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EC number: 211-745-8 | CAS number: 693-21-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1.3.1975-25.2.1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Comparable guideline study, tested with the source substance Nitroglycerin. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
- Reference Type:
- publication
- Title:
- The development of a human amnion strain of cells.
- Author:
- Fernandes, M.V.
- Year:
- 1 956
- Bibliographic source:
- Texas Repts. Biol. Med., 16, 48.
- Reference Type:
- publication
- Title:
- Chromosome Cytology.
- Author:
- Moorhead, P.S. and P.C. Nowell
- Year:
- 1 964
- Bibliographic source:
- In Methods In Medical Research, H. N. Eisen, Ed. Yearbook Medical Publ., Inc., Chicago, p. 310.
- Reference Type:
- publication
- Title:
- Virus-cell interaction with tumor producing virus.
- Author:
- Vogt, M. and R. Dulbecco
- Year:
- 1 960
- Bibliographic source:
- Proc. Nat. Acad. Sci., 46, 365 - 370
- Reference Type:
- publication
- Title:
- Chromosome Praparations of Leukocytes Cultured from Humn Peripheral Blood
- Author:
- Moorhead, P.S:, Nowell, W.J., Mellman, W.J., Battips, D.M., Hunger, D.A.
- Year:
- 1 960
- Bibliographic source:
- Expt.Cell Res., 20: 613
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Principles of method if other than guideline:
- Kidney cells from kidney tissue removed at autopsy were cultured by the trypsinization method of Fernandes (1958). Cultures were maintained in Eagle's medium as modified by Vogt and Dulbecco (1960). Cells were processed for spreading on slides by the method of Moorhead & Newell (1964). Slides were stained with Giemsa stain. Chromosomes were counted and morphological aberrations were examined from photographic negatives of up to 50 metaphase cells [ Lee, et al., (1976)].
DEVIATIONS FROM OECD PROTOCOL #475.
This study was carried out on rats that had been dosed in their diet for 5 and 13 weeks, respectively. The study also had no positive control. Two hundred cells were evaluated / rat for measuring cell ploidy. Kidney samples from fewer than five rats total were evaluated. The report does not specify whether the kidneys were from males, females, or both. Mitotic indices were not calculated. - GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Glycerol trinitrate
- EC Number:
- 200-240-8
- EC Name:
- Glycerol trinitrate
- Cas Number:
- 55-63-0
- IUPAC Name:
- propane-1,2,3-triyl trinitrate
- Details on test material:
- - Name of test material (as cited in study report): Nitroglycerin, TNG
- Molecular formula (if other than submission substance): C3H5N3O9
- Molecular weight (if other than submission substance): 227.08
- Smiles notation (if other than submission substance): [O-][N+](=O)OCC(CO[N+](=O)[O-])O[N+](=O)[O-]
- InChl (if other than submission substance): InChI=1/C3H5N3O9/c7-4(8)13-1-3(15-6(11)12)2-14-5(9)10/h3H,1-2H2
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type: technical product
- Physical state: a 10 % mixture on lactose
- Analytical purity: 9.72% +/- 0.09%
- Lot/batch No.: D17-H3 (Source: Atlas Chemical Division, ICI America Inc., Wilmington, DE)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD® rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Lab., Wilmington, Mass.
- Fasting period before study: ad libitum
- Housing: plastic cage with filter tops
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 75+/-5°F
- Humidity (%):50+/-10%
- Air changes (per hr):10 air chenges per hour
- Photoperiod (hrs dark / hrs light): 12-hour on and 12-hour off
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- - Vehicle(s)/solvent(s) used: lactose
- Justification for choice of solvent/vehicle: TNG was desensitized in lactose.
- Concentration of test material in vehicle: 10% - Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): standard rodent chow
- Storage temperature of food: room temperature - Duration of treatment / exposure:
- 4 weeks or 13 weeks
- Frequency of treatment:
- 24 hrs/day - The animal feeders were refilled after the 4th day and emptied completely after the 7th day before the freshly prepared TNG-feed mixture was used.
