Registration Dossier
Registration Dossier
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EC number: 211-063-0 | CAS number: 628-96-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity of glyceryl trinitrate (nitroglycerin) in Salmonella typhimurium
- Author:
- Maragos, C.M., Andrews, A.W., Keefer, L.K. and Elespuru, R.K.
- Year:
- 1 993
- Bibliographic source:
- Mutation Research, 298:187-195
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Glycerol trinitrate
- EC Number:
- 200-240-8
- EC Name:
- Glycerol trinitrate
- Cas Number:
- 55-63-0
- Molecular formula:
- C3H5N3O9
- IUPAC Name:
- propane-1,2,3-triyl trinitrate
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium, other:
- Details on mammalian cell type (if applicable):
- TA1975, TA102, TA1538, TA100, TA100NR, YG1026
- Metabolic activation:
- with and without
- Metabolic activation system:
- hamster liver S9
- Test concentrations with justification for top dose:
- 0.1 to 10.0 µmol/plate, 10.1% NG in vehicle
- Vehicle / solvent:
- lactose
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- other: positive, but attributed to nitric oxide generation
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- all tested strains
- Additional information on results:
- One strain (TA1535) of S. typhimurium showed susceptibility to single base pair changes (i.e., C→T transitions) (Wink et al.,1991). A follow-up AMES test on this strain and six others (Maragos et al., 1993) suggested that NG is weakly mutagenic to this particular strain and none of the others tested. Specifically, the single base pair changes were observed in the first or second position of the hisG46 codon (CCC). Using the TA1535 strain, this same pattern of mutagenicity was observed in response to nitric oxide. Given that nitric oxide is generated when NG is metabolized, the authors postulated that it is likely nitric oxide and not NG that is responsible for the mutagenicity observed in the TA1535 strain.
Applicant's summary and conclusion
- Conclusions:
- negative
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