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Diss Factsheets
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EC number: 234-126-4 | CAS number: 10544-72-6
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- The responses of animals inhaling nitrogen dioxide for single, short-term exposures
- Author:
- Carson TR, Rosenholtz MS, Wilinski FR and Weeks MH
- Year:
- 1 962
- Bibliographic source:
- Am. Ind. Hyg. Assoc. J. 1962 Nov-dec; 23; 457-62
Materials and methods
- Principles of method if other than guideline:
- Groups of animals were exposed to various concentrations of the test item for single, short-term exposures.
- GLP compliance:
- no
- Remarks:
- Pre-dates GLP
- Limit test:
- no
Test material
- Reference substance name:
- Nitrogen dioxide
- EC Number:
- 233-272-6
- EC Name:
- Nitrogen dioxide
- Cas Number:
- 10102-44-0
- IUPAC Name:
- nitrous acid
- Test material form:
- gas
- Details on test material:
- - Physical appearance: gas
- Purity: not indicated
- Batch No.: not indicated
- Supplier: not indicated
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young
- Weight at study initiation: 100 to 120 gm
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure:
- whole body
- Details on inhalation exposure:
- Experimental procedures
Techniques of exposures
-Dispersion: the test item was metered from a cylinder through a 1000 mL expansion flask and a manometer containing silicone oil and then into a 400 L dynamic exposure chamber. The test item cylinder expansion flask, and manometer were maintained at 31 °C in a constant temperature box.
- Collection and analysis of chamber air samples: chamber air samples were pulled by vacuum into calibrated gas sampling bottles. Sampling bottles of volume from 50 to 1000 mL and sampling rates from 50 to 500 mL/min were used; the choice depended on the concentration of the test item being sampled. The gas bottles were then cooled in a dry ice-acetone bath and the absorbing reagent was introduced. The samples were analyzed colorimetrically. A sample was drawn before and another during the 5-min exposure. Two to 3 samples were drawn during the longer exposures. There was very little variation between the several samples taken at various times during the exposures. The concentrations are expressed as ppm of the test item.
Exposure of animals
- High level exposures: young male rats were exposed in groups of 10 to various concentrations of the test item for single 5-, 15-, 30-, and 60-min periods.
- Low level exposures: in order to determine the levels of the test item causing minimal or no toxic effects, young male rats were exposed in groups of 30 for single 5-, 15-, and 60-min periods to progressively lower concentrations approximating 50, 25 and 15 % of each of the LC50¿s. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- >= 5 - <= 60 min
- No. of animals per sex per dose:
- - High level exposures: 10/sex/dose
- Low level exposures: 30/ sex/dose - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 21 days
Exposed rats at all concentrations and a group of controls were sacrificed in groups of 5 at 4, 24, and 48 h; and 7, 21, and 42 d after exposure. Toxic signs, kidney to body and lung to body weight ratios, and pathologic changes were used in evaluating the effects of each exposure. Kidney to body weight ratios were determined only at concentrations of 50 and 25 % of the LC50¿s.
Rats from the high level exposures were examined for gross pathologic changes. Organs from animals exposed to the test item at concentrations below the LC50 level were examined for both macro- and microscopic changes. These organs included lung, liver, kidney, spleen, heart, eyes, and gastrointestinal tract. Thiopental sodium was used, interperitoneally, to sacrifice the animals. The kidneys and lungs used to determine organ-body weight ratios were removed from rats held under light anesthesia. Control animals for each exposure group were sacrificed under the same conditions. Tissues for microscopic studies were fixed in 10 % Formalin and stained with hematoxylin and eosin.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 416 ppm
- Based on:
- test mat.
- Exp. duration:
- 5 min
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 201 ppm
- Based on:
- test mat.
- Exp. duration:
- 15 min
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 162 ppm
- Based on:
- test mat.
- Exp. duration:
- 30 min
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 115 ppm
- Based on:
- test mat.
- Exp. duration:
- 60 min
- Mortality:
- - High level exposure: the times of death varied from 30 min to 3 d after exposure.
-Low level exposure: no deaths - Clinical signs:
- other: -High level exposure: toxic signs included severe respiratory distress, eye irritation as shown by reddened conjunctiva, 10 to 15 % body weight suppression lasting for 2 d and death. Animals surviving 3 d after exposure appeared to have recovered from the
- Gross pathology:
- - High level exposures: the gross pathology in rats showed many darkened areas about the surface of the lungs, and, in some instances, purulent modules involving entire lungs of some of the surviving rats were seen.
- Low level exposure: the gross pathologic findings in rats exposed to concentrations approximating 50 % of the LC50¿s showed many darkened areas about the surface of the lungs during the first 7 d after exposure. At 21 and 42 d after exposure some rats showed area of consolidation. Microscopic studies in rats showed pulmonary edema during the first 48 h after exposure. Examination for more complex pulmonary parenchymal lesions was complicated by the presence of chronic murine pneumonia. This pneumonitic process became more prevalent and more extensive as the post-exposure time was increased. There was an impression that exposure to the test item at this concentration level increased the likelihood of seeing chronic murine pneumonia. There were no microscopic changes in the eyes. Other organs studied were within the normal ranges.
No gross pathologic lesions were noted in rats exposed to concentrations approximating 25 % of the rat LC50 values. However, some of the rats examined microscopically at 24 and 48 h after exposure manifested pulmonary edema. Chronic murine pneumonia also was present in some rats. No histological changes were seen in the eyes or other organs studied, except in the lungs.
At concentrations approximating 15 % of the LC50¿s no pathological changes different from the controls were seen. - Other findings:
- No changes were noted in the hematocrits or blood platelet counts.
Any other information on results incl. tables
LC50values for animals exposed to the test item
Exposure time (min) |
LC50(ppm) |
19/20 confidence limits (ppm) |
Slope |
Standard error of the slope |
5 |
416 |
376- 461 |
9.5 |
± 4.2 |
15 |
201 |
191- 212 |
15.3 |
± 4.1 |
30 |
162 |
152- 169 |
20.7 |
± 5.1 |
60 |
115 |
113- 117 |
43.3 |
± 12.8 |
Exposure to low levels of the test item
Exposure time (min) |
Concentrations of the test item Approximate percentage of the LC50¿s for rats |
||
50 % (ppm) |
25 % (ppm) |
15 % (ppm) |
|
5 |
190 |
104 |
74 |
15 |
90 |
65 |
33 |
60 |
72 |
28 |
11 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: Regulation (EC) 1272/2008
- Conclusions:
- Rats were exposed for single 5 to 60 minute periods to various concentrations of the test item. Changes in lung to body weight ratios of rats correlated directly with the severity of exposure to the test tiem. Based on the lung to body weight ratio and the pathological changes found in exposed animals, the threshold concentrations of the test item found were 104, 65 and 28 ppm for 5, 15 and 60 min, respectively.
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