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:
2011-02-24 to 2011-02-24
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:

Purity: >99.87%
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals/frequency for test medium samples: days 0, 7, 14, 21, 26, and 28
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): Tween 80
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)):
Test solution 1: 0.003 mg/L test material, 0.012 mg/L Tween 80
Test solution 2: 0.0003 mg/L test material, 0.0012 mg/L Tween 80
Control: 0.012 mg/L Tween 80
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Weight: 2.88 +/- 0.26 g
Length: 6.7 +/- 0.2 cm
Lot: 110112
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Test temperature:
24.8 ° +/- 0.2 °C
pH:
7.8 +/- 0.1
Dissolved oxygen:
7.8 mg/L +/- 0.1 mg/L
Nominal and measured concentrations:
nominal concentration
0.0005 mg/L:
analytically measured concentrations:
day 7: 0.000463 mg/L;
day 14: 0.000515 mg/L
day 21: 0.000508 mg/L
day 26: 0.000447 mg/L
day 28: 0.000453 mg/L
day 30: 0.000480 mg/L

nominal concentration
0.00005 mg/L:
analytically measured concentrations:
day 7: 0.0000497 mg/L;
day 14: 0.0000521 mg/L
day 21: 0.0000523 mg/L
day 26: 0.0000463 mg/L
day 28: 0.0000436 mg/L
day 30: 0.0000423 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 show that the nominal concentrations were maintained at about
Reference substance (positive control):
no
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.003 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: solubilzer TWEEN 80 was applied
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.003 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: solubilzer TWEEN 80 was applied
Duration:
14 d
Dose descriptor:
EC50
Effect conc.:
> 0.003 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: solubilzer TWEEN 80 was applied
Duration:
28 d
Dose descriptor:
EC50
Effect conc.:
> 0.003 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: solubilzer TWEEN 80 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 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 0.003 and 0.0003 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 30 days of exposure.

Conclusion

The test material showed no relevant toxic potential at a concentration of 0.003 mg/L. The NOEC was >= 0.003 mg/L and the EC (48 h) clearly exceeds 0.003 mg/L.

Validity criteria fulfilled:
yes
Conclusions:
The test material showed no relevant toxic potential at a concentration of 0.003 mg/L. The NOEC was >= 0.003 mg/L and the EC (48 h) clearly exceeds 0.003 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 0.003 mg/L. The NOEC was >= 0.003 mg/L and the EC (48 h) clearly exceeds 0.003 mg/L.

Description of key information

For this endpoint data from a long term (28 d) bioconcentration study provide adequate information.

This study has used Tween 80 as vehicle to increase water solubility. In the long term 28 days study no mortality was observed up to 0.003 mg/L. Therefore the test material does not exhibit a significant potential for toxicity up 0.003 mg/L. To ensure maximum exposure above the water solubility of the pure substance, solubiliser TWEEN 80 was applied.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.001 mg/L

Additional information

NOEC (BCF, 28d) >= 0.0005 mg/L (with Tween 80 as solubiliser).