4-[Difluor(3,4,5-trifluorphenoxy)methyl]-3,5-difluor-4'-propyl-1,1'-biphenyl

Long-term toxicity to fish

Administrative data

Endpoint:

adult fish: sub(lethal) effects

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2004-11-15 to 2005-01-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

study performed according to OECD 305

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluoro-4'-propyl-1,1'-biphenyl

EC Number:

608-462-0

Cas Number:

303186-20-1

Molecular formula:

C22H15F7O

IUPAC Name:

4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluoro-4'-propyl-1,1'-biphenyl

Specific details on test material used for the study:

Batch:S000034
Purity: 99.5% (GC)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals/frequency for test medium samples: days 0, 7, 14, 21, 28

Test solutions

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)): 0.5 and 0.05 mg/l
Dose 1: Test item: 0.50 mg/L , Vehicle: 30 mg/L
Dose 2: Test item: 0.05 mg/L , Vehicle: 30 mg/L
Vehicle Control: test item: - , Vehicle: 30 mg/L

Test organisms

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Weight: 7.7 g
Length: 8.7 cm
Lot: 040906c
Date: 2004-11-26

Study design

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

28 d

Test conditions

Test temperature:

25 ° +/- 2 °C

pH:

7.7 +/- 0.0

Dissolved oxygen:

7.4 +/- 0.1 mg/L

Nominal and measured concentrations:

nominal concentration 0.02 mg/L:
analytically measured concentrations:

day 7: 0.0185 mg/L;
day 14: 0.0213 mg/L
day 21: 0.0183 mg/L
day 24: 0.0188 mg/L
day 28: 0.0168 mg/L

nominal concentration 0.002 mg/L
analytically measured concentrations:

day 7: 0.00198 mg/L
day 14: 0.00198 mg/L
day 21: 0.00189 mg/L
day 24: 0.00198 mg/L
day 28: 0.00187 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, and 28. The analytical values show that the nominal concentrations of 0.5 and 0.05 mg/L were maintained at about 100% using solubiliser, respectively. At days 0, 7, 14, 21 and 28 two fish each were removed from each test group. Body weight was determined. The fish were homogenised and extracted using organic solvents. The extract was analysed with HPLC. Due to the low bioaccumulation potential, no depuration phase was required.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

0.5 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Effect concentrations 2

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

0.5 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was 0.5 mg/L and thus higher than the limit of water solubility.The test material showed no relevant toxic potential at water saturated conditions.