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EC number: 228-846-8 | CAS number: 6362-80-7
- 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
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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:
- Start of study: 8 April 2005. End of study: 25 July 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to guideline and GLP.
- Qualifier:
- according to guideline
- Guideline:
- other: Methods for Testing of New Chemical Substances, etc.
(Yakushokuhatsu No. 1121002, Heisei 15.11.13 Seikyoku No. 2, Kanpokihatsu No. 031121002, 2003). - GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Two sets were analyzed during the exposure period (the start of exposure and before water renewal after 24 hours, and after water renewal after 48 hours and before water renewal after 72 hours). 0.75 mL of test solution was collected from each test vessel, and after adding and mixing an equal amount of acetonitrile, it was analyzed by high performance liquid chromatography (HPLC). The test substance concentration in each test solution was quantified from the ratio the peak area of the standard solution
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The method of preparing test solutions is shown below. Test substance stock solution II was prepared at the time of use.
Dilution water only for the control group and water containing only the solvent (concentration: 100 μL/L) for the solvent control group were prepared.
Test substance stock solution I was prepared at the start of the exposure period, and stored in a refrigerator during the exposure period. The stock solution I was confirmed to be stable refrigerated for 96 hours or more.
(1) Preparation of test substance stock solution I
Amount collected:35 mg
Solvent: N,N-dimethylformamide
Final volume: 25 mL
Vessel: Measuring bottle
Concentration: 1400 mg/L
Mixing system: Manual invention
(2) Preparation of test substance stock solution II
Amount of stock solution I collected: 520 μL
Solvent: Test water = dilution water
Final volume: 5200 mL x 3
Vessel: Measuring flask
Concentration: 0.140 mg/L
Solvent concentration: 100 μL/L
Mixing system Stirrer: 2 min
3) Preparation of solvent stock solution
Reagent: N,N-dimethylformamide
Preparation of test solution:
Each stock solution of (2) and (3) was collected to prepare test solutions (see table 1 in materials and methods)
Test solution (final volume):5.0L
Vessel: 5.0L glass aqualium
Mixing system: stirred with glass stick
Concentration ratio: 1.4 - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- TEST ORGANISM
- Common name: Japanese Medaka
- Source: Tsunashima Fishing (5-18-1 Tsunashimanishi, Kohoku-ku, Yokohama-shi, Kanagawa)
- Age at study initiation: Within 1 year after hatching
- Length at study initiation: Mean 2.16 cm (1.94-2.56 cm), n=10
- Weight at study initiation: Mean 0.075 g (0.056-0.135 g), n=10
- Feeding during test: Not fed
ACCLIMATION
-Water: Dilution water
-Method: Flow-through system
-Water temperature: 24±1°C
-Percent of dissolved oxygen: 80% or more of saturated concentration
-pH: 6.5-8.5
-Light: Room lighting, 16 hours (1000 lux or less) / 8 hours dark
-Type of Feed: Tetrawerke Tetramin
-Amount of feed: About 2% of body weight/day (not fed for 24 hours before start of exposure) - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Test temperature:
- Minimum: 23.3
Maximum: 24.3
Refer to table 7 in results section - pH:
- Minimum: 7.2
Maximum7.9
Refer to table 9 in results section - Dissolved oxygen:
- Minimum:5.7
Maximum: 8.4
Refer to table 8 in results section - Nominal and measured concentrations:
- Refer to table 1 in results section
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 5.0 L capacity glass water tank (water surface covered with Tephlon lid)
- Renewal rate of test solution: Total exchange of test solution every 24 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1
TEST MEDIUM / WATER PARAMETERS
The dilution water used was dechlorinated Yokohama city tap water with residual chlorine removed by activated carbon, which was sufficiently aerated and temperature controlled at 24±2°C. A total of 35 measurement items indicated in the marine product water standard (1983) are measured in the dechlorinated tap water periodically (every 6 months). Hardness is ordinarily 30-100 mg/L (CaCO3 conversion) and pH is 6.5-8.5. The absence of residual chlorine was verified at the time of use. The water quality was judged to be appropriate for the fish.
