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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-11-09 to 2015-11-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD test guideline 203 and EU method C.1
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: all
- Sampling method: daily taken from freshly prepared test media and from corresponding aged test media after 24h. The test item concentrations were diluted with fish dilution water with the last dilution step in a 20 mL headspace vial containing approx. 1 g sodium chloride. 100 pL methanol were added to the vials before sealing.
- Sample storage conditions before analysis: Original samples were stored at room temperature before preparation, if necessary. All prepared samples were stored at room temperature (in autosampler) before start of analysis, if necessary.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Appropriate volumes of the test item were pipetted into measuring flasks filled with 5000 mL of the dilution water. The test media were stirred on a magnetic stirrer (30 minutes, 1100 rpm, room temperature). This procedure was repeated for each renewal day.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebrafish
- Source: single brood stock (supplier: Umweltbundesamt, Schichauweg 58, D-12307 Berlin)
- Length at study initiation (length definition, mean, range and SD): mean: 2.34 cm
- Weight at study initiation (mean and range, SD): mean: 0.156 g
- Feeding during test: no

ACCLIMATION
- Acclimation period: 12 d
- Acclimation conditions (same as test or not): same
- Type and amount of food: Sera Vipan, 4% of fish body weight per feeding day
- Feeding frequency: 3 times/week (The fish were not be fed 24 h before test start)
- Health during acclimation (any mortality observed): no mortality observed
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
10-250 mg CaCO3/L
Test temperature:
22.1 - 23.2°C
pH:
6..0 -8.5
Dissolved oxygen:
87 - 100% saturation
Nominal and measured concentrations:
Nominal: 0 (control), 0.342, 0.751, 1.65, 3.64, 8.00 mg/L
Measured (geometric mean):
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquaria of 13 L were used, filled with 5 L of dilution water (dimensions: 25.5/18/28 cm, depth of water: 20 cm)
- Type: semi-static (covered with aluminium foil)
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.218 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin
- Chlorine: filtered on activated charcoal and aerated for at least 24 hours to remove chlorine
- Hardness: 10 - 250 mg CaCO3/L
- pH: 6.0 - 8.5
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 9 hours/day
- Light intensity: mean: 0.81 µmol photons/m²s

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, visible abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation, etc.) after 2, 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Range finding study: yes
- Test concentrations: preliminary test with 0.5 mg/L (43% mortality), first definitive test as limit test with 6.8 mg/L (100% mortality)
- Results used to determine the conditions for the definitive study: yes, full test with 5 test concentrations
Reference substance (positive control):
not required
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
2.2 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
3.47 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CI: 2.20 - 5.46 mg/L
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
5.46 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities:
- Observations on body length and weight:
- Other biological observations: staggering, missing escape reflex and hyperventilation observed in highest test concentration (5.46 mg/L)
- Mortality of control: no
- Other adverse effects control: no
Sublethal observations / clinical signs:

Table 1: Cumulative mortality (%) (n=7)

Geometric mean measured concentration (mg/L)

Cumulative mortality (%) after different exposure periods (hours)

 

2

24

48

72

96

5.46

0

0

0

86

100

2.20

0

0

0

0

0

1.12

0

0

0

0

0

0.712

0

0

0

0

0

0.249

0

0

0

0

0

Control

0

0

0

0

0

 

Table 2: Environmental conditions

Exposure time (days)

Geometric mean measured concentration (mg/L)

Mean oxygen saturation (%)

pH value

Temperature (°C)

0

5.46

100

7.69

22.1

2.20

100

7.69

22.1

1.12

100

7.68

22.2

0.712

100

7.67

22.2

0.249

100

7.61

22.1

Control

100

7.51

22.1

1

5.46

94.5

7.40

23

2.20

94

7.37

22.8

1.12

94

7.37

22.9

0.712

94.5

7.35

22.9

0.249

95.5

7.19

22.8

Control

94.5

7.08

22.8

2

5.46

96.5

7.44

22.9

2.20

95

7.41

22.9

1.12

95

7.37

23

0.712

95.5

7.31

22.9

0.249

95.5

7.20

23

Control

94.5

7.06

22.7

3

5.46

95

7.42

23.1

2.20

95

7.22

23.1

1.12

96

7.19

23

0.712

96

7.16

23.1

0.249

96

7.13

23

Control

95

7.10

22.9

4

5.46

90

7.36

23.1

2.20

87

7.35

23.1

1.12

89

7.33

22.9

0.712

92

7.30

23

0.249

91

7.23

23

Control

87

7.22

22.9

- no measurements due to 100% mortality

 

Validity criteria fulfilled:
yes
Conclusions:
The toxicity of the test item on Danio rerio was tested in a GLP study according to OECD 203. The LC50 was determined to be 3.47 mg/L based on mean measured concentrations.

Description of key information

LC50 (96 h): 3.47 mg/L based on mortality of D. rerio (OECD 203).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
3.47 mg/L

Additional information

The toxicity of the test item to fish was determined in a semi-static test performed according to OECD 203 and GLP. Individuals of Danio rerio were exposed to nominal test concentrations of 0.342, 0.751, 1.65, 3.64 and 8.00 mg/L, equivalent to geometric mean measured concentrations of 0.249, 0.712, 1.12, 2.20 and 5.46 mg/L. The test concentrations were analysed by GC-FID daily. After 96 h 100% mortality was observed at 5.46 mg/L whereas 0% mortality was recorded at 2.2 mg/L. The LC50 (96 h) was calculated at 3.47 mg/L (measured).