Registration Dossier

Administrative data

Endpoint:
long-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 Jun 2003 - 04 Jul 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD TG 305

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Qualifier:
according to
Guideline:
other: OECD 305
Principles of method if other than guideline:
longer exposure period (28 days)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: with solubiliser Tween 80, 20 mg/L

Sampling and analysis

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 (e.g. sample preparation, analytical methods):

Water: Extraction with CH2Cl2 with further HPLC analysis.

Test solutions

Vehicle:
yes
Details on test solutions:
Tween 80, 20 mg/L as solubiliser

Test organisms

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

Study design

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d

Test conditions

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:
0.05 mg/L
0.005 mg/L
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
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
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: no
- Mortality and/or behavioural abnormalities of control: no
- Loss of test substance during test period: no
- Results with vehicle control: no effects

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was > 0.05 mg/L and thus higher than the limit of water solubility.
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 0.05 and 0.005 mg/Lwere used in this study. The exposure was concentration was maintained using Tween 80 as solubiliser. The concentrations were verified analytically using a HPLC method with UV detection.

Results

There were 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.