OTHER TEST CONDITIONS
- Adjustment of pH: Test solution pH was not regulated
- Photoperiod: 16 hours light/ 8 hours dark
- Light intensity: Room lighting, 1000 lux or less
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
The number of mortalities was recorded 24, 48, 72 and 96 hours after start of exposure, and any signs of toxicity and abnormalities observed were recorded. Symptoms commonly described and their definitions are shown below*. Dead fish were quickly removed upon discovery to avoid degrading water quality.
* Common symptoms and their definitions
Mortality: The fish does not react to stimulation.
Abnormal respiration: Movement of the operculum is abnormal compared to the control group fish.
Abnormal swimming: Swimming is clearly different from the control group fish, such as sluggish movement, hyper reaction, convulsion, inversion.
Inability to swim: Although moving at the bottom or at the surface of water, the fish is unable to swim in the water. Includes overturning and apparent death.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: Test concentrations were set with a solubility of the test substnace in the dilution water of 0.14 mg/L (in-house measurement) or less.
- Range finding study
- Test concentrations: 0.014, 0.044, 0.140 mg/L
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.092 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% confidence intervals could not be determined
- Details on results:
- Test substance concentration in test solutions:
Results of analysis of test substance concentration in test solutions are shown in Table 1. For results of analysis of test solutions, the ratio of the measured value to the nominal value was 87-93% at the time of preparation of test solution, and 42-53% after 24 hours. The main reason for decrease in concentration was thought to be sublimation of the test substance.
Median lethal concentration (LC50):
Cumulative mortality at each time is shown in Table 2. 96-hour mortality in the control group was 10% and 0% in the solvent control group, which fulfilled the validity conditions of the test.
The median lethal concentration (LC50) based on the above results is shown in Table 3 and below.
96-hour LC50: >0.092 mg/L (95% confidence interval could not be determined)
Highest 0% mortlaity concentration and lowest 100% mortality concentration
The highest concentration with 0% mortality and the lowest concentration with 100% mortality at each time are shown in Table 4, and the results calculated for 96 hours are shown below.
Highest concentration causing 0% mortality for 96 hours: >0.092 mg/L
Lowest concentration causing 100% mortality for 96 hours: >0.092 mg/L
Toxicological symptoms:
Observed toxicological symptoms are shown in Table 5.
No abnormalities were observed during the exposure period in the control, solvent control, 0.040, 0.055, 0.075, 0.100 mg/L group. Internal hemorrhage and surfacing were observed in the 0.140 mg/L group.
Appearance, temperature, percent of dissolved oxygen and pH of test solutions:
Appearance of test solutions is shown in Table 6, temperature in Table 7, percent of dissolved oxygen in Table 8 and pH in Table 9.
The appearance of test solutions was colorless throughout the exposure period in all test groups.
The water temperature was 24±1°C in all test groups, the percent of dissolved oxygen was 60% or more of the saturated dissolved oxygen (saturated dissolved oxygen at 24.0°C: 8.25 mg/L), which all fulfilled the test standards. pH was within the appropriate range (6.0-8.5) of environment for Medaka - Sublethal observations / clinical signs:
