1-Butyloxy-2,3-difluor-4-(4-trans-propylcyclohexyl)-benzene

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:

2004-11-19 to 2005-01-25

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)

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:

According to guideline PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Chemical name of vehicle (organic solvent, emulsifier or dispersant): SPAN 20- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): Dose 1: Test item: 0.1 mg/L , Vehicle: 0.5 mg/LDose 2: Test item: 0.01 mg/L , Vehicle: 0.05 mg/LControl: Test item: --, Vehicle: 0.5 mg/L

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Lot No. 40726 from 2004-07-26
Weight: 2.11 +/- 0.21 g
Length: 5.7 +/- 0.20 cm

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

28 d

Hardness:

250 mg/L

Test temperature:

25.6 ° +/- 0.4 °C

pH:

7.2 +/- 0.1

Dissolved oxygen:

7.3 +/- 0.4 mg/L

Nominal and measured concentrations:

nominal concentration 0.1 mg/L: analytically measured concentrations: day 0: 0.0926 mg/Lday 7: 0.0913 mg/L day 14: 0.0995 mg/Lday 21: 0.0102 mg/Lday 26: 0.0876 mg/Lday 28: 0.0102 mg/Lnominal concentration 0.01 mg/Lanalytically measured concentrations:day 0: 0.00856 mg/Lday 7: 0.00967 mg/L day 14: 0.00955 mg/Lday 21: 0.00826 mg/Lday 26: 0.00817 mg/Lday 28: 0.00985 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 0.1 and 0.01 mg/L were maintained at about 100% using SPAN 20, 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.

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

> 0.1 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.:

> 0.1 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

Validity criteria fulfilled:

yes

Conclusions:

The test material showed no toxic potential, the NOEC was > 0.1 mg/L.

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 0.1 and 0.01 mg/L were used in this study. SPAN 20 was used as vehicle at concentrations of 0.5 and 0.05 mg/L. The exposure was maintained during the couse of the study at about 100% of the nominal concentrations. The concentrations have been verified analytically using a LC method with UV detection.

Results

There was 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

For this endpoint data from a long term (28 d) bioconcentration study provide adequate information. This study has used SPAN 20 as vehicle to increase water solubility. In the long term 28 days study no mortality was observed up to 0.1 mg/L. Therefore the test material does not exhibit a significant potential for toxicity up the limit of water solubility.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.1 mg/L

Additional information

NOEC (BCF, 28d) > 0.1 mg/L (with SPAN 20 as solubiliser)