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EC number: 201-209-1 | CAS number: 79-46-9
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Not GLP, some biochemical and histological analyses that are performed in guideline studies were not conducted. Some of the test material may have been ingested. Animals may have been exposed to a decomposition product. Weights of high dose animals were significantly less than controls. Animals were group housed during inhalation exposures.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Reference Type:
- publication
- Title:
- Subchronic inhalation toxicity of nitromethane and 2-nitropropane
- Author:
- Lewis TR, Ulrich CE and Busey WM.
- Year:
- 1 977
- Bibliographic source:
- J Environmen Pathol Toxicol 2:233-249
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2-nitropropane
- EC Number:
- 201-209-1
- EC Name:
- 2-nitropropane
- Cas Number:
- 79-46-9
- Molecular formula:
- C3H7NO2
- IUPAC Name:
- 2-nitropropane
- Details on test material:
- Purity of the test material was 94.45 % (by weight). It also contained 3.07% 1-nitropropane, 1.96% nitroethane, 0.42% 2-nitro-2-methylpropane, 0.03% 2-nitrobutane and < 0.01% water. Other minor impurities were not listed.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Two hundred fifty male, Sprague-Dawley rats (100 g) were acclimated for 14 days. All animals were allowed food and tap water ad libitum. The animals were randomly allocated to 25 groups of 10 animals each.
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- Generation of vapor: Test material was pumped at a constant flowrate to the vaporization apparatus. Vaporization was accomplished by utlizing a counter-current flow of heated air. The temperatures at the top and bottom of the column were 75 and 120 degrees C, respectively. Air flows were within 18-25 l/min. The concentrated vapor-air mixture was piped to the exposure chamber inlet and diliuted with air flowing at approximately 1000 l/min. The volume of the exposure chambers was 6 cubic meters. Air was supplied by an air conditioning system separate from the general laboratory system. It was controlled for both temperature (21.5 degrees C) and relative humidity (50%). Chamber flowrate was monitored as the pressure drop across a sharp-edged orifice.
Rats were housed in the chambers 24 hours/day. They were caged (10/cage) in wire mesh stainless steel cages, with a dropping pan beneath. Once per day (just prior to exposure) animals were removed from the chambers and all pans and the chamber interiors were hosed down with hot water and a disinfectant. All cages were exchanged for clean ones once per week. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Each chamber was autosampled approximately every hour for concentration of test material. The samples were analyzed using a calibrated Wilks MIRAN I infrared absorption spectrophotometer (at a wavelength of 3.4 microns). Chamber concentrations were read from the charts twice daily. Nominal concentrations were obtained by noting the volume of compound used during the each day.
- Duration of treatment / exposure:
- Groups of 10 animals were daily exposed to 25 or 200 ppm (nominal) test material and euthanized at 2 days, 10 days, 1 month, 3 months or 6 months.
- Frequency of treatment:
- 7 hours/day, 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 25 or 200 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 27.2 +/- 3.1 ppm and 207 +/- 15 ppm
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10 male rats/dose/group
- Control animals:
- yes
- Details on study design:
- Groups of 10 animals were exposed to 25 or 200 ppm (nominal) test material and euthanized at 2 days, 10 days, 1 month, 3 months or 6 months. Animals were weighed at unlisted intervals. Average weights of controls and rats exposed to 27 ppm were 171 g at time of exposure. Blood for hematolgic (hematocrit, hemoglobin, erythrocyte count, prothrombin time and methemoglobin) and biochemical (serum glutamic-pyruvic transaminase, ornithine carbamyl transferase and thyroxin) analyses was obtained from the abdominal aorta at each termination. All animals that died or survived to termination were given complete necropsies. The liver, kidney, thyroid, lungs plus trachea (both wet and dry) and brain (both wet and dry) were weighed. The lungs, adrenals, bronchi, cerebellum, cerebral hemispheres, eyes, kidneys, liver, spleen, thyroid and trachea were processed and evaluated microscopically.
Examinations
- Observations and examinations performed and frequency:
- Animals were weighed at unlisted intervals.
- Sacrifice and pathology:
- Blood for hematolgic (hematocrit, hemoglobin, erythrocyte count, prothrombin time and methemoglobin) and biochemical (serum glutamic-pyruvic transaminase, ornithine carbamyl transferase and thyroxin) analyses was obtained from the abdominal aorta at each termination. All animals that died or survived to termination were given complete necropsies. The liver, kidney, thyroid, lungs plus trachea (both wet and dry) and brain (both wet and dry) were weighed. The lungs, adrenals, bronchi, cerebellum, cerebral hemispheres, eyes, kidneys, liver, spleen, thyroid and trachea were processed and evaluated microscopically.
