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

Publication Date : 2010
Code : 78
245 Visited Entry Date : 2017/10/02

International

English
Volume 58 Pages
Document type Guide & Procedure
Subject Characterization & Testing
Summary

The unique properties of manufactured nanomaterials raise the question of whether the current OECD Test Guidelines are adequate to appropriately address their characterisation and the assessment of their toxicological properties. Based on the discussion held in preparing the "Preliminary Review of OECD Test Guidelines for their Applicability to Manufactured Nanomaterials", The OECD Working Party on Manufactured Nanomaterials (WPMN) recognised that it is essential to develop a guidance document on sample preparation and dosimetry. It called special attention to this guidance as crucial in using test guidelines when considering the unique chemical and physical characteristics of nanomaterials.

The purpose of this document is primarily to assist sponsors as they conduct testing in support of the WPMN’s exploratory testing programme (OECD Sponsorship Programme for the Testing of Manufactured Nanomaterials) as well as other users involved in the testing of manufactured nanomaterials. This guidance includes general and common issues (Section I to Section IV) as well as specific consideration (Section V) on sample preparation and dosimetry for the safety testing of manufactured nanomaterials.

It is important to note that this document is a “living document” and as such, it will be updated and amended based upon knowledge accumulation and evolving communication and as experience is gained with nanomaterial testing.
Content

ABOUT THE OECD

 

FOREWORD

 

ABOUT THE WORKING PARTY ON MANUFACTURED NANOMATERIALS (WPMN)

 

ABOUT THE PROJECT ON MANUFACTURED NANOMATERIALS AND TEST GUIDELINES

 

EXECUTIVE SUMMARY

 

SECTION I: GENERAL INTRODUCTION

 

SECTION II: TERMINOLOGY

   Dispersion versus solubility    

   Consideration of stability in sample preparation    

   Agglomerate (Working definition from ISO TS27687 2008)    

   Aggregate (Working definition from ISO TS28687 2008)    

 

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, size distribution, and degree of agglomeration              

         A.1.2 Chemical description (composition and identification)              

         A.1.3 Specific surface area              

         A.1.4 Surface chemistry              

         A.1.5 Surface charge, zeta potential and Hamaker constant             

         A.1.6 Influence of water chemistry on nanomaterial properties and dispersion behaviour              

         A.1.7 Preparation of liquid dispersions; octanol/water partition coefficients (Kows)              

         A.1.8 Crystal structure              

         A.1.9 Interfacial tension              

      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.3 Non-Aqueous Media Preparation         

         B.3.1 Method of nanomaterial introduction               

         B.3.2 Media quality              

         B.3.3 Physical/Chemical Characterisations              

      B.4 References         

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

      C. 1 Introduction to Existing Knowledge         

         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 distribution              

            C. 2.1.1 Methods                   

            C. 2.1.2 Dosage and sample preparation for physical-chemical fate studies                   

         C. 2.2 Degradation and transformation              

            C. 2.2.1 Methods for degradation                   

            C. 2.2.2 Dosage and sample preparation for degradation studies                   

         C. 2.3 Bioaccumulation               

            C. 2.3.1 Methods for bioconcentration and bioaccumulation                   

            C. 2.3.2 Dosage, exposure and sample preparation for bioaccumulation                    studies

      C. 3 References         

   D. HEALTH EFFECTS AND DOSIMETRY    

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

      D.2 Measurements on test dispersions or salines during experiments         

      D.3 Special considerations for physiological salines used in mammalian studies         

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

         D.4.1 Respiratory tract exposures              

         D.4.2 Oral Exposure              

         D.4.3 Dermal Exposures              

         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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