1-Ethoxy-2,3-difluoro-4-(trans-4-propylcyclohexyl)-benzene

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:

Jun 30 - Aug 16, 2004

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:

yes

Details on sampling:

0; 24, 48, 72, 96 h

Vehicle:

yes

Details on test solutions:

According to guideline

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): SPAN 60
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)):

Dose 1: Test item: 86.4 mg/L , Vehicle: 900 mg/L
Dose 2: Test item: 75.5 mg/L , Vehicle: 900 mg/L
Dose 3: Test item: 51.3 mg/L , Vehicle: 900 mg/L
Dose 4: Test item: 47.7 mg/L , Vehicle: 900 mg/L
Dose 5: Test item: 42.4 mg/L , Vehicle: 900 mg/L
Dose 6: Test item: 31.4 mg/L , Vehicle: 900 mg/L

Control: Positive control: 0.5 mg/L , Vehicle: 900 mg/L
Negative Control: Test item: --, Vehicle: 900 mg/L

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Weight: 0.2 g
Length: 3.2 cm
Lot: 40501

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

no

Test temperature:

25.1 +/- 0.2 °C

pH:

7.7

Dissolved oxygen:

7.1 mg/L

Nominal and measured concentrations:

31.4, 42.4, 47.4, 51.3, 75.5, 86.4 mg/L (adjusted with SPAN 60 as vehicle; measured by LC)

Details on test conditions:

10 fish per 4 L

Reference substance (positive control):

not specified

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 86 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 900 mg/L SPAN 60 as solubiliser

Details on results:

- Mortality of control: 0 % after 96 hours
Mortality in %
-----------------------------------------------------------
Test material (mg/L) 24 h 48 h 72 h 96 h
-----------------------------------------------------------
31.4 0 0 0 0
42.4 0 0 0 0
47.4 0 0 0 0
51.3 0 0 10 20
75.5 0 10 10 20
86.4 10 20 20 30
-----------------------------------------------------------
SPAN 60 0 0 0 0
-----------------------------------------------------------
Control Group (Vehicle: 900 mg/L): no mortality observed during the study
- Effect concentrations exceeding solubility of substance in test medium:
All concentrations tested were at or above the solubility limit of the pure test substance.

To achive the exposure concentrations, solvent SPAN 60 was used.

Validity criteria fulfilled:

yes

Conclusions:

The LC50 of the test material with solubilizer exceeds 86.4 mg/L, which is clearly above the limit of water solubility.

Executive summary:

The acute toxicity of the test material was studied in a pretest for a bioaccumulation study (OECD 305) using solvents to increase exposure. The GLP test was performed according to the METI Guideline: Concentration Test on Chemical Substances in Fish.

To achieve the exposure concentrations, solvent SPAN 60 was used. All concentrations tested were at or above the solubility limit of the pure test substance. For the test Brachydanio rerio (new name: Danio rerio) was used. The following concentrations have been applied: 31.4, 42.4, 47.4, 51.3, 75.5, 86.4 mg/L (adjusted with SPAN 60 as vehicle; measured by LC).

At a test material concentration of 86.4 mg/L adjusted with SPAN 60 as solubiliser a mortality of 10, 10, 20, and 30 % was observed after 24, 48, 72 and 96 hours, respectively. No mortality was observed in the control group containing only the vehicle (SPAN 60) at a concentration of 900 mg/L. The test material does not possess acute toxic potential to fish up to the limit of solubility in water. Using SPAN 60 as solubiliser toxicity was observed at higher concentrations. The 96 hours LC50 exceeds 86.4 mg/L which is above the water solubility limit of the pure substance.

The LC50 of the test material with solubilizer exceeds 86.4 mg/L, which is clearly above the limit of water solubility.

Description of key information

The LC50 of the test material with solubilizer exceeds 86.4 mg/L, which is clearly above the limit of water solubility.

Additional information

The acute toxicity of the test material was studied in a pretest for a bioaccumulation study (OECD 305) using solvents to increase exposure. The GLP test was performed according to the METI Guideline: Concentration Test on Chemical Substances in Fish.

To achieve the exposure concentrations, solvent SPAN 60 was used. All concentrations tested were at or above the solubility limit of the pure test substance. For the test Brachydanio rerio (new name: Danio rerio) was used. The following concentrations have been applied: 31.4, 42.4, 47.4, 51.3, 75.5, 86.4 mg/L (adjusted with SPAN 60 as vehicle; measured by LC).

At a test material concentration of 86.4 mg/L adjusted with SPAN 60 as solubiliser a mortality of 10, 10, 20, and 30 % was observed after 24, 48, 72 and 96 hours, respectively. No mortality was observed in the control group containing only the vehicle (SPAN 60) at a concentration of 900 mg/L. The test material does not possess acute toxic potential to fish up to the limit of solubility in water. Using SPAN 60 as solubiliser toxicity was observed at higher concentrations. The 96 hours LC50 exceeds 86.4 mg/L which is above the water solubility limit of the pure substance.

The LC50 of the test material with solubilizer exceeds 86.4 mg/L, which is clearly above the limit of water solubility.