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EC number: 215-222-5 | CAS number: 1314-13-2
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Organ biodistribution, clearance, and genotoxicity of orally administered zinc oxide nanoparticles in mice
- Author:
- Li C-H, Shen C-C, Cheng Y-W, Huang S-H, Wu C-C, Kao C-C, Liao,J-W and Kang J-J
- Year:
- 2 012
- Bibliographic source:
- Nanotoxicology, 6(7):746-56
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- the publication does not specify GLP compliance
- Test type:
- other: limit test
- Limit test:
- yes
Test material
- Reference substance name:
- Zinc oxide
- EC Number:
- 215-222-5
- EC Name:
- Zinc oxide
- Cas Number:
- 1314-13-2
- Molecular formula:
- ZnO
- IUPAC Name:
- oxozinc
- Test material form:
- other: nano- and micromaterial
- Details on test material:
- uncoated ZnO nanoparticle:
- Diameter: 50 nm approximately
- Hydrodynamic diameter: 93.35 ± 14.53 nm
ZnO microparticles:
- Diameter: >100 nm
- Hydrodynamic diameter 1226.2 ± 120.4 nm
Other information: The suspensions of ZnO particles (stock concentration: 50 mg/mL) were prepared using anhydrous dimethyl sulfoxide (DMSO). ZnO-nanoparticle and ZnO microparticle were diluted with sterile water plus 1% hydroxypropyl methyl cellulose (HPMC) or culture medium, then mixed vigorously, sonicated, and then immediately applied to mice or human cells to minimize agglomeration. Finally, the DMSO concentration was less than 1% (in vivo study).
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- - Rationale for the selection of the starting dose: Based on the result of another study (Yamaki & Yoshino 2009).
- Doses:
- 5,000 mg/kg bw for both ZnO nanoparticle and microparticle
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes
- Details on study design:
- Thirty mice were divided into three groups (five males and five females per group). Mice were fed with vehicle (control group), 5,000 mg/kg bw ZnO-nanoparticle suspension or 5,000 mg/kg bw ZnO-microparticles suspension. Dosed mice were conditioned for 14 d. The mortality and clinical behaviour were observed daily. Body weights were recorded twice weekly. At the end of the study (on Day 14), the mice were anaesthetised with isoflurane and blood (for serum biochemistry analysis) was collected from the orbital sinus, followed by gross necropsy. Tissue samples (for histopathologic examination) were taken and fixed in 10% neutral buffered formalin
- Statistics:
- All data were expressed as the mean ± SD from at least three independent experiments (N ‡ 3). The significance of the difference between the control and each experimental test condition was analysed by Student’s t-test. Statistically significant differences among groups were determined using one-way analysis of variance (ANOVA). A value of p < 0.05 was taken as statistically significant.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Not observed
- Clinical signs:
- other: Not observed
- Body weight:
- other body weight observations
- Remarks:
- In comparison with vehicle control group, ZnO microparticles treated group showed a body weight reduction in both males (Days 5 and 10) and females (Days 5, 10, and 14); the body weight changes were unobvious in ZnO nanoparticle treated groups.
- Gross pathology:
- Decreased wet weights of the spleen, kidney, and liver were observed in ZnO microparticles treated females but not in ZnO nanoparticle treated males. However, no obvious gross pathological signs were found in the study.
- Other findings:
- All serum biochemistry measures were without any significant alternation except for marginal variations in certain parameters.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the study details, the LD50 value of both the ZnO nanoparticles and ZnO microparticles can be established at >5,000 mg/kg bw in mice.
- Executive summary:
The study was conducted to examine the acute toxicity of both ZnO nanoparticles and ZnO microparticles in mice.
Thirty mice were divided into three groups (five males and five females per group). Mice were fed with vehicle (control group), 5,000 mg/kg bw ZnO-nanoparticle suspension or 5,000 mg/kg bw ZnO-microparticles suspension. Dosed mice were conditioned for 14 d.
All the mice survived throughout the testing period without exhibiting any abnormalities related to the test substances. In comparison with the vehicle control group, ZnO-microparticles treated group showed a body weight reduction in both males (Days 5 and 10) and females (Days 5, 10, and 14); the body weight changes were not obvious in ZnO-nanoparticle treated groups. All serum biochemistry measures were without any significant alterations except for marginal variations in certain parameters.
Based on the study details, the LD50 value of both the ZnO nanoparticles and ZnO microparticles can be established at >5,000 mg/kg bw in mice.
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