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EC number: 473-690-8 | CAS number: 738602-93-2
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 2004 - Mar 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- -
- EC Number:
- 473-690-8
- EC Name:
- -
- Cas Number:
- 738602-93-2
- Molecular formula:
- not applicable for UVCB
- IUPAC Name:
- (2R,3R,4S,5S,6R)-2-{[(2R,3R,4R,5S,6R)-5-{[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-{[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}oxan-2-yl]oxy}-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-6-(hydroxymethyl)oxane-3,4,5-triol; (2S,3R,5R)-4-{[(2R,3R,4R,5S,6R)-5-{[(2R,3R,4R,5S,6R)-3,4-dihydroxy-6-(hydroxymethyl)-5-{[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}oxan-2-yl]oxy}-3,4-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}hexane-1,2,3,5,6-pentol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: Hayashibara Biochemical laboratories, Inc. Lot 3I021
- Purity, including information on contaminants, isomers, etc.: solid content of 72.5 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: at preparation, reaction to the vehicle was confirmed
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: not stated
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: Water soluble
- Reactivity of the test material with the incubation material used (e.g. plastic ware): not stated
Method
- Target gene:
- no single target gene but whole genome
Species / strain
- Species / strain / cell type:
- Chinese hamster lung (CHL/IU)
- Details on mammalian cell type (if applicable):
- CELLS USED
- Type and source of cells: CHL/IU cell line as frozen stock from Japan Health Sciences Foundation, Health Science Research Resources Bank
- Suitability of cells: The CHL cell line is a practical model because its chromosomes are small in number and comparatively large in size. additionally, CHL/IU is sensitive to chemicals that induce chromosomal aberration.
- Normal cell cycle time (negative control): 15 hours
For cell lines:
- Absence of Mycoplasma contamination: yes
- Number of passages if applicable: 7 at receipt, 8 at stock
- Methods for maintenance in cell culture: not stated
- Cell cycle length, doubling time or proliferation index : 16.7 h
- Modal number of chromosomes: 25 +-2
- Periodically checked for karyotype stability: not stated
- Periodically ‘cleansed’ of spontaneous mutants: not stated
MEDIA USED
- Type and composition of media, CO2 concentration, humidity level, temperature, if applicable: 10% CS MEM
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 rat liver
- Test concentrations with justification for top dose:
- 1250, 2500, and 5000 µg/mL
- Vehicle / solvent:
- water for injection
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- mitomycin C
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments 2 (short-term treatment, contineous treatment)
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 1*20^4 cells/mL
- Test substance added in medium;
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 6 h /24 h
- Harvest time after the end of treatment (sampling/recovery times): 18 h / 0 h
FOR CHROMOSOME ABERRATION AND MICRONUCLEUS:
- Spindle inhibitor (cytogenetic assays): iColcemid, 10 µg/mL
- Methods of slide preparation and staining technique used including the stain used (for cytogenetic assays): after fixation with Carnoys fixative solution, staining with Giemsa
- Number of cells spread and analysed per concentration (number of replicate cultures and total number of cells scored): 100 cells/dish
- Criteria for scoring chromosome aberrations (selection of analysable cells and aberration identification):
according to "Sofuni T. Production Mechanism, Classification, and Criteria of Chromosomal Aberrations. In: Environmetnal Mutagen Society of Japan, Mammalian Mutagenicity Study Group. the Atlas of Chromosomal Aberration on Chemical Commpounds: first ed. Tokyo: Asakura shoten; 1988. p. 16-35
- Determination of polyploidy: according to "Sofuni T. Production Mechanism, Classification, and Criteria of Chromosomal Aberrations. In: Environmetnal Mutagen Society of Japan, Mammalian Mutagenicity Study Group. the Atlas of Chromosomal Aberration on Chemical Commpounds: first ed. Tokyo: Asakura shoten; 1988. p. 16-35
- Determination of endoreplication:according to "Sofuni T. Production Mechanism, Classification, and Criteria of Chromosomal Aberrations. In: Environmetnal Mutagen Society of Japan, Mammalian Mutagenicity Study Group. the Atlas of Chromosomal Aberration on Chemical Commpounds: first ed. Tokyo: Asakura shoten; 1988. p. 16-35 - Rationale for test conditions:
- according to Guideline
- Evaluation criteria:
- Ishidate's method was used to determine the frequency of cells with chromosomal aberrations in the test article treatment group. The judgement criteria are shown below. Negative (-) frequency < 5 %, Equivocal(+-) 5% <= frequence < 10 %, Positve (+) 10% <= frequency
- Statistics:
- none applied
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Acceptance Criteria:
The frequencies of cells with chromosomal aberrations in the negative and positive control groups were within th erange (Mean +. 2 SD) of the background data. Accordingly, it was judged that th echromosomal aberration test was performed satisfactorily.
Changes in pH by Test Article and Test Article Precipitations
Color changes indicating changes in pH in the culture medium were not observed upon addition of the test article preparation. Test article precipitation in the culture medium was not observed at up to 5000 µg/mL at the start or end of test article treatment.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of hte study, MG-60 did not induce chromosomal aberrationsin CHL/IU cells, regardless of a metabolic activation system or treatment time length
- Executive summary:
In order to evaluate th eclastogenicity of MG-60, an invitro chromosomal aberration test using Chinese hamster lung (CHL/IU) cells was performed, and the frequencies of cells having structural and numerical chromosomal aberrations were investigated. Three dose levels, 1250, 2500 and 5000 µg/mL, were set for short-term treatments without and with metabolic activation, and for continuous treatment for 24 hours.
1) in chort-treatments without and with metabolic activation, and in continuous treatment for 24 hours, the frequencies of cells having structural and numerical chromosomal aberrations were below 5%, and no devrease was noted in the cell proliferation ratio at up to the highest dose level, which was estimated from the viable cell count.
2) Color changes indicating changes in pH in the culture medium were not observed upon addition of the test article preparation. Test article precipitation i n the culture medium was not observed at up to 5000 µg/mL at the start or end of test article treatment.
3) The frequencies of cells havin gchromosomal aberrations in the negative and poitive control groups in short-term treatmnets without and with metabolic activation, and in continuous treatment for 24 hours, were within the range of the backgorund data. Accordingly, it was judged that thhe chromosomal aberration test was performed satisfactorily.
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