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Long-term toxicity to fish

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Reference
Endpoint:
long-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 Sep 2005 - 05 Dec 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP study performed according to OECD TG 305
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Deviations:
yes
Remarks:
Longer exposure period - 28 days
Qualifier:
according to guideline
Guideline:
other: OECD 305
Principles of method if other than guideline:
longer exposure period (28 days)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals/frequency for test medium samples: days 7, 14, 21, 26, 28
- Sample storage conditions before analysis: no storage
- Analysis: HPLC
Vehicle:
yes
Details on test solutions:
HCO-40: 10 g/L as solubiliser
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Weight: 6.6 g
Length: 8.3 cm
Lot: 050714c
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Test temperature:
24.6 - 25 °C
pH:
7.3-7.4
Dissolved oxygen:
saturated
Salinity:
According to guideline
Nominal and measured concentrations:
nominal concentration 0.5 mg/L:
analytically measured concentrations:
day 4: 0.199 mg/L
day 7: 0.196 mg/L;
day 14: 0.194 mg/L
day 21: 0.198 mg/L
day 28: 0.196 mg/L

nominal concentration 0.05 mg/L
analytically measured concentrations:
day 4: 0.0200 mg/L
day 7: 0.0202 mg/L
day 14: 0.0194 mg/L
day 21: 0.0201 mg/L
day 28: 0.0195 mg/L
Reference substance (positive control):
no
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
> 0.2 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
> 0.2 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
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 toxic potential at concentrations at or above the water solubility. The NOEC was > 0.2 mg/L and thus higher than the limit of water solubility.
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 0.2 and 0.02 mg/Lwere used in this study. The exposure was concentration was maintained using HCO-40 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 concentrations above the limit of water solubility.

Description of key information

The information 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.

NOEC > 0.2 mg/L

Key value for chemical safety assessment

Additional information

For this compound a bioconcentration study according to OECD 305 was performed. In the study solubilizer was applied to achieve maximum exposure above the water solubility of the pure substance. No toxicological relevant effects have been reported after 28 days of exposure.

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