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:
supporting study
Study period:
not available
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: documentation insufficient for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
N-Methyl-N'-Nitroguanidine: Irritation, Sensitization, and Acute Oral Toxicity, Genotoxicity, and Methods for Analysis in Biological Samples
Author:
Kinkead et al.
Year:
1993
Bibliographic source:
Toxicology and Industrial Health, Vol. 9, No. 3, pp. 457-477

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
Remarks:
data from publication
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- no information available

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
- animals were dosed three times at 24-hr intervals
Frequency of treatment:
- animals were dosed three times at 24-hr intervals
Post exposure period:
- range finding assay: 3 days
- micronucleus assay: 24 hrs
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
range finding test: 0.1 to 1538 mg/kg
Basis:
no data
volume administered to animals was limited to 10 ml/kg
Remarks:
Doses / Concentrations:
micronucleus assay: 320 to 1600 mg/kg
Basis:
no data
volume administered to animals was limited to 10 ml/kg
No. of animals per sex per dose:
- range finding assay: 3
- micronucleus assay: 5
Control animals:
yes
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
- bone marrow from femurs

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

- no clinical symptoms in any animals

- no clinical symptoms in any animals of any dose group in the micronucleus assay

- no treatment-related deaths

- no significant changes in body weight in treated animals relative to vehicle control

- no statistically significant increases in the number of MPCEs

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Under the experimental conditions of the test, the test substance did not induce damage to the chromosomes or the mitotic apparatus of erythroblasts, by analysis of erythrocytes as sampled in bone marrow of CD-1 mice.
Executive summary:

In a CD-1 mouse bone marrow micronucleus assay, 5 animals per sex and per dose were treated by oral gavage with N-Methyl-Nā€™-Nitroguanidine at a doses range of 320 to 1600 mg/kg bw. Bone marrow cells were harvested 24 hours post-treatment. 

There were no signs of toxicity during the study. 

There was not a significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after treatment.