Table 1: Measured concentration of the test substance in test water
Nominal concentration (mg/L)
Measured concentration mg/L
(percent of nominal)
Meanameasured concentration (mg/L)
0 hour (new)
24 hours (old)
48 hours (new)
72 hours (old)
Control
<0.003
<0.003
<0.003
<0.003
---
Solvent Control
<0.003
<0.003
<0.003
<0.003
---
0.040
0.036
(90)
0.018
(45)
0.035
(88)
0.017
(43)
0.025
(63)
0.055
0.050
(91)
0.025
(45)
0.048
(87)
0.029
(53)
0.037
(67)
0.075
0.066
(88)
0.036
(48)
0.068
(91)
0.037
(49)
0.050
(67)
0.100
0.092
(92)
0.042
(42)
0.090
(90)
0.043
(43)
0.064
(64)
0.140
0.130
(93)
0.060
(43)
0.127
(91)
0.067
(48)
0.092
(66)
a: time weighted mean
new: freshly prepared test solutions
old: test solutions on 24 hours after preparation of new solutions
Table 2: Mortality of the Medaka exposed to the test substance
Nominal concentration (mg/L)
Meanameasured concentration (mg/L)
Cumulative mortality (percent mortality)
24 hours
48 hours
72 hours
96 hours
Control
---
0 (0)
0 (0)
0 (0)
1 (10)
Solvent control
---
0( 0)
0( 0)
0( 0)
0( 0)
0.040
0.025
0 (0)
0 (0)
0 (0)
1 (10)
0.055
0.037
0( 0)
0( 0)
0( 0)
0( 0)
0.075
0.050
0 (0)
0 (0)
0 (0)
0 (0)
0.100
0.064
0( 0)
0( 0)
0( 0)
0( 0)
0.140b
0.092
0 (0)
0 (0)
0 (0)
0 (0)
a: time weighted mean
b: The maximum attainable concentration under the present test conditions and preparation methods
Table 3: Calculated LC50 values
Exposure period (hours)
LC50
(mg/L)
95 percent confidence limits (mg/L)
Statistical method
24
>0.092
--
--
48
>0.092
--
--
72
>0.092
--
--
96
>0.092
--
--
--: Could not be determined
The LC50 value and its 95% confidence limits could not be determined by statistical method because the mortality of Medaka at the maximum concentration level was less than 50%
Table 4: Highest concentration in 0% mortality and the lowest concentration in 100% mortality
Exposure period (hours)
Highest concentration in 0% mortality
(mg/L)
Lowest concentration in 100% mortality
(mg/L)
24
>0.092
>0.092
48
>0.092
>0.092
72
>0.092
>0.092
96
>0.092
>0.092
Table 5: Observed toxicological symptoms
Nominal concentration (mg/L)
Meanameasured concentration (mg/L)
Symptoms
(Symptom-number of fish)
24 hours
48 hours
72 hours
96 hours
Control
---
N
N
N
N
Solvent control
---
N
N
N
N
0.040
0.025
N
N
N
N
0.055
0.037
N
N
N
N
0.075
0.050
N
N
N
N
0.100
0.064
N
N
N
N
0.140b
0.092
N
Ihi-1
SUR-2(Ihi-1)
SUR-2(Ihi-1)
a: time weighted mean
N: No toxicological symptom was observed
Ihi: integument internal hemorrhage
SUR: surfacing
Table 6: Appearance of test solutions
Nominal concentration (mg/L)
Meanameasured concentration (mg/L)
Appearance of test solutions
0 hours
24 hours
48 hours
72 hours
96 hours
new
old
new
old
new
old
new
old
Control
---
C-
C-
C-
C-
C-
C-
C-
C-
Solvent control
---
C
C-
C-
C-
C-
C-
C-
C-
0.040
0.025
C-
C-
C-
C-
C-
C-
C-
C-
0.055
0.037
C-
C-
C-
C-
C-
C-
C-
C-
0.075
0.050
C-
C-
C-
C-
C-
C-
C-
C-
0.100
0.064
C-
C-
C-
C-
C-
C-
C-
C-
0.140
0.092
C-
C-
C-
C-
C-
C-
C-
C-
a: time weighted mean
new: freshly prepared test solutions
old: test solutions on 24 hours after preparation of new solutions
C-: Colorless
Table 7: Temperature of test solutions
Nominal concentration (mg/L)
Meanameasured concentration (mg/L)
Temperature (°C)
0 hours
24 hours
48 hours
72 hours
96 hours
new
old
new
old
new
old
new
old
Control
---
23.5
23.9
23.8
23.8
23.8
24.1
23.9
24.0
Solvent control
---
23.5
23.9
23.8
23.9
23.9
24.2
24.0
24.2
0.040
0.025
23.6
24.0
23.8
