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Toxicological information

Genetic toxicity: in vivo

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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:
2001
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

Constituent 1
Chemical structure
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 nitrite
Details on test material:
sodium nitrite, purity: 99%

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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