Multi constituent substance

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

GLP compliance:

yes

Type of assay:

other: micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Multi constituent substance

EC Number:

916-604-0

IUPAC Name:

Multi constituent substance

Specific details on test material used for the study:

No information available

Test animals

Species:

mouse

Strain:

other: CFW 1

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

0.9% sodium chloride solution

Duration of treatment / exposure:

Sacrifice time : 24, 48, 72 hours after treatment

Frequency of treatment:

Once

Post exposure period:

24, 48, 72 hours after treatment

Doses / concentrations

Dose / conc.:

5 000 mg/kg bw/day

No. of animals per sex per dose:

Six/sex/dose group

Control animals:

yes, concurrent vehicle

Positive control(s):

Cyclophosphamide (10mg/kg)

Examinations

Tissues and cell types examined:

Bone marrow

Evaluation criteria:

The test substance was classified as mutagenic if it induced a clear increase in the number of micronucleated polychromatic erythrocytes in a single dose group.

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

During the exposure period, no deaths were observed among male and female treated animals. The test item had no influence on the ratio of polychromatic/normochromatic erythrocytes compared to the controls. The test item did not induce a consistently sharp rise in the number of micronucleated polychromatic erythrocytes.

Applicant's summary and conclusion

Conclusions:

It was concluded from the results obtained that the test item failed to show any evidence of mutagenic potential when administered orally in this in vivo test for chromosomal aberrations.

Executive summary:

The test item was assessed in the micronucleus assay for the incidence of chromosomal aberrations in males and female mice according to OECD guideline 474. A dose of 5000 mg/kg bw, suspended in 0.9% sodium chloride solution, was administered by oral gavage. Bone marrow smears from both femurs from each animal were prepared 24, 48 and 72 hours after the administration of the test item and evaluated for micronuclei. At the dose of 5000 mg/kg bw and the time intervals of 24, 48 and 72 hours. the group mean micronucleated cell count of the test item was comparable with the concurrent control values. It was concluded from the results obtained that the test item failed to show any evidence of mutagenic potential when administered orally in this in vivo test for chromosomal aberrations.