L-Ascorbic acid, 2-(dihydrogen phosphate), sodium salt (1:3)

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Not guideline indicated, GLP: no data

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1981

Materials and methods

Test guideline

Qualifier:

no guideline followed

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Ascorbic acid

EC Number:

200-066-2

EC Name:

Ascorbic acid

Cas Number:

50-81-7

IUPAC Name:

5-(1,2-dihydroxyethyl)-3,4-dihydroxyfuran-2(5H)-one (non-preferred name)

Details on test material:

- Name of test material (as cited in study report): Ascorbic Acid

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles-River, Paris

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

- Vehicle(s)/solvent(s) used: DMSO

Details on exposure:

The substance was administered i.p. twice, 24 hrs apart.

Duration of treatment / exposure:

2 doses within 24 hours

Frequency of treatment:

24 hours

Post exposure period:

The animals were killed 6 hours after the second application.

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 80, 160, 320 mg/kg bw
Basis:
nominal conc.

No. of animals per sex per dose:

2

Control animals:

yes, concurrent vehicle

Positive control(s):

no data

Examinations

Tissues and cell types examined:

Femoral bone marrow cells

Details of tissue and slide preparation:

DETAILS OF SLIDE PREPARATION:
Smears were prepared according to the method described by Schmid (1973: Agents Actions 3: 77-85) (1975: the micronucleous test. Mutat Res. 31: 9-15). For staining the slides, phosphate buffer 8pH 6.88) was used instead of distilled water. All slides were coded.

METHOD OF ANALYSIS:
Screening of the slides was performed, using 10x16 magnification, for regions where cells were well spread and optimally stained. 1,500 polychromatic erythrocytes per animal were analysed under oil-immersion high power magnification (10x100). The number of micronucleated polychromatic erythrocytes (MPEs) were counted, but not the number of micronuclei.

Evaluation criteria:

1) two or more mice per group with MPE frequencies above 0.40 %
2) one or more tested groups with mean MPE frequencies above 0.30 %
3) statistical significance (Kastenbaum and Bowman, 1970) in one or more treated groups

A test substance was judged positive when all three of these criteria were met, negative when they were not, and questionable when one or two were met.

Statistics:

Statistical significance (Kastenbaum and Bowman, 1970)

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

not examined

Additional information on results:

Micronucleated polychromatic erythrocytes (%):
Negative control: 0.12 (0.00-0.20)
80 mg/kg bw: 0.15 (0.13-0.20)
160 mg/kg bw: 0.05 (0.00-0.13)
320 mg/kg bw: 0.08 (0.00-0.13)