Registration Dossier

Ecotoxicological information

Long-term toxicity to fish

Currently viewing:

Administrative data

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:
from 05-06-2003 to 04-07- 2003
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
- Details on sampling and analysis of test organisms and test media samples: Water: Extraction with CH2Cl2 with further HPLC analysis.
Vehicle:
yes
Details on test solutions:
- Solubilising agent: Tween 80
- Concentration of the solubilising agent: 20 mg/L
Test organisms (species):
Cyprinus carpio
Details on test organisms:
- Weight: 2.82 g
- Length: 6.4 cm
- Lot: 30407
- Acclimatisation: 07.04.2003 - 29.05.2003
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Hardness:
250 mg/L
Test temperature:
24.6 °C
pH:
7.1
Dissolved oxygen:
7.3 mg/L
Salinity:
According to guideline
Nominal and measured concentrations:
Concentrations: 0.05 mg/L, 0.005 mg/L
Reference substance (positive control):
no
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
> 0.05 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.:
> 0.05 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: none
- Mortality and/or behavioural abnormalities of control: none
- Loss of test substance during test period: none
- Results with vehicle control: no effects
Validity criteria fulfilled:
yes
Conclusions:
The test item showed no toxic potential at concentrations at or above the water solubility. The NOEC was determined to be > 0.05 mg/L and thus higher than the limit of water solubility.
Executive summary:

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 item concentrations for exposure to Cyprinus carpio. 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. Two environmental concentrations of the test item were used in this study - 0.05 and 0.005 mg/L. The exposure concentration was maintained using Tween 80 as solubiliser. The concentrations were verified analytically using a HPLC method with UV detection. There was no mortality and no signs of toxicity detected throughout the study in any dose group up to 28 days of exposure. The test item showed no relevant toxic potential at concentrations above the limit of the water solubility. The NOEC at 14-d and 28-d exposure was determined to be >0.05 mg/L.

Description of key information

The test item showed no toxic potential at concentrations at or above the water solubility. The NOEC was determined to be > 0.05 mg/L and thus higher than the limit of water solubility.

Key value for chemical safety assessment

Additional information

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 item concentrations for exposure to Cyprinus carpio. 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. Two environmental concentrations of the test item were used in this study - 0.05 and 0.005 mg/L. The exposure concentration was maintained using Tween 80 as solubiliser. The concentrations were verified analytically using a HPLC method with UV detection. There was no mortality and no signs of toxicity detected throughout the study in any dose group up to 28 days of exposure. The test item showed no relevant toxic potential at concentrations above the limit of the water solubility. The NOEC at 14-d and 28-d exposure was determined to be >0.05 mg/L (reference 6.1.2-1).