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EC number: 835-272-7 | CAS number: 256374-76-2
- 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:
- June 3, 2013 to June 7, 2013
- 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:
- OECD Guidelines for Testing of Chemicals, No.203, July 17, 1992, “Fish, Acute Toxicity Test”
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Test Guidelines
- Version / remarks:
- “Fish acute toxicity test” stipulated in the "Test Methods of the New Chemical Substances etc." (March 31, 2011, Yakushokuhatsu 0331 No.7, Heisei 23.03.29 Seikyoku No.5, Kanpokihatsu No.110331009, partly amended by Yakushokuhatsu 0402 No.1, Heisei 24.03.28 Seikyoku No.2, Kanpokihatsu No. 120402001 on April 2, 2012)
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- No further details specified in the study report.
- Analytical monitoring:
- yes
- Details on sampling:
- Frequency of measurement: At the start and the end of exposure.
Sampling methods: Samples were taken from the middle depth of the test vessel.
Sampling amount: Approximately 10 mL was sampled for all test groups. - Vehicle:
- no
- Details on test solutions:
- The provided substance was weighed and mixed with the dilution water in a vessel for preparation.
Then this mixture was stirred by a magnet stirrer for 48 hours in order to prepare 100 mg/L of the test solution. - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- Species: Killifish (Oryzias latipes)
Reason for selection of the species: Use of the species is recommended in the test guidelines.
Supply source: Kurume Laboratory, Chemicals Evaluation and Research Institute (in-house production)
Body length: Entire length 2.3 ± 1.2cm
Group allocation: Random sampling
Acclimatization:
Date of hatching: November 14, 2012 (age in month when used for the test: 6 months)
Rearing water: Dechlorinated tap water
Acclimatization method: Flow through system
Dissolved oxygen: 80% and above of the saturated dissolved oxygen concentration
Water temperature: 24 ± 1 °C
Lighting cycle: Room light, 16-hour light/8-hour dark cycle
Feeding: Formulated food, crumble type 2C, for juvenile corps (Nippon Formula Feed Manufacturing Company Limited)
Frequency and amount of feed: Feeding everyday by 3% amount of fish weight/day
Medication bath: None
Acclimatization period: 42 days (from April 22, 2013 to June 3, 2013)
Mortality of fish used for the test: 0% (during 7 days before used for the test)
No feeding period: Fish was not fed for 24 hours before used for the test. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- No post exposure observation period specified in the study report
- Hardness:
- Not specified
- Test temperature:
- Water temperature of the test solution was 24.2 to 24.7 °C.
- pH:
- pH was 7.8 to 7.9
- Dissolved oxygen:
- The dissolved oxygen concentration was 8.0 to 8.2 mg/L
- Salinity:
- Not applicable
- Conductivity:
- Not specified
- Nominal and measured concentrations:
- 100 mg/L nominal (as a limit test at the upper concentration limit for used test method)
- Details on test conditions:
- Test equipment and apparatus
Test vessel: 3 L glass vessel (diameter 16cm, depth 16cm)
Cover: A transparent cover made of plastic
Thermostatic bath: Plastic water bath, heating/cooling unit HCA 250 (Sato Kogei Co., Ltd.)
Test conditions
Exposure system: Static water system (without exchange of the test water)
Exposure period: 96 hours
Test concentration: 100 mg/L (as a limit test at the upper concentration limit for used test method)
This test concentration was determined based on the result of the preliminary study.
Control group: Dilution water without the test substance, which was treated by the same preparation method for the test solution.
Number of the replicates: 1 replicate/test group
Number of test organisms: 7 organisms/test group
Volume of the test solution: Approximately 2.8 L/test group
Water temperature: 24 ± 1 °C
Aeration: Moderate aeration
pH adjustment: None
Lighting: Room light, 16-hour light/8-hour dark cycle
Feeding: Food was not given.
Observation and measurement
Observation of the test organisms
Fish were inspected for their death and general symptoms at 3, 24, 48, 72 and 96 hours after the start of exposure. The individual was considered as dead if there was no visible movement (movement of proboscis or gill cover etc.,) and if gently touching of the caudal peduncle with a glass rod produced no reaction.
Body length and weight of the test organisms
Body lengths and weights of the test organisms of the control group were measured at the end of exposure.
Condition of the test solution
Condition of the test solution was observed at the start and the end of exposure.
Quality of the test solution
Measurement items: Concentration of dissolved oxygen concentration, pH and water temperature
Frequency of measurement: At the start of exposure and following every 24 hours
Measurement methods: Aliquot of the test solution sampled from the test vessel was measured.
Instruments: Dissolved oxygen meter, YSI MODEL 58 (YSI Incorporated), Portable pH meter, HM-21P (TOA D.K.K), Certified glass stem thermometer
Test substance concentration in the test solution
Frequency of measurement: At the start and the end of exposure.
Sampling methods: Samples were taken from the middle depth of the test vessel.
Sampling amount: Approximately 10 mL was sampled for all test groups. - Reference substance (positive control):
- yes
- Remarks:
- copper sulfate (II) pentahydrate
- 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:
- Mortality
During the exposure period, death of the organism was not observed in the test concentration group. In addition, death of the organism was not observed in the control group, and the validity criteria (number of dead fish should not exceed 1) was fulfilled.
Observation results of symptom
No symptom of test organisms was observed in the control group. All these observation results were based on comparison with the control group, and no symptom of the test organisms in the test concentration group was observed during the exposure period.
