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Toxicological information

Genetic toxicity: in vivo

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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The publication is a summary of several mutagenicity studies performed on methylhydrazine. The summarized report has been reviewed by the Information Office (OI) and is releasable to the National Technical Information Service (NTIS). Some data are absent (GLP statement, data on the test item(batch number, expiry date), environmental conditions...).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
GLP compliance:
not specified
Type of assay:
rodent dominant lethal assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MH
- Substance type: monoconstituent
- Physical state: clear liquid

Test animals

Species:
mouse
Strain:
ICR
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 to 8 week-old
- Weight at study initiation: 30 +/- 2.5 g
- Fasting period before study: no data
- Housing: 5 per cages
- Diet (e.g. ad libitum): 4% fat diet
- Water (e.g. ad libitum): acidified water
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: corn oil or water
Duration of treatment / exposure:
Five days
Frequency of treatment:
Daily
Post exposure period:
8 weeks
Doses / concentrations
Remarks:
Doses / Concentrations:
0.26, 0.86 and 2.6 mg/kg/day
Basis:
no data
No. of animals per sex per dose:
10 males per dose-level
Control animals:
yes, concurrent vehicle
Positive control(s):
- Triethylenemelamine
- Route of administration: intraperitoneal
- Doses / concentrations: 0.3 mg/kg in 0.85% saline

Results and discussion

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

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Dominant lethality, which is indicated by a high percentage of dead implants to total implants, was not demonstrated (a clear dominant lethal effect was observed with the positive control but only in the first 3 weeks of observation).