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

Jun 30 - Aug 16, 2004

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, 25, 28

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 20
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)):
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
Control: Test item: --, Vehicle: 0.2 mg/L

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Lot No. 40626 from 2004-05-26
Weight: 0.8 +/- 0.09 g
Length: 4.6 +/- 0.20 cm

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

28 d

Hardness:

250 g/L

Test temperature:

25.6 +/- 0.4 °C

pH:

7.2 +/- 0.1

Dissolved oxygen:

7.1 +/- 0.4 mg/L

Nominal and measured concentrations:

nominal concentration 0.02 mg/L:
analytically measured concentrations: day 0: 0.0193 mg/L, day 7: 0.0172 mg/L, day 14: 0.0180 mg/L, day 21: 0.0199 mg/L, day 23: 0.0203 mg/L, day 25: 0.0205 mg/L, day 28: 0.0164 mg/L
nominal concentration 0.002 mg/L
analytically measured concentrations: day 0: 0.00197 mg/L, day 7: 0.00199 mg/L, day 14: 0.00180 mg/L, day 21: 0.00199 mg/L, day 23: 0.00200 mg/L, day 25: 0.00198 mg/L, day 28: 0.00188 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, 25 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.

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

Details on results:

- Mortality of test organisms: no effects
- Behavioural abnormalities: no effects
- Observations on body length and weight: no effects
- Other biological observations: no effects

Validity criteria fulfilled:

yes

Conclusions:

The test material showed no relevant toxic potential at concentrations above the limit of water solubility, thus, having a NOEC corresponding to 100 mg/L nominal concentration.

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. SPAN 20 was used as vehicle at concentrations of 0.2 and 0.02 mg/L. The exposure was maintained during the course of the study at about 100 % of the nominal concentrations. The concentrations have been verified analytically using a LC method with UV detection.

Results

There was 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, thus, having a NOEC corresponding to 100 mg/L nominal concentration.

Description of key information

The test material showed no relevant toxic potential at concentrations above the limit of water solubility, thus, having a NOEC 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

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. SPAN 20 was used as vehicle at concentrations of 0.2 and 0.02 mg/L. The exposure was maintained during the course of the study at about 100 % of the nominal concentrations. The concentrations have been verified analytically using a LC method with UV detection.

Results

There was 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, thus, having a NOEC corresponding to 100 mg/L nominal concentration.