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Ecotoxicological information

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:
Apr 14, 2014 - Jun 29, 2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
no OECD GLP
Justification for type of information:
The study was performed for a registration in a non-EU country.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Remarks:
Guidelines of Good Laborato,y Practices on Chemical Testing (HJIT 155-2004, MEP, China)
Analytical monitoring:
yes
Details on sampling:
The concentrations oftest solutions were measured at the start and end of the exposure, before and after each renewal. 100 mL sample was taken from treated groups and injected to analyze concentration after pretreatment.
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Preparation: 0.0115 g of test substance were weighed and dissolved into the breeding water with at a volume of 11.5 L resulting in a turbid liquid of 1 mg/L (nominal concentration). The mixture was
stirred for about 48h without filtering and centrifugating. Then the non-dissolved test substance appears on the surface of test solution following a period of 24 hours settling were separated to prepare the test
solution.

- Preparation frequency: Every 24 hours.
- Storage: Test solutions were prepared just before use.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Source: Suzhou Weimei Aquarium


ACCLIMATION
- Acclimation period: Feeding fry held for 28 days supplied with a continuous flow of aerated water before test. Fish to be used for test was held for 9 days under test conditions.
- Acclimation conditions (same as test or not): yes
- Type and amount of food during acclimation: Fairy shrimp eggs were purchased from Tianjin. The eggs were hatched to larva as the food for fish.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
50 mg/L (CaCO3)
Test temperature:
23.6-24.6 °C
pH:
7.31 - 7.72
Dissolved oxygen:
67.2~ 103.0 %
Nominal and measured concentrations:
1 mg/L (nominal) = 0.0483 mg/L (measured)

The test solutions were prepared in fish breeding water as follows then analyzed via GC. The
recovery of RELJ~RELS were in the range of 86.67%~103.33%, and RSD=6.70%; the recovery of
REH I ~REHS were in the range of 103.80%~ I 09.82%, and RSD=2.38%. The results met the criteria for
recovery, i.e., between 80%~ 110% of nominal concentration with RSD less than 20%.
Details on test conditions:
TEST SYSTEM
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.178 g fish/L

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

OTHER TEST CONDITIONS
- Photoperiod: 14 h light/10 h dark


EFFECT PARAMETERS MEASURED:
mortality, inactivity, abnormal swimming pattern, other abnormal behaviour recorded at 3, 6, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1 mg/L (nominal)
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 mg/L
Nominal / measured:
nominal
Conc. based on:
other: accomodated fraction (WAF)
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 0.048 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mortality (fish)
Remarks on result:
other: value based on measured concentration
Results with reference substance (positive control):
24h-LC50: 375.55 mg/L (potassium dichromate)
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the test item to Zebra fish (Brachydanio rerio) was determined in a study according to OECD GL 203. In this study no toxic effects were observed within 96 h. Therefore, the LC50 is determined to be >1 mg/L (nominal) corresponding to 0.0483 mg/L (measured concentration).
Executive summary:

Objective

To evaluate the short-term toxicity effects of the test substance on zebra-fish species with the determination of a 96hr LC50 in a semi-static aquatic system.

Methods

According to the results of the preliminary test, one treatment group with the nominal concentration of 1 mg/L and blank group (fish breeding water) are designed in the definitive test. Each group contained ten fish without replicate. The duration of the test was 96 hours. The test fish were exposed in closed bottles filled with the test solution under the semi-static conditions with test solution renewed every 24 hours. Testing was performed under the conditions of 14 hours photoperiod daily, 23.4~24.6 °C water temperature, pH of 7.3 I~ 7. 72, 67.2%- 103.0% air saturation value of dissolved oxygen concentration and without feeding. The fish were observed at 3, 6, 24, 48, 72 and 96 hours after the start of the exposure. The concentrations of the test substance were measured at the start and end of the exposure, before and after each renewal with GC analysis.

Results

At the end of the test, the cumulative mortalities were 0% and visible abnormalities were not found in the blank group and treated group. The measured concentrations before renewal were without the range of 80%~ 120% of the initial concentration. Therefore, LC50 values were estimated based on the time weighted average (TWA) of measured concentrations. TWA of measured concentration during test period of 96 hours was 0.0483 mg/L in the treated group. The LC50 (96h) value of the test material on Zebrnfish species was greater than 0.0483 mg/L based on measured concentration (TWA).

Conclusion

In this study no toxic effects were observed within 96 h. Therefore, the LC50 is determined to be >1 mg/L (nominal) corresponding to 0.0483 mg/L (measured concentration).

Description of key information

OECD 203: In this study no toxic effects were observed within 96 h. Therefore, the LC50 is determined to be >1 mg/L (nominal) corresponding to 0.0483 mg/L (measured concentration).

Key value for chemical safety assessment

Additional information