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Long-term toxicity to fish

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Reference
Endpoint:
adult fish: sub(lethal) effects
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
March 15, 2012 to Sep 10, 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
study performed according to OECD 305
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:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Tween 80
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 0.08 mg/L
Dose 1: Test item: 0.02 mg/L , Vehicle: 0.08 mg/L
Vehicle Control: test item: - , Vehicle: 0.08 mg/L
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Common carp Cyprinus carpio (Lot No. 120316)
Supplier: Commercial Breeding Farm (Japan)
Dates purchased Mar 16, 2012
Feeding and acclimatization:
After receiving the fish at the Institute of Ecotoxicology Co., Ltd., those with a total length of approx. 6.7 ± 0.3 cm were selected.
Mean bodyweight 2.88 ± 0.35 g
Mean total length 6.7 ± 0.2 cm
Mortality of fish during the experiment
High exposure level 0%
Low exposure level 0%
Control 0%

Lipid contents (by chloroform/methanol extraction method)
Before experiment 4.8% (Mean value, n=2)
After experiment 4.2 % (Mean value, n=2)
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Test temperature:
26.5 ° +/- 0.2 °C
pH:
7.7 +/- 0.1
Dissolved oxygen:
DO of test water: 7.23 ± 0.1 mg/L
Nominal and measured concentrations:
nominal concentration 0.02 mg/L:
analytically measured concentrations:

day 0: 0.0192 mg/L
day 7: 0.0174 mg/L
day 14: 0.0191 mg/L
day 21: 0.0201 mg/L
day 26: 0.0196 mg/L
day 28: 0.0211 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 at nominal concentrations of 0.04 was maintained at about 100% using solubiliser, respectively.
Key result
Duration:
28 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: concentration was above the water solubility limit stabilized with Tween 80
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: concentration was above the water solubility limit stabilized with Tween 80
Key result
Duration:
28 d
Dose descriptor:
EC50
Effect conc.:
> 0.02 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: concentration was above the water solubility limit stabilized with Tween 80
Duration:
14 d
Dose descriptor:
EC50
Effect conc.:
> 0.02 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: concentration was above the water solubility limit stabilized with Tween 80
Validity criteria fulfilled:
yes
Conclusions:
The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was 0.02 mg/L and thus higher than the limit of water solubility.The test material showed no relevant toxic potential at water saturated conditions.
Executive summary:

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.

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 concentration was maintained using Tween 80 as solubiliser. The concentrations were verified analytically using a HPLC method with UV detection.

There were no mortality and no signs of toxicity detected throughout the study in any dose group up to 28 days of exposure.

The test material showed no relevant toxic potential at water saturated conditions.

Description of key information

The test material showed no toxic potential at concentrations at or above the water solubility when tested in a BCF study with 28 days exposure (uptake phase). The NOEC was 0.02 mg/L and thus higher than the limit of water solubility.The test material showed no relevant toxic potential at water saturated conditions.

Key value for chemical safety assessment

Additional information