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EC number: 700-937-1 | CAS number: 1312021-45-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Sep. - 04 Apr. 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 126, Short Guidance on the Threshold Approach for Acute Fish Toxcitiy
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Staatliches Gewerbeaufsichtsamt Hildesheim, Niedersachsen, Germany
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: all concentrations
- Sampling method: fresh media after 0 and 72 h, aged media after 24 and 96 h (first and second definitve test)
- Sample storage conditions before analysis: All original samples were stored at room temperature before preparation. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: An appropriate amount of the test item was weighed and test medium transferred into a test vessel filled with an appropriate amount of the dilution water. The test media were mixed with an laboratory blender (1 min, 17000 rpm). This procedure was repeated for every
water renewal. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Source: Umweltbundesamt, Berlin, Germany
- Age at study initiation (mean and range, SD): juveniles
ACCLIMATION
- Acclimation period: at least 9 days of acclimatization
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: Sera Vipan; SERA GmbH, Germany, ad libitum
- Feeding frequency during acclimation: 3 times a week
- Health during acclimation (any mortality observed): no mortality observed
FEEDING DURING TEST
no feeding - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 55 mg/L (first and second definitve test)
- Test temperature:
- 20.8 - 22.4 °C (first definitve test)
20.9 - 22.7 °C (second definitve test) - pH:
- 7.15 - 7.69 (first definitve test)
7.21 - 7.98 (second definitve test) - Dissolved oxygen:
- 62 - 100% (second definitve test)
85 - 100% (second definitve test) - Conductivity:
- 149 μS/cm (recent measurement 2020-01-21)
- Nominal and measured concentrations:
- Nominal test concentration: 34.0 mg/L (first definitve test)
Nominal test concentration: 2.13, 4.25, 8.50, 17.0 mg/L (second definitve test)
Geometric mean measured concentrations: 25.1 mg/L (first definitve test)
Geometric mean measured concentrations: 1.54, 3.76, 8.63, 14.9 mg/L (second definitve test) - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria
- Type (delete if not applicable): covered with a glass plates.
- Material, size, headspace, fill volume: glass, 3 L (dimensions: 11.5/13/20 cm, depth of water: approx. 17 cm)
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): daily renewal
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.0812 g/L (first definitve test); 0.101 g/L (second definitve test)
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin. The water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine.
- Total organic carbon: < 2 mg/L (first and second definitve test)
- Alkalinity: 0.6 mmol/L (recent measurement 2020-01-21)
- Culture medium different from test medium: no
- Intervals of water quality measurement: measured at 0, 24, 48, 72 and 96 hours
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16:8 h light/dark cycle
- Light intensity: 772 to 871 Lux (first definitve test), 676 to 972 Lux (second definitve test)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and symptoms after 2 ± 0.5 h, 5 ± 1 h and 24 ± 2 h. On days 2-4 of the test, all vessels with living fish were inspected twice per day.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study : not given - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 19.3 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: no
- Other adverse effects control: 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: no - Reported statistics and error estimates:
- The LC50-value was calculated with straight line regression of the concentration causing 0 and 86 or 100 % mortality using the software GraphPad Prism. The concentrations enclosed to the LC50-value were chosen as lower and upper confidence limits.
