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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:
from 2015-12-21 to 2016-02-19
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 medium samples: days 0, 4, 7, 11, 14, 18, 21, 25, 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): HCO-40
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 0.0015 and 0.00015 mg/l
Dose 1: Test item: 0.00148 mg/L , Vehicle: 15 mg/L
Dose 2: Test item: 0.000148 mg/L , Vehicle: 1.5 mg/L
Vehicle Control: test item: - , Vehicle: 15 mg/L
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Weight: 8.5 g
Length: 9.0 cm
Lot: 150608c
Date: 2015-08-06
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Test temperature:
23 - 24.2 °C
pH:
7.3-7.9
Dissolved oxygen:
6.1 - 7.5 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, 4, 7, 11, 14, 18, 21, 25 and 28. The analytical values show that the nominal concentrations of 0.0015 and 0.00015 mg/L were maintained at about 100% using solubiliser, respectively.
Reference substance (positive control):
no
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
> 0.002 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: solubiliser HC-O was applied
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
> 0.002 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: solubiliser HC-O was applied
Validity criteria fulfilled:
yes
Conclusions:
The test material showed no toxic potential at concentrations at or above the water solubility. The NOEC was 0.0015 mg/L and thus higher than the limit of water solubility.The test material showed no relevant toxic potential at water saturated conditions.
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 0.0015 and 0.00015 mg/Lwere used in this study. The exposure was concentration was maintained using HCO-40 as solubiliser. The concentrations were 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 water saturated conditions.

Description of key information

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


NOEC (28 d) > 0.00155 mg/L (1 mg/L HCO-40)


LC50 (28 d)  > 0.00155 mg/L (1 mg/L HCO-40)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
NOEC
Effect concentration:
> 0.002 mg/L

Additional information

NOEC (BCF, 28d) > 0.00155 mg/L