Registration Dossier

Administrative data

Endpoint:
adult fish: sub(lethal) effects
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2005-08-25 to 2005-10-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
study performed according to OECD 305

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

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
Principles of method if other than guideline:
SPAN 20 used as solubilizer
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Batch: L540638
Purity: 99.8% (GC)

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling intervals/frequency for test water analysis: days 0, 7, 14, 21, 23, 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): SPAN 20
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 0.1 and 0.01 mg/l
Dose 1: Test item: 0.02 mg/L , Vehicle: 0.1 mg/L
Dose 2: Test item: 0.002 mg/L , Vehicle: 0.01 mg/L
Vehicle Control: test item: - , Vehicle: 0.1 mg/L

Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
Weight: 2.76 +/- 0.32 g
Length: 6.20 +/- 0.30 cm
Lot: 50111
Date: 2005-01-11

Study design

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

Test conditions

Test temperature:
25 ° +/- 2 °C
pH:
7.7 +/- 0.0
Dissolved oxygen:
7.4 +/- 0.1 mg/L
Nominal and measured concentrations:
nominal concentration 0.02 mg/L:
analytically measured concentrations:
day 0: 0.0181 mg/L;
day 7: 0.0218 mg/L;
day 14: 0.0209 mg/L
day 21: 0.0214 mg/L
day 23: 0.0210 mg/L
day 28: 0.0182 mg/L

nominal concentration 0.002 mg/L
analytically measured concentrations:
day 0: 0.00220 mg/L
day 7: 0.00217 mg/L
day 14: 0.00195 mg/L
day 21: 0.00211 mg/L
day 23: 0.00188 mg/L
day 28: 0.00210 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 0.02 and 0.002 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
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
0.02 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
0.02 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 > 0.02 mg/L and thus higher than the limit of water solubility.The test material showed no relevant toxic potential at water saturated conditions.