Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials

Publication Date : 2012
Code : 105
915 Visited Entry Date : 2017/10/02

International

English
Volume 93 Pages
Document type Guide & Procedure
Subject Characterization & Testing
Summary

The unique properties of manufactured nanomaterials have raised the question as to whether the current OECD Test Guidelines are adequate to appropriately address their characterisation and the assessment of their toxicological properties. Since it was recognised that there is a need to develop a guidance document on sample preparation and dosimetry, to which special attention should be paid in using test guidelines when considering the chemical and physical characteristics of nanomaterials, the first version of the guidance document, Preliminary Guidance Notes on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials was published in May 2010.

As this guidance document has been recognised as a living document, it is subject to amendment and refinement as researchers gain greater understanding of how to handle nanomaterials in test situations. It was proposed, at the 8th meeting of the WPMN held in March 2011, to set up a specific task group to review the first version of the Guidance Notes on Sample Preparation and Dosimetry (GNSPD) with experience gained through both the sponsorship programme analyses of data from the sponsored nanomaterials and other efforts.

This document is the revision which was initially prepared by the task group and was reviewed by Steering Group four of OECD Working Party on Manufactured Nanomaterials (WPMN) taking into account the latest experience on testing of manufactured nanomaterials as well as the scientific knowledge from relevant experts.

Also, it is worth noting that the results/recommendations from the OECD-WPMN horizontal expert meeting with regard to inhalation toxicity testing for nanomaterials, held in October 2011, has contributed to this update. Section V-A (PhysicalChemical Properties) was updated taking into consideration the progress achieved by ISO. Several endpoints (such as dustiness, crystallite size) have been newly introduced.
Content

SECTION I: GENERAL INTRODUCTION

 

SECTION II: TERMINOLOGY

   Dispersion versus solubility    

 

SECTION III: CONSIDERATIONS ON APPROPRIATE DOSE-METRICS

 

SECTION IV: COMMON ISSUES REGARDING SAMPLE PREPARATION AND DOSIMETRY

   1. Storage and stability of test material    

   2. The chemical composition of the test media    

   3. Characterisation of stock dispersions    

   4. Characterisation of samples (prepared from stock dispersions) prior to administration/testing    

   5. References    

 

SECTION V: SPECIFIC CONSIDERATIONS

   A. PHYSICAL-CHEMICAL PROPERTIES    

      A.1 Tentative Guidance Relevant to Sample Preparation and Dosimetry for Physical-Chemical Characterisation          

         A.1.1 Particle size, shape, and size distribution              

         A.1.2 Particle Size Distribution              

         A.1.3 Aggregation and Agglomeration              

         A.1.4 Chemical description (composition and identification)              

         A.1.5 Specific surface area              

         A.1.6 Surface chemistry              

         A.1.7 Surface charge, zeta potential and Hamaker constant              

         A.1.8 Influence of water chemistry on nanomaterial properties and dispersion behaviour              

         A.1.9 Preparation of liquid dispersions; octanol/water partition coefficients (Kows)              

         A.1.10 Crystal structure              

         A.1.11 Interfacial tension              

         A.1.12 Dustiness              

         A.1.13 Crystallite Size              

         A.1.14 Electron Microscopy              

         A.1.15 Photocatalytic Activity              

         A.1.16 Pour Density               

         A.1.17 Porosity              

         A.1.18 Octanol-Water Partition Coefficient              

         A.1.19 Radical Formation Potential              

      A.2 References         

   B. GUIDANCE ON PREPARING SAMPLES OF NANOMATERIAL IN EXPOSURE MEDIA FOR ECOTOXICITY STUDIES    

      B.1 Introduction         

      B.2 Aquatic Media Preparation         

         B.2.1 Methods of suspension              

         B.2.2 Media quality              

         B.2.3 Physical-Chemical Characterisations              

         B.2.4 Reporting results for media preparation approaches              

      B.3 Non-Aqueous Media Preparation         

         B.3.1 Method of nanomaterial introduction              

         B.3.2 Media quality               

         B.3.3 Physical-Chemical Characterisations              

         B.3.4 Reporting results for media preparation approaches              

      B.4 References         

   C. GUIDANCE ON PREPARING NANOMATERIAL SAMPLES FOR DEGRADATION, TRANSFORMATION AND ACCUMULATION STUDIES    

      C. 1 Introduction         

         C. 1.1 Environmental behaviour              

         C. 1.2 Degradation and transformation              

         C. 1.3 Bioaccumulation              

      C. 2 Test Method Applicability and Dosimetry         

         C. 2.1. Environmental behaviour              

         C. 2.2 Degradation and transformation              

         C. 2.3 Bioaccumulation              

      C. 3 References         

   D. HEALTH EFFECTS, PREPARATION OF A TEST SUBSTANCE AND DOSIMETRY    

      D.1 Knowledge transfer from environmental chemistry and stock dispersion preparation         

      D.2 Recommended control measurements on test dispersions and test vehicles during experiments         

      D.3 Special considerations for vehicles e.g. physiological media used in cell-free, cell-based, and mammalian studies         

      D.4 Routes of delivery and the behaviour of nanomaterials dispersions in mammalian studies          

      D.4.1 Respiratory tract exposures              

         D.4.2 Oral Exposure              

         D.4.3 Dermal Exposure              

         D.4.4 Injection routes              

         D.4.5 Cell cultures and dispersion of NPs in culture media              

      D.5 References       
Organization
  • Organisation for Economic Co-operation and Development Published by
  • Inter-Organisation Programme for the Sound Management of Chemicals Supported by
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