Registration Dossier
Registration Dossier
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EC number: 231-555-9 | CAS number: 7632-00-0
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
- Principles of method if other than guideline:
- NTP method
- GLP compliance:
- yes
- Remarks:
- testing lab.
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Sodium nitrite
- EC Number:
- 231-555-9
- EC Name:
- Sodium nitrite
- Cas Number:
- 7632-00-0
- Molecular formula:
- HNO2.Na
- IUPAC Name:
- sodium nitrate
- Details on test material:
- sodium nitrite, purity: 99%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- dissolved in phosphate-buffered saline
- Duration of treatment / exposure:
- 3 injections
- Frequency of treatment:
- three times at 24-hour intervals
Doses / concentrations
- Remarks:
- Doses / Concentrations:
7.81, 15.63, 31.25, 62.5, 125, or 250 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control(s):
- The positive control animals received injections of cyclophosphamide.
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- The animals were killed 24 hours after the third injection and blood smears were prepared from bone marrow cells obtained from the femurs.
Air-dried smears were fixed and stained. 2000 polychromatic erythrocytes (PCEs) were scored for the frequency of micronucleated cells in up to 5 animals per dose group. - Statistics:
- The frequency of micronucleated cells among PCEs was analyzed by a statistical software package that tested for increasing trend over dose groups with a one-tailed Cochrane-Armitage trend test followed by pairwise comparisons between each dosed group and the control group.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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