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Toxicological information

Genetic toxicity: in vitro

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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:
1979
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:
1999
Bibliographic source:
Journal of Toxicology 1999 18 (suppl. 3): 1-26

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):Sodium erythorbate

Method

Species / strain
Species / strain:
other: Chinese hamster lung (CHL)
Details on mammalian cell lines (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:
Ethanol or DMSO was used as a solvent when the chemical was insoluble in physiological saline.
Controls
Negative controls:
yes
Solvent 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 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:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other:
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.