Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety - A proposal for further actions.

Over the recent years, EU chemicals legislation, guidance and test guidelines have been developed or adapted for nanomaterials to facilitate safe use of nanomaterials. This paper provides an overview of the information requirements across different EU regulatory areas. For each information requirement, a group of 22 experts identified potential needs for further action to accommodate guidance and test guidelines to nanomaterials. Eleven different needs for action were identified, capturing twenty-two information requirements that are specific to nanomaterials and relevant to multiple regulatory areas. These were further reduced to three overarching issues: 1) resolve issues around nanomaterial dispersion stability and dosing in toxicity testing, in particular for human health endpoints, 2) further develop tests or guidance on degradation and transformation of organic nanomaterials or nanomaterials with organic components, and 3) further develop tests and guidance to measure (a)cellular reactivity of nanomaterials. Efforts towards addressing these issues will result in better fit-for-purpose test methods for (EU) regulatory compliance. Moreover, it secures validity of hazard and risk assessments of nanomaterials. The results of the study accentuate the need for a structural process of identification of information needs and knowledge generation, preferably as part of risk governance and closely connected to technological innovation policy.

Cobalt, nickel and chromium release from dental tools and alloys.

BACKGROUND: Cobalt-chromium alloys are used as casting alloys by dental technicians when producing dental prostheses and implants. Skin exposure and metal release from alloys and tools used by the dental technicians have not been studied previously. OBJECTIVES: To study the release of cobalt, nickel and chromium from alloys and tools that come into contact with the skin of dental technicians. METHODS: Cobalt and nickel release from tools and alloys was tested with the cobalt spot test and the dimethylglyoxime test for nickel. Also, the release of cobalt, nickel and chromium in artificial sweat (EN1811) at different time-points was assessed. Analysis was performed with inductively coupled plasma-mass spectrometry. RESULTS: Sixty-one tools were spot tested; 20% released nickel and 23% released cobalt. Twenty-one tools and five dental alloys were immersed in artificial sweat. All tools released cobalt, nickel and chromium. The ranges were 0.0047-820, 0.0051-10 and 0.010-160 µg/cm(2) /week for cobalt, nickel and chromium, respectively. All dental alloys released cobalt in artificial sweat, with a range of 0.0010-17 µg/cm(2) /week, and they also released nickel and chromium at low concentrations. CONCLUSIONS: Sensitizing metals are released from tools and alloys used by dental technicians. This may cause contact allergy and hand eczema.