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Exposure related observations in humans: other data

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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:
2012
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

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:
OZn
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.

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

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