Trans-2-{4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluorophenyl}-5-(trans-4-propylcyclohexyl)-1,3-dioxane

Short-term toxicity to fish

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:

February 25, 2013 - July 5, 2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No OECD GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 mg/L and 100 mg/L
- Sampling method: For the analysis of the actual test substance concentrations, 2 mL of the test solution was taken from each vessel at the beginning and at the end of the test.

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION

A nominal concentration of 100 mg/L of the test substance was prepared and stirred (via magnetic stirrer) in the dark for 72 h at 500 rpm followed by filtration using a 0.45 µm nitrocellulose membrane to make a saturated solution.

Vehicle: Tap water, dechlorinated by activated carbon and sterilised by UV lamp was used.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Strain: Dania rerio
- Source: Shanghai Xiexing Aquariumi
- Length at study initiation: 2.4 ± 0.1 cm (Mean ± SD)
- Weight at study initiation: 0.24 ± 0.05 g (Mean ± SD)
- Method of breeding: standard
- Feeding during test: commercial fish diet during acclimatization

ACCLIMATION
- Acclimation period: > 14 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: fish were fed daily until 24 hours before test was started
- Feeding frequency during acclimation: daily
- Health during acclimation (any mortality observed): no mortality observed


FEEDING DURING TEST
none

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

no

Hardness:

165 mg CaCO3/L

Test temperature:

22.0 - 23.4 °C

pH:

7.78 to 8.11

Dissolved oxygen:

67.1 to 84.6 %

Salinity:

no data

Conductivity:

no data

Nominal and measured concentrations:

Nominal Concentration: 100 mg/L
Mean measured concentration: < 0.113 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 5 L glass tank
- Type: open
- Material, size, headspace, fill volume: 5 L glass tanks were used containing 4 L test solution
- Aeration: none
- 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/preparation of dilution water: Tap water, dechlorinated by activated carbon and sterilized by UV lamp
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: Light : Dark = 12 h : 12 h

EFFECT PARAMETERS MEASURED: mortality

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: nominal 100 mg/L and Control
- Results used to determine the conditions for the definitive study: no mortality at nominal 100 mg/L

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no
- Observations on body length and weight: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: yes

Sublethal observations / clinical signs:

Results

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 value throughout the test duration. Hence, the test was considered to be valid. During the test, the measured concentrations of the test substance were below the limit detection of the test substance (0.113 mg/L).

 

Conclusion

There was no acute toxicity of the saturated solution in the limit test. The 96h LC50 of the test substance to Danio rerio was higher than the concentration of the saturated solution (which measured concentration was below 0.113 mg/L) under test conditions.

Validity criteria fulfilled:

yes

Conclusions:

There was no acute toxicity of the saturated solution in the limit test. The 96-h LC50 of the test substance to Danio rerio was higher than the concentration of the saturated solution (which measured concentration was below 0.113 mg/L) under test conditions.

Executive summary:

A 96-h study with zebrafish was conducted according to OECD 203 to determined the acute toxicity of the test item on fish. A nominal concentration of 100 mg/L of the test substance was prepared and stirred (via magnetic stirrer) in the dark for 72 h at 500 rpm followed by filtration using a 0.45 µm nitrocellulose membrane to make a saturated solution of test system as the test solution. 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. 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 value throughout the test duration. Hence, the test was considered to be valid. During the test, the measured concentrations of the test substance were below the limit detection of the test substance (0.113 mg/L). There was no acute toxicity of the saturated solution in the limit test. The 96-h LC50 of the test substance to Danio rerio was higher than the concentration of the saturated solution (which measured concentration was below 0.113 mg/L) under test conditions.

Description of key information

There was no acute toxicity of the saturated solution in the limit test. The 96-h LC50 of the test substance to Danio rerio was higher than the concentration of the saturated solution (which measured concentration was below 0.113 mg/L) under test conditions (reference 6.1.1-1).

Additional information

A 96-h study with zebrafish was conducted according to OECD 203 to determine the acute toxicity of the test item on fish (reference 6.1.1-1). A nominal concentration of 100 mg/L of the test substance was prepared and stirred (via magnetic stirrer) in the dark for 72 h at 500 rpm followed by filtration using a 0.45 µm nitrocellulose membrane to make a saturated solution of test system as the test solution. 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. 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 value throughout the test duration. Hence, the test was considered to be valid. During the test, the measured concentrations of the test substance were below the limit detection of the test substance (0.113 mg/L). There was no acute toxicity of the saturated solution in the limit test. The 96-h LC50 of the test substance to Danio rerio was higher than the concentration of the saturated solution (which measured concentration was below 0.113 mg/L) under test conditions.