These documents have been developed with the participation of many stakeholders: Industry, Member States and NGOs.
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Reference name:
NIOSH
Description:
This document, published by the US National Institute for Occupational Safety and Health (NIOSH), provides occupational safety and health guidance for carbon nanotubes (CNT) and carbon nanofibres (CNF), and specifically:
- reviews the animal and other toxicological data relevant to assessing the potential non-malignant adverse respiratory effects of CNT and CNF;
- provides a quantitative risk assessment based on animal dose-response data;
- proposes a recommended exposure limit (REL) of 1 µg/m3 elemental carbon as a respirable mass 8-hour time-weighted average (TWA) concentration, and;
- describes strategies for controlling workplace exposures and implementing a medical surveillance program.
The NIOSH REL is expected to reduce the risk for pulmonary inflammation and fibrosis. However, because of some residual risk at the REL and uncertainty concerning chronic health effects, including whether some types of CNTs may be carcinogenic, continued efforts should be made to reduce exposures as much as possible.
Document(s):
Download NO_FILE.PDF (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
Guidelines on the Precautionary Matrix for Synthetic Nanomaterials BAG/BAFU 2018, Version 3.1
Description:
The precautionary matrix helps businesses to assess the need for nanospecific measures (“need for precautions”) in connection with synthetic nanomaterials and applications of these materials for employees, consumers and the environment. In addition, it helps to identify po-tential sources of risk in the development, production, use and disposal of synthetic nano-materials. This pragmatic approach of applying a limited number of meaningful parameters should under no circumstances be equated with a nanospecific risk assessment.
Document(s):
Download WEGLEITUNG-VORSORGERASTER-NANOMATERIALIEN.PDF (1/21/2020 3:55:35 PM)
URL(s):
Tools for handling nanomaterials (1/21/2020 3:56:35 PM)
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Reference name:
Identification of nanomaterials through measurements (JRC Policy Report)
Description:
This document aims to support the implementation of the European Commission’s Recommendation on the definition of nanomaterials (2011/696/EU). It is a follow-up of a previous JRC Science for Policy Report on concepts and terms used in the definition. The present report addresses the identification of nanomaterials by measurements and discusses options and points to consider when assessing whether a particulate material is a nanomaterial or not according to the definition of nanomaterials.
H. Rauscher, A. Mech, N. Gibson,
D. Gilliland, A. Held, V. Kestens,
R. Koeber, T. P. J. Linsinger,
E. A. Stefaniak
Document(s):
Download KJNA29942ENN.PDF (1/22/2020 9:48:23 AM)
URL(s):
Identification of nanomaterials through measurements (1/22/2020 9:49:03 AM)
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Reference name:
PGNanoRIG: Framework and Guidance
Description:
This document provides guidance on the caLIBRAte Phase-Gate Nano-Risk Innovation Governance (PGNanoRIG ) Framework and implemented the caLIBRAte Stage-Gate Nano-Risk Innovation Governance tool included in the caLIBRAte Nano-Risk Governance Platform. The document gives basic principles and recommends generic project activities and aspects that to be considered as part of a manufactured nanomaterial and/or nanoproduct innovation project.
The guidance is applicable to all Phase-gates concerning governance, risk assessment, risk management of nanotechnologies, different nanomaterial and nanotechnology innovation projects.
Document(s):
Download PGNANORIG FRAMEWORK AND GUIDANCE_V1.1ORIG.PDF (9/8/2020 12:54:59 PM)
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Reference name:
EC: Definition of a nanomaterial
Description:
The EU adopted a definition of a nanomaterial in 2011 (Recommendation on the definition of a nanomaterial (2011/696/EU)). Its provisions include a requirement for review "in the light of experience and of scientific and technological developments. The review should particularly focus on whether the number size distribution threshold of 50 % should be increased or decreased".
URL(s):
EC: Definition of a nanomaterial (9/28/2020 3:14:57 PM)
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Reference name:
ECHA’s activities on nanomaterials
Description:
Nanomaterials fall under the existing REACH and CLP definition of a substance, and provisions set by both regulations apply. In 2011, the European Commission released a recommendation for a definition of a nanomaterial.
As of 1 January 2020, explicit legal requirements under REACH apply for companies that manufacture or import nanoforms. These reporting obligations address specific information requirements, outlined in revised annexes to the REACH regulation:
Characterisation of nanoforms or sets of nanoforms covered by the registration (Annex VI);
Chemical safety assessment (Annex I);
registration information requirements (Annexes III and VII-XI); and
Downstream user obligations (Annex XII).
URL(s):
ECHA’s activities on nanomaterials (9/28/2020 12:00:00 AM)
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Reference name:
Nano-specific appendices to the guidance on information requirements and chemicals safety assessment
Description:
Four appendices (1 new and 3 updates) for nanomaterials applicable to Chapters R.6, R.7a, R.7b and R.7c of the IR&CSA guidance. The documents include two new pieces of guidance as well as recommendations and updates of the existing guidance on nanomaterials.
