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Diss Factsheets
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EC number: 446-420-1 | CAS number: 474044-10-5
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 November 2003 to 25 February 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Details on test material:
- Name: HSY-2701
Lot No.: 1004-1
Purity: 99.8 %
Impurity: Unknown substance 0.2 %
Storage condition: Stored at room temperature (measured temperature: 19.1 - 23.0 °C) protected from light.
Appearance at room temperature: Red powder
Stability: Stable at room temperature
Constituent 1
Method
- Target gene:
- Not applicable for chromosome aberration studies.
Species / strain
- Species / strain / cell type:
- other: Chinese Hamster Lung CHL/IU
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Eagle's minimum essential medium (MEM) and MEM culture medium
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix prepared using homogenate of the livers of Sprague Dawley rats treated with phenobarbital 4 times and 5,6-benzoflavone once.
- Test concentrations with justification for top dose:
- - S9 mix assay: 313, 625, 1250, 2500, 5000 µg/mL
+ S9 mix assay: 313, 625, 1250, 2500, 5000 µg/mL
24 hour assay: 313, 625, 1250, 2500, 5000 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: In the preliminary test for the selection of the solvent it was found that the tet substance did not dissolve and did not suspend uniformly in saline or in 1 % w/v sodium carboxymethylcellulose solution at 50 mg/mL. It suspended almost uniformly at 250 mg/mL in DMSo and in acetone. In the preparations using acetone, however precipitation was recognised sooner that when using DMSO. No heat, discolouration or foaming was observed when using DMSO.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Migrated to IUCLID6: Without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Migrated to IUCLID6: With S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 24 (continuous) or 6 hours (short term)
- Expression time (cells in growth medium): 18 hours in the short term assay
- Fixation time : Two hours prior to the end of culture.
SPINDLE INHIBITOR: Colcemid
STAIN: Giemsa's solution
NUMBER OF REPLICATIONS: Performed in duplicate
NUMBER OF CELLS EVALUATED: 100 cells per plate
DETERMINATION OF CYTOTOXICITY
- Method: Cell growth, 50 % cell growth inhibition, mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: Polyploid cells with 35 or more centromeres (including endoreduplicated cells) - Evaluation criteria:
- Negative: Both structural and numerical aberrant cells were obseved at lower than 5 % in the test substance treatment group.
Inconclusive: The structural or numerical aberrant cells were observed at 5 % or higher but lower than 10 % in the test substance treatment group.
Positive: The structural or numberical aberrant cells were observed at 10 % or higher in the test substance treatment group and increased dose-dependently. - Statistics:
- Cell growth inhibition was not inhibited by more than 50% under any treatment condition. Therefore 50% cell growth inhibition concentration (IC50) was not calculated.
Measurement of growth index: A portions of the cells was used for cell counting with a haemocytometer. Cell growth index was calculated based on the negative control value (average as 100 %). Measurement of cell growth was not conducted for the positive controls.
Measurement of mitotic index and relative mitotic index: The number of metaphase cells was counted by examining 500 cells per one plate (i.e. 1000 cells per concentration). Mitotic index % was calculated for each dose according to the following equation:
Mitotic index = (number of metaphase cells)/(number of cells examined) x 100
From the mitotic index, relative mitotic index % at the dose was calculated according to the following equation.
Relative mitotic index = (Mitotic index in cells treated with the test substance)/(Mitotic index in cells treated with the negative control) x 100
No statistical analysis was performed.
Results and discussion
Test results
- Species / strain:
- other: Chinese Hamster Lung CHL/IU
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In the cell growth inhibition test and the chromosomal aberration test, some of the test substance floated or precipitated in the treatment medium at the begining and the end of the treatment in each test substance treatment group in each treatment condition.
RANGE-FINDING/SCREENING STUDIES:
In the cell growth inhibition test, the test substance did not inhibit cell growth more than 50 % under any treatment condition. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
In the attached document, the tabulated results are presented. Graphical representations of the results are also included.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative With and without metabolic activation.
HSY-2701 was considered not to have the ability to induce chromosomal aberration under the conditions employed in the study. - Executive summary:
In a GLP compliant study conducted to guideline OECD 473, the test substance HSY-2701 was considered not to have the ability to induce chromosomal aberrations in Chinese hamster lung cells (CHL/IU).
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.
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