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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:
27 Feb - 03 Mar 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Staatliches Gewerbaufslchtsamt Hildeshelm
Test material information:
Composition 1
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Control and highest test item concentration (100 mg/L)
- Sampling method: Samples were taken for analysis from the freshly prepared solutions at 0 and 48 hours, and the old solutions at 48 and 96 hours.
- Sample storage conditions before analysis: All original samples were stored at room temperature.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Appropriate volume of the test item was pipetted directly into the test vessel and filled with dilution water and mixed with an ultraturrax (1 min, 17000 rpm).
- Controls: yes, test medium control
- Eluate: no
- Differential loading: yes
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebrafish
- Age at study initiation (mean and range, SD): at least 12 days
- Length at study initiation (length definition, mean, range and SD): 2.86 cm
- Weight at study initiation (mean and range, SD): 0.27 g
- Method of breeding: at 23 ± 2 °C and diffuse light (7 - 750 Lux, natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80% of the air saturation value.

ACCLIMATION
- Acclimation period: at least 12 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: The amount of food was 4% of the fish body weight per feeding day with Sera Vipan; Sera GmbH, Heinsberg, Germany
- Feeding frequency during acclimation: Food was provided 3 times per week. The test fish were not be fed 24 h before test start.
- Health during acclimation (any mortality observed): No mortality was observed during this time. No disease treatments were administered throughout holding and testing.

FEEDING DURING TEST: Fish were not fed during the test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
71 mg/L as CaCO3
Test temperature:
22.6 - 22.9 °C (Control)
22.5 - 23.0 °C (100 mg/L)
pH:
7.71 - 7.91 (Control)
7.45 - 7.94 (100 mg/L)
Dissolved oxygen:
92 - 100% (Control)
90 - 100% (100 mg/L)
Conductivity:
181 µS/cm
Nominal and measured concentrations:
Control and 100 mg/L (threshold approach)
Details on test conditions:
TEST SYSTEM
Test vessel:
- Type: open (covered with glass plates)
- Material, size, headspace, fill volume: Glass aquaria of 24 L, filled with approx 20 L of dilution water (dimensions: 22/39/28 cm, depth of water: 23.5 cm)
- Renewal rate of test solution (frequency/flow rate): after 48 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: Fish density in the test vessels was 0.094 g fish per litre test solution

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin was used for holding; filtered on activated charcoal and aerated for at least 24 h to remove chlorine
- Total hardness: 10 - 250 mg CaCO3/L
- pH-value: 6.0 - 8.5
- Acidity: 0.2 mmol/L
- Acid capacity: 1.0 mmol/L
- Conductivity: 181 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: The pH-value, temperature and oxygen saturation were measured in all test vessels at start and end of the exposure and every 24 h.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours photoperiod
- Light intensity: 7 - 750 Lux

EFFECT PARAMETERS MEASURED: Mortality after 4, 24, 48, 72 and 96 h; fish were considered dead if there was no visible movement and if touching of the caudal peduncle produced no reaction. Records were kept of visible abnormalities.

Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: slow escape reflex was observed from 24 to 72 h. At test end no escape reflex was obsreved for three fish and slow escape reflex for four fish.
- Mortality of control: no
- Others: Analytical Results are summarized with the Table 1 in section "Any other information on results incl tables".
Reported statistics and error estimates:
The LC0 and LC100 after 96 h was derived from the raw data of the limit concentration. LC50-values do not have to be calculated in a limit test.

The analytical results are presented in the following table.

Table 1: Measured Concentrations and Percent of the Nominal Concentrations of the Test Item

Sampling date

2017-02-27 0 hours (Fresh medium)

2017-03-01 48 hours (Old medium)

2017-03-01 48 hours (Fresh medium)

2017-03-03 96 hours (Old medium)

Start of analysis

2017-02-27

2017-03-01

2017-03-01

2017-03-03

 

Phenylacetaldehyde Dimethyl Acetal

Nominal concentration of the test item [mg/L]

Meas. conc. [mg/L]

%

Meas. conc. [mg/L]

%

Meas. conc. [mg/L]

%

Meas. conc. [mg/L]

%

100

84.5 1)

84

92.4 1)

92

105 1)

105

89.4

89

Control

 

< LOQ

 

< LOQ

 

< LOQ

 

< LOQ

Meas. conc. = Measured concentration of the test item, dilution factor taken into account, mean value of two injections

% = Percent of nominal concentration of the test item

LOQ = Limit of Quantification (2.0 mg/L test item)

1) = reanalyzed on 2017-03-02

Validity criteria fulfilled:
yes
Conclusions:
The test item had no acute toxic effects on Danio rerio in a 96-h static test according to OECD 203 and GLP up to 100 mg/L (nominal). No mortality was recorded and a LC50 (96 h) > 100 mg/L was derived.

Description of key information

LC50 (96 h): > 100 mg/L (OECD 203, Danio rerio, nominal)

Key value for chemical safety assessment

LC50 for freshwater fish:
100 mg/L

Additional information

One experimental study is available investigating the effects of the substance to freshwater fish. The study was performed according to OECD 203 (GLP) using Danio rerio as test organism under semi-static conditions. A threshold approach was performed with control and a limit concentration of 100 mg/L. The actual exposure concentrations were verified by LC-MS analysis after 0 and 48 hours and from the corresponding 48 hours aged test media after 48 and 96 h of the study (fresh and aged media). Since the measured concentrations were within the range between 80 and 120% of nominal, the effect concentrations were based on the nominal concentrations. After an exposure time of 96 h a LC50 of >100 mg/L resulted based on mortality.