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

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

adult fish: sub(lethal) effects

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2004-04-28 to 2004-06-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

other: METI Guideline: Concentration Test on Chemical Substances in Fish

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SPAN 20 used as solubilizer

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals/frequency for test water analysis: days 0, 7, 14, 21, 26, 28

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): SPAN 20 (Sorbitan Monolaureate)
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 0.2 and 0.02 mg/L
Dose 1: Test item: 0.02 mg/L , Vehicle: 0.2 mg/L
Dose 2: Test item: 0.002 mg/L , Vehicle: 0.02 mg/L
Vehicle Control: test item: - , Vehicle: 0.2 mg/L

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Weight: 1.83 +/- 0.22 g
Length: 5.50 +/- 0.20 cm
Lot: 40311

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

28 d

Test temperature:

24.7 +/- 0.2 °C

pH:

6.5 +/- 0.2

Nominal and measured concentrations:

After acclimatisation period, the fish (Cyprinus carpio) were transferred into the test media under flow through conditions. Exposure concentrations were analytically verified at days 0, 7, 14, 21, 26 and 28. The analytical values show that the nominal concentrations of 0.02 and 0.002 mg/L were maintained at about 100 % using SPAN 20, respectively. At days 0, 7, 14, 21, 26 and 28 two fish each were removed from each test group. Body weight was determined. The fish were homogenised and extracted with acetonitrile and n-hexane. The extract was analysed with HPLC. Due to the low bioaccumulation potential, no depuration phase was required.

Reference substance (positive control):

not specified

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

>= 0.02 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 0.02 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Validity criteria fulfilled:

yes

Conclusions:

The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was >= 0.02 mg/L, corresponding to 100 mg/L nominal concentration, and thus higher than the limit of water solubility.

Executive summary:

Purpose

The purpose of this study was to determine the bioconcentration potential of the test material in fish under flow-through conditions. During the GLP compliant test the lethal and other effects in fish were determined during the exposure period of 28 days.

 

Study Design

The study was performed according to the OECD Guideline for Testing of Chemicals 305 (Bioconcentration: Flow-through Fish Test) adopted on June 14, 1996 using two test material concentrations for exposure to Cyprinus carpio. Two environmental concentrations of the test material of 0.02 and 0.002 mg/L were used in this study. The exposure was concentration was maintained using SPAN 20 as solubiliser. The concentrations were verified analytically using a HPLC method with UV detection.

 

Results

There were no mortality and no signs of toxicity detected throughout the study in any dose group up to 28 days of exposure.

 

Conclusion

The test material showed no relevant toxic potential at concentrations above the limit of water solubility.

The NOEC was >= 0.02 mg/L, corresponding to 100 mg/L nominal concentration, and thus higher than the limit of water solubility.

Description of key information

The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was >= 0.02 mg/L, corresponding to 100 mg/L nominal concentration, and thus higher than the limit of water solubility.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

NOEC

Effect concentration:

> 100 mg/L

Additional information

Purpose

The purpose of this study was to determine the bioconcentration potential of the test material in fish under flow-through conditions. During the GLP compliant test the lethal and other effects in fish were determined during the exposure period of 28 days.

 

Study Design

The study was performed according to the OECD Guideline for Testing of Chemicals 305 (Bioconcentration: Flow-through Fish Test) adopted on June 14, 1996 using two test material concentrations for exposure to Cyprinus carpio. Two environmental concentrations of the test material of 0.02 and 0.002 mg/L were used in this study. The exposure was concentration was maintained using SPAN 20 as solubiliser. The concentrations were verified analytically using a HPLC method with UV detection.

 

Results

There were no mortality and no signs of toxicity detected throughout the study in any dose group up to 28 days of exposure.

 

Conclusion

The test material showed no relevant toxic potential at concentrations above the limit of water solubility.

The NOEC was >= 0.02 mg/L, corresponding to 100 mg/L nominal concentration, and thus higher than the limit of water solubility.