Registration Dossier
Registration Dossier
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EC number: 203-615-4 | CAS number: 108-78-1
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: NTP studies are considered as high quality studies, even if GLP was formally not stated. The studies are peer reviewed. The available data are only very condensed ones.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: NTP standards
- Principles of method if other than guideline:
- The chemical to be examined is administered to the test animals. Bone marrow is taken from the femur and the chromosomes in metaphase are examined microscopically.
- GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Melamine
- EC Number:
- 203-615-4
- EC Name:
- Melamine
- Cas Number:
- 108-78-1
- Molecular formula:
- C3H6N6
- IUPAC Name:
- 1,3,5-triazine-2,4,6-triamine
- Details on test material:
- - Name of test material (as cited in study report): melamine
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Corn oil.
- Details on exposure:
- No data
- Frequency of treatment:
- 1
- Post exposure period:
- Sampling time: 36 h p.a.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 - 150 - 300 - 600 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 8 males per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- DMBA (25 mg/kg)
Examinations
- Tissues and cell types examined:
- Bone marrow
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Remarks:
- only the mid dose is positive
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- The number of cells with aberrations was significantly increased only in the mid dose, but not in the low or high doses, compared to the control. The overall trend was negative. Therefore an overall negative result is concluded.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative Negative for the low and high dose, only the mid dose is positive.
- Executive summary:
Melamine was administered to mice. Bone marrow was taken from the femur and the chromosomes in metaphase were analysed microscopically. The number of cells with aberrations was significantly increased only in the mid dose, but not in the low or high doses, compared to the control. The overall trend was negative. Therefore an overall negative result is concluded.
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