The size of the test organisms
[Mean value ± standard deviation (n = 7)]
Body length 2.4 ± 0.1 cm
Body weight 0.10 ± 0.02 g
Observation and measurement results of the test solution
Condition of the test solution
The test solution was colorless and transparent at the start of the exposure and the condition was the same at the end of exposure.
Water quality of the test solution
The dissolved oxygen concentration was 8.0 to 8.2 mg/L, the pH was 7.8 to 7.9, and water temperature of the test solution was 24.2 to 24.7 °C. The dissolved oxygen concentration fulfilled the validity criteria (at 60% or above of the saturated dissolved oxygen concentration* at the test water temperature).
* Saturated dissolved oxygen concentrations at 23 to 25oC are 8.39 to 8.11 mg/L, JIS K 0102: 2008
Test substance concentration in the test solution
The measured concentrations of the test substance in test solution were 100 mg/L both at the start of exposure and at the end of exposure (100 % of the nominal concentration). These concentrations were maintained within ± 20 % of the nominal concentration. - Results with reference substance (positive control):
- Acute toxicity tests are periodically performed with the reference substance. The latest data is shown below.
Reference substance: copper sulfate (II) pentahydrate (special grade, Lot No. LAJ5671, Wako Pure Chemical Industries, Ltd.)
Test period: from May 13, 2013 to May 17, 2013
96-hour LC50: 0.45 mg/L
This value was within the determined range of the background data in Kurume Laboratory, which is a range of “mean ± 2 x standard deviation” [mean ± standard deviation: 0.53 ± 0.19 mg/L (n = 52)]. All these data are expressed as amount of Copper sulfate (II). - Reported statistics and error estimates:
- Not specified
- Sublethal observations / clinical signs:
Cumulative mortality
Nominal concentration
(mg/L)
Cumulative mortality (%)
3 hours
24 hours
48 hours
72 hours
96 hours
Control
0
0
0
0
0
100
0
0
0
0
0
Observed abnormal response
Nominal concentration
(mg/L)
Result of observation
(Left column: Number of affected fish/Total survival number Right column: Symptom detail)
3 hours
24 hours
48 hours
72 hours
96 hours
Control
0/7
N
0/7
N
0/7
N
0/7
N
0/7
N
100
0/7
N
0/7
N
0/7
N
0/7
N
0/7
N
N: Normal (No abnormal response)
Dissolved oxygen concentration of test solutions
Nominal concentration
(mg/L)
At the start
24 hours
48 hours
72 hours
At the end
Control
8.2
8.2
8.2
8.0
8.2
100
8.2
8.2
8.2
8.1
8.2
Unit: mg/L
pH of test solutions
Nominal concentration
(mg/L)
At the start
24 hours
48 hours
72 hours
At the end
Control
7.8
7.8
7.8
7.9
7.8
100
7.8
7.8
7.8
7.9
7.8
Temperature of test solutions
Nominal concentration
(mg/L)
At the start
24 hours
48 hours
72 hours
At the end
Control
24.3
24.7
24.5
24.5
24.2
100
24.3
24.7
24.5
24.5
24.3
Unit: °C
Measured concentrations of test item in test solutions
Nominal concentration
(mg/L)
Measured concentration (mg/L)
(Percentage of measured concentration versus nominal concentration %)
At the start
At the end
Geometric mean
Control
n.d.
n.d.
100
100
(100)
100
(100)
100
(100)
n.d.: <20.0 mg/L
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test was carried out as a limit test to confirm the presence or absence of the effect of the test substance to the test organism at the upper concentration limit (100 mg/L) specified in used test method. As a result, there is no effect to the test organisms and therefore it is considered that the test substance causes no acute effect to the test organisms at the upper concentration limit of the test method. The test substance concentration in the test solution was maintained ±20% of the nominal concentration, and the environmental conditions were within the proper range for the test. Therefore, it was considered that this study was in accordance with the test method.
Both 48 and 96-hour LC50 of the test substance to killifish were > 100 mg/L. - Executive summary:
Test organism: Killifish (Oryzias latipes)
Dilution water: Dechlorinated tap water
Test groups: 100 mg/L group and a control group
Preparation of test solutions: Prepared by dissolving the test substance in the dilution water and then stirring for 48hours.
Exposure system: Static water system
Exposure period: 96 hours
Number of replicates: 1 replicate per test group
Number of test organisms: 7 organisms per test group
Volume of the test solution: Approximately 2.8L per test group
Water temperature: 24.2 - 24.7 °C
Aeration: Moderate aeration
Lighting: Room light, 16-hour light/8-hour dark cycle
Feeding: None
Measurement of the test substance concentration: HPLC method (at the start and end of exposure)
The test was carried out as a limit test to confirm the presence or absence of the effect of the test substance to the test organism at the upper concentration limit (100 mg/L) specified in used test method. As a result, there is no effect to the test organisms and therefore it is considered that the test substance causes no acute effect to the test organisms at the upper concentration limit of the test method. The test substance concentration in the test solution was maintained ±20% of the nominal concentration, and the environmental conditions were within the proper range for the test. Therefore, it was considered that this study was in accordance with the test method.
Both 48 and 96-hour LC50 of the test substance to killifish were > 100 mg/L.
Reference
Description of key information
96-hour LC50 of the test substance to killifish: > 100 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
The test was carried out as a limit test to confirm the presence or absence of the effect of the test substance to the test organism at the upper concentration limit (100 mg/L) specified in used test method. As a result, there is no effect to the test organisms and therefore it is considered that the test substance causes no acute effect to the test organisms at the upper concentration limit of the test method.
Both 48 and 96-hour LC50 of the test substance to killifish were > 100 mg/L.
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