- Statistics:
- Data were first evaluated for homogeneity using Bartlett's test, with the rejection level set at p = 0.01. A one-way analysis of variance was then conducted (with the critical value set at p = 0.10). Data that were significantly different were then analyzed with the Student's t-test to determine which means were significantly different from control. The critical value for these analyses was P = 0.05.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- Effects at 207 ppm: There was no effect of treatment on body weight. Hematocrit, hemoglobin, red blood cells and prothrombin time were decreased at 10 days and 1 month in rats exposed to 207 ppm. At three months, the prothrombin time of rats exposed to 207 ppm was decreased and red blood cells were increased. Methemoglobin concentrations were increased at 6 months. None of the hematologic changes were considered by the authors to be related to exposure. Serum glutamic-pyruvic transaminase was increased in rats exposed to 207 ppm at 10 days and 1 and 6 months. Serum throxin was increased in rats exposed to 207 ppm at 3 months. Wet/dry weights of lungs were increased in rats exposed to 207 ppm for 1, 3 or 6 months. Relative lung and liver weights of animals exposed to 207 ppm test material were elevated at 3 and 6 months. At 1, 3 and 6 months, rats exposed to 207 ppm had an increased incidence dark hemorrhagic foci in the lungs. The livers of rats exposed to 207 ppm for 3 months had areas of necrosis and surface lesions and were paler in color than controls. After 6 months of exposure to 207 ppm, the livers were enlarged and pale with numerous masses and lesions.
No exposure-related microscopic alterations were seen in any of the tissues of rats exposed for 2 or 10 days, or 1 month. In all 9 rats euthanized after exposure to 207 ppm test material for 3 months, numerous focal areas of hepatocellular hypertrophy were noted. The hepatocytes in these foci were more eosinophilic than the surrounding cells and usually contained large, vesiculated nuclei. In 4 of the 9 rats, basophilic foci containing hyperplastic, small hepatocytes with hyperchromatic nuclei were observed. Occasionally, mitotic figures were present.
Multiple hepatocellular carcinomas and numerous neoplastic nodules were present in the livers of all 10 rats exposed to 207 ppm test material for 6 months. In many cases, the normal hepatic parenchyma was destroyed. The neoplasms were composed of anaplastic hepatocytes, sometimes forming broad sheets or trabeculae several cells thick. Blood-filled cysts were occasionally seen in the neoplasm. Mitotic figures were commonly observed. The carcinomas appeared to be rapidly growing. However, no metastatic hepatocellular carcinomas were seen in any of the other tissues examined.
Effects at 27 ppm : There was no effect of treatment on body weight. Hematocrit and red blood cells were decreased and methemoglobin was increased at 10 days in rats exposed to 27 ppm. Hematocrit also was decreased at 1 month in rats exposed to 27 ppm. Rats exposed to 27 ppm for 3 months had increased hematocrit, hemoglobin and red blood cells. Methemoglobin concentrations were increased at 6 months. None of the hematologic changes were considered by the authors to be related to exposure. Wet/dry weights of lungs were increased in rats exposed to 27 ppm for 3 months. No exposure-related macroscopic or microscopic changes were observed in any organ that was examined.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 27 ppm (analytical)
- Sex:
- male
- Dose descriptor:
- LOAEL
- Effect level:
- 207 ppm (analytical)
- Sex:
- male
- Basis for effect level:
- other: Liver effects
- Dose descriptor:
- other: 6-hour LC50
- Effect level:
- 400 ppm
- Sex:
- male
- Dose descriptor:
- other: 6 hour LC50
- Effect level:
- > 580 ppm
- Sex:
- female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The study
was conducted at the Huntingdon Research Center under NIOSH contract No.
210-75-0039.
The material nitromethane was tested concurrently (at 98 and 745 ppm) in
this study. This
material had no effect on the pathology of the liver. 2-nitropropane
also was tested in rabbits at the same concentrations. Rabbits
and rats were exposed in the same chambers. The
results for the rabbit study are described in a different summary.
The 6-hr LC50 value also was determined, using rats of both sexes. In
males, this value was approximately 400 ppm. Females
were less sensitive, as none died after exposure to a concentration that
killed all of the males (580 ppm).
The high dose for the study was originally 400 ppm (instead of 200 ppm).
However,
since excessive mortality occurred within 3 days, the exposure was
stopped. New
groups of rats with average weights of 96 g were then exposed to 200 ppm
(nominal). These
animals weighed less than controls or rats exposed to 27 ppm (avg.
weight 171 g). Therefore,
results for rats exposed to 207 ppm were compared to those of controls
that had significantly higher weights. A
new control group comprised of rats with weights approximating those of
rats exposed to 207 ppm should have been added when animals were exposed
to 207 ppm.
The authors noted that some of the material may have decomposed during
the vaporization process, which was conducted at 75-120 degrees C.
Therefore,
the possibility exists that a decomposition product contributed to the
toxicity.
Since food and water were not withdrawn during exposure, it is possible
that some of the material was ingested.
The NOAEL for this study was 27 ppm. Increased wet/dry lung weights that
occurred at 3 months were not supported by histologic evidence of edema.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL is 27 ppm and the LOAEL is 207 ppm.
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