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Ecotoxicological information

Long-term toxicity to fish

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Reference
Endpoint:
adult fish: sub(lethal) effects
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2007-12-12 to 2008-03-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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: L57020431
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals/frequency for test medium samples: days 0, 7, 14, 21, 23, 28, 30
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 (Polyoxyethylen Sorbitan Monooleate)
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 0.025 and 0.0025 mg/l
Dose 1: Test item: 0.025 mg/L , Vehicle: 0.075 mg/L
Dose 2: Test item: 0.0025 mg/L , Vehicle: 0.0075 mg/L
Vehicle Control: test item: - , Vehicle: 0.075 mg/L
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Weight: 5.2 +/- 0.64 g
Length: 7.6 +/- 0.30 cm

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
30 d
Test temperature:
25 °C
pH:
7.75 +/- 0.25
Dissolved oxygen:
7.4 mg/L
Nominal and measured concentrations:
nominal concentration 0.02 mg/L:
analytically measured concentrations:
day 0: 0.0235 mg/L;
day 7: 0.0238 mg/L;
day 14: 0.0229 mg/L
day 21: 0.0253 mg/L
day 23: 0.0239 mg/L
day 28: 0.0238 mg/L
day 30. 0.0261 mg/L

nominal concentration 0.003 mg/L
analytically measured concentrations:
day 0: 0.00222 mg/L
day 7: 0.00242 mg/L
day 14: 0.00235 mg/L
day 21: 0.00265 mg/L
day 23: 0.00227 mg/L
day 28: 0.00238 mg/L
day 30: 0.00238 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, 28, and 30. The analytical values show that the nominal concentrations of 0.025 and 0.0025 mg/L were maintained at about 100% using Tween 80, respectively. At days 0, 7, 14, 21, 23, 28, and 30 two fish each were removed from each test group. Body weight was determined.
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
> 0.025 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.:
> 0.025 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. The NOEC was > 0.02 mg/L and thus higher than the limit of water solubility.

Description of key information

GLP OECD 305: NOEC (BCF, 28d) = 0.025 mg/L (with Tween 80 as solubiliser)

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater fish:
0.025 mg/L

Additional information

For this endpoint data from a long term (30 d) bioconcentration study provide adequate information. This study has used Tween 80 as vehicle to increase water solubility. In the long term 30 days study no clinical signs and no mortality was observed up to 0.025 mg/L. Therefore the test material does not exhibit a significant potential for toxicity up the limit of water solubility.