- Post exposure period:
- 4 weeks
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
59 mg/kg/day
Basis:
nominal in diet
male average daily intake for first 5 weeks (from highest dose level), TNG intake was corrected for evaporation loss.
- Remarks:
- Doses / Concentrations:
229.5 mg/kg/day
Basis:
nominal in diet
male average daily intake for weeks 6-13, incl. (from highest dose level). TNG intake was corrected for evaporation loss.
- Remarks:
- Doses / Concentrations:
59.3 mg/kg/day
Basis:
nominal in diet
female average daily intake for first 5 weeks (from highest dose level). TNG intake was corrected for evaporation loss.
- Remarks:
- Doses / Concentrations:
233.8 mg/kg/day
Basis:
nominal in diet
female average daily intake for weeks 6-13, incl. (from highest dose level). TNG intake was corrected for evaporation loss.
- No. of animals per sex per dose:
- 16 females and 16 males per dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- kidney cultures
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Since the rat kidneys were from the highest dose group and the investigators concluded that there appeared to be no effect on the parameters measured, chromosome aberration analyses were not carried out on kidney cells from rats dosed at lower levels.
KIDNEY CULTURES
Kidney tissue samples were removed at necropsy and cultured by the trypsinization method of Fernandes. All cultures were maintained in Eagle´s medium as modified by Vogt and Dulbecco.
CHROMOSOME ANALYSIS
Actively dividing kidney cultures and phytohemaglutin-stimulated lymphocytes were arrested in metaphase by short-term colchicine treatment. The cells were trypsinized, swollen in hypotonic solution and processed for spreading on glass slide by the method Moorhead and Nowell. Slides were stained with giemsa and scanned under low power optics. Cell polyploidy was estimated by examination of 200 cells. Slides showing minimum scattering of cells in metaphase were selected for analysis under oil immersion optics. - Evaluation criteria:
- Chromosomes were counted and morphological aberration were examined from photographic negatives of up to 50 metaphase cells.
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Vehicle controls validity:
- not specified
Any other information on results incl. tables
Rat kidney cells
Daily dose (mg/kg) |
No.of rats |
Chromosome frequency |
Tetraploids per 100 cells |
||||
40 |
41 |
42 |
43 |
44 |
|||
WKS 1-5 |
|
|
|
|
|
|
|
0 |
4 |
41 |
4 |
42 |
1 |
0 |
0.59±0.192 |
Ave.59 |
3 |
3 |
1 |
44 |
1 |
0 |
0.65±0.33 |
WKS 6-13 |
|
|
|
|
|
|
|
0 |
4 |
4 |
4 |
42 |
1 |
0 |
0.59±0.19 |
Ave.229.5 |
4 |
4 |
2 |
43 |
1 |
0 |
0.75±0.25 |
1mean,2mean±standard error
Dose (mg/kg) |
No. of rats |
Chromatid breaks&gaps/50 cells |
Translocations/50 cells |
Total aberrations/50 cells |
WKS 1-5 |
|
|
|
|
0 |
4 |
1.5±0.31 |
0.5±0.6 |
2±0.3 |
Ave.59 |
3 |
2±0.6 |
1±0.1 |
2±1.3 |
WKS 6-13 |
|
|
|
|
0 |
4 |
1.5±0.3 |
0.5±0.3 |
2±0.3 |
Ave.233.8 |
4 |
1±0.7 |
0.5±0.3 |
1.5±0.9 |
1mean
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The data are indicative, but incomplete by contemporary standards. There is no apparent suggestion of an effect, but the small number of control and test rats evaluated and the lack of information as to the sexes involved make statistical evaluation of the results questionable. The test animal standard errors usually were larger than those for the control animal physical aberration measurements, suggesting more scatter in the test animal measurements, but there does not appear to be any real suggestion of an effect.
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