Registration Dossier
Registration Dossier
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EC number: 228-973-9 | CAS number: 6381-77-7
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- 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:
- Study of the mutagenic potential of three GRAS chemicals in mice by the heritable translocation test
- Author:
- Jorgenson, T. A., C. J. Rushbrook, G. W. Newell, and S. Green
- Year:
- 1 978
- Bibliographic source:
- Mutat. Res. 53:125.
- 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:
- International Journal of Toxicology 1999 18 (suppl. 3): 1-26
Materials and methods
- Principles of method if other than guideline:
- Proven breeder male rats were distributed into groups of 10 each. Treatments were by gavage as a single dose and also with 5 consecutive dally doses; 3 dosage levels were used for each regimen. Untreated reference controls and positive controls receiving a single i.p. injection of triethylenemelamine were used with each compound studied. Following treatment, each single-dose male was mated to two adult females weekly for 8 weeks; each multiple-dosed male was mated to two adult females weekly for 7 weeks.
- GLP compliance:
- not specified
- Type of assay:
- rodent dominant lethal assay
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 erthorbate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- Single dose and also with 5 consecutive daily doses
- Frequency of treatment:
- Daily
- No. of animals per sex per dose:
- 10 males per group
20 females per group - Control animals:
- yes, concurrent no treatment
- Positive control(s):
- triethylenemelamine
- Route of administration: single i.p. injection
Examinations
- Statistics:
- All data were subjected to a computerized statistical program.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
In the rat, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone was not mutagenic by the dominant lethal method. - Executive summary:
In the rodent dominant lethal test, male rats were treated (daily or for 5 consecutive days with 3 dosage regimens) by oral gavage with 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone.
The positive control induced the appropriate response. No consistent responses occurred to suggest that
2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone was mutagenic to the rat by the dominant lethal procedure.
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