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Diss Factsheets
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EC number: 271-904-2 | CAS number: 68611-70-1
- 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)
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- 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
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Oral zinc tolerance test was performed in humans to study the absorption of zinc from various zinc compounds including zinc oxide.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Zinc oxide
- EC Number:
- 215-222-5
- EC Name:
- Zinc oxide
- Cas Number:
- 1314-13-2
- IUPAC Name:
- oxozinc
- Details on test material:
- - Name of test material (as cited in study report): Zinc oxide
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age: 51-66 yr
Race: Six were black and four were white
Exclusion criteria: Malignancy, diabetes, rheumatoid arthritis, alcoholism, chronic liver or renal disease, malabsorption syndrome, use of medications that may affect zinc metabolism, and any chronically debilitating illness.
Administration / exposure
- Route of administration:
- oral: capsule
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Not applicable
- Duration and frequency of treatment / exposure:
- Single administration
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Test material equivalent to 50 mg elemental zinc
- No. of animals per sex per dose / concentration:
- Six females and four males
- Control animals:
- other: not applicable
- Positive control reference chemical:
- Not applicable
- Details on study design:
- No data
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption)
- Tissues and body fluids sampled: Blood
- Time and frequency of sampling: Two samples (15 min apart) for baseline data at start of study; various samples at 30 min and thereafter at hourly intervals for 5 h after drug administration.
- Statistics:
- Crunch version 3.0 was used for the statistical analysis of variance.
Results and discussion
- Preliminary studies:
- Not performed
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Zinc was least absorbed after oral administration of zinc oxide among all the zinc compounds tested. Peak plasma concentration of 159.3 ± 29.5 µg/dL reached after 2.5 hr of zinc oxide administration. Plasma concentration reached the near baseline value after 4.5 hr. (see table 1 for details).
Area under the curve generated by percent changes in plasma zinc was lowest (~ 500) after zinc oxide administration among all the zinc compounds tested (Refer Fig. 3 of the reference).
Refer to Fig. 1 and Fig. 2 of the reference for the time related changes in plasma zinc levels and percent changes in plasma zinc, respectively. - Details on distribution in tissues:
- Not performed
- Details on excretion:
- Not performed
Toxicokinetic parametersopen allclose all
- Test no.:
- #1
- Toxicokinetic parameters:
- Cmax: 159.3 ± 29 µg/dL
- Test no.:
- #1
- Toxicokinetic parameters:
- Tmax: 2.5 h
- Test no.:
- #1
- Toxicokinetic parameters:
- AUC: ca. 500 ( for percent change in plasma zinc)
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- Not applicable
Any other information on results incl. tables
Table 1. Changes in plasma zinc levels following the oral zinc oxide administration
Time point |
Plasma Zinc (µg/dL) (mean±SD) |
Base I |
113.0 ± 22.0 |
Base II |
105.3 ± 18.8 |
After Zn administration |
|
30 min |
112.9 ± 20.7 |
1 h 30 min |
143.4 ± 43.6 |
2 h 30 min |
159.3 ± 29.5 |
3 h 30 min |
126.3 ± 25.9 |
4 h 30 min |
113.9 ± 29.8 |
5 h 30 min |
98.4 ± 23.1 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: Least absorption of zinc after zinc oxide administration
Under the study conditions, zinc oxide was least absorbed among all the zinc compounds tested. A comparison of AUC values for different zinc forms were compared, it appeared that the bioavailability of zinc oxide was about 60% of the bioavailability of the soluble forms. - Executive summary:
Oral zinc tolerance test was performed in humans to study the absorption of zinc from various zinc compounds including zinc oxide.
Six female and four male volunteers were administered orally a zinc compound capsule containing 50 mg elemental zinc. Two blood samples were drawn (15 min. apart) for baseline data at initiation of study. Further samples were drawn at 30 min. and thereafter at hourly intervals for 5 h after drug administration. Various zinc compounds (zinc acetate, zinc oxide, zinc sulfate, zinc aminoate and zinc methionine) were tested as described at same dose level in same individuals after every 2 wk intervals.
Zinc was least absorbed after oral administration of zinc oxide among all the zinc compounds tested. Peak plasma concentration of 159.3 ± 29.5 µg/dL reached after 2.5 h of zinc oxide administration. Plasma concentration reached the near baseline value after 4.5 h. Area under the curve generated by percent changes in plasma zinc was lowest (~ 500) after zinc oxide administration among all the zinc compounds tested. A comparison of AUC values for different zinc forms were compared, it appeared that the bioavailability of zinc oxide was about 60% of the bioavailability of the soluble forms.
Under the study conditions, zinc oxide was least absorbed among all the zinc compounds tested.
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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