4-Ethyl-2',3'-difluor-4''-propyl-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:

other: GLP study performed according to OECD 305 and METI Guideline: Concentration Test on Chemical Substances in Fish.

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)

Specific details on test material used for the study:

Batch: L56069211
Puritiy: 99.8 % (HPLC)
Water Solubility: 0.0028 mg/L

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:

According to guideline

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: 0.0025 mg/L ,
Dose 2: Test item: 0.00025 mg/L

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Cyprinus carpio
Lot: 131018c
Weight: 5.5 g
Length: 7.7 cm

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

35 d

Test temperature:

25.0 ° +/- 0.4 °C

pH:

7

Dissolved oxygen:

7.0 mg/L

Nominal and measured concentrations:

nominal concentration 0.0025 mg/L:
Solubilizer used: HCO-40, 1.0 mg/L

analytically measured concentrations:
day 4: 0.00249 mg/L
day 7: 0.00246mg/L;
day 14: 0.00244 mg/L
day 21: 0.00249mg/L
day 28: 0.00241 mg/L
day 35: 0.00248 mg/L

nominal concentration 0.00025 mg/L
Solubilizer used: HCO-40, 1 g/L
analytically measured concentrations:
day 4: 0.000255 mg/L
day 7: 0.000247mg/L;
day 14: 0.000247 mg/L
day 21: 0.000252mg/L
day 28: 0.000247 mg/L
day 35: 0.000245 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 0.0025 and 0.000252 mg/L were maintained during the experimental phase.
At days 0, 5, 14, 21, 25 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 and the extract was analysed.

Due to the low bioaccumulation potential, no depuration phase was required.

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

> 0.003 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

> 0.003 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 > 0.0025 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 0.0025 and 0.00025 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

Data from a GLP study according to OECD TG 305 are available.

NOEC (28 d) = 0.0025 mg/L (1 mg/L HCO-40)

LC50 (28 d)  > 0.0025 mg/L (1 mg/L HCO-40)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.003 mg/L

Additional information

NOEC (BCF, 28d) > 0.0025 mg/L