2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone

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

Reference

Reference 1

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 2

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

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

Test material information

Constituent 1

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

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.