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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 March 2017 - 17 July 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
version 1992
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Limit test:
Based on the results of the OECD 201 and 202, a single concentration was prepared in ISO 6341 medium by water accommodated fractions (WAF) at a loading rate equivalent to 65 mg test item.L-1. A control was set up with the test medium only. There were 10 fish for each
condition.
The test was performed in a thermostatic chamber maintained at 23°C ± 2.
After 3, 24, 48, 72 and 96 hours, the number of deaths was recorded.
pH and dissolved oxygen were recorded each day.
Test solution analysis:
The test item quantification was performed according to a validated analytical method to measure the concentration of test item at the start and the end of the test.
Test item solution and control were sampled (approximately 50 mL) and transferred to analyse the same day.
Vehicle:
no
Details on test solutions:
Since the test item is a poorly soluble substance under the test conditions, test solutions were prepared by water accommodated fractions (WAF) approach according to OECD monograph No. 23. Measured quantity of test item was added directly to test medium and mixed for 72
hours to achieve an equilibrated concentration of dissolved and dispersed or emulsified components in the aqueous phase. Following cessation of mixing and a period of settling (to allow phase separation) the aqueous phase was drawn off for testing.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Brachydanio rerio are produced and maintained in Rovaltain Research Company laboratory. To reduce the number of fish used for acute toxicity testing, quality and sensitivity of fish was checked once a year by a test with reference item according to guideline OECD 236.
Housing conditions are the following:
Medium: ISO 6341 medium
Temperature: 23°C ± 2
Light/dark cycle: 16 h/8 h
pH: Between 6 and 8.5
Hardness (CaCO3): Between 10 and 250 mg.L -1
Test type:
static
Water media type:
other: reconstituted test water
Remarks:
ISO 6341 medium
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
The control fish were placed in quarantine for 15 days before returning to the breeding aquarium.
The fish exposed to the test item were euthanized. For this, fish were placed for about ten minutes in a crystallizer containing sodium methasulfonate or MS22 (CAS number 886-86-2) at a lethal concentration of 300 mg.L-1.
Hardness:
CaCO3: between 10 and 250 mg/L
Test temperature:
23°C
pH:
6.99 - 7.76
Dissolved oxygen:
7.50 - 8.90 mg/L
Nominal and measured concentrations:
65 mg/L
Details on test conditions:
Light/dark cycle: 16h/8h
Reference substance (positive control):
yes
Remarks:
3-4 dichloroaniline
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 65 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
The study is valid since the mortality in the control within the 96-hour test period was lower than 10 % (actual value: 0 % of mortality in the control), and the dissolved oxygen in the control during the whole test period was higher than 5.3 mg.L-1 (actual value : 7.69 mg.L-1).
Results with reference substance (positive control):
The last test performed with the reference item 3-4 dichloroaniline (19 May 2017) gave an EC50(0-96h) = 3.00 mg/L, indicating that the fish sensitivity is correct (within the accepted interval of 1.2 to 4.1 mg/L)
Sublethal observations / clinical signs:

Results of the limit test:

 ID

 Loading rate

(mg test item/L)

                Immobilized fish Mortality (%)
                  Exposure time  
     0 h  3 h  24 h  48 h  72 h  96 h  96 h
Control  0  0  0  0  0  0  0
Test  65  0  0  0  0  0  0  0
Validity criteria fulfilled:
yes
Conclusions:
Under the experimental conditions of the test conducted under OECD 203 guideline, the effects of the test item added by water-accomodated fractions to OECD modified test medium at the loading rate of 65 mg.L-1 to Brachydanio rerio were investigated. Based on the mortality, the CL50-96h was estimated to be > 65 mg test item.L-1.

Description of key information

Under the experimental conditions of a test conducted under OECD 203 guideline, the effects of the test item added by water-accomodated fractions to OECD modified test medium at the loading rate of 65 mg.L-1 to Brachydanio rerio were investigated. Based on the mortality, the CL50-96h was estimated to be > 65 mg test item.L-1.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
> 65 mg/L

Additional information