Xylitol

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

yes

Remarks:

no positive controls

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Xylitol

EC Number:

201-788-0

EC Name:

Xylitol

Cas Number:

87-99-0

Molecular formula:

C5H12O5

IUPAC Name:

(2R,3r,4S)-pentane-1,2,3,4,5-pentol

Details on test material:

- Purity: not reported

Test animals

Species:

mouse

Strain:

other: Fullinsdorf albino (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Males: average weight about 38 g
Females: average weight about 33 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

dissolved in PBS

Duration of treatment / exposure:

treated twice, 30 and 6 hours before sacrifice

Frequency of treatment:

two times

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

1 820 mg/kg bw/day (actual dose received)

Doses / concentrations 2

Dose / conc.:

3 280 mg/kg bw/day (actual dose received)

Doses / concentrations 3

Dose / conc.:

5 333 mg/kg bw/day (actual dose received)

No. of animals per sex per dose:

3/sex/dose

Control animals:

yes

Positive control(s):

no data

Examinations

Tissues and cell types examined:

Smears of the bone marrow of both femora were prepared and stained as described by Schuepbach. 4000 erythrocytes per animal were checked for micronuclei.

Details of tissue and slide preparation:

Bone marrow was collected in foetal calf serum from the femur of each animal. The tube was centrifuged at 1000 rev/min for 5 minutes. The supernatant is removed and the cells in the sediment were carefully mixed by aspiration using a pipette. A small drop of the suspension was smeared on a fresh microscope slide, and the slides were air dried. Slides were stained with May-Gruenwald solution, May-Gruenwald diluted with distilled water (1:1), followed by Giemsa diluted with distilled water (1:6). Slides were then rinsed in distilled water, blotted dry and the back was cleaned with methanol. The slide was cleared in xylene and a cover glass was mounted.

Statistics:

The statistical analysis was performed by means of the Student-t-test.

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

After two-fold application of the test substance (doses up to 5333 mg/kg) no significant increase of micronuclei containing erythrocytes could be shown in the bone marrow of Füllinsdorf Albino mice of either sex.

Applicant's summary and conclusion

Conclusions:

The test substance caused no observable mutagenic effect in the system studied.

Executive summary:

The micronucleus test in the mouse was carried out to assess potential mutagenic activity of the test substance. Three male and three female mice were used per dosage group. They were treated twice, 30 and 6 hours before sacrifice, with up to 5333 mg/kg of the test substance dissolved in PBS. Erythrocytes were checked for micronuclei. After twofold applications, no significant increase of micronuclei containing erythrocytes could be shown in the bone marrow of Füllinsdorf Albino mice of either sex. Therefore, the test substance causes neither chromosome breaks nor mitotic non-disjunction in the bone marrow of the mouse.