Excel, MICROSOFT CORPORATION
GraphPad Prism, GRAPHPAD SOFTWARE, INC. - Sublethal observations / clinical signs:
Table 1: Cumulative Mortality [%] in the First Definitive Test
(number of fish: n = 7)
Geometric mean
measured test item
concentration
[mg/L]
Cumulative mortality [%] at observation time [hours]
Day 0
Day 1
Day 2
Day 3
Day 4
2
5
24
48
52
72
76
93
97
25.1
0
0
86
100
--
--
--
--
--
Control
0
0
0
0
0
0
0
0
0
Table 2: Observations in the First Definitive Test
(number of fish: n = 7)
Geometric mean
measured test item
concentration
[mg/L]
Effect*
Cumulative mortality [%] at observation time [hours]
Day 0
Day 1
Day 2
Day 3
Day 4
2
5
24
48
52
72
76
93
97
25.1
(E)
0
0
6
7
--
--
--
--
--
(1)
7
7
1
--
--
--
--
--
--
Control
(1)
7
7
7
7
7
7
7
7
7
*) The numbers in brackets correspond to the following observations:
(1) = Normal behavior
E = Exitus letalis
Table 3: Cumulative Mortality [%] in the Second Definitive Test
(number of fish: n = 7)
Geometric mean
measured test item
concentration
[mg/L]
Cumulative mortality [%] at observation time [hours]
Day 0
Day 1
Day 2
Day 3
Day 4
2
5
24
48
52
72
76
93
97
1.54
0
0
0
0
0
0
0
0
0
3.76
0
0
0
0
0
0
0
0
0
8.63
0
0
0
0
0
0
0
0
0
14.9
0
0
0
0
0
0
0
0
0
Control
0
0
0
0
0
0
0
0
0
Table 4: Observations in the Second Definitive Test
(number of fish: n = 7)
Geometric mean
measured test item
concentration
[mg/L]
Effect*
Cumulative mortality [%] at observation time [hours]
Day 0
Day 1
Day 2
Day 3
Day 4
2
5
24
48
52
72
76
93
97
14.9
(1)
7
7
7
7
7
7
7
7
7
8.63
(1)
7
7
7
7
7
7
7
7
7
3.76
(1)
7
7
7
7
7
7
7
7
7
1.54
(1)
7
7
7
7
7
7
7
7
7
Control
(1)
7
7
7
7
7
7
7
7
7
*) The numbers in brackets correspond to the following observations:
(1) = Normal behavior
E = Exitus letalis
Table 5: Measured Concentrations of the Test Item during the first
Definitive Test
Sampling
date:
0 hours,
Fresh medium
24 hours,
Old medium
72 hours,
Fresh medium
96 hours,
Old medium
Nominal
concentration
of the test
item [mg/L]
Test item
Geometric mean
measured
concentration of
the test item [mg/L]
Meas.
conc.
[mg /L]
%
Meas.
conc.
[mg /L]
%
Meas.
conc.
[mg /L]
%
Meas.
conc.
[mg /L]
%
Control
<LOQ
<LOQ
<LOQ
<LOQ
-
34.0
33.2
98
19.0
56
n.d.
n.d.
25.1
Table 6: Measured Concentrations of the Test Item during the second
Definitive Test
Sampling
date:
0 hours,
Fresh medium
24 hours,
Old medium
72 hours,
Fresh medium
96 hours,
Old medium
Nominal
concentration
of the test
item [mg/L]
Test item
Geometric mean
measured
concentration of
the test item [mg/L]
Meas.
conc.
[mg /L]
%
Meas.
conc.
[mg /L]
%
Meas.
conc.
[mg /L]
%
Meas.
conc.
[mg /L]
%
Control
<LOQ
<LOQ
<LOQ
<LOQ
-
2.13
2.41
113
< LOQ
2.35
111
< LOQ
1.54
4.25
5.00
118
3.42
80
5.09
120
2.29
71
3.76
8.50
9.54
112
8.10
95
9.86
116
7.27
86
8.63
17.0
19.5
115
12.5
74
17.0
100
12.1
71
14.9
Table 7: Validity criteria for OECD 203.
Criterion from the guideline
Outcome
Validity criterion fulfilled
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test
0%
yes
The dissolved oxygen concentration must have been at least 60 per cent of the air
saturation value throughout the test
first definitive test: ≥ 62% and second definitive test ≥
85%
yes
There must be evidence that the concentration of the substance being tested has been satisfactorily maintained, and preferably it should be at least 80% of the
nominal concentration throughout the test. If the deviation from the nominal
concentration is greater than 20%, results should be based on the measured
concentration.
80 to 120% of nominal
yes
- Validity criteria fulfilled:
- yes
- Remarks:
- Please refer to "Any other information on results incl. tables"
Reference
Description of key information
LC50 (96 h): 19.3 mg/L (meas. geom. mean, OECD 203)
Key value for chemical safety assessment
Additional information
The acute toxicity to fish (Danio rerio) was investigated in a study following OECD 203 and GLP. Two definitive tests were carried out. The first test was set up as a threshold approach with a nominal test concentration of 34 mg/L. A semi-static test system with a daily renewal rate was set up in this first test. The test concentrations in the fresh and aged media were analytically determined by LC-MS. The geometric mean measured concentration was 25.1 mg/L. A mortality of 100% was observed after 48 h of exposure. Therefore, a second definitive test was performed with nominal test concentrations of 2.13, 4.25, 8.50 and 17.0 mg/L. The test medium was renewed daily and the test concentrations were analytically verified by LC-MS (fresh and aged media). The geometric mean measured concentrations in the second definitive test were 1.54, 3.76, 8.63, 14.9 mg/L. Mortality or symptoms of intoxication were not observed in the second test at the tested concentrations. A LC50 (96 h) of 19.3 mg/L (meas. geom. mean) was reported based on the combined results of the two tests.
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