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EC number: 939-559-9 | CAS number: -
- 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
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Jan - 12 Feb 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 305 (Bioaccumulation in Fish: Aqueous and Dietary Exposure) -I: Aqueous Exposure Bioconcentration Fish Test
- Version / remarks:
- October, 2012
- Deviations:
- no
- GLP compliance:
- yes
- Radiolabelling:
- no
- Details on sampling:
- - Sampling intervals/frequency for test organisms: Test fish were analysed 5 times during uptake phase; 4 fish per treatment group at each sampling time. Test fish analsis was performed at intervals more than 48 hours, and final analsis was conducted after 28 days.Test fish of control was analysed at test start and at test end.
- Sampling intervals/frequency for test medium samples:Test water was analyzed once before addition of the test fish and thereafter.
- Details on sampling and analysis of test organisms and test media samples:
45 mL water sample and 1 mL sulfuric acid were added and concentrate to 1 mL (electric griddle), ultrasonic irradiation (ultrasonic bath), filled up to 10 mL, filtrate and used for ICP AES analysis
1 g fish sample and 2 mL sulfuric and nitric acid and 2 mL, wet ashing (organic sythesizer 140 °C 2 h) cooling, filled up to 50 mL and filtrate (membrane filter pore size 0.45 µm) and used for ICP AES analysis - Vehicle:
- no
- Details on preparation of test solutions, spiked fish food or sediment:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
For level 1: stock solution of 14.0 mg/L was prepared and appropriate amount was used to achieve the taget test item concentration of 700 µg/L
For level 2: stock solution of 1.40 mg/L was prepared and appropriate amount was used to achieve the taget test item concentration of 70 µg/L
- Controls: yes
PREPARATION OF SPIKED FISH FOOD
- Details on fish food: Feed for carp Composition : Proteins content 2:30.0%, Lipid content: 2:4.0% Manufacturer; amount corresponding to approximately 3% of total body weight was fed twice a day in halves (once aday in all at holiday); fish were fasted for 24 hours before sampling
- Details of spiking: a stock solution was prepared with ion-exchange water; those were used to achieve the required test item concentration. - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Common carp
- Strain: Cyprinus carpio
- Source: CERI Kurume
- Age at study initiation: yearling fish
- Length at study initiation: 7.0 - 7.4 cm (at the beginning of exposure)
- Lipid content at test initiation: 3.10%
- Health status: Mortality during acclimatization was less than 5%
- Feeding during test
- Food type: Feed for carp(proteins content ≥30%
- Amount: approximately 3% of total body weight
- Frequency: twice a day in halves (once a day in all at holiday)
ACCLIMATION
- Acclimation period: After rearing in the underground water for 16 days, the fish were acclimatized in the dechlorinated water for 21 days.
