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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
yes
Remarks:
The temperature was lower than stated in the guideline. As no mortality occurred during the test, this deviation was stated as not critical
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
The temperature was lower than stated in the guideline. As no mortality occurred during the test, this deviation was stated as not critical
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 and 100 mg/L
- Sampling method: 1.5 mL sample was required for measurement. Each sample was collected from the middle of the aquarium. Care was taken not to collect solid particles (excrements). The unfiltered samples were directly injected in the gas chromatograph
- Sample storage conditions before analysis: The samples were stored in a fridge at 2 – 8°C until measurement.

samples were withdrawn from the treatment solutions at 0, 24, 48, 72 and 96 hours. Concentrations of the test article were determined by a GC chromaotographic method of analysis.
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: flow-through
- Differential loading
- Controls: dechlorinated tap water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): water
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): controls: 0 mg/L; stock solution: 5g/L; final test solutions: 100 mg/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc): none stated
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: not stated
- Strain: HAMILTON-BUCHANAN
- Source: Dehner Garten Centre, D-67433 Neustadt
- Age at study initiation (mean and range, SD): not stated. Fish were bought as sexually immature young fish, length 2 +/- 1 cm. They were kept for 14 days under test conditions before being used in the test
- Length at study initiation (length definition, mean, range and SD): not stated
- Weight at study initiation (mean and range, SD): not stated
- Method of breeding: not stated
- Feeding during test: three times a day with warm water fishfood and daphnia, totalling to about 1-2% of body weight per day
- Food type: warm water fishfood
- Amount: 1 - 2% of body weight per day


ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: warm water fishfood, 1 - 2% of body weight per day
- Health during acclimation (any mortality observed): mortality in this period was not more than 5%
Test type:
flow-through
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
Not stated
Hardness:
1.18 mmol/L (analysis of dilution water 30.10.2010)
Test temperature:
23+/- 1 oC
pH:
8.0 - 8.3
Dissolved oxygen:
Above 82% throughout the test
Salinity:
not stated
Nominal and measured concentrations:
See tabulated results below
Details on test conditions:
TEST SYSTEM
- Test vessel: polyethylene aquaria
- Type (delete if not applicable): open / closed: not stated
- Material, size, headspace, fill volume: not stated
- Aeration: not stated
- Type of flow-through (e.g. peristaltic or proportional diluter): not stated
- Renewal rate of test solution (frequency/flow rate): medium renewal was twice a week
- No. of organisms per vessel: 7
- No. of vessels per control: 1
- No. of vessels per vehicle control: not stated
From the study text there was one vessel containg 10.5L test solution and seven fish and one vessel containing 10.5L dilution water and seven fish.
- Biomass loading rate: not stated

TEST MEDIUM / WATER PARAMETERS
Parameter Value Unit
sodium 3.8 mg/L
potassium 2.4 mg/L
calcium 23.8 mg/L
magnesium 1.9 mg/L
aluminium < 0.01 mg/L
iron < 0.005 mg/L
mangane < 0.001 mg/L
ammonium < 0.05 mg/L
nitrate < 1 mg/L
nitrite < 0.01 mg/L
chloride 7 mg/L
sulphate 8 mg/L
TOC < 1.0 mg/L
antimony < 0.001 mg/L
arsenic < 0.001 mg/L
lead < 0.001 mg/L
cadmium < 0.0002 mg/L
chromium < 0.001 mg/L
copper 0.001 mg/L
nickel < 0.001 mg/L
mercury < 0.0001 mg/L
selenium < 0.001 mg/L
bor < 0.005 mg/L
cyanide < 0.01 mg/L
fluoride < 0.2 mg/L
benzene < 0.25 µg/l
PAH < 0.004 µg/L
COC < 1.0 µg/L
pesticides and biocides < LOD
pH 8.23
conductivity at 20 °C 142 µS/cm
hardness 1.18 mmol/L
LOD = limit of detection
COC: chlorinated organic compounds


OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 12/12 hours
- Light intensity: neon tubes

Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks:
No abnormal behaviourof the surviving fish was observed
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities:
- Observations on body length and weight: none reported
- Other biological observations: none
- Mortality of control: zero
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none stated
- Effect concentrations exceeding solubility of substance in test medium: no
Reported statistics and error estimates:
It was not possible to determine the 95% confidence interval for any of the endpoints (NOEC, LC50, LC100)
Sublethal observations / clinical signs:

Analytical determinations

Measurement

Nominal Concentration mg/L

 

0

100

Measured Conc. in mg/L 0h Replicate 1

n. d.

124

Measured Conc. in mg/L 0h Replicate 2

n. d.

76

Mean in mg/L

n. d.

100

Measured Conc. in mg/L 24h Replicate 1

n. d.

86

Measured Conc. in mg/L 24h Replicate 2

n. d.

82

Mean in mg/L

n. d.

84

Measured Conc. in mg/L 48h Replicate 1

n. d.

60

Measured Conc. in mg/L 48h Replicate 2

n. d.

57

Mean in mg/L

n. d.

58

Measured Conc. in mg/L 72h Replicate 1

n. d.

115

Measured Conc. in mg/L 72h Replicate 2

n. d.

116

Mean in mg/L

n. d.

116

Measured Conc. in mg/L 96h Replicate 1

n. d.

109

Measured Conc. in mg/L 96h Replicate 2

n. d.

85

Mean in mg/L

n. d.

97

Geometric Mean in mg/L

n. d.

89

n. d. = not detectable

Mortalities

Nom. Conc. in mg/L

Total of fish used

dead fish

24 h

48 h

72 h

96 h

0

7

0

0

0

0

100

7

0

0

0

0

Biological results

Parameter

Value

95%-confidence-interval

24h NOEC

100 mg/L

not determinable

24h LC50

> 100 mg/L

not determinable

24h LC100

> 100 mg/L

not determinable

48h NOEC

100 mg/L

not determinable

48h LC50

> 100 mg/L

not determinable

48h LC100

>100 mg/L

not determinable

72h NOEC

100 mg/L

not determinable

72h LC50

> 100 mg/L

not determinable

72h LC100

> 100 mg/L

not determinable

96h NOEC

100 mg/L

not determinable

96h LC50

> 100 mg/L

not determinable

96h LC100

> 100 mg/L

not determinable

Validity criteria fulfilled:
yes
Conclusions:
The toxicity against Danio rerio was tested using a flow-through test design.
The main study was performed as a limit test with 100 mg/L nominal concentration. Seven fish were exposed to the test item for 96 hours. There were no mortalities in the treated group.
At the start and at the end of the test and every 24 hours, the content of the test item in the test solutions was determined using gas chromatography.The determination of the results was based on the nominal concentration.

The following results for the test item dimethyl carbonate could be determined:

96h NOEC = 100 mg/L
96h LC50 > 100 mg/L

The validity criteria for this test were fulfilled


Description of key information

the 96h LC50 for freshwater fish was determined to be >100 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

the 96h NOEC for freshwater fish was determined to be 100 mg/L