Registration Dossier
Registration Dossier
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EC number: 200-471-4 | CAS number: 60-34-4
Genetic toxicity: in vivo
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:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- GLP compliance:
- not specified
- Type of assay:
- rodent dominant lethal assay
Test material
- Reference substance name:
- Methylhydrazine
- EC Number:
- 200-471-4
- EC Name:
- Methylhydrazine
- Cas Number:
- 60-34-4
- Molecular formula:
- CH6N2
- IUPAC Name:
- methylhydrazine
- Details on test material:
- - Name of test material (as cited in study report): MH
- Substance type: monoconstituent
- Physical state: clear liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system 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).
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