Registration Dossier
Registration Dossier
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EC number: 231-818-8 | CAS number: 7757-79-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Primary mutagenicity screening of food additives currently used in Japan.
- Author:
- Ishidate Jr., M; Sofuni, T; Yoshikawa, K; Hasashi, M; Nohmi, T; Sawada, M; Matsuoka, A
- Year:
- 1 984
- Bibliographic source:
- Fd.Chem. Toxic. 22: 623-636.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- According to Ishidate & Odashima (1977).
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Potassium nitrate
- EC Number:
- 231-818-8
- EC Name:
- Potassium nitrate
- Cas Number:
- 7757-79-1
- Molecular formula:
- HNO3.K
- IUPAC Name:
- potassium nitrate
- Test material form:
- solid: crystalline
- Details on test material:
- - Analytical purity: 99.8%
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Chinese hamster fibroblast cell line (CHL)
- Details on mammalian cell type (if applicable):
- fibroblast cell line
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- Potassium nitrate: 0-1.0 mg/ml
- Vehicle / solvent:
- physiological saline
- Details on test system and experimental conditions:
- - Exposure duration: 24 and 48 hr
- Colcemid was added 2 h prior to cell harvesting
- cells fized with acetic-acid methanol
- stained with Giemsa
- 100 metaphases observed
Results and discussion
Test results
- Key result
- Species / strain:
- other: Chinese Hamster Fibroblast cell line
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
Any other information on results incl. tables
GENOTOXIC EFFECTS
Potassium nitrate was not clastogenic.
|
Incidence of cells with structural aberrations |
|
Without S9-mix |
|
potassium nitrate |
24 hr |
Not presented |
48 hr |
3.0% |
CYTOTOXIC CONCENTRATION
Maximum dose tested = non cytotoxic dose
Polyploid cells 2.0%
Applicant's summary and conclusion
- Conclusions:
- does not cause structural chromosomal aberrations
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