Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Between 28 August 2008 and 6 January 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted to recognised testing methodology to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Yakushokuhatsu No. 1121002 on November 21, 2003, Heisei 15.11.17 Seikyoku No. 2, Kanpokihatsu No. 031121002, final revision: November 20, 2006
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): JKY-214
- Molecular formula (if other than submission substance): Not applicable
- Molecular weight (if other than submission substance): Not applicable
- Smiles notation (if other than submission substance): Not applicable
- InChl (if other than submission substance): Not applicable
- Structural formula attached as image file (if other tha n submission substance): Not applicable
- Substance type: Organic
- Physical state: White crystal
- Analytical purity: 99.5% w/w
- Impurities (identity and concentrations): Not specified
- Composition of test material, percentage of components:
- Isomers composition: Not applicable
- Purity test date: Not specified
- Lot/batch No.: RM05-58
- Expiration date of the lot/batch: Not specified
- Radiochemical purity (if radiolabelling): Not applicable
- Specific activity (if radiolabelling): Not applicable
- Locations of the label (if radiolabelling): Not applicable
- Expiration date of radiochemical substance (if radiolabelling): Not applicable
- Stability under test conditions: Stable. After the completion of the study, infrared absorption spectrum of the test substance stored in a desiccator for test material storage. The spectrum obtained was consistent with that measured before the initiation of the study. Therefore it was determined that the test substance was stable during storage
- Storage condition of test material: Room temperature, dark, tightly sealed
- Other: Not specified
Constituent 1
- Radiolabelling:
- no
Sampling and analysis
- Details on sampling:
- - Sampling intervals/frequency for test organisms: On Days 4, 7, 14, 21, 42, and 61 after start of the exposure
- Sampling intervals/frequency for test medium samples: Before the exposure (Day 0) and Days 4, 7, 14, 21, 28, 35, 42, 48, and 61 after start of the exposure
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods):
- Two fish (One fish in the excretion test) Weight determination (about 12 g)
- Cut into pieces with scissors
- Homogenize (for about 1 min. at about 8000 rpm) × 4
- Collect 2.5 g of the pulverized sample extracted with Acetonitrile 20 mL
- Homogenize (for 5 min. at about 8000 rpm) and acetonitrile phase collected
Aspiration • filtration (Kiriyama funnel 40TYPE filter paper)
- Residue extracted with Acetonitrile 20 mL, Homogenized (for 3 min. at about 8000 rpm), Aspiration • filtration (Kiriyama funnel 40TYPE filter paper). Residue discarded. The acetonitrile added to the acetonitrile phase
- Combined acetonitrile phase made up to 50 ml
- 10 ml aliquot passed through Sep-Pak C8 (Conditioned with about 5 mL of acetonitrile) and added to To 0.5 mL of 0.1% (v/v) formic acid aqueous solution, the equivalent amount of passing solution and mixed well
- Analysis conducted by HPLC analysis.
Test solutions
- Vehicle:
- yes
- Details on preparation of test solutions, spiked fish food or sediment:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 2g of test sample dissolved in vehicle and made up to 1000 ml to prepare 2000 mg/ml sample. Then further diluted in vehicle to prepare 1000 mg/ml sample
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): 2-methoxyethanol
- Evidence of undissolved material (e.g. precipitate, surface film, etc): none reported
Test organisms
- Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
Species: Carp (Cyprinus carpio)
Source: Niikura Fish Farm (1217, Shimoya, Isehara-city, Kanagawa, Japan)
Date of purchase: January 15, 2008
Lot No.: 08-K-0115
Preacclimatization: At the start of acclimatization, macroscopic observation was made to remove the fish with any abnormalities. The remaining normal fish were reared in an aquarium with continuous flow water. No medical dipping was conducted during the acclimatization period.
Body length: 8 ± 4 cm
Body weight: about 6 g
Age: Within 1 year old after hatching
(Cultivation)
At the time of purchasing, the fish with any diseases, the debilitated fish or the fish with any other abnormalities were removed. The remaining normal fish were reared in an aquarium with continuous flow water. If necessary, medical dipping was made whereas such fish were not employed for the test for 2 weeks after medical dipping.
(Acclimation)
Aquarium number: A-13
Water temperature: 24 ± 2ºC
Period: July 9, 2008 - September 4, 2008
Feed: Babygold from Kyorin
Feeding: The food equivalent to about 2% of body weight was given once a day.
Mortality during 1 week before the test: < 5%
Study design
- Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 61 d
- Total depuration duration:
- 63 d
Test conditions
- Hardness:
- not reported
- Test temperature:
- 24 ± 2ºC
- pH:
- 6.0 - 8.5
- Dissolved oxygen:
- more than 60% of the saturated dissolved oxygen concentration (more than 5 mg/L in case of 24ºC)
- TOC:
- not reported
- Salinity:
- not reported
- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass vessel
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 800 L
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): 40 mL/day
-First concentration area: 32 fish/50 L of test water
(more than 1 L/day per 1.0 g)
-Second concentration area: 32 fish/50 L of test water
(more than 1 L/day per 1.0 g)
-Control area: 12 fish/50 L of test water
(more than 1 L/day per 1.0 g)
OTHER TEST CONDITIONS
- Photoperiod: Approximately 16 hr/day, Hf fluorescent lamp (wave length 400 - 700 nm)
- Light intensity:
RANGE-FINDING / PRELIMINARY STUDY
- Test concentrations:
- Results used to determine the conditions for the definitive study: - Nominal and measured concentrations:
- 2000 and 200 mg/l
- Reference substance (positive control):
- no
Results and discussion
Lipid contentopen allclose all
- Lipid content:
- 6.2 %
- Time point:
- start of exposure
- Lipid content:
- 6.4 %
- Time point:
- end of exposure
Bioaccumulation factor
- Type:
- BCF
- Value:
- <= 41 dimensionless
- Basis:
- whole body w.w.
- Time of plateau:
- 24.8 d
- Calculation basis:
- steady state
- Metabolites:
- Details of metabolites are included in the attached sheet.
- Results with reference substance (positive control):
- Not applicable
Any other information on results incl. tables
96hr-LC50of the test substance inOryzias latipeswas >10 mg/L.
The test substance concentration mg/L |
Accumulated mortality (%) |
|||
24 hr |
48 hr |
72 hr |
96 hr |
|
0 |
0 |
10 |
10 |
10 |
10 |
0 |
0 |
0 |
0 |
Based on the above findings, it was confirmed that the test concentration of the bioaccumulation tests was not more than 1/100 and 1/1000 of 96hr-LC50,respectively.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The test substance is considered to be not bioaccumulative in fish.
- Executive summary:
The bioaccumulation of the substance has been assessed by continuous flow-through exposure of the substance to common carp over a period of 61 days with a 63 day depuration period. The BCF was calculated to be <=41 and is therefore considered to be 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Hoewel ECHA veel materiaa in uw taal online heeft, is een deel van deze pagina in het Engels. Meer informatie van ECHA over meertaligheid.
Welkom op de ECHA-website. In Internet Explorer 7 (en vroegere versies) wordt deze site niet volledig ondersteund. U schakelt het best op een recentere versie van Internet Explorer over.
Deze website maakt gebruik van cookies om het surfen zo aangenaam mogelijk te maken.
Lees meer over hoe wij cookies gebruiken.