Registration Dossier
Registration Dossier
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EC number: 216-983-6 | CAS number: 1712-64-7
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:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Toxicology and Carcinogenesis Studies of Pentaerythritol Tetranitrate (CAS No 78-11-5) with 80% D-Lactose Monohydrate (PETN, NF) in F344/N Rats and B6C3F1 MICE
- Author:
- John R. Bucher
- Year:
- 1 989
- Bibliographic source:
- National Toxicology Program P.O Box 12233 Research Triangle Parc, NC 27709
- Reference Type:
- review article or handbook
- Title:
- Himiya otravlyayushtih veshtestv (Chemistry of poisonous substances)
- Author:
- Nekrasov V. V.
- Year:
- 1 929
- Bibliographic source:
- Nauchnoe chimico-technicheskoe izdatelstvo
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar 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:
- [3-nitrooxy-2,2-bis(nitrooxymethyl)propyl] nitrate
- Cas Number:
- 78-11-5
- Molecular formula:
- C5H8N4O12
- IUPAC Name:
- [3-nitrooxy-2,2-bis(nitrooxymethyl)propyl] nitrate
Constituent 1
- Specific details on test material used for the study:
- The presence in the molecule of a substance of the nitrogen atom associated with double bond oxygen almost always determines the toxicity of the compound. The reason most likely is that substances of this nature are easily recovering, i.e. they release oxygen and are strong oxidants. Therefore, all such compounds, such as nitro compounds R-NO2, nitroso compounds R-NO, nitric acid esters - nitrites RO-NO and nitric acid esters - nitrates RO-NO2, - substantially affect the organism in an analogous way destroy hemoglobin in the blood by oxidizing it to methaemoglobin. In addition, their poisonous effect is manifested in all the cells and tissues of the body.
Pentaerythritol Tetranitrate is the lipid soluble polyol ester of nitric acid belonging to the family of nitrovasodilators that exhibit vasodilatory property. Pentaerythritol tetranitrate releases free nitric oxide (NO) after denitration reaction, which triggers NO-dependent signaling transduction involving soluble guanylate cyclase (sGC). NO binds reversibly to the ferrous-heme center of sGC, thereby causes conformational change and activates the enzyme. Activation results in increasing cellular levels of cyclic guanosine monophosphate (cGMP) within vascular smooth muscle, which results in vasodilation mediated by cGMP-dependent protein kinases. Furthermore, this agent causes arterial and venous bed dilation in a dose-dependent manner.
Considering the fact that both PETN and Isopropyl nitrate are esters with nitric acid, we assume that the available data on genetic toxicity of PETN is valid also for Isopropyl nitrate.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced
- Test concentrations with justification for top dose:
- doses up to 10 mg/plate
- Vehicle / solvent:
- No data available.
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: all cell types tested
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in S.typhimirium strains TA98, TA100, TA 1535 or TAT1537.
There is no evidence of cancerogenic activity of the substance referred to.
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