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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test according to state-of-the-art operating procedures for testing of metal bioelution.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Objective of study:
bioaccessibility (or bioavailability)
Principles of method if other than guideline:
The release/dissolution of zinc from zinc oxide in artificial lysosomal fluid was measured. The resulting value is termed bio-accessibility, and is defined as the fraction of a substance that is soluble under physiological conditions and therefore potentially available for absorption into systemic circulation. The simulated lysosomal fluid represents an exposure-relevant exposure route (inhalation exposure.). The compound was introduced as powder in a test item / solution ratio of 2g/L during 24, 48 and 72 hours.


GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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: nanomaterial (coated)
Details on test material:
- Name of test material (as cited in study report): Z-COTE® HP1
- Physical state: white powder, solid, odourless
- non-flammable
- melting point: approx. 1970 °C
- density: 5.47g/cm3
- solubility in water: practically insoluble: 1.6 mg/L (21 °C); soluble in diluted mineral acids , solubility in M4 medium: 2.4 mg/l
- particle size <200 nm
- particle surface area of 12-24 m²/g
- Lot/batch No: NPL Ref#: ZB250#65
- Expiration date of the lot/batch: at least until June 2014
Radiolabelling:
no

Test animals

Details on test animals or test system and environmental conditions:
not applicable

Administration / exposure

Details on exposure:
not applicable

Results and discussion

Preliminary studies:
not applicable
Main ADME results
Type:
other: bioaccessibility
Results:
artificial lysosomal fluid (ALF) - as %Zn released of total Zn content: >90

Toxicokinetic / pharmacokinetic studies

Details on absorption:
not applicable
Details on distribution in tissues:
not applicable
Details on excretion:
not applicable

Bioaccessibility (or Bioavailability)

Bioaccessibility (or Bioavailability) testing results:
lysosomal bioaccessibility - as %Zn released of total Zn content: >90%

Any other information on results incl. tables

pH 4.5 artificial lysosomal fluid:

 test item  %Zn released of total Zn content   
 blank <0.01     
 Z-COTE HP1  >90  
 Z-COTE  >90   
 microscaled  >90 

Applicant's summary and conclusion

Conclusions:
Interpretation of results: other: High bioaccessibility of Zn2+ from ZnO. The dissolution in artificial lysosomal fluid is used to estimate bioavailability after inhalation exposure
Bio-elution test according to state-of-the-art procedures, useful for determining dissolution capacity of Zn in artificial lysosomal fluid.
Executive summary:

During this study on ZnO in different forms (nano- (coated, non-coated) and microscaled ZnO) at a loading of 2 g/L in artificial lysosomal fluid (pH 4.5), it was shown that high amounts of zinc were measured. For nano ZnO, coated a zinc release of >90% was found.