5-Brom-2-[(3,4,5-trifluorphenoxy)-difluormethyl]-1,3-difluorbenzene

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:

16 Mar- 26 Sep 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

yes

Remarks:

reconstituted water

Details on test solutions:

Before exposure of the fish, the test medium (reconstituted water and test material) was freshly prepared: The calibrated flask with test material and vehicle (reconstituted water) was treated in an ultrasonic device for 1 hour. Subsequently, the preparation was aerated, and stirred with an magnetic stirrer for further 23 hours. After 24 hours the formulation was given through a Nutsch filter (pore size >10 <16 µm). The filtrate was used for the study.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: Institute of Toxicology, Merck KGaA
- Length at study initiation (length definition, mean, range and SD): 2.0 +/- 1 cm
- Weight at study initiation (mean and range, SD): 8.3 g (control group), 6.8 g (test group)

ACCLIMATION
- Acclimation period: > 14 days
- Acclimation conditions (same as test or not): in reconstituted water

FEEDING DURING TEST
- Food type: flakes (Tetra Min (R) diet, Tetra GmbH, Melle, Germany) and daphnia or artemia or frozen mosquitolarva
- Frequency: daily

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

ca. 15° dH (about 267 mg/L CaCO3), the proportion of Ca to Mg ions was 4:1 and that of Na to K ions 10:1

Test temperature:

24-26 °C

pH:

control group: 7.16 - 7.91
test material group: 7.22 - 7.89

Dissolved oxygen:

The dissolved oxygen concentrations were >60 % oxygen saturation throughout the study.

Details on test conditions:

Administration:
At the start of the experimental phase, 10 zebra fish per group were inserted into an aquarium (all-glass) with about 9 litres of reconstituted water (control group) or test medium (test material group). The aquaria were labeled to assure an unequivocal identification.
Observation schedule:
The behaviour and general condition of all fish were checked immediately after the introduction into the test medium or reconstituted water, after 3 hours, and then daily.
Laboratory tests:
Dissolved oxygen (O2) concentration in % and pH values were measured in the control and test material groups at the beginning and at the end of the exposure period.
During the experimental part, the temperature was registered in the control vessel with an electronic thermometer containing a maximum and minimum memory display.

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:

No clinical findings were observed in the control and the test material group during the experimental part.

All fish survived the observation period.

A dose group with nominal 100 mg/L af the test item (max. solubility 0.01 mg/L analytically) revealed no aquatic toxicity in this test system. The analytical 24, 48, 72 and 96 h LC50 values exceed the maximum solubility of the test material.
No remarkable observations were made concerning the appearance of the test material solution. The test medium was a clear precipitation and stayed unchenged throughout the study.

- Mortality of control: no

Validity criteria fulfilled:

yes

Conclusions:

An aqueous solution of the test material of a nominal concentration of 100 mg/L revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebra fish exceeded the max. solubility of < 0.01 mg/L (as established analytically) of the test material in reconstituted water.

Executive summary:

The objective of this study was to determine the acute toxicity of the test material in zebra fish, Danio rerio. For this purpose, 10 fish (test material group) and further 10 fish (control group) were exposed over 96 hours, under defined conditions in a limit test. The fish were observed for signs of toxicity or death for 96 hours. Zebra fish of the test material group were exposed to a saturated aqueous material solution of nominal 100 mg/L (limit test) in an open static system.

The zebra fish exposed to an aqueous solution, with a nominal concentration of 100 mg/L were not affected. The analysis revealed , that the solubility of the test item in water was < 0.01 mg/L. Due to this low water solubility and the fact that the study was performed as a limit test, the test material concentrations in the aqueous medium at the start and the end of this study were not quantified.

The 96 h LC50 value to zebra fish exceeded the maximal solubility of < 0.01 mg/L (as established analytically) of the test material in reconstituted water and, thus, could not be determined in this test.

Description of key information

OECD 203: 96-h LC50 > 100 mg/L (nominal)

Additional information

The objective of this study was to determine the acute toxicity of the test material in zebra fish, Danio rerio. For this purpose, 10 fish (test material group) and further 10 fish (control group) were exposed over 96 hours, under defined conditions in a limit test. The fish were observed for signs of toxicity or death for 96 hours. Zebra fish of the test material group were exposed to a saturated aqueous material solution of nominal 100 mg/L (limit test) in an open static system.

The zebra fish exposed to an aqueous solution, with a nominal concentration of 100 mg/L were not affected. The analysis revealed , that the solubility of the test item in water was < 0.01 mg/L. Due to this low water solubility and the fact that the study was performed as a limit test, the test material concentrations in the aqueous medium at the start and the end of this study were not quantified.

The 96 h LC50 value to zebra fish exceeded the maximal solubility of < 0.01 mg/L (as established analytically) of the test material in reconstituted water and, thus, could not be determined in this test.