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. 2019 Jun:104:74-83.
doi: 10.1016/j.yrtph.2019.02.008. Epub 2019 Mar 1.

Developing OECD test guidelines for regulatory testing of nanomaterials to ensure mutual acceptance of test data

Kirsten Rasmussen  1 , Hubert Rauscher  2 , Peter Kearns  3 , Mar González  4 , Juan Riego Sintes  5
Affiliations

Developing OECD test guidelines for regulatory testing of nanomaterials to ensure mutual acceptance of test data

Kirsten Rasmussen et al. Regul Toxicol Pharmacol. 2019 Jun.

Abstract

The OECD Working Party on Manufactured Nanomaterials (WPMN) provides a global forum for discussion of nano-safety issues. Together with the OECD Test Guidelines Programme (TGP) the WPMN has explored the need for adaptation of some of the existing OECD Test Guidelines (TGs) and Guidance Documents (GDs) as well as developing new TGs and GDs to specifically address NM issues. An overview is provided of progress in the TGP and WPMN, and information on supporting initiatives, regarding the development of TGs for nanomaterials addressing Physical Chemical Properties, Effects on Biotic Systems, Environmental Fate and Behaviour, and Health Effects. Three TGs specifically addressing manufactured nanomaterials have been adopted: a new TG318 ″Dispersion Stability of Nanomaterials in Simulated Environmental Media", and adaptation of TG412 and TG413 on Subacute Inhalation Toxicity: 28-Day Study/90-day Study. The associated GD39 on Inhalation Toxicity Testing has also been revised. The TGP current develops four new TGs and four GDs. One new TG and six GDs are developed in the WPMN. Six new proposals were submitted to the TGP in 2018. Furthermore, as TGs are accompanied by OECD harmonised templates (OHTs) for data collection, an outline of recently developed OHTs particularly relevant for NMs is also included.

Keywords: Hazard assessment; Nanomaterial; OECD test guidelines; Test methods.

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Figures

Fig. 1
Fig. 1
Processes in the OECD TGP, from the idea described in the Standard Project Submission Form (SPSF) to the publication of the final document. The dotted line indicates a simplified adoption procedure that has been put into effect by which endorsement by the Joint Meeting automatically implies adoption by the OECD Council (Abbreviations: NGO: non-governmental Organisation, BIAC: Business and Industry Advisory Committee to the (OECD), TG: test guideline, WNT: Working Group of National Co-ordinators of the Test Guidelines Programme).
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References

    1. Baun A., Sayre P., Steinhäuser K.G., Rose J. Regulatory relevant and reliable methods and data for determining the environmental fate of manufactured nanomaterials. NanoImpact. 2017;8:1–10.
    1. Drasler B., Sayre P., Steinhäuser K.G., Petri-Fink A., Rothen-Rutishauser B. In vitro approaches to assess the hazard of nanomaterials. NanoImpact. 2017;8:99–116. https://www.sciencedirect.com/science/article/pii/S2452074817300459
    1. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). OJ No. L396, 30.12.2006.
    1. EU, European Union, Commission Regulation (EU) 2018/1881 of 03 December 2018 Amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as Regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to Address Nanoforms of Substances. OJ L 308 of 04 December 2018.
    1. European Commission, Commission Staff Working Paper. SWD(2012) 288 Final of 3.10.2012. Types and Uses of Nanomaterials, Including Safety Aspects, Accompanying the Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee on the Second Regulatory Review on Nanomaterials.

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