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Volume XII, Number 335

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OECD Accepting Comment on Draft Study Report on Applicability of the Key Event Based TG 442D for In Vitro Skin Sensitisation Testing of Nanomaterials

The Organization for Economic Cooperation and Development (OECD) has published for comment a draft study report entitled “Applicability of the key event based TG 442D for in vitro skin sensitisation testing of nanomaterials.” Switzerland conducted experimental work with selected nanomaterials using OECD Test Guideline (TG) 442D (KeratinoSensTM) and made a basic in vitro to in vivo correlation to outline the potential relevance of the results for prediction of skin sensitisation of nanomaterials. According to the draft report, a limited number of relevant nanomaterials for testing within this project, as well as limited availability of in vivo skin sensitisation data for nanomaterials, led Switzerland, in discussion with experts and the OECD secretariat, “to the final conclusion that a study report was the most appropriate way of documenting the outcome of this project and to make it available by publication in the Series on Testing and Assessment for any interested parties carrying out further work related to nanomaterials in the area of skin sensitisation.” The test materials included:

  • Two qualities of titanium dioxide nanoparticles and a nickel (II) oxide particle preparation. All three materials showed negative results in the KeratinoSensTM At least partial cytotoxicity at the top concentration indicated that there was cellular exposure.

  • Silver and gold were obtained in dispersion form and tested directly without further processing. Both silver and gold gave a clear, dose-dependent luciferase induction in KeratinoSensTM Cytotoxicity was measured in parallel, and the positive result occurred at non-cytotoxic levels, indicating a final positive rating according to the standard prediction model.

  • Three tattoo inks were tested as tattoo inks have been discussed in regard to the potential induction of skin sensitisation. Both qualities of black tattoo inks were negative in the KeratinoSensTM assay, while a preparation with pigment red tattoo ink gave a clearly positive result at non-cytotoxic concentrations.

  • Polyethylenglycoldiacrylate nanotubes (PEGDA 575) made from organic polymers tested negative in KeratinoSensTM.

Comments are due November 7, 2022. Instructions for commenting are available on the OECD website.

©2022 Bergeson & Campbell, P.C.National Law Review, Volume XII, Number 273
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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...

202-557-3809
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