Registration Dossier

Administrative data

Endpoint:
adult fish: sub(lethal) effects
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2011-07-29 to 2011-09-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
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

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Batch: E011009938

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling intervals/frequency for test water analysis: days 0, 7, 14, 21, 26, 28

Test solutions

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 / SPAN 80 = 3 / 1
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 0.024 and 0.024 mg/l
Dose 1: Test item: 0.008 mg/L , Vehicle: 0.024 mg/L
Dose 2: Test item: 0.0008 mg/L , Vehicle: 0.0024 mg/L
Vehicle Control: test item: - , Vehicle: 0.024 mg/L

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
Weight: 3.07 +/- 0.23 g
Length: 6.70 +/- 0.20 cm
Lot: 110419
Date: 2011-04-19

Study design

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

Test conditions

Test temperature:
24.7 ° +/- 0.2 °C
pH:
6.5 +/- 0.2
Dissolved oxygen:
6.5 +/- 0.2
Nominal and measured concentrations:
nominal concentration 0.008 mg/L:
analytically measured concentrations:
day 0: 0.00799 mg/L;
day 7: 0.00788 mg/L;
day 14: 0.00780 mg/L
day 21: 0.00792 mg/L
day 26: 0.00788 mg/L
day 28: 0.00797 mg/L

nominal concentration 0.0008 mg/L
analytically measured concentrations:
day 0: 0.000776 mg/L
day 7: 0.000775 mg/L
day 14: 0.000764 mg/L
day 21: 0.000781 mg/L
day 26: 0.000778 mg/L
day 28: 0.000784 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 of 0.008 and 0.0008 mg/L were maintained at about 100% using solubiliser, respectively. At days 0, 7, 14, 21, 26 and 28 two fish each were removed from each test group. Body weight was determined.

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
> 0.008 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.:
> 0.001 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality

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 > 0.008 mg/L and thus higher than the limit of water solubility.The test material showed no relevant toxic potential at water saturated conditions.