Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

California's Department of Toxic Substances Control (CDTSC) held a conference today during which they identified the next six nanoscale materials they intend to target in their second round of data call ins.  Regular readers may remember that CDTSC targeted 26 manufacturers/importers of carbon nanotubes with its first data call in in 2009. 

In addition to identifying the nanoscale materials which will be the subject of the data call in, CDTSC also provided a preliminary list of manufacturers/importers that will receive the data call in, as well as the proposed questions they will be asked.  We cover each material below.

CDTSC also indicated that carbon nanotube manufacturers/importers will receive a second round of data call in questions. 

CDTSC plans to issue all of these new data call ins sometime before the end of the year.  Stay tuned . . .

Nano Silver

Proposed Questions:  What is the chemical composition of your nanosilver material? What is particle size of your nanosilver material used? What is the concentration of nanosilver used in your material? What are the instrumental techniques used to characterize your nanosilver material?What are the analytical methods used in your nanosilver material? How do you measure and monitor fate and transport after useful life of your nanosilver material? How do you detect, measure and monitor releases during facility operations?

Preliminary Recipients:  Nano Composix, Cambrios Technologies, Seashell Technology, Sun Innovations, Stanford Materials, MTI Corporation.

Nano Zero Valent Iron

Proposed Questions:  What are the analytical methods for assessment of toxic effects and safe uses of nano zero valent iron across its lifecycle? How do you sample, measure, and monitor quality? Performance? How do you detect, measure, and monitor releases from facility operations? How do you measure and monitor fate and transport after useful life?

Preliminary Recipients:  American Elements, AMEC Geomatrix, hepure Technologies, OnMaterials, Quantum Sphere, Stanford Materials, Sun Innovations.

Nano Titanium Dioxide

Proposed Questions: What machines and methods do you use to analyze your materials? What are the properties of your materials? After modification? What types of monitoring program are you using in your work place? In air? In water? What is the toxicity when your material is directly contacted with human skin? What is the weathering, liberation rate of your material into the environment? Impacts? What is you actual production amount this year?

Preliminary Recipients:  DuPont, BASF, Evonik, Ishihara, Altair nano, Huntsman, Kronos, Kemira, Kon Corp., Tronox, Nanocompsix, Nano-oxide, Green millenium, MK nano, Advanced Nano, NanoCo, Pilkington.

Nano Zinc Oxide

Proposed Questions:  Describe .specifically the nanostructure, functionalities, and properties (physical, chemical, and biological) of nano zinc oxide material that is produced in the facility.  Describe the in-house instrument and analytical methods you use to determin the presence of nano zinc oxide in the workplace and environment. Describe the chemical information provided by external vendors relative to nano zinc oxide nanostructure, functionalities, and properties.  Describe the instrumentation and analytical methods used by external laboratories that provided the above chemical information.

Preliminary Recipients:  UC San Diego, UC Berkeley, USC, Ferity Zinc Oxide Inc., APF Laboratories, Atomate Corporation, Stanford Materials, Alpha Enivornmental, Nanophase technologies, Sokang nano, Antaria Corporation, Ocean Nano Tech, LaamScience, Advanced nanotechnology, NanoGate, Inframat Advanced Materials, Reade Advanced Materials, KIA, Nanjing Hi Tech Nano Material Co., ltd., Nanozinc Oxide South Africa, NanoMaterials Technology, UmiCore Group, Horsehead Corporation.

Nano Cerium Oxide

Proposed Questions:  What machines and methods do you use to analyze your materials?  What are the properties of your materials? After modification? What types of monitoring program are you using in your work place? In air? In water? Do you know reactions when your material is released into aquatic environment? Do you know reactions when your material is released into air? What is you actual production amount this year?

Preliminary Recipients:  Saint-Gobain, Evonik, Meliorum Tech., Inframat Advanced materials, Antaria, HEFA Rare Earth Canada, Nanocerox, Nyacol, Energenics, MTI Corporation.

Quantum Dots

Proposed Questions:  What are the chemical compositions (purity, concentration, and chemical make-up) of your product's core and shell structures (including organic and inorganic attachments)? Specify its size, hydrodynamic diameter (HD), and surface area.  What analytical detection methods do you use to determine its presence in the workplace and environment? What are the surface properties (surface reactivity, groups, charge) and solubility in water and other solvents? What is the stability of your product in different environments (variable pH, temp, pressure, O2, UV light, water, etc.)? Does it aggregate in aquatic media?

Preliminary Recipients:  Nanosys/QD Soleil, Bloo Solar, Life Technologies, Stio, Quantum Dot Corporation, Chemicon International, Zymera, Invisage Technologies, University of California schools, Intelligent Optical Systems, Kovlo, NanoGram, Philips Lumileds Lighting Co., Toshiba America Electronics Components, Samsung Semiconductor, SEMI, Ultratech, Shrink Nanotechnologies.

