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Diss Factsheets

Ecotoxicological information

Long-term toxicity to fish

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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:
2006-08-21 to 2006-11-15
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.
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)
Specific details on test material used for the study:
Puritiy: > 99.0 %
Analytical monitoring:
yes
Details on sampling:
- Sampling intervals/frequency for test organisms: days 0, 5, 8, 14, 21, 28
- Sampling intervals/frequency for test medium samples: days 0, 5, 8, 14, 21, 28
Vehicle:
yes
Details on test solutions:
According to guideline

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- 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)): 12 mg/l

Dose 1: Test item: 0.2 mg/L ,
Dose 2: Test item: 0.02 mg/L
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Cyprinus carpio
Lot: 060710c
Weight: 5.8 g
Length: 7.3 cm

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Hardness:
250 g/L
Test temperature:
25.0 ° +/- 0.4 °C
pH:
7
Dissolved oxygen:
saturated
Nominal and measured concentrations:
nominal concentration 0.20 mg/L:
Solubilizer used: HCO-40, 12 mg/L

analytically measured concentrations:
day 4: 0.200 mg/L
day 7: 0.195 mg/L;
day 14: 0.196 mg/L
day 21: 0.198 mg/L
day 28: 0.201 mg/L


nominal concentration 0.02 mg/L
Solubilizer used: HCO-40, 12 g/L
analytically measured concentrations:
day 4: 0.0200 mg/L
day 7: 0.0199mg/L;
day 14: 0.0198 mg/L
day 21: 0.0200mg/L
day 28: 0.0200 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, 5, 14, 21, and 28. The analytical values show that the nominal concentrations of 0.2 and 0.02 mg/L were maintained during the experimental phase.


Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
0.2 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Concentrations maintained using HCO-40
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
0.2 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Concentrations maintained using HCO-40
Validity criteria fulfilled:
yes
Conclusions:
The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was 0.2 mg/L and thus higher than the limit of water solubility.
Executive summary:

Purpose


The purpose of this study was to determine the bioconcentration potential of the test material in fish under flow-through conditions. During the GLP compliant test the lethal and other effects in fish were determined during the exposure period of 28 days.


 


Study Design


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 0.20 and 0.020 mg/L were used in this study. HCO-40 was used as vehicle at concentrations of 12 mg/L. The exposure was maintained during the couse of the study at expected nominal values. The concentrations have been verified analytically using a HPLC method with UV detection.


 


Results


There were no mortality and no signs of toxicity detected throughout the study in any dose group up to 28 days of exposure.


 


Conclusion


The test material showed no relevant toxic potential at concentrations above the limit of water solubility.

Description of key information

Data from a GLP study according to OECD TG 305 are available.

NOEC (28 d) = 0.20 mg/L (12 mg/L HCO-40)

LC50 (28 d)  > 0.20 mg/L (12 mg/L HCO-40)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.2 mg/L

Additional information

NOEC (BCF, 28d) > 0.20 mg/L