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
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The information was obtained from the peer reviewed, 2006 OECD SIDS dossier due to the original report being unavailable.

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
2006
Report Date:
2006
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
other: No data
Duration of treatment / exposure:
Single dose
Frequency of treatment:
Single dose
Post exposure period:
up to 48 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 500, 1500 & 5000 mg/kg
Basis:
no data
No. of animals per sex per dose:
No data
Control animals:
yes
Positive control(s):
Cyclophosphamide-treated positive control group

Examinations

Tissues and cell types examined:
No data
Details of tissue and slide preparation:
No data
Evaluation criteria:
No data
Statistics:
No data

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
valid

Any other information on results incl. tables

Mortality was observed at the high dose, and reduced body weight gain was observed in the mid- and high-dose groups. There was no evidence of chromosome damage as measured by increases in chromosome aberrations, altered mitotic index, or chromosome number when compared to the concurrent control group. In the cyclophosphamide-treated positive control group, a significant increase in the average number of aberrations, percent of cells with aberrations, and decreased mitotic index was observed confirming the sensitivity of the assay. Under the conditions of this study the test material is not clastogenic.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Under the conditions of this studythe test material is not clastogenic.
Executive summary:

The test material was evaluated in an In Vivo Rat Bone Marrow Assay similar to OECD Test Guideline 474.

The test material was administered to rats at dose levels of 0, 500, 1500, and 5000 mg/kg. Six rats/sex from each group were sacrificed at 6, 12, 24, and 48 hours after treatment. The bone marrow cells were aspirated from each femur and processed for cytogenetic analysis. Slides from five rats of each sex (60 cells per animal) were examined for chromosomal aberrations for the 6-, 12, and 24-hour groups. Sixty cells were examined per animal.

Mortality was observed at the high dose, and reduced body weight gain was observed in the mid- and high-dose groups. There was no evidence of chromosome damage as measured by increases in chromosome aberrations, altered mitotic index, or chromosome number when compared to the concurrent control group. In the cyclophosphamide-treated positive control group, a significant increase in the average number of aberrations, percent of cells with aberrations, and decreased mitotic index was observed confirming the sensitivity of the assay. Under the conditions of this studythe test material is not clastogenic.