24.0
23.8
24.2
23.9
24.2
0.055
0.037
23.6
24.0
23.8
24.0
23.9
24.2
24.0
24.3
0.075
0.050
23.6
24.0
23.8
24.0
23.8
24.2
23.8
24.2
0.100
0.064
23.3
24.0
23.7
24.0
23.7
24.2
23.8
24.2
0.140
0.092
23.5
24.0
23.7
24.0
23.7
24.2
23.9
24.2
a: time weighted mean
new: freshly prepared test solutions
old: test solutions on 24 hours after preparation of new solutions
Table 8: Dissolved oxygen concentrations in test solution
Nominal concentration (mg/L)
Meanameasured concentration (mg/L)
Dissolved oxygen concentration (mg/L)
0 hours
24 hours
48 hours
72 hours
96 hours
new
old
new
old
new
old
new
old
Control
---
8.4
6.2
8.3
6.0
8.3
6.0
8.1
5.8
Solvent control
---
8.3
6.7
8.3
6.4
8.3
6.4
8.1
6.3
0.040
0.025
8.3
6.2
8.3
6.0
8.3
6.0
8.2
5.7
0.055
0.037
8.3
6.6
8.3
6.4
8.3
6.6
8.1
6.4
0.075
0.050
8.3
6.5
8.3
6.4
8.3
6.5
8.1
6.6
0.100
0.064
8.3
5.7
8.3
5.7
8.3
5.8
8.1
5.8
0.140
0.092
8.3
5.9
8.2
5.7
8.3
6.0
8.1
5.7
a: time weighted mean
new: freshly prepared test solutions
old: test solutions on 24 hours after preparation of new solutions
Table 9: pH values of test solutions
Nominal concentration (mg/L)
Meanameasured concentration (mg/L)
Dissolved oxygen concentration (mg/L)
0 hours
24 hours
48 hours
72 hours
96 hours
new
old
new
old
new
old
new
old
Control
---
7.7
7.3
7.9
7.2
7.8
7.3
7.7
7.2
Solvent control
---
7.7
7.4
7.9
7.3
7.8
7.3
7.8
7.3
0.040
0.025
7.7
7.3
7.9
7.3
7.8
7.3
7.8
7.2
0.055
0.037
7.7
7.3
7.9
7.3
7.8
7.4
7.8
7.3
0.075
0.050
7.7
7.3
7.9
7.3
7.8
7.3
7.8
7.4
0.100
0.064
7.8
7.3
7.9
7.2
7.8
7.3
7.8
7.3
0.140
0.092
7.8
7.2
7.9
7.2
7.8
7.3
7.8
7.3
a: time weighted mean
new: freshly prepared test solutions
old: test solutions on 24 hours after preparation of new solutions
- Validity criteria fulfilled:
- yes
- Remarks:
- 96 hour mortality in the control group was 10% and 0% in the solvent control group, which fulfilled the validity conditions of the test.
- Conclusions:
- The LC50 after 96 h exposure based on time weighted mean was >0.092 mg/L.
Reference
Description of key information
The LC50 after 96 h exposure based on time weighted mean was >0.092 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 0.092 mg/L
Additional information
Summary
1) Exposure method: Semi-static (total exchange of test solution every 24 hours). Water surface covered with Teflon sheet
2) Exposure time: 96 hours
3) Test concentrations: Control group, solvent control group, 0.040, 0.055, 0.075, 0.100, 0.140 mg/L (Maximum preparable concentration of test solution) (Nominal value)
Common ratio
Solvent concentration: 100μL/L (N,N-dimethylformamide)
4) Test solution volume: 5.0 L/vessel
5) Replicates: 1 vessel/test group
6) Number of animals: 10 fish/test group
7) Test temperature: 24 ± 1°C
8) Lighting: Room lighting, 16 hours (1000 lux or less) / 8 hours dark
9) Analysis: High performance liquid chromatography (HPLC)
Test Results:
1) Test Substance Concentration in Test Solutions:
For results of analysis of test solutions, the ratio of the measured value to the nominal value was 87-93% at the time of preparation of test solution, and 42-53% after 24 hours. The main reason for decrease in concentration was thought to be volatilization of the test substance.
2) Median lethal concentration (LC50) after 96-hr exposure: >0.092 mg/L (95% confidence interval could not be determined
3) Highest concentration causing 0% mortality after 96-hr exposure: >0.092 mg/L
4) Lowest concentration causing 100% mortality after 96-hr exposure: >0.092 mg/L
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