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 July 22, 2013 to Sep 17, 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
study performed according to OECD 305
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)
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals/frequency for test organisms: days 0, 7, 14, 21, 23, 28
Vehicle:
yes
Details on test solutions:
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)): 0.03 and 0.003 mg/l
Dose 1: Test item: 0.001 mg/L , Vehicle: 0.03 mg/L
Dose 2: Test item: 0.0001 mg/L , Vehicle: 0.003 mg/L
Vehicle Control: test item: - , Vehicle: 0.03 mg/L
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Common carp Cyprinus carpio (Lot No. 90325)
Supplier: Commercial Breeding Farm (Japan)
Dates purchased Jul 17, 2013
Feeding and acclimatization:
After receiving the fish at the Institute of Ecotoxicology Co.,
Ltd., those with a total length of approx. 8.0 ± 4.0 cm were
selected.
Mean bodyweight 3.07 ± 0.14 g
Mean total length 5.5 ± 0.2 cm
Mortality of fish during the experiment
High exposure level 0%
Low exposure level 0%
Control 0%

Lipid contents (by chloroform/methanol extraction method)
Before experiment 5.2% (Mean value, n=2)
After experiment 5.2 % (Mean value, n=2)
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Test temperature:
26.5 ° +/- 0.5 °C
pH:
7.7 +/- 0.1
Dissolved oxygen:
DO of test water: 7.3 ± 0.1 mg/L
Nominal and measured concentrations:
nominal concentration 0.02 mg/L:
analytically measured concentrations:

day 7: 0.0185 mg/L;
day 14: 0.0213 mg/L
day 21: 0.0183 mg/L
day 24: 0.0188 mg/L
day 28: 0.0168 mg/L

nominal concentration 0.002 mg/L
analytically measured concentrations:

day 7: 0.00198 mg/L
day 14: 0.00198 mg/L
day 21: 0.00189 mg/L
day 24: 0.00198 mg/L
day 28: 0.00187 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, 23 and 28. The analytical values at nominal concentrations of 0.01 and 0.001 mg/L were maintained at about 100% using solubiliser, respectively.
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
0.01 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: concentration was above the water solubility limit stabilized with Tween 80
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
0.01 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: concentration was above the water solubility limit stabilized with Tween 80
Key result
Duration:
28 d
Dose descriptor:
EC50
Effect conc.:
> 0.01 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: concentration was above the water solubility limit stabilized with Tween 80
Duration:
14 d
Dose descriptor:
EC50
Effect conc.:
> 0.01 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: concentration was above the water solubility limit stabilized with Tween 80
Validity criteria fulfilled:
yes
Conclusions:
The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was 0.01 mg/L and thus higher than the limit of water solubility.The test material showed no relevant toxic potential at water saturated conditions.

Description of key information

The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was 0.01 mg/L and thus higher than the limit of water solubility.The test material showed no relevant toxic potential at water saturated conditions.

Key value for chemical safety assessment

Additional information