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EC number: 858-735-5 | CAS number: 2337348-25-9
- 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:
- 2020-12-21 to 2020-12-25
- 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:
- 2019-06-18
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 100, 55.6, 30.9, 17.1, 9.53 mg/L and controls at the start of exposure and every 24 hours
- Sampling method: The test solution for measurement was taken out from the test vessel.
(except continuous temperature) - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stirring
- Controls: Dechlorinated tap water
- Test concentration separation factor: 1.8
- Other relevant information: Dilution water (3 L) was placed in preparation container, and the test sample (316µL*) was added using a microsyringe. The mixture was stirred with a magnetic stirrer and dissolved to prepare the stock solution of 100 mg/L. The stock solution was prepared at 6 L (3 L x 2). Required volume of the stock solution was mixed with dilution water in the test
vessel and stirred to prepare the test solution. In the test level of 100 mg/L, the stock solution was used as the test solution without treatment. The stock solution and the test solution were
newly prepared for each renewal. *: 0.300 g [= 316µL x density (0.949 g/mL at 25° C)] - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- TEST ORGANISM
- Common name: Medaka
- Source: in-test facility production
- Age at study initiation (mean and range, SD): hatching date: November 9, 2020 (age at the start of exposure; one-month-old)
- Length at study initiation (length definition, mean, range and SD): 1 - 2 cm
ACCLIMATION
- Acclimation period: 11 days (December 10, 2020 - December 21, 2020)
- Acclimation conditions (same as test or not): same as test conditions
- Type and amount of food during acclimation: Newly hatched Artemia nauplii, saturation volume
- Feeding frequency during acclimation: daily
- Health during acclimation (any mortality observed): 0% (during 7 days before the start of exposure)
FEEDING DURING TEST
None - Test type:
- semi-static
- Water media type:
- freshwater
- Remarks:
- Dechlorinated tap water
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 45.1 mg CaCO3/L
- Test temperature:
- Thermometer of glass stick type: 24.0 - 24.3 °C
Thermo recorder (continuously-measured): 23.7-24.5 °C - pH:
- 7.7 - 8.0
- Dissolved oxygen:
- 8.3 - 8.8 mg/L
- Salinity:
- Not reported
- Conductivity:
- 7.4 mS/m of dilution water
- Nominal and measured concentrations:
- 100, 55.6, 30.9, 17.1, 9.53 mg/L as nominal concentration (a geometric series with a factor of 1.8); renewal after 48 h
The results of this study were estimated based on the nominal concentrations since the measured concentrations of the test item in the test solutions of all exposure levels were maintained within the range of 80-120% of the nominal concentrations during exposure. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 3L glass tank (diameter: 16 cm, depth: 17 cm)
- Aeration: Conducted gently
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water
- Total organic carbon: < 0.5 mg/L
- Particulate matter: suspended solid: < 1 mg/L
- Metals: all < 0.1 mg/L
- Pesticides: all < 0.002 mg/L
- Chlorine: < 0.02 mg/L
- Alkalinity: 17 CaCO3 mg/L
OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: Room light, 16-hour light/8-hour dark
- Light intensity: illuminance 540-1000 lx
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8 - Reference substance (positive control):
- no
- Remarks:
- A 96-hour acute toxicity study of a reference substance with the test organism was periodically conducted.
- 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 (fish)
- Details on results:
- - Observations on body length and weight:
Total length 1.7 ± 0.1 cm (1.6 - 1.9 cm)
Body weight 0.046 ± 0.006 g (0.041 - 0.058 g)
- Mortality of control: 0%
- Other adverse effects control: None
- Abnormal responses: Observed abnormal responses during exposure were at the surface, complete loss of equilibrium, reduced activity, and extended abdomen.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test solutions in all test levels were colorless and clear at the start of exposure and before the renewal.
