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Ecotoxicological information

Short-term toxicity to fish

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Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-12-02 - 2011-01-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: METI Guideline: Concentration Test on Chemical Substances in Fish
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Principles of method if other than guideline:
This study was performed according to GLP and the methods applied were fully compliant with OECD TG 203. However, a solvent was used to increase exposure. The OECD 203 test was performed as part of a GLP compliant OECD TG 305 study.
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
0; 24, 48, 72, 96 h
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION: Done according to guideline.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): TWEEN 20
- Concentration of vehicle in test medium: 15 mg/L vehicle in test item groups and vehicle control group, 0 mg/L in control group without vehicle
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Name: Danio rerio
Weight: 0.29 +/- 0.03 g
Length: 3.4 +/- 0.1 cm
Lot: 101202
Date: 2010-12-02
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
not specified
Test temperature:
25.8 +/- 0.5 °C
pH:
7.7
Dissolved oxygen:
7.1 mg/L
Salinity:
not applicable
Conductivity:
not specified
Nominal and measured concentrations:
5.0, 2.6, 1.3 , 0.7, 0.3, 0 mg/L (measured)
Details on test conditions:
10 fish per 4 L
Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1.8 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: no
- Observations on body length and weight: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: yes

Sublethal observations / clinical signs:
Concentrations / [mg/L]
Mortality / [%]
Test Material
Vehicle
24 h
48 h
72 h
96 h
5.0
15
50
100
100
100
2.6
15
0
30
70
90
1.3
15
0
0
10
20
0.7
15
0
0
0
0
0.3
15
0
0
0
0
0
15
0
0
0
0
0
0
0
0
0
0

96 h LC50 = 1.8 mg/L

Validity criteria fulfilled:
yes
Conclusions:
The LC50 of the test material is at 1.8 mg/L and thus clearly above the limit of water solubility.
Executive summary:

The acute toxicity of the test material was studied in a pretest for a bioaccumulation study (OECD 305) using solvents to increase exposure. The GLP test was performed according to the METI Guideline: Concentration Test on Chemical Substances in Fish.


To achieve the exposure concentrations, solvent TWEEN 20 was used. All concentrations tested were at or above the solubility limit of the pure test substance. For the test Brachydanio rerio (new name: Danio rerio) was used. The following concentrations have been applied: 5, 2.6, 1.3, 0.7, 0.3 mg/L (adjusted with TWEEN 20 (15 mg/L as vehicle; measured).


The test material caused mortality at concentrations clearly above the water solubility limit. With TWEEN 20 as vehicle, mortality was observed above 1.3 mg/L. The 96 h LC50 amounts to 1.8 mg/L.


The LC50 of the test material is at 1.8 mg/L and thus clearly above the limit of water solubility.

Description of key information

A OECD 203 test was performed as part of a GLP compliant OECD 305 study. To achieve the exposure concentrations, solvent TWEEN 20 was used. All concentrations tested were at or above the solubility limit of the pure test substance. The LC50 of the test material is at 1.8 mg/L and thus clearly above the limit of water solubility.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
1.8 mg/L

Additional information

The acute toxicity of the test material was studied in a pretest for a bioaccumulation study (OECD 305) using solvents to increase exposure. The GLP test was performed according to the METI Guideline: Concentration Test on Chemical Substances in Fish.


To achieve the exposure concentrations, solvent TWEEN 20 was used. All concentrations tested were at or above the solubility limit of the pure test substance. For the test Brachydanio rerio (new name: Danio rerio) was used. The following concentrations have been applied: 5, 2.6, 1.3, 0.7, 0.3 mg/L (adjusted with TWEEN 20 (15 mg/L as vehicle; measured).


The test material caused mortality at concentrations clearly above the water solubility limit. With TWEEN 20 as vehicle, mortality was observed above 1.3 mg/L. The 96 h LC50 amounts to 1.8 mg/L.


The LC50 of the test material is at 1.8 mg/L and thus clearly above the limit of water solubility.