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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Additional toxicological data

Currently viewing:

Administrative data

additional toxicological information
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
other: Not applicable
Rationale for reliability incl. deficiencies:
other: Review on nano-sized cosmetics and their no risk to human skin or human health
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 Type:
review article or handbook
Nanotechnology, cosmetics and the skin: is there a health risk?
Nohynek GJ, Dufour EK and Roberts MS
Bibliographic source:
Skin pharmacology and physiology 21:136-149

Materials and methods

Type of study / information:
Review of existing studies on human toxicology concerning nano titanium dioxide and zinc oxide
Principles of method if other than guideline:
Not applicable

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc oxide
EC Number:
EC Name:
Zinc oxide
Cas Number:
Molecular formula:
Details on test material:
Not applicable

Results and discussion

Any other information on results incl. tables


Applicant's summary and conclusion

This review considers a large database on conventional in vitro and in vivo dermal penetration studies which consistenly shows that nano-structured ZnO does not significantly penetrate through living human or animals. Nano-sized ZnO did not penetrate into or through pig skin. Whereas the conclusion that nano-sized ZnO does not penetrate intact skin, there remain some questions as to the dermal penetration of ZnO through comprised skin. This question is not specific to nano-sized ZnO. It pertains to all substances in particular dermatological drug preparations that are applied to potentially compromised skin. The evidence suggests that biologically inert nanomaterials such as ZnO should be regarded as low priority concerning their skin penetration.
Executive summary:

Sunscreens contain TiO2 or ZnO nanoparticles (NP), which are efficient UV filters, protecting consumers from the harmfull effects of UV exposure including skin ageing, herpes as well as skin and lip cancers.

A number of studies suggest that insoluble NP do not penetrate into or through human skin. The results of in vivo toxicity tests showed that TiO2 and ZnO NP are non-toxic. Studies on wear debris nano- and microparticles support the traditional view that toxicity of small particles is related to their chemistry, rather than their particle size. There is little evidence supporting a general rule that adverse effects of

particles on the skin or other tissues increase with smaller particle size, or produce novel toxicities relative to those of

larger particles. Overall, the current evidence suggests that nano-sized cosmetic or sunscreen ingredients pose no potential

risk to human health, whereas their use in sunscreens has large benefits, such as the protection of human skin against skin cancer.