 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Readers may be interested in the recent resolution of a quantum dot patent infringement lawsuit between Nanosys and Nanoco/Sigma-Aldrich. 

In April 2009, Nanosys sued Nanoco and Sigma-Aldrich in Wisconsin federal court for allegedly infringing three quantum dot patents owned by MIT which were exclusively licensed to Nanosys.  Nanoco purportedly marketed and sold competing luminous quantum dot nanocrystals under its Lumnidot brand through its U.S. distributor Sigma-Aldrich.  The suit was brought in Wisconsin because that was where the products allegedly infringing the patents were sold.

In the complaint initiating the lawsuit, Nanosys explained that its "technology is covered by a portfolio of over 500 patents and patent applications, including patents in the quantum dot field, that is currently being applied to opportunities in multiple industries including energy, electronics, optoelectronics, life science, and defense. Current application areas of Nanosys technology include flat-panel displays, non-volatile memory, fuel cells, solid-state lighting, chemical analysis chips and medical devices."

The lawsuit was resolved prior to any substantive defense.  In June 2009, the parties told the Court that the case had been settled and that they were drafting the final settlement documentation.  In July 2009, Nanosys voluntarily dismissed the case with prejudice as to both defendants -- as to any prior act, or infringement by selling quantum dot nanocrystals having a CdSe/Zns core-shell structure.

According to a Nanoco press release, the parties settled the case without an admission of liability by Nanoco or Sigma-Aldrich. However, as part of the settlement, Nanoco agreed to terminate its U.S. business for heavy metal quantum dots. Nanoco's CEO explained the cost of defending the litigation was unwarranted by the amount of business generated by the product.  He further stated that the company would continue to market its quantum dot products based on heavy metal-free technology, differing from the technology involved in the lawsuit.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

A recent in vivo study published in NanoLetters focuses on the impact of ultraviolet radiation on the ability of Quantum Dots (QD) to penetrate skin.

L. Mortensen, et al., "In Vivo Skin Penetration of Quantum Dot Nanoparticles in the Murine Model: The Effect of UVR," NanoLetters, Vol. 8, No. 9, pp. 2779-2787 (August 2008).

The article begins by noting that "[n]anoparticles (NP) are commonly used in sunscreens and other cosmetics, and since consumer use of sunscreen is often applied to sun damaged skin, the effect of UVR on NP skin penetration is a concern due to potential toxicity;" and "[t]he question of whether or not NP can penetrate the healthy stratum corneum skin barrier in vivo remains largely unanswered."

The authors note that there are conflicting results from recent studies in this area, which they attribute to different researchers using different nanoscale materials with different sizes/diameters. The authors point out that the inconsistent results of prior studies "highlight the need for standardization of experimental techniques in ex vivo skin models are to be useful."

Despite the authors’ stated concern with possible dermal penetration of NP contained in cosmetics and sunscreens, they chose to test a nanoscale material which is not used in any cosmetic or sunscreen – Quantum Dots.

The authors explain:

We selected to investigate QD, as they posses ideal characteristics for in vivo experimentation including broad excitability, narrow emission bandwidth, high fluorescence quantum yield, photostability, and ease of surface functionalization. Moreover, QD are of a similar size to TiO2 NP used in sunscreen applications, they intrinsically generate ROS species, and the carboxyl terminated QD have a similar negative oxide surface chemistry to the TiO2 and ZnO raw materials often used in sunscreen applications.

There are no lack of manufacturers selling the very type of nanoscale zinc oxide and titanium oxide used in consumer cosmetics and sunscreens. Quantum dots are very remote cousins to these particles.  Why not test the substances themselves rather than a surrogate?

Regarding the animals used in the experiment, the researchers selected 6-7 week old SKH-1 hairless, albino mice.  The QD mouse application vehicle was a solution of 75% glycerol/25% carboxyl QD Stock Solution (pH=9.0 borate buffer, 8μm QD).  One half of the mice received an acute single UVR dose, which was administered by using UVA Sun 340 lamps (320-400 nm (UVA)) (290-320 nm (UVB)). 

The scientists found increased QD penetration for 8 hr and 24 hr treatment conditions after UVR exposure.  However, "[m]ost strikingly, under no circumstances is there evidence for massive QD penetration, even for UVR exposed mice 24 hr after QD application." "[N]one of the penetration observed was at a very high level."

The scientists conclude that "[t]hese studies demonstrate the importance of skin condition to effect the penetration of QD nanoparticles . . . in the . . . mouse model.  We have shown that QD work their way between corneocytes of the stratum corneum and penetrate deep in the epidermis and dermis of an in vivo model with UVR penetration exacerbation." "The minimal QD penetration observed in our study on barrier intact (non-UVR exposed) skin suggests the preponderance of current literature suggesting TiO2 and ZnO NP used in commercial sunscreens exhibit limited penetration in layers below the lower SC."
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

• Email This
• Print
• Comments
• Trackbacks
• Share Link