Zinc neodecanoate

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

review article or handbook

Title:

Nanotechnology, cosmetics and the skin: is there a health risk?

Author:

Nohynek GJ, Dufour EK and Roberts MS

Year:

2009

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

Test material information

Constituent 1

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

Details on test material:

Not applicable

Results and discussion

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

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.