Registration Dossier
Registration Dossier
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EC number: 231-554-3 | CAS number: 7631-99-4
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Nitrate WHO Food Additives Series
- Author:
- World Health Organization (WHO)
- Year:
- 1 996
- Bibliographic source:
- Nitrate WHO Food Additives Series; p. 325-60
Materials and methods
- Type of study / information:
- Biotransformation, distribution and excretion
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
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
Results and discussion
- Results:
- In healthy volunteers administered 10 mg sodium nitrate, the cumulative salivary nitrate excretion, over 24 h expressed as percentage of the ingested dose, was 28%. The plasma nitrate half-life was approximately 6.5 h and the volume of distribution was approximately 33 litres.
Applicant's summary and conclusion
- Conclusions:
- The current study indicated a predominantly tubular excretion of nitrate.
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