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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:
January - April 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
other: Ministry of environmental protection of the people's Republic of China, The Guidelines for the Testing of Chemicals-Effects on Biotic System, 203 Fish, Acute Toxicity Test
Version / remarks:
2013
Deviations:
no
Qualifier:
according to
Guideline:
other: GB/T 29763-2013 Chemicals-Rare Minnow (Gobiocypris rarus) acute toxicity test
Version / remarks:
2013
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
For the analysis of the actual test substance concentration, 20 mL of test solution was taken from each test vessel at the beginning, before and after each renewal, and at the end of the test.
Vehicle:
no
Details on test solutions:
Based on the information provided by the sponsor, the test substance is practically insoluble in the water and the purity of the test substance was 86.3%. A nominal concentration of 116 mg/L( the nominal concentration of the active component was 100 mg/L) of the test substance was prepared and stirred at approximately 1100 rpm (via magnetic stirrer) in the dark for 72h followed by filtration using a 0.22 µm nitrocellulose membrane to make a saturated solution of the test substance in the test water.The saturated solution was checked via laser beam (Tyndall effect) for undissolved test item (formation of an emulsion / suspension).
Test organisms (species):
other: Chinese Rare Minnow (Gobiocypris rarus)
Details on test organisms:
TEST ORGANISM
- Common name: Chinese Rare Minnow
- Source: Bioassay and Safety Assessment Lab, Shanghai Academy of Public Measurement (ID: GR-SAPM-180515)
- Age at study initiation: not available
- Length at study end: 2.5 ± 0.2 cm (Mean ± SD)
- Weight at study end: 0.25 ± 0.03 g (Mean ± SD)

ACCLIMATION
- Acclimation period: more than 14 days
- Acclimation conditions: same as test conditions
- Feeding frequency during acclimation: fish were fed with brine shrimp flake (O.S.I®, USA) daily until 24 hours before the test was started.
- Health during acclimation: No diseases were observed during the acclimation period. No mortality was observed within the 7 days before the start of the test.

FEEDING DURING TEST
- Food type: none
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
21.7-22.9°C
pH:
6.34 to 7.24
Dissolved oxygen:
60.9%-91.5% of the air saturation value
Nominal and measured concentrations:
Nominal concentration: 116 mg/L
Geometric mean measured concentration: 1.20 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Five litre glass tanks
- Material, size, fill volume: glass, 5L, 4L
- Aeration: no
- Renewal rate of test solution: the frequency of renewal was every 24 h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: about 0.6 g fish/litre

TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: Tap water, dechlorinated by activated carbon and sterilized by UV lamp, was used.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 hours/12 hours
- Light intensity: not available

EFFECT PARAMETERS MEASURED:
mortality: at 0, 3, 24, 48, 72 and 96 hours after test initiation
pH, dissolved oxygen concentration and temperature: at the beginning, before and after each renewal, and at the end of the test
body length and weight: at the end of the test

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: Two concentrations of 10% and 100% of the saturated solution
- Results used to determine the conditions for the definitive study: yes, no mortality observed
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1.2 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
1.2 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations that might cause a difference between measured and nominal values: no
Results with reference substance (positive control):
96h LC50 and its 95% confidence limits of the reference substance Potassium dichromate to Gobiocypris rarus: 257 mg/L (207 - 309)
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the test substance to Gobiocypris rarus was determined by a semi-static test. The LC50 is higher than 1.20 mg/L.
Executive summary:

The acute toxicity of the test substance to Gobiocypris rarus was determined by a semi-static test according to "Ministry of environmental protection of the people's Republic of China, The Guidelines for the Testing of Chemicals-Effects on Biotic System, 2013, 203 Fish, Acute Toxicity Test", "OECD, Guidelines for the Testing of Chemicals. 203 Fish, Acute Toxicity Test, 1992" and "GB/T 29763-2013 Chemicals-Rare Minnow (Gobiocypris rarus) acute toxicity test". The test substance is practically insoluble in the water and the purity of the test substance was 86.3%. A nominal concentration of 116 mg/L (the nominal concentration of the active component was 100 mg/L) of the test substance was prepared and stirred at approximately 1100 rpm (via magnetic stirrer) in the dark for 72 h followed by filtration using a 0.22 µm nitrocellulose membrane to make a saturated solution of the test substance in the test water. The saturated solution was checked via laser beam (Tyndall effect) for undissolved test item (formation of an emulsion / suspension). Based on the results of the range-finding test, the saturated solution was used to perform the limit test with a blank control. The test duration was 96 h and the frequency ofwaterrenewal was every 24 h. There were no mortalities and abnormalities observed in treatment group during the test period. No mortality occurred in the control during the test and the dissolved oxygen concentration was greater than 60.0%of the air saturation valuethroughout the test duration. Hence, the test was considered to be valid. During the test, the measured concentrations of the test substance analyzed by Ultra-Performance Liquid Chromatography-Triple Quadrupole Tandem Mass Spectrometer (UPLC-MS) varied less than 20% during each renewal (-15.3% to 18.5%), while all new solutions varied within ± 20% of its arithmetic mean measured concentrations (-9.05% to 10.3%). There was no acute toxicity of the saturated solution in the limit test. The 96 h LC50 for the test substance to Gobiocypris rarus was higher than the concentration of the saturated solution (the geometric mean measured concentration was 1.20 mg/L) under tested conditions.

Description of key information

The acute toxicity of the test substance to Gobiocypris rarus was determined by a semi-static test. The LC50 is higher than 1.20 mg/L.

Key value for chemical safety assessment

Additional information

The acute toxicity of the test substance to Gobiocypris rarus was determined by a semi-static test according to "Ministry of environmental protection of the people's Republic of China, The Guidelines for the Testing of Chemicals-Effects on Biotic System, 2013,203 Fish, Acute Toxicity Test", "OECD, Guidelines for the Testing of Chemicals. 203 Fish, Acute Toxicity Test, 1992" and "GB/T 29763-2013 Chemicals-Rare Minnow (Gobiocypris rarus) acute toxicity test" (reference 6.1 -1). The test substance is practically insoluble in the water and the purity of the test substance was 86.3%. A nominal concentration of 116 mg/L (the nominal concentration of the active component was 100 mg/L) of the test substance was prepared and stirred at approximately 1100 rpm (via magnetic stirrer) in the dark for 72h followed by filtration using a 0.22 µm nitrocellulose membrane to make a saturated solution of the test substance in the test water. The saturated solution was checked via laser beam (Tyndall effect) for undissolved test item (formation of an emulsion / suspension). Based on the results of the range-finding test, the saturated solution was used to perform the limit test with a blank control. The test duration was 96 h and the frequency ofwaterrenewal was every 24 h. There were no mortalities and abnormalities observed in treatment group during the test period. No mortality occurred in the control during the test and the dissolved oxygen concentration was greater than 60.0% of the air saturation valuethroughout the test duration. Hence, the test was considered to be valid. During the test, the measured concentrations of the test substance analyzed by Ultra-Performance Liquid Chromatography-Triple Quadrupole Tandem Mass Spectrometer (UPLC-MS) varied less than 20% during each renewal (-15.3% to 18.5%), while all new solutions varied within ± 20% of its arithmetic mean measured concentrations (-9.05% to 10.3%). There was no acute toxicity of the saturated solution in the limit test. The 96 h LC50 for the test substance to Gobiocypris rarus was higher than the concentration of the saturated solution (the geometric mean measured concentration was 1.20 mg/L) under tested conditions.