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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 September 2016 - 16 December 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. QA statement)

Test material

Specific details on test material used for the study:
Sa 57

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Water samples were taken (at least in duplicate) from each concentration during the definitive test at 0, 24, 48, 72 and 96 h. 50 mL collected water samples were extracted twice with 25 mL hexane. The combined organic phases were dried with rotary evaporator, and then redissolved with 2.00 mL acetonitrile. The final solutions were analyzed by UPLC.

Test solutions

Vehicle:
no
Details on test solutions:
In the range-finding test, the test solution was prepared by directly adding appropriate amounts of test substance into dilution water and then facilitating its dispersion by stirring for 30 min. The 1.00 mg/L test solution was colourless and clear. The test solutions with concentration of 10.0 and 100 mg/L showed white turbidity.
In the limit test, a W AF (water accommodated fraction) with a nominal concentration of 110 mg/L was prepared by adding an appropriate amount of the test substance to the test medium in glass aspirator bottles with appropriate size. The mixing aspirator bottle was stoppered and the aqueous test substance mixture was stirred by Teflon stir bar using a stirring rate about 500 rpm at room temperature (about 23°C ~ 25°C) for 24 hours. At the end of the 24 h, stirring was stopped and the test substance was allowed to settle down. The mixture was allowed to settle for 1 hour at room temperature. Then the aqueous portion removed through the outlet of the aspirator stirring bottle was the W AF of the test substance without further filtration to remove any remaining undissolved test substance.

Test organisms

Test organisms (species):
other: Gobiocypris rarus
Details on test organisms:
The test fish Rare minnow, Gobiocypris rarus (Batch No.: F20160830G), were bred by the test institute.
Fish to be used in the test were held for 7 days in water of the quality and temperature to be used in the test.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
145 mg/L (CaCO3)
Test temperature:
23.0°C to 23 .1°C
pH:
7,3 - 7,84
Dissolved oxygen:
74% and 95% of the air saturation

Results and discussion

Effect concentrations
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 110 mg/L
Nominal / measured:
nominal
Conc. based on:
other: water accommodated fraction (WAF)
Basis for effect:
mortality (fish)
Results with reference substance (positive control):
Reference substance: Potassium dichromate, K2Cr20 7, CAS: 7778-50-9; Purity: 99.8%; Lot number: L VC0052; J&K Scientific Ltd. The test with the reference substance is performed at least once with each batch of fish as a means of assuring that the laboratory test conditions are adequate and have not changed significantly. The resulting 24 h-LC50 should be in the range of200 mg/L to 400 mg/L. Otherwise, the test is regarded as invalid.
The recent results (Study No: S2016RI001-07) were LC50(24h) 325 mg/L (95% Confidence Limit 286~371 mg/L).

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The results show that under valid static test conditions, the 96 h-LC50 of Sa57 to fish (Rare minnow, Gobiocypris rarus) is greater than the nominal concentration of the 110 mg/L WAF (measured concentration 2.71 mg/L), while the maximum concentration causing no mortality (96h-LC0) was equal to the nominal concentration of 110 mg/L W AF (measured concentration 2.71 mg/L).

96 h-LC50 > 110 mg/L WAF (measured concentration 2.71 mg/L);
96 h-LC0 = 110 mg/L WAF (measured concentration 2.71 mg/L).
Executive summary:

The results show that under valid static test conditions, the 96 h-LC50 of Sa57 to fish (Rare minnow, Gobiocypris rarus) is greater than the nominal concentration of the 110 mg/L WAF (measured concentration 2.71 mg/L), while the maximum concentration causing no mortality (96h-LC0) was equal to the nominal concentration of 110 mg/L W AF (measured concentration 2.71 mg/L).

96 h-LC50 > 110 mg/L WAF (measured concentration 2.71 mg/L);

96 h-LC0 = 110 mg/L WAF (measured concentration 2.71 mg/L).