: None
- Renewal rate of test solution (frequency/flow rate): Test water was renewed every 24 h.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water
- Intervals of water quality measurement: Temperature, oxygen and pH were measured every 24 h.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/8 h dark
- Light intensity: White fluorescent lamp

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Abnormalities or mortalities were recorded after 3, 6, 24, 48, 72 and 96 h.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No mortality was observed. Therefore, a limit test with a test substance concentration of 100 mg/L has been conducted in the main study.
Reference substance (positive control):
yes
Remarks:
copper sulfate (II) pentahydrate

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 102.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
120 h
Dose descriptor:
LC50
Effect conc.:
> 102.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
No toxicity symptoms were observed during th exposure duration period (120 h).
- Mortality of control: None
- Other adverse effects control: None
- Analytics: The measured test substance concentration in the freshly prepared media ranged from 100.8 to 103.9% of nominal values. In the old media, the measured concentration was 102.2 to 102.8% of nominal values.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- LC50 (96h): 0.26 mg/L (95% CL: 0.18 - 0.37 mg/L)
- Date of experiment: 26 Nov - 30 Nov 2005

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The LC50 for the test substance was > 102.4 mg/L after 96 h under the conditions reported.