- Acclimation conditions (same as test or not): 25±2 °C
- Health during acclimation (any mortality observed): The external disinfection was carried out in an aqueous solution containing OTC for fisheries (Oxytetracyclinehydrochloride, Kyoritsu Seiyaku) and sodium chloride (The Salt Industry Center of Japan); Mortality during acclimatization was less than 5% - Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 28 d
- Hardness:
- 41.1 mg CaCO3/L (Level 1)
40.2 mg CaCO3/L (Control) - Test temperature:
- Before uptake phase:
23.9 - 24.0 °C (Level 1)
23.9 - 24.0 °C (Level 2)
23.8 - 23.9 °C (Control)
uptake phase:
23.9 - 24.2 °C (Level 1)
23.9 - 24.2 °C (Level 2)
23.8 - 24.1 °C (Control) - pH:
- Before uptake phase:
7.6 (Level 1, Level 2 and Control)
uptake phase:
7.4, 7.5 (Level 1)
7.4, 7.5 (Level 2)
7.6, 7.6 (Control) - Dissolved oxygen:
- Before uptake phase:
7.9 mg/L (Level 1)
7.9 mg/L (Level 2)
7.5 mg/L (Control)
uptake phase:
7.7 - 8.0 mg/L (Level 1)
7.6 - 7.9 mg/L (Level 2)
7.6 - 8.0 mg/L (Control) - TOC:
- before uptake phase:
<1.00 mgC/L, <1.00 mgC/L (Level 1, Level 2 and Control)
uptake phase:
<1.00 mgC/L (Level 1, Level 2 and Control) - Conductivity:
- 150 µS/µcm (dilution water)
- Details on test conditions:
- TEST SYSTEM
Test vessel:
- Type: open
- Material, size, headspace,fill volume: Test vessel: 70 L glass tank, Fill volume: no information
- Aeration:The test tanks were supplied with air during the exposure
- Type of flow-through: Flow-through system assembled at the laboratory was used
- Renewal rate of test solution (frequency/flow rate): 0.04 mL/min for stock solution and 800 mL/min for dilution water, 1152 L/day of test water were supplied
- No. of organisms per vessel: at the beginning of exposure: 28 (Level 1 and 2), 12 (Control)
- No. of vessels per concentration (replicates): 1 test tank per level
- No. of vessels per control / vehicle control (replicates): 1 test tank
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated water [City water was treated by charcoal bed system (ORGANO Co., Ltd.)]
- pH: 7.7
- Particulate matter (suspended solids): < 1 mg/L
- Total organic carbon: < 0.5 mg/L
- Chemical oxygen demand: < 1 mg/L
- Metals (mg/L): Total mercury < 0.0005, Cadmium < 0.001, Chromium (VI) <0.01, Lead < 0.001, Arsenic < 0.005, Iron <0.01, Copper 0.001, Cobalt < 0.001, Manganese < 0.005, Aluminium <0.02, Zinc <0.1, Nickel < 0.001, Silver < 0.0001
- Pesticides (mg/L): 1,2-Dichloropropane <0.002, Chlorothalonil < 0.001, Propyzamide < 0.0008, Chlomitrofen < 0.0001, Simazine < 0.0003, Thiobencarb < 0.001, Diazinon < 0.0005, Isoxathion < 0.0008, Fenitrothion <0.0003, EPN <0.0006, Dichlorvos <0.001, Iprobenfos <0.0008, PCB < 0.0005, Fluorine 0.4, Anionic surfactant <0.02
- Chlorine (residual): < 0.02 mg/L
- Alkalinity: 38 mg/L
- Total hardness (Ca,Mg): 35 mg/L
- Intervals of water quality measurement: Date of Analysis January 5, 2016: lt was confirmed that the dilution water meets the criteria as stipulated in the standard operation procedure
- Intervals of test medium replacement: once a week
OTHER TEST CONDITIONS
- Photoperiod:14 h light/10h dark
- Light intensity: artificial light of white fluorescent lamp
RANGE-FINDING / PRELIMINARY STUDY: no range-finding test was performed - Nominal and measured concentrations:
- Control, 70 µg/L (low exposure level, L2) and 700 µg/L (high exposure level, L1)
- Reference substance (positive control):
- no
- Lipid content:
- 3.1 %
- Time point:
- start of exposure
- Lipid content:
- 2.87 %
- Time point:
- end of exposure
- Conc. / dose:
- 716 µg/L
- Temp.:
- >= 23.9 - <= 24.2 °C
- pH:
- 7.5
- Type:
- BCF
- Value:
- > 2.3 - <= 12 dimensionless
- Basis:
- not specified
- Time of plateau:
- 28 d
- Remarks on result:
- not determinable
- Conc. / dose:
- 70.9 µg/L
- Temp.:
- >= 23.9 - <= 24.2 °C
- pH:
- 7.5
- Type:
- BCF
- Value:
- < 23 dimensionless
- Basis:
- not specified
- Time of plateau:
- 28 d
- Rate constant:
- growth rate constant (d-1)
- Value:
- 0.019
- Remarks on result:
- other: Level 1
- Rate constant:
- growth rate constant (d-1)
- Value:
- 0.02
- Remarks on result:
- other: Level 2
- Rate constant:
- growth rate constant (d-1)
- Value:
- 0.015
- Remarks on result:
- other: Control
- Details on results:
- - Mortality of test organisms: Mortality or other adverse effects/disease in both control and test group was not observed
- Behavioural abnormalities: no abnormal behaviour was noted - Validity criteria fulfilled:
- yes
Reference
Validity criteria:
The temperature variation is less than ±2 °C of set water temperature 25 °C.
