4-Butyl-4''-ethyl-2',3'-difluor-1,1':4',1''-terphenyl

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:

2007-12-19 to 2008-03-19

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)

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, 5, 8, 14, 21, 28
- Sampling intervals/frequency for test medium samples: days 0, 5, 8, 14, 21, 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): HCO-40
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 1.0 mg/L

Dose 1: Test item: 0.0015 mg/L
Dose 2: Test item: 0.00015 mg/L

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Cyprinus carpio
Lot: 081007c
Weight: 6.6 g
Length: 8.3 cm

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

28 d

Hardness:

250 g/L

Test temperature:

25.0 +/- 0.4 °C

pH:

7

Dissolved oxygen:

saturated

Nominal and measured concentrations:

nominal concentration 0.0015 mg/L:
Solubilizer used: HCO-40, 1.0 mg/L

analytically measured concentrations:
day 4: 0.00146 mg/L
day 7: 0.00154 mg/L
day 14: 0.00151 mg/L
day 21: 0.00148 mg/L
day 28: 0.00150 mg/L
day 35: 0.00151 mg/L

nominal concentration 0.00015 mg/L
Solubilizer used: HCO-40, 1 mg/L
analytically measured concentrations:
day 4: 0.000150 mg/L
day 7: 0.000152 mg/L
day 14: 0.000144 mg/L
day 21: 0.000150 mg/L
day 28: 0.000148 mg/L
day 35: 0.000147 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, 5, 14, 21, and 28. The analytical values show that the nominal concentrations of 0.0015 and 0.00015 mg/L were maintained during the experimental phase.

Key result

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

> 0.002 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Concentrations maintained using HCO-40

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

> 0.002 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Concentrations maintained using HCO-40

Validity criteria fulfilled:

yes

Conclusions:

The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was > 0.0015 mg/L 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 0.0015 and 0.00015 mg/L were used in this study. HCO-40 was used as vehicle at concentrations of 1.0 mg/L. The exposure was maintained during the couse of the study at expected nominal values. The concentrations have been 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.

Description of key information

NOEC (28 d) = 0.0015 mg/L (1 mg/L HCO-40)

LC50 (28 d)  > 0.0015 mg/L (1 mg/L HCO-40)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

NOEC

Effect concentration:

0.002 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 0.0015 and 0.00015 mg/L were used in this study. HCO-40 was used as vehicle at concentrations of 1.0 mg/L. The exposure was maintained during the couse of the study at expected nominal values. The concentrations have been 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.