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EC number: 231-555-9 | CAS number: 7632-00-0
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic information given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
- GLP compliance:
- not specified
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
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: drinking water
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 1000, 2000, 3000 mg/l (0, 10, 100, 250 or 350 mg/kg bw/day)
Basis:
nominal in water
- No. of animals per sex per dose:
- 8
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Body weight; once a month
- Sacrifice and pathology:
- Mortality; Methemoglobin; Blood chemistry; glucose, pyruvate, lactate
Pathology; heart, lungs, kidneys, liver, spleen, pancreas, adrenals and some brains.
Results and discussion
Results of examinations
- Details on results:
- There were no significant differences in growth, development, mortality or total haemoglobin levels between the control and treated groups. However, the methaemoglobin levels in the groups receiving 100, 250 and 350 mg/kg bw/day sodium nitrite were raised significantly throughout the study and averaged 5, 12 and 22% of total haemoglobin, respectively.
The main histopathological changes occurred in the lungs and heart. Focal degeneration and fibrosis of the heart muscle were observed in animals receiving the highest dose of nitrite. The coronary arteries were thin and dilated in these aged animals, instead of thickened and narrow as is usually seen at that age. Changes in the lungs consisted of dilatation of the bronchi with infiltration of lymphocytes and alveolar hyperinflation. Such changes were observed in rats receiving 100, 250 and 350 mg/kg bw/day sodium nitrite.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 10 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: (focal degeneration and fibrosis of the heart, dilatation of the bronchi with infiltration of lymphocytes and alveolar hyperinflation in lungs) equivalent to 6.7 mg NO2/kg bw/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an acceptable daily nitrite intake of 0 to 0.07 mg NO2/kg bw/day by applying a safety factor of 100 to this NOEL.
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