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:
937-72-1*
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD 305 and METI Guideline: Concentration Test on Chemical Substances in Fish.
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
Qualifier:
according to
Guideline:
other: METI Guideline: Concentration Test on Chemical Substances in Fish
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
Batch: E004115
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals/frequency for test medium samples: days 4, 11, 25, 32, 46, 60
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Solutions prepared with vehicle
- Controls: vehicle control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): HCO-40
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 800 mg/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Length: 7.3 - 10.0 cm
Batch: TFC-000920-II
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
60 d
Test temperature:
25 +/- 2 °C
pH:
7.7-8.1
Dissolved oxygen:
7.6 - 8.1 mg/L
Nominal and measured concentrations:
Nominal concentration: 0.1 mg/L
Measured on day
4 0.0951 mg/L
11 0.1000 mg/L
25 0.0981 mg/L
32 0.0962 mg/L
46 0.0961 mg/L
60 0.0979 mg/L

Nominal concentration: 0.01 mg/L
Measured on day
4 0.00930 mg/L
11 0.00977 mg/L
25 0.00927 mg/L
32 0.00956 mg/L
46 0.00992 mg/L
60 0.00968 mg/L
Key result
Duration:
60 d
Dose descriptor:
NOEC
Effect conc.:
> 0.1 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
> 0.1 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Validity criteria fulfilled:
yes
Conclusions:
The test material showed no toxic potential at concentrations at or above the water solubility (NOEC > 0.1 mg/L ).

Description of key information

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 305.

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 material concentrations for exposure to Cyprinus carpio. Two environmental concentrations of the test material of 0.1 and 0.01 mg/L were used in this study. HCO-40 was used as vehicle at concentrations of 800 mg/L. The exposure was maintained during the course of the study at about 95 % of the nominal concentrations. The concentrations have been verified analytically using a GC method with FID detection. There were no mortality and no signs of toxicity detected throughout the study in any dose group up to 60 days of exposure. The test material showed no relevant toxic potential at concentrations above the limit of water solubility.