The concentration of dissolved oxygen does not fall below 60% of saturated concentration 8.1 mg/L at 25 °C.
The concentration of the test item in the test tank maintained within ±20% of the mean of the measured values during the test period.
Mortality or other adverse effects/disease in both control and test group is not observed.
Analytical Results:
Concentrations of the test item were maintained 2: 94% of nominal concentrations and the variations were within ±20% of the average measured concentrations. Concentrations of the test item in test water before the uptake phase were 736 µg/L (Level 1) and 63.0 µg/L (Level 2). The measured concentration of the test item in test water of control before and after the uptake phase were less than the LOQ of the test item.
Table 1: Measured concentrations of test item in test water (Unit : µg/L)
Level |
After 5days |
After 13days |
After 18days |
After 21days |
After 28days |
Average (Standard deviation) |
1 |
733 |
795 |
688 |
691 |
674 |
716 (49.3) |
2 |
66.1 |
80.1 |
67.4 |
72.8 |
68.1 |
70.9 (5.73) |
Table 2: BCFs Values in the parenthesis shows the average.
Level |
After 5days |
After 13 days |
After 18 days |
After 21 days |
After 28 days |
1 |
<2.3 |
4.9 |
12 |
8.0 |
5.8 |
|
2.5 |
4.4 |
8.4 |
8.7 |
7.0 |
|
|
(4.6) |
(10) |
(8.4) |
(6.4) |
2 |
<23 |
<23 |
<23 |
<23 |
<23 |
|
<23 |
<23 |
<23 |
<23 |
<23 |
Description of key information
The substance can be regarded as not bioaccumulative (Cyprinus carpio, OECD 305, nominal)
Key value for chemical safety assessment
Additional information
One experimental study (CBMM Europe BV, Key, 2016, Bioaccumulation) is available investigating uptake, depuration and metabolism of the test item in fish and water according OECD 305 and GLP. 10 fish were exposed to two levels of test item concentration 700 µg/L (Level 1) and 70 µg/L (Level 2) in a flow-through system for 28 days. Test water and tested fish were analysed. Test water was analyzed once before addition of the test fish and thereafter, analyzed at the same time as analysis of test fish during the uptake phase. Test water of the control was analyzed before addition of the test fish and after the experimental completion. Tested fish were analyzed five times during the uptake phase.Test fish analysis was carried out at intervals of more than 48 hours, and the final analysis was conducted after 28 days. The lipid content in fish was 3.10% before experimental start and 2.87% after the experimental completion. Concentrations of the test item were maintained 2: 94% of nominal concentrations and the variations were within ±20% of the average measured concentrations. Concentrations of the test item in test water before the uptake phase were 736 µg/L (Level 1) and 63.0 µg/L (Level 2). The BCFs were between <2.3 and 12 for Level 1 and < 23 for Level 2. The kg calculated from the all individual test fish weight data were 0.0195 (Level 1), 0.0204 (Level 2) and 0.0155 (Control). The values are substantially lower than the threshold values for bioaccumulating (or very bioaccumulating) substances, according to Japan's Chemical Substances Control Law and Regulation (EC) No 1907/2006 (REACh). Therefore, the substance can be regarded as not bioaccumulative.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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