Guanidine, N-methyl-N'-nitro-

Genetic toxicity: in vivo

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 for cross-reference:

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

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

Test material information

Constituent 1

Reference substance name:

-

EC Number:

433-400-2

EC Name:

-

Cas Number:

4245-76-5

Molecular formula:

C2H6N4O2

IUPAC Name:

1-Methyl-3-nitro-guanidine

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 / concentrations

Doses / concentrations 1

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

Doses / concentrations 2

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-N’-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.