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Diss Factsheets
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EC number: 235-101-0 | CAS number: 12068-53-0
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Pulmonary effects of inhaled zinc oxide in human subjects, guinea pigs, rats, and rabbits
- Author:
- Gordon, T., et al.
- Year:
- 1 992
- Bibliographic source:
- Am Ind Hyg Assoc J 53(8): 503-509
Materials and methods
- Principles of method if other than guideline:
- Fischer 344 rats were exposed to the test material for 3 h. After 0, 4 or 24 h observation time animals were anesthetized and cellular/biochemical changes occurring in bronchoalveolar lavage fluid were examined.
- GLP compliance:
- not specified
- Test type:
- other: Pulmonary study
- Limit test:
- no
Test material
- Reference substance name:
- Zinc oxide
- EC Number:
- 215-222-5
- EC Name:
- Zinc oxide
- Cas Number:
- 1314-13-2
- Molecular formula:
- OZn
- IUPAC Name:
- (oxido)zinc
- Details on test material:
- - Name of test material (as cited in study report): zinc oxide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Weight at study initiation: 200-250 g
- Housing: hanging steel mesh cages
- Diet (e.g. ad libitum): standard laboratory animal chow (Purina Indianapolis Ind), ad libitum
- Water (e.g. ad libitum): sater, ad libitum
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Cannon 52 portchamber. LabProducts Inc., Maywood, NJ
- System of generating particulates/aerosols: Zinc granules were heated to approximately 550 °C in a crucible and the generated vapours were carried downstream by inert argon gas in the furnace to react with oxygen yielding zinc oxide vapours which was mixed with filtered air in a series of cooling/dilution heads before entering the exposure chamber.
- Method of particle size determination: Differential mobility analyzer (TSI Inc., St. Paul, Minn.)
- Temperature, humidity, pressure in air chamber: 25-30 °C and 30 %
TEST ATMOSPHERE
- Brief description of analytical method used: Monitored gravimetrically with teflon filters (Type FG 0.2 µm. Millipore, Bedford, Mass.) and Cahn balance (Model 21, Cahn InstrumentCerritos, Calif.) and filters were analyzed by atomic absorption spectroscopy periodically.
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 0.17 µm - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- (Atomic absorption spectroscopy)
- Duration of exposure:
- 3 h
- Concentrations:
- 0, 2.5 and 5 mg/m³
- No. of animals per sex per dose:
- no data
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 0, 4 or 24 h
- Necropsy of survivors performed: Yes (animals were intraperitoneally anesthetized with Pentobarbital-390 mg/kg)
- Pulmonary lavage preparation: Tracheas were cannulated with sterile, blunt needles and lavaged twice with sterile, pyrogen-free, phosphate-buffered saline.
- Other examinations performed: Biochemical and cellular parameters like protein content, lactate dehydrogenase (LDH), β-glucuronidase level and cell counts were examined in bronchoalveolar lavage fluid. - Statistics:
- Differences in lavage fluid parameters were analysed by one-way analysis of variance followed by a two-sided Dunnett's t-test.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 5 mg/m³ air
- Exp. duration:
- 3 h
- Sex:
- male
- Dose descriptor:
- other: Increased level of total cell counts, protein content, LDH, and β-glucuronidase
- Effect level:
- 2.5 mg/m³ air (nominal)
- Exp. duration:
- 3 h
- Mortality:
- No mortality occured up to the end of the observation period.
- Clinical signs:
- other: Not applicable
- Body weight:
- Not applicable
- Gross pathology:
- Not applicable
- Other findings:
- - Other observations: Significant increases in protein content, lactate dehydrogenase (LDH), β-glucuronidase and cell counts were observed. The test material caused dose-dependent acute inflammation of lungs in rats under the conditions of this test.
Any other information on results incl. tables
LC50 values were not calculated within the publication. However, as no mortality was reported up to the end of the observation period, a LC50 > 5mg/m³ is considered.
Cellular and biochemical changes occurring in bronchoalveolar lavage fluid were examined. Significant increases in protein content, LDH, β-glucuronidase and cell counts were observed.
Table1: Retention of ultrafine test material particles
Exposure Conc.(mg/m3) | Exposure duration (h) | Minute volumeA (L) | Total Zn InhaledB(µg) | Baseline Zn levelC, D(µg Zn/g tissue) | Zn Lung BurdenC(µg Zn/g tissue) | Total Zn DepositedC, Eµg | RetentionC, F(%) |
4.3 | 3 | 0.1 | 77 | 22.0 ± 0.8 | 34.0 ± 0.9 | 9.0 ± 0.8 | 11.5 ± 1.0 |
Where
AMinute volume was calculated on the basis of the equation Y = aMbwhere Y is minute volume; M is mass in kg; and a and b are the coefficient and exponent, respectively, derived by Stahl
BTotal Zn inhaled = (exposure conc.) x (exposure duration) x (minute volume)
CValues are mean ± SE
DDerived from fumace gas-exposed animals.
ETotal Zn deposited = {(Zn lung burden) - (baseline Zn level)} x (wet lung weight)
F% retention = total Zn deposited / total Zn inhaled
Table 2: Exposure concentration
Target concentration | Actual concentration |
2.5 mg/m3 | 2.7 ± 0.1 |
5.0 mg/m3 | 5.4±0.7 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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