1-Ethoxy-2,3-difluor-4-[4-(trans-4-propylcyclohexyl)-1-cyclohexen-1-yl]-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 2009-08-13 to 2009-10-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

study performed according to OECD 305

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals/frequency for test organisms: days 0, 7, 14, 21, 23, 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): Tween 80
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 0.0225 and 0.00225 mg/L
Dose 1: Test item: 0.0075 mg/L , Vehicle: 0.0225 mg/L
Dose 2: Test item: 0.00075 mg/L , Vehicle: 0.00225 mg/L
Vehicle Control: test item: - , Vehicle: 0.0225 mg/L

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Weight: 3.88 +/- 0.33 g
Length: 7.40 +/- 0.20 cm
Lot: 90325
Date: 2009-03-25

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

28 d

Test temperature:

25 +/- 2 °C

pH:

7.7 +/- 0.0

Dissolved oxygen:

7.4 +/- 0.1 mg/L

Nominal and measured concentrations:

nominal concentration 0.0075 mg/L:
analytically measured concentrations:
day 7: 0.00691 mg/L
day 14: 0.00701 mg/L
day 21: 0.00686 mg/L
day 23: 0.00690 mg/L
day 28: 0.00711 mg/L

nominal concentration 0.00075 mg/L
analytically measured concentrations:
day 7: 0.000690 mg/L
day 14: 0.000709 mg/L
day 21: 0.000694 mg/L
day 23: 0.000713 mg/L
day 28: 0.000742 mg/L

Details on test conditions:

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, 23 and 28. The analytical values show that the nominal concentrations of 0.0075 and 0.00075 mg/L were maintained at about 100 % using solubiliser, respectively. At days 0, 7, 14, 21, 23 and 28 two fish each were removed from each test group. Body weight was determined.

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.:

0.007 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: concentration was above the water solubility limit stabilized with Tween 80

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

0.007 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: concentration was above the water solubility limit stabilized with Tween 80

Validity criteria fulfilled:

yes

Conclusions:

The NOEC was 0.075 mg/L and higher than the limit of water solubility, thus, corresponding to 100 mg/L nominal concentration.

Executive summary:

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. 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 0.0075 and 0.00075 mg/L were used in this study. The exposure concentration was maintained using Tween 80 as solubiliser. The concentrations were verified analytically using a HPLC method with UV detection. No mortality and no signs of toxicity were detected throughout the study in any dose group up to 28 days of exposure. The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was 0.075 mg/L and higher than the limit of water solubility, thus, corresponding to 100 mg/L nominal concentration.

Description of key information

The NOEC was 0.075 mg/L and higher than the limit of water solubility, thus, corresponding to 100 mg/L nominal concentration.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

NOEC

Effect concentration:

> 100 mg/L

Additional information

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. 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 0.0075 and 0.00075 mg/L were used in this study. The exposure concentration was maintained using Tween 80 as solubiliser. The concentrations were verified analytically using a HPLC method with UV detection. No mortality and no signs of toxicity were detected throughout the study in any dose group up to 28 days of exposure. The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was 0.075 mg/L and higher than the limit of water solubility, thus, corresponding to 100 mg/L nominal concentration.