Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1983

Materials and methods

Principles of method if other than guideline:
Guaranteed fertile males were treated by an unspecified route.
GLP compliance:
not specified
Type of assay:
rodent dominant lethal assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No details available

Test animals

Species:
mouse
Strain:
Swiss
Sex:
male
Details on test animals and environmental conditions:
Not included in references above.

Administration / exposure

Route of administration:
other: No data
Vehicle:
No data
Details on exposure:
No data
Duration of treatment / exposure:
No data
Frequency of treatment:
No data
Post exposure period:
No data
Doses / concentrations
Remarks:
Doses / Concentrations:
1400 mg/kg bw
Basis:
no data
No. of animals per sex per dose:
No data
Positive control(s):
Yes, METEPA (probably tris(1-(2-methyl)aziridinyl) phosphine oxide)

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:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
No data

Any other information on results incl. tables

Results with METEPA confirmed the validity of the system.

TOTM was not mutagenic when compared with the positive control

Applicant's summary and conclusion