- Effect concentrations exceeding solubility of substance in test medium: None - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- LC50: 0.22 mg/L
- Other: Reference substance Copper (II) sulfate pentahydrate - Reported statistics and error estimates:
- The LC50 was estimated as "> the highest test concentration" since the mortality over 50%
in the range of the test concentrations was not observed. The results of this study were
estimated based on the nominal concentrations since the measured concentrations of the test item in the test solutions of all exposure levels were maintained within the range of 80-120% of the nominal concetrations during exposure. - Sublethal observations / clinical signs:
Table 1 Cumulative mortality
Nominal concentration (mg/L)
Cumulative mortality(%)
2 hours
5 hours
24 hours
48 hours
54 hours
72hours
78 hours
96 hours
Control
0
0
0
0
0
0
0
0
9.53
0
0
0
0
0
0
0
0
17.1
0
0
0
0
0
0
0
0
30.9
0
0
0
0
0
0
0
0
55.6
0
0
0
0
0
0
0
0
100
0
0
0
0
0
0
0
0
Table 2 Observed abnormal response
Nominal concentration (mg/L)
Result of observation
(Left column: Number of affected fish/Total survival number, Right column: Symptom detail)
2hours
5 hours
24 hours
48 hours
Control
0/7
N
0/7
N
0/7
N
0/7
N
9.53
0/7
N
0/7
N
0/7
N
0/7
N
17.1
0/7
N
0/7
N
0/7
N
0/7
N
30.9
0/7
N
0/7
N
1/7
AS(l)
0/7
N
55.6
3/7
AS(3)
0/7
N
3/7
AS(3)
3/7
AS(3)
100
7/7
AS(4) CLE(4)
717
AS(7) CLE(2)
717
AS(7) CLE(2)
717
AS(7) CLE(2)
RA(7)
RA(7)
RA(7)
RA(5)
Nominal concentration (mg/L)
Result of observation
(Left column: Number of affected fish/Total survival number, Right column: Symptom detail)
54 hours
72hours
78 hours
96 hours
Control
0/7
N
0/7
N
0/7
N
0/7
N
9.53
0/7
N
0/7
N
0/7
N
0/7
N
17.1
0/7
N
0/7
N
0/7
N
0/7
N
30.9
0/7
N
0/7
N
0/7
N
1/7
AS(l)
55.6
4/7
AS(4)
3/7
AS(3)
3/7
AS(3)
3/7
AS(3)
100
7/7
AS(7) CLE(2)
717
AS(7) CLE(2)
717
AS(7) CLE(2)
717
AS(7) CLE(3)
RA(5)
RA(5)
RA(5)
RA(5)EA(3)
N: Normal (No abnormal response)
Value in parentheses expresses the number of individuals that showed the symptom. Abbreviation of symptoms
AS: At the surface
CLE: Complete loss of equilibrium RA: Reduced activity
EA: Extended abdomen
Table 3-1 Dissolved oxygen concentration of test solution
Nominal
concentration (mg/L)
At the start
24
hours
48 hours
72
hours
At the end
Old
New
Control
8.8
8.5
8.6
8.7
8.4
8.7
9.53
8.8
8.5
8.5
8.7
8.3
8.5
17.1
8.8
8.4
8.5
8.7
8.4
8.5
30.9
8.8
8.4
8.5
8.7
8.3
8.5
55.6
8.8
8.5
8.4
8.7
8.3
8.5
100
8.8
8.5
8.4
8.7
8.3
8.6
Old: before the renewal
New: after the renewal Unit: mg/L
Table 3-2 pH of test solution
Nominal
concentration (mg/L)
At the start
24
hours
48 hours
72
hours
At the end
Old
New
Control
7.9
7.9
7.9
7.9
7.9
7.7
9.53
7.9
7.9
7.9
7.9
7.9
7.8
17.1
7.9
7.9
7.9
8.0
7.9
7.9
30.9
7.9
7.9
8.0
8.0
7.9
7.9
55.6
7.9
8.0
8.0
8.0
7.9
7.9
100
7.9
8.0
8.0
8.0
7.9
8.0
Old: before the renewal
New: after the renewal
Table 3-3 Temperature of test solution
Nominal concentration (mg/L)
At the start
24
hours
48 hours
72
hours
At the end
Old
new
Control
24.2
24.3
24.1
24.2
24.3
24.0
9.53
24.2
24.3
24.1
24.2
24.3
24.0
17.1
24.2
24.3
24.1
24.2
24.3
24.0
30.9
24.2
24.3
24.1
24.1
24.3
24.1
55.6
24.2
24.3
24.1
24.1
24.3
24.1
100
24.2
24.3
24.1
24.1
24.3
24.1
Old: before the renewal
New: after the renewal
Unit: °C
Table 4 LC50 to Medaka
Exposure duration
LC50 (mg/L)
95% confidence limits (mg/L)
(Slope of regression line)
Statistical procedure used for determination
ofLC50
24-hour
>100
-
(-)
-
48-hour
>100
- ( - )
-
72-hour
>100
-
( - )
-
96-hour
>100
-
(-)
-
-: Not obtained
- Validity criteria fulfilled:
- yes
- Remarks:
- Number of dead fish in all exposure levels and control at the end of exposure was 0, which met the criterion for the validity of the test (i.e. not exceed one fish in the control).
- Conclusions:
- This study was conducted in order to estimate the LC50 on the test organisms. Although toxic symptoms were confirmed in a concentration-dependent manner, no mortality was observed in all exposure levels. As a are result, the 96-hour LC50 was > 100 mg/L. The test item concentrations in the test solutions were maintained within 80-120% of the nominal concentrations during exposure and the environmental conditions were within the suitable range. Therefore, it is concluded that this study complied with the applied test guideline.
Reference
Description of key information
This study was conducted in order to estimate the LC50 on the test organisms. Although toxic symptoms were confirmed in a concentration-dependent manner, no mortality was observed in all exposure levels. As a are result, the 96-hour LC50 was > 100 mg/L. The test item concentrations in the test solutions were maintained within 80-120% of the nominal concentrations during exposure and the environmental conditions were within the suitable range. Therefore, it is concluded that this study complied with the applied test guideline.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Remarks:
- 96-hour LC50 > 100 mg/L
Additional information
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