Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
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: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labeling and/or risk assessment.

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:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
no positive controls
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: not reported

Test animals

Species:
mouse
Strain:
other: Fullinsdorf albino (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
Three males (average weight about 38 g) and three 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
Post exposure period:
treated twice, 30 and 6 hours before sacrifice
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1820, 3280 and 5333 mg/kg/body weight
Basis:
actual ingested
No. of animals per sex per dose:
3 males and 3 females per dose group
Control animals:
not specified
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. 4000 erythrocytes per animal were checked for micronuclei.
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

Any other information on results incl. tables

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:
Interpretation of results (migrated information): negative

This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
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 tests 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.