4-ethoxy-2,3-difluoro-4'-propyl-1,1'-biphenyl

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:

2010-11-26 - 2011-04-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

June 14, 1996

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

Principles of method if other than guideline:

GLP study performed according to OECD 305 and 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, 26, 28

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION: Done according to guideline.
- 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)):
Dose 1: Test item: 0.004 mg/L , Vehicle: 0.024 mg/L
Dose 2: Test item: 0.0004 mg/L , Vehicle: 0.0024 mg/L
Control: Test item: --, Vehicle: 0.024 mg/L

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Lot No. 110112
from 2011-01-12
Weight: 3.0 +/- 0.46 g
Length: 6.6 +/- 0.30 cm

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

28 d

Hardness:

250 mg/L

Test temperature:

25.0 ° +/- 2.0 °C

pH:

7.8 +/- 0.1

Dissolved oxygen:

7.7 +/- 0.1 mg/L

Salinity:

not applicable

Conductivity:

not specified

Nominal and measured concentrations:

concentration 0.004 mg/L:
analytically measured concentrations:
day 0: 0.00320 mg/L
day 7: 0.00348mg/L
day 14: 0.00320 mg/L
day 21: 0.00320 mg/L
day 26: 0.00319 mg/L
day 28: 0.00337 mg/L

concentration 0.0004 mg/L
analytically measured concentrations:
day 0: 0.000322 mg/L
day 7: 0.0000346 mg/L
day 14: 0.000318 mg/L
day 21: 0.000321 mg/L
day 23: 0.000320 mg/L
day 28: 0.000318 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, 26 and 28. The analytical values show that the nominal concentrations of 0.004 and 0.0004 mg/L were maintained at about 100 % using TWEEN 80, 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. The extract was analysed with LC.

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.:

> 0.004 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: above limit of water solubility

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

> 0.004 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: above limit of water solubility

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
- Bound residues forming a plateau: no
- Mortality and/or behavioural abnormalities of control: no
- Loss of test substance during test period: no
- Results with vehicle control: no effects

Validity criteria fulfilled:

yes

Conclusions:

The test material showed no toxic potential, the NOEC was > 0.004 mg/L, corresponding to 100 mg/L nominal concentration which is clearly above the water solubility limit.

Executive summary:

The purpose of this study was to determine the bioconcentration potential of the test material in fish under flow-through conditions. 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 0.004 and 0.0004 mg/L were used in this study. To achieve the exposure concentrations, solvent TWEEN 80 was used as vehicle at concentrations of 0.024 and 0.0024 mg/L. All concentrations tested were at or above the solubility limit of the pure test substance. The exposure was maintained during the course of the study at about 80-100 % of the nominal concentrations. The concentrations have been verified analytically using a LC method with UV detection.

No signs of toxicity were observed throughout the study.

The NOEC is larger than 0.004 mg/L corresponding to 100 mg/L nominal concentration which is clearly above the water solubility limit.

Description of key information

The test material showed no toxic potential, the NOEC was > 0.004 mg/L, corresponding to 100 mg/L nominal concentration which is clearly above the water solubility limit. 

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. 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 0.004 and 0.0004 mg/L were used in this study. To achieve the exposure concentrations, solvent TWEEN 80 was used as vehicle at concentrations of 0.024 and 0.0024 mg/L. All concentrations tested were at or above the solubility limit of the pure test substance. The exposure was maintained during the course of the study at about 80-100 % of the nominal concentrations. The concentrations have been verified analytically using a LC method with UV detection.

No signs of toxicity were observed throughout the study.

The NOEC is larger than 0.004 mg/L corresponding to 100 mg/L nominal concentration which is clearly above the water solubility limit.