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EC number: 482-120-7 | 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 61: 18198-18202, April 24, 1996
- GLP compliance:
- yes
- Remarks:
- US FDA 21 CFR 58, US EPA 40 CFR 792, Japanese GLP Standards, and OECD
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): C-4000
- Physical state: liquid
- Analytical purity: 86.3 +/- 0.7%
- Purity test date: 2008-01-01 through 2008-01-25
- Lot/batch No.: 51V034K7
- Expiration date of the lot/batch: 2008-02-01
- Storage condition of test material: 2-8 degrees; protected from light
Constituent 1
Method
- Target gene:
- HGPRT
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: F12 medium without hypoxanthine, supplemented with 5% dialyzed fetal bovine serum
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes, for each frozen batch
- Periodically checked for karyotype stability: yes, for each frozen batch
- Periodically "cleansed" against high spontaneous background: yes, with HAT (hypoxanthine, aminopterin and thymidine). Cells used in the mutation assay will not exceed four subpassages from time of cleansing.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S-9
- Test concentrations with justification for top dose:
- Preliminary toxicity assay: 0.5, 1.5, 5, 15, 50, 150, 500, 1500, 5000 ug/mL
Cytotoxicity testing: 5, 10, 15, 25, 50 ug/mL
Mutation assay: 5, 10, 15, 25, 50 ug/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility of the test article and compatibility with the target cells.
Controls
- Untreated negative controls:
- yes
- Remarks:
- Vehicle used as negative control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Ethylmethanesulfonate was used as the positive control for the non-activates test system and benzo(a)pyrene was used as the positive control for the S-9 activatetd system.
Migrated to IUCLID6: and benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: Cells seeded 18-24 hours before treatment
- Exposure duration: 5 hours
- Expression time (cells in growth medium): 7-9 days
- Selection time (if incubation with a selection agent): 7-9 days
- Fixation time (start of exposure up to fixation or harvest of cells): 14 to 18 days from treatment to staining of mutant colonies.
SELECTION AGENT (mutation assays): 6-thioguanine (6-TG)
SPINDLE INHIBITOR (cytogenetic assays): N/A
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: 2 at each test article concentration.
NUMBER OF CELLS EVALUATED: 106 cells treated at each concentration, 2 x 106 cells seeded for mutant selection.
DETERMINATION OF CYTOTOXICITY
- relative cloning efficiency
OTHER EXAMINATIONS:
- Determination of polyploidy: N/A
- Determination of endoreplication: N/A
- Other: mutant colonies (6-TG-resistant)
- Evaluation criteria:
- The cloning efficiency of the solvent control must be greater than 50%. The spontaneous mutant frequency in the solvent control must fall within the range of 0 25 mutants per 106 clonable cells. The positive control must induce a mutant frequency at least three times that of the solvent control and must exceed 40 mutants per 106 clonable cells. There must be at least four analyzable test article concentrations with mutant frequency data.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: None noted.
- Effects of osmolality: No effect, the solvent and treat cultures had virtually the same osmolality.
- Evaporation from medium: None noted.
- Water solubility: DMSO was the solvent for the test article
- Precipitation: There was visible precipitate in the treatment medium at concentrations ≥ 50 µg/mL.
- Other confounding effects: N/A
RANGE-FINDING/SCREENING STUDIES: Range-finding assay done to determine concentrations for the mutation assays.
COMPARISON WITH HISTORICAL CONTROL DATA: Yes, controls were within range.
ADDITIONAL INFORMATION ON CYTOTOXICITY: N/A
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
All criteria for a valid study as described in the protocol were met. C-4000 was negative in the CHO/HGPRT Mutation Assay under the conditions of this study. - Executive summary:
The test article, C-4000, was tested in the CHO/HGPRT Mutation Assay in the absence and presence of metabolic activation using Aroclor-induced rat liver S9. The preliminary toxicity assay was used to establish the concentration range for the initial mutagenesis assay. The initial and independent repeat mutagenesis assays were used to evaluate the mutagenic potential of the test article.
Dimethyl sulfoxide (DMSO) was chosen as the solvent for the test article based on information from the Sponsor and compatibility with the target cells. The test article was soluble in DMSO at a concentration of 500 mg/mL, the maximum concentration prepared for the preliminary toxicity assay.
In the preliminary toxicity assay, the maximum concentration of C-4000 (Lot51V034K7)tested was 5000 µg/mL. There was visible precipitate in the treatment medium at concentrations ≥ 50 µg/mL. Selection of concentrations for the mutagenesis assay was based on the cloning efficiency relative to the solvent control and precipitation profile. No substantial toxicity, i.e., cloning efficiency ≤ 50% of the solvent control, was observed with or without S9 activation. Based on these findings, the concentrations chosen for the mutagenesis assay ranged from 2.5 to 50 µg/mL for both the non-activated and S9-activated cultures.
In the initial mutagenesis assay, no positive responses, i.e., treated cultures with mutant frequencies >40 mutants per 106 clonable cells, were observed. Visible precipitate was observed in treatment medium at 50 µg/mL. No toxicity, i.e., cloning efficiency ≤50% of the solvent control, was observed.
In the independent repeat assay, no positive responses were observed. Visible precipitate was observed in treatment medium at 50 µg/mL. No toxicity was observed.
C-4000 was negative in the CHO/HGPRT Mutation Assay under the conditions of this study.
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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