Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-222-5 | CAS number: 1314-13-2
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment. However, nanomaterial characterisation of ZnO used in this study was poorly described
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
- Type of study / information:
- photosensitization; Occlusive patch test in humans
- Endpoint addressed:
- other: photosensitisation
- Principles of method if other than guideline:
- photoallergy maximization test
- GLP compliance:
- 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: nanomaterial (coated)
- Details on test material:
- TEST ITEM
- Name of test material (as cited in study report): Zano 10 Plus
- Physical state: solution
- Composition of test material, percentage of components: ZnO coated with octyl triethoxysilane [25% suspension of the test substance in corn oil
- Lot/batch No.: ZP1011001
- Expiration date of the lot/batch: N.I.
- Storage condition of test material: N.I.
Constituent 1
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Exposure assessment:
- not specified
Results and discussion
- Results:
- No adverse effects were observed, thus ZnO as tested was not photo-allergenic
Applicant's summary and conclusion
- Conclusions:
- ZnO as tested was neither a skin photoirritant nor a skin photosensitiser
- Executive summary:
This study was conducted to determine the photoallergenic potential of a topically applied product under maximization conditions.
0.2g of the test material or hydrophilic ointment USP (negative control) was placed onto a 2cm x 2 cm occlusive hypoallergenic patch, then applied to subject's back. The patch is then applied directly to the skin of the infrascapular regions of the back. After 24 hours the test sites are wiped dry with gauze and one site is exposed to 3 Mininimal Erythemal Dose (MED) of solar simulating radiation while the alternate site is left nonirradiated. This sequence is repeated for a total of 6 exposures twice weekly.
7 -10 days after the final induction exposure. Similar occlusive applications are made for 24 hours to a previously unexposed untreated area of normal skin. The sites are then irradiated with 10.0 Joules/cm2 of UV-A radiation
Observation times for skin reaction were scored 48 and 72 hours post challenge irradiation
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
