(trans,trans)-5-{(4-Propyl[1,1-bicyclohexyl]-4-yl)-difluormethoxy}-1,2,3-trifluorbenzene

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Reference

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2005-02-07 to 2005-04-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

HCO-40 was used as solubilizer

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch:S000033
Purity: 99.5% (GC)

Radiolabelling:

no

Details on sampling:

- Sampling intervals/frequency for test organisms: days 0, 4, 7, 14, 21, 28
- Sampling intervals/frequency for test medium samples: days 0, 4, 7, 14, 21, 28
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods):
Water: Extraction with CH2Cl2 with further GC analysis.
Fish: two fish per sampling homogenised, and extracted with acetonitril/n-hexane. The analysis was performed using HPLC.

Vehicle:

yes

Details on preparation of test solutions, spiked fish food or sediment:

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: 500 mg/L
Dose 2: Test item: 0.05 mg/L , Vehicle: 50 mg/L

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Weight: 7.1 g
Length: 8.4 cm
Lot: 050113c
Date: 2005-02-24

Route of exposure:

aqueous

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

28 d

Test temperature:

25 ° +/- 2 °C

pH:

7.4 - 7.5

Salinity:

According to guideline

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

Nominal and measured concentrations:

nominal concentration 0.5 mg/L:
analytically measured concentrations:

day 4: 0.500 mg/L;
day 7: 0.497 mg/L;
day 14: 0.491 mg/L
day 21: 0.505 mg/L
day 28: 0.510 mg/L

nominal concentration 0.05 mg/L
analytically measured concentrations:

day 4: 0.0490 mg/L;
day 7: 0.0483 mg/L
day 14: 0.0487 mg/L
day 21: 0.0488 mg/L
day 28: 0.0472 mg/L

Details on estimation of bioconcentration:

according to guideline

Conc. / dose:

0.5 mg/L

Temp.:

25 °C

pH:

7.5

Type:

BCF

Value:

7 dimensionless

Basis:

normalised lipid fraction

Time of plateau:

4 d

Calculation basis:

steady state

Conc. / dose:

0.05 mg/L

Temp.:

25 °C

pH:

7.5

Type:

BCF

Value:

19 dimensionless

Basis:

not specified

Time of plateau:

4 d

Calculation basis:

steady state

Details on kinetic parameters:

Steady state was reached within 4 days
Due to the low uptake, no depuration phase was necessary

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 relevant bioaccumulation at concentrations at or above the water solubility. The steady state BCF values were at 7 and 19 (mean 12).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Bioaccumulation test of a chemical substance in fish or shellfish" provided in "the Notice on the Test Method Concerning New Chemical Substances"

Version / remarks:

Range finder to OECD 305

Principles of method if other than guideline:

RANGE-FINDING / PRELIMINARY STUDY for OECD 305

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(trans,trans)-5-{(4-Propyl[1,1-bicyclohexyl]-4-yl)-difluormethoxy}-1,2,3-trifluorbenzene

EC Number:

606-647-0

Cas Number:

208338-50-5

Molecular formula:

C₂₂H₂₉F₅O

IUPAC Name:

(trans,trans)-5-{(4-Propyl[1,1-bicyclohexyl]-4-yl)-difluormethoxy}-1,2,3-trifluorbenzene

Test organisms

Test organisms (species):

Oryzias latipes

Details on test organisms:

TEST ORGANISM
- Common name: Medeka , Rice fish
- Length at study initiation: 3.3 cm (3.1-3.5 cm)
- Weight at study initiation: 0.4 g

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Test temperature:

25 °C +- 2 °C

pH:

7.2 - 7.5

Nominal and measured concentrations:

100 mg/L nominal

Details on test conditions:

according to guideline

Results and discussion

Effect concentrations

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes