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

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:

from 2005-09-13 to 2005-12-10

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

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)):

- Nominal values

Substance Concentration Solubilizer SPAN-60
pos. Control 0.05 mg/L -
pos. Control 0.5 mg/L -
Test item: 107.5 mg/L 800 mg/L

Vehicle
Control: - 800 mg/L

Negative
Control - -

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Weight: 0.22 +/- 0.02 g
Length: 3.1 +/- 0.2 cm
Lot: 50729
Date: 2005-07-29

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

no

Test temperature:

24.5 +/- 0.8 °C

Nominal and measured concentrations:

107.5 mg/L

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.:

> 107.5 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: with SPAN 60 as solibiliser

Sublethal observations / clinical signs:

- Mortality of control: 0 % after 96 hours

Mortality in %

Sample		Mortality / [%]
Test Material	Concentration / [mg/L]	24 h	48 h	72 h	96 h
Positive Control	0.5	20	70	100	100
Positive Control	0.05	0	0	0	0
Test material (+vehicle)	107.5	0	0	0	0
SPAN-60	800	0	0	0	0
Blank	0	0	0	0	0

All concentrations tested were at or above the solubility limit of the pure test substance. To achive the exposure concentrations, solubiliser was used.

Validity criteria fulfilled:

yes

Conclusions:

The LC50 of the test material exceeds 107.5 mg/L and 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 TG 305) using solvents to increase exposure. The GLP test was performed according to the METI Guideline: Concentration Test on Chemical Substances in Fish. For this assay a pre-test on acute toxicity in fish according to OECD 203 was performed with Danio rerio.

To achieve the exposure concentrations of 107.5 mg/L, solvent SPAN 60 (800 mg/L) was used. All concentrations tested were at or above the solubility limit of the pure test substance.

Negative control and vehicle control did not show signs of toxicity. The positive showed mortality in the expected concentration range.

At a test material concentration of 107.5 mg/L, adjusted with solubilizer, no mortality was observed after 24, 48, 72 and 96 hours, respectively. The test material does not possess acute toxic potential to fish up to the limit of solubility in water. The 96 hours LC50 exceeds the water solubility limit of the pure substance.

The LC50 of the test material exceeds 107.5 mg/L and is clearly above the limit of water solubility.

Description of key information

The LC50 of the test material exceeds 107.5 mg/L and is clearly above the limit of water solubility.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

> 107.5 mg/L

Additional information

The acute toxicity of the test material was studied in a pretest for a bioaccumulation study (OECD TG 305) using solvents to increase exposure. The GLP test was performed according to the METI Guideline: Concentration Test on Chemical Substances in Fish. For this assay a pre-test on acute toxicity in fish according to OECD 203 was performed with Danio rerio.

To achieve the exposure concentrations of 107.5 mg/L, solvent SPAN 60 (800 mg/L) was used. All concentrations tested were at or above the solubility limit of the pure test substance.

Negative control and vehicle control did not show signs of toxicity. The positive showed mortality in the expected concentration range.

At a test material concentration of 107.5 mg/L, adjusted with solubilizer, no mortality was observed after 24, 48, 72 and 96 hours, respectively. The test material does not possess acute toxic potential to fish up to the limit of solubility in water. The 96 hours LC50 exceeds the water solubility limit of the pure substance.

The LC50 of the test material exceeds 107.5 mg/L and is clearly above the limit of water solubility.