Registration Dossier
Registration Dossier
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EC number: 231-554-3 | CAS number: 7631-99-4
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- genetic toxicity in vivo, other
- Remarks:
- heritable translocation test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The reliability and summary were made based on the HPV program adopted during OECD SIAM 25 (October 2007). non GLP
Data source
Reference
- Reference Type:
- publication
- Title:
- In vivo genotoxicity of nitrate and nitrites in germ cells for male mice. I. Evidence for gonadal exposure and lack of heritable effects.
- Author:
- Alavantic, D., Sunjevaric, I., Pecevski, J., Bozin, D., and Cerovic, G.
- Year:
- 1 988
- Bibliographic source:
- Mutation Research.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- OECD 485 is not followed, not GLP, no positive control, less animals used
- GLP compliance:
- not specified
- Type of assay:
- heritable translocation assay
Test material
- Reference substance name:
- Sodium nitrate
- EC Number:
- 231-554-3
- EC Name:
- Sodium nitrate
- Cas Number:
- 7631-99-4
- Molecular formula:
- HNO3.Na
- IUPAC Name:
- sodium nitrate
- Test material form:
- solid: crystalline
- Details on test material:
- - Physical appearance: not indicated
- Purity: not indicated
- Batch No.: not indicated
- Supplier: not indicated
Constituent 1
Test animals
- Species:
- mouse
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-12 weeks
- Housing: in wire-topped polycarbonate cages
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 60
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- distilled water
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- daily
- Post exposure period:
- At 10 days after the last treatment, each male was mated with 2 virgin females. Mating interval was 7 days.
At 5 weeks after treatment, treated and control males were killed by cervical dislocation for cytogenetic analysis.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
600 and 1,200 mg NaNO3/kg/day
Basis:
- No. of animals per sex per dose:
- 25 males
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- no data
Examinations
- Tissues and cell types examined:
- P1 generation:
- cytogenetic analysis performed
- spermatocytes collected from all males, analysed in diakinesis-metaphase I.
- 100 cells per male analysed
F1 generation:
- F1 males were killed at 10-12 weeks.
- cytogenetic analysis performed on up to 3 males per litter from treated P males, and in 25 F1 males from controls.
- spermatocytes collected, analysed in diakinesis-metaphase I.
- 50 cells per F1 male analysed
- Details of tissue and slide preparation:
- chromosomal preparations made by Evans' air drying method, stained by orcein.
- Statistics:
- Student's t-test
Results and discussion
Test resultsopen allclose all
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Remarks:
- no translocations in P1 males
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Remarks:
- no heritable chromosomal translocations in F1 males
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Sex chromosomal univalency was significantly higher at both doses.
Applicant's summary and conclusion
- Conclusions:
- The substance was not mutagenic: negative no translocations in P1 males, no heritable chromosomal translocations in F1 males
Sex chromosomal univalency was significantly higher at both doses.
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