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EC number: 228-973-9 | CAS number: 6381-77-7
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic information provided
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Chromosomal aberration tests on 29 chemicals combined with S9 mix in vitro.
- Author:
- Matsuoka, A., M. Hayashi, and M. Ishidate, Jr.
- Year:
- 1 979
- Bibliographic source:
- Mutat. Res. 66:277- 290
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Ascorbyl Palmitate, Ascorbyl Dipalmitate, Ascorbyl Stearate, Erythorbic Acid, and sodium Erythorbate
- Author:
- F. Alan Andersen, Cosmetic Ingredient Expert Review Panel
- Year:
- 1 999
- Bibliographic source:
- Journal of Toxicology 1999 18 (suppl. 3): 1-26
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone
- EC Number:
- 228-973-9
- EC Name:
- 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone
- Cas Number:
- 6381-77-7
- Molecular formula:
- C6H8O6.Na
- IUPAC Name:
- sodium (2R)-2-[(1R)-1,2-dihydroxyethyl]-4-hydroxy-5-oxo-2,5-dihydrofuran-3-olate
- Details on test material:
- - Name of test material (as cited in study report):Sodium erythorbate
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Chinese hamster lung (CHL)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Eagle's MEM supplemented with 10% heat-inactivated calf serum.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Polychlorinated biphenyls-induced Wistar rat S9
- Test concentrations with justification for top dose:
- 2000 µg/mL (10mM)
- Vehicle / solvent:
- Ethanol or DMSO was used as a solvent when the chemical was insoluble in physiological saline.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- 0.5, 1, 2 mM with and without S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 3 hrs +/-S9
- Fixation time (start of exposure up to fixation or harvest of cells): 24 hrs
SPINDLE INHIBITOR (cytogenetic assays): 0.2µg of colcemid
STAIN (for cytogenetic assays): 1% Giemsa solution (pH 6.8)
NUMBER OF CELLS EVALUATED: The number of cells with chromosomal aberrations was counted on 100 wellspread metaphases. The incidence of polyploid cells in the 100 metaphases was also recorded. - Evaluation criteria:
- Negative (-), if less than 4.9% of the aberration was detected even when doses of the test compound were elevated to sub-lethal amounts, where almost no mitosis was observed; suspicious (±), if between 5.0-9.9%; and positive if between 10.0-19.9% (+), 20.0-49.9% (++) or more than 50.0% (+++).
Results and discussion
Test results
- Species / strain:
- other: Chinese hamster lung (CHL)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Main test
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: In vitro chromosome aberration test on Sodium Erythorbate in CHL cells
Substance | Dose | Incidence of chromosomal aberrations (%) | |||||
mg/mL | mM | Without S9 mix | Judge | With S9 mix | Judge | ||
Benzo[a]pyrene | 0.128 | 0.51 | 7.0 g, b | ± | 6.0 g, b, t | ± | |
0.256 | 1 | 3.0 g | - | 8.0 g, b, t | ± | ||
0.512 | 2 | 4.0 g, b, t | - | 22.0 g, b,t | ++ | ||
Sodium Erythorbate | 2 | 10 | 3.0 b,t | - | 1.0 t | - | |
Suspicious (±), if between 5.0-9.9%; and positive if between 10.0-19.9% (+), 20.0-49.9% (++) or more than 50.0% (+++). | |||||||
Types of aberration: g, gap; b, break, t. exchange, r, ring; f, fragmentation; italic, aberrations predominantly observed. |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Based on the results of this study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone was nonmutagenic in the chromosomal aberration test using Chinese hamster cells (CHL). - Executive summary:
In a mammalian cell cytogenetics assay (Chromosome aberration), CHL cell cultures were exposed to 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone at a concentration of 2000 µg/mL with and without metabolic activation (Polychlorinated biphenyls-induced Wistar rat S9)
Positive controls induced the appropriate response. There was no evidence of chromosome aberration induced over background.
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