Development and standardisation of methods for the safety testing of manufactured nanomaterials at OECD.

Livrables

This document will be the minutes from the 2nd WP4 workshop which will be focused on reviewing progress and identify synergies between the different deliverables

TGP_ Project 3.16_Aquatic (Environmental) abiotic transformation of nanomaterials

The purpose will be to develop the appropriate analytical strategies to measure solution and solidphase speciation for quantification and derivation of transformation rates evaluated This Guidance will provide the concepts for the experimental design for identification and quantification of transformation products

e-Brochure

The brochure will be prepared upon completion of the project to disseminate the outcome to the regulatory and regulated communities available standardised methodologies testing frameworks countries activities and howwhy the OECD work fits in the global picture This brochure will be available online in an electronic form

TGP Project 3.11_Study Report on Nanomaterial removal from wastewater

The purpose of this study report is to assess the feasibility of complementary methods to currently existing ones and to address specific unknown factors such as the relevance of measuring an equilibrium isotherm while reducing the cost and time burdens associated with performing tests such as those described by OECD 303A The TG will address removal of emerging chemicals eg nanomaterials from wastewater by interaction with activated sludge andor wastewater additives such as flocculants and coagulants typically encountered in the clarifying stages of wastewater treatment Originally the project intended to develop a new Test Guideline for removal of nanomaterials from wastewater treatment plants The lead country decided to abandon efforts in that direction and stopped the projectrelated activities including testing of robustness and reproducibility of the methodology As a risk mitigation measure and in order to better understand whether the lack of a standardized OECD Test Guideline in this area was perceived as a critical gap in the regulatory toolbox the OECD Secretariat organized a webinar in June 2022 with key experts recognized internationally see deliverable D11 Conclusions were generally supportive of research efforts in developing computational models to assess to removaldistributiondissipation of various types of nanomaterials in different media including wastewater treatment plants rather than developing experimental methods that are costly difficult to implement and suffer from a lack of reproducibility

TGP Project 3.9_Guidance Document for the testing and interpretation of data on dissolution rate and dispersion stability of nanomaterials for effects and exposure assessment

This project is underway however the final stages need to be implemented for the completion of the Guidance Document This GD provides guidance on experimental steps and procedures when addressing relevant methods for dissolution rate testing in water and biological fluids and transformation in the environment

Minutes 1st WP4 Workshop

This document will be the minutes from the 1st WP4 workshop which will be focused on reviewing progress and identify synergies between the different deliverables

e-Chemical Safety Newsletter

This Newsletter is disseminated to about 40K recipients around the world who subscribe to the Newsletter It consists of systematic updates on all ongoing activities draft documents meetings webinars workshops etc on various projects managed by the OECD Environment Health and Safety Division It is prepared by OECD staff for a public audience httpbitlynewsletterchemicalsafety months 4 12 20 28

TGP Project 2.51_Guidance Document on Aquatic (and Sediment) Toxicity Testing of Nanomaterials

This project is underway however the final stages need to be implemented for the completion of the Guidance Document The purpose is to develop guidance for using TG addressing aquatic and sediment ecotoxicity to the hazard testing of manufactured nanomaterials

TGP_ Project 3.14_Guidance Document to support the implementation of TG 312 for Nanomaterial Safety Testing

The aim is to identify the relevant elements which need to be addressed to improve the applicability of the existing OECD TG 312 Leaching in Soil Columns to NMs As such the GD will indicate where protocol modifications and special considerations should be applied when the test item is a NM

TGP Project 1.8_Draft TG on Determination of the Dustiness of Manufactured Nanomaterials

This aims to determine the dustiness of MNs and its subsequent use in the frameworks of worker exposure As such specific methods will be selected to determine the dustiness of a powder eg mass and number dustiness indexes together with a framework comparing different dustiness methods

TGP Project 1.7_Draft New TG on Determination of Surface Hydrophobicity of Manufactured nanomaterials

The proposed TG will provide criteria helping the user choose the appropriate instrument and to enable a full quantification of the nanomaterial surface hydrophobicity by using affordable analytical techniques

