4-trans-Propyl-4-trans-(3,4,5-trifluorphenyl)-[1,1-bicyclohexyl]

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:

2000-09-14 to 2000-12-27

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)

Specific details on test material used for the study:

Batch: E998833

Analytical monitoring:

yes

Details on sampling:

- Sampling intervals/frequency for test organisms: days 0, 7, 14, 21, 28, 35, 42, 49, and 60

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)):
Test solution 1: 0.02 mg/L mg/L test material, 0.4 mg/L HCO-40
Test solution 2: 0.002 mg/L test material, 0.04 mg/L HCO-40
Control: 0.4 mg/L HCO-40

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Weight: 5 g
Length: 8 +/- 4 cm
Lot: 00-K-0630

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

60 d

Test temperature:

23.4-24.2°C

pH:

7.2-7.7

Dissolved oxygen:

7.1-7.5 mg/L

Nominal and measured concentrations:

nominal concentration
0.02 mg/L:
analytically measured concentrations:
day 7: 0.0203 mg/L;
day 14: 0.0201 mg/L
day 21: 0.0204 mg/L
day 28: 0.0202 mg/L
day 35: 0.0203 mg/L
day 42: 0.0202 mg/L
day 49: 0.0199 mg/L
day 60: 0.0198 mg/L

nominal concentration
0.002 mg/L:
analytically measured concentrations:
day 7: 0.00179 mg/L;
day 14: 0.00182 mg/L
day 21: 0.00182 mg/L
day 28: 0.00186 mg/L
day 35: 0.00189 mg/L
day 42: 0.00191 mg/L
day 49: 0.00189 mg/L
day 60: 0.00189 mg/L

Reference substance (positive control):

no

Key result

Duration:

60 d

Dose descriptor:

NOEC

Effect conc.:

>= 0.02 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: solubilzer HCO-40 was applied

Key result

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 0.02 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: solubilzer HCO-40 was applied

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

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 60 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 0.02 and 0.002 mg/Lwere used in this study. The exposure was concentration was maintained using HCO-40 as solubiliser. The concentrations were verified analytically using a GC method with MS detection.

Results

There were no mortality and no signs of toxicity detected throughout the study in any dose group up to 60 days of exposure.

Conclusion

The test material showed no relevant toxic potential at a concentration of 0.02 mg/L. The NOEC was >= 0.02 mg/L and the EC (48 h) clearly exceeds 0.02 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

The test material showed no relevant toxic potential at a concentration of 0.02 mg/L. The NOEC was >= 0.02 mg/L and the EC (48 h) clearly exceeds 0.02 mg/L.

Executive summary:

The informtion for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 305.

The test material showed no relevant toxic potential at a concentration of 0.02 mg/L. The NOEC was >= 0.02 mg/L and the EC (48 h) clearly exceeds 0.02 mg/L.

Description of key information

For this endpoint data from a long term (60 d) bioconcentration study provide adequate information.

This study has used HCO-40 as vehicle to increase water solubility. In the long term 60 days study no mortality was observed up to 0.02 mg/L. Therefore, the test material does not exhibit a significant potential for toxicity up to 0.02 mg/L. To ensure maximum exposure above the water solubility of the pure substance, solubiliser HCO-40 was applied.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.02 mg/L

Additional information

NOEC (BCF, 28d) >= 0.02 mg/L (with HCO-40 as solubiliser).