Registration Dossier

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

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:
1978
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:
1999
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium erthorbate

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 valid:
not specified
Negative controls valid:
yes
Positive controls valid:
yes

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.