TGP Project 1.6_Guidance Document -Identification and quantification of the surface chemistry and coatings on nano- and microscale materials

This will be a new guidance for identification and quantification of organic and inorganic surface chemistry and coatings on nano and microscale materials To be able to identify and quantify organic and inorganic coatings on a broad range of different MNs a combination of several analytical techniques and subprocedures is needed Surface coating and chemistry may determine the materials physicochemical and toxicological properties and is therefore crucial information for a proper hazard assessment

TGP Project 1.3_ Draft TG on Determination of the (Volume) Specific Surface Area of Manufactured Nanomaterials

The objective is to develop a Test Guideline for the determination of the Specific Surface Area of Manufactured Nanomaterials MNs based on the Brunauer Emmett and Teller BET technique and further developments ie ISO NanoDefine Specific Surface Area SSA can have an influence on the hazardous properties of MNs both for human health and the environment and it is recognised as the biologically most effective dose metric for acute nanoparticle toxicity in the lungs Thus the TG is expected to contribute to the current regulatory information requirements in the OECD Member Countries but also to the general harmonisation of dose metrics in toxicity studies and risk assessment evaluations

TGP Project 1.4_Draft TG on Particle Size and Size Distribution of Manufactured Nanomaterials

To develop a new TG on particle size and size distribution of nanomaterials including fibrous particle morphology as an addition to the existing TG 110 which determines Particle Size Distribution Fibre Length and Diameter Distributions for conventional chemicals Thus the new TG will update the existing methodology so it is applicable for testing nanomaterials This project started in May 2017 and comprises the conceptual and experimental development of the test method to determine particle size and size distribution of particulate and fibrous nanomaterials

TGP Project 1.5_Draft Guidance Document for the Determination of solubility and dissolution rate of nanomaterials in water and relevant synthetic biological media

The purpose is to facilitate the determination of solubility limit and dissolution rate of dispersible materials including MNs in welldefined test water and biologically relevant fluids This should include recommendations on how to apply the data for modelling purposes The GD is anticipated to provide a tiered testing approach to generate data that can be applied for nanomaterials registration readacross grouping and risk assessment

Conferences and Workshops

The OECD attends conferences and workshop were we have the opportunity to disseminate work underway. We will use these events as an opportunity to inform the different audiences on work underway and to broaden the expertise and inputs for the completion of the projects.The information regarding OECD's participation in these events will be included in the intermediate (D1.1) and final report (D.1.2)

NM safety testing webinar

There will be two public webinars where ongoing activities will be presented with updates on progress and timelines for the next steps This is part of a series of regular webinars organised by the OECD They are free accessible upon registration and can be followed realtime or viewed online a few days after the eventThe first webinar will be done around month 18 and the second toward the end of the project month 36 to allow the inclusion of all the deliverables from packages 25

NM safety testing webinar -1

This webinar will present the work completed and underway related to the development of Test Guidelines and associated guidance documents for the safety testing of manufactured nanomaterials

Publications

GUIDANCE DOCUMENT ON AQUATIC AND SEDIMENT TOXICOLOGICAL TESTING OFNANOMATERIALS

Auteurs: OECD
Publié dans: Series on Testing and Assessment, Numéro No. 317, 2020
Éditeur: ENV Publications

GUIDANCE DOCUMENT FOR THE TESTING OF DISSOLUTION AND DISPERSIONSTABILITY OF NANOMATERIALS AND THE USE OF THE DATA FOR FURTHERENVIRONMENTAL TESTING AND ASSESSMENT STRATEGIES

Auteurs: OECD
Publié dans: Series on Testing and Assessment, Numéro No. 318, 2021
Éditeur: ENV Publications

GUIDANCE DOCUMENT ON TESTING NANOMATERIALS USING OECD TG No. 312“LEACHING IN SOIL COLUMNS”

Auteurs: OECD
Publié dans: Series on Testing and Assessment, Numéro No. 342, 2021
Éditeur: ENV Publications

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