The new publications are:
Nano-specific Appendix to Chapter R.6 of the Guidance on Information Requirements and Chemical Safety Assessment (QSARs and grouping of chemicals): It advises registrants on how to justify the use of hazard data between nanoforms (and the non-nanoforms) and within groups of nanoforms of the same substance.
How to prepare registration dossiers that cover nanoforms - best practices: This document gives recommendations for distinguishing between different nanoforms of a substance, and how to report information on nanoforms consistently in the dossiers. This document was originally intended to be a guidance document, but as a consequence of the Board of Appeal decision in Case A-011-2014, ECHA is publishing this as an advisory best practice document.
URL(s):
Guidance on Information Requirements and Chemical Safety Assessment (9/29/2020 11:04:23 AM)REACH Guidance for nanomaterials published (9/29/2020 11:03:21 AM)
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Reference name:
OECD
Description:
This Guidance Document describes in detail the process of Test Guideline development, including the structure of the Test Guidelines Programme (TGP) and the responsibilities of those involved.
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
The main purpose of this document is to assist the regulated community and regulators in selecting the most appropriate acute inhalation TG so that particular data requirements can be met while reducing animal usage and suffering. This Guidance Document also contains additional supporting information on the conduct and interpretation of studies performed using the inhalation test guidelines: TG 403, TG 436, TG 433, TG 412, and TG 413.
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
This document provides guidance for aquatic (including sediment) ecotoxicity testing of MNs for the purposes of determining their hazard.
URL(s):
Open URL (2/26/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
This document provides guidance for the methods to address dissolution rate and dispersion stability for nanomaterials with focus on environmental aqueous media.
URL(s):
Open URL (2/26/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
This document provides specific guidance for test preparation, implementation, performance, analysis and reporting using the OECD TG No. 312 for testing the mobility and retention of NMs in different types of soils. The GD is likely also relevant for colloidal materials of greater size ranges, because transport of these materials occurs via the same kinetically dominated processes that determine the fate of NMs. The document informs on necessary modifications and additions to the standard test protocol including preparation and application of the test materials, analytics and data reporting.
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
Guiding Principles for Measurements and Reporting for Nanomaterials: Physical Chemical Parameters
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
This document provides guidance on which test methods are (or are not) appropriate to measure a given physico-chemical parameter considered key to characterization and identification, for a given type of nanomaterial. It is important to note that this document is not intended for risk assessment per se but rather presents an approach to gather fit-for-purpose physico-chemical information to more fully understand the behaviour of nanomaterials in biotic and abiotic systems.
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
GRACIOUS
Description:
The Framework streamlines the process for assessing the risk associated with Nanomaterials by logically grouping them thereby allowing extrapolation between (read-across) nanomaterials and reducing the need to assess exposure to and toxicity on a case by case basis.
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
Australian Government
Description:
cost–benefit analysis (CBA) to assess regulatory proposals in order to encourage better decision making. A CBA involves a systematic evaluation of the impacts of a regulatory proposal, accounting for all the effects on the community and economy, not just the immediate or direct effects, financial effects or effects on one group. It emphasises, to the extent possible, valuing the gains and losses from a regulatory proposal in monetary terms
Document(s):
Download COST-BENEFIT ANALYSIS GUIDANCE NOTE.PDF (2/27/2023 12:00:00 AM)
URL(s):
Open URL (2/26/2023 12:00:00 AM)
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Reference name:
ECHA
Description:
This guidance document describes the hazard assessment procedure of chemicals
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EFSA
Description:
EFSA guidance for submission for food additive evaluations
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EFSA
Description:
EFSA guidance to safety of feed additives for the environment
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EFSA
Description:
EFSA guidance on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health 2021
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
European Parliament
Description:
European regulation on biocidal products (Regulation (EU) 528/2012)
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
ECHA
Description:
ECHA guidance for biocidal products.
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
European Parliament
Description:
European directive on directive medicinal products for human use (Directive (EC) 2001/83)
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EMA
Description:
EMA note for guidance on test procedures for new drugs (chemical substances)
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EMA
Description:
EMA note for guidance on testing carcinogenic potential
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EMA
Description:
EMA guideline on the non-clinical investigation of the dependence potential of medicinal products
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EMA
Description:
EMA note for guidance on immunotoxicity studies for human pharmaceuticals
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EMA
Description:
EMA guideline on environmental risk assessment of medicinal products for human use
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA note for guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA guideline on risk assessment of medicinal products on human reproduction and lactation
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EMA
Description:
EMA guideline on repeated dose toxicity
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EMA
Description:
MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA reflection paper on the data requirements for intravenous liposomal products
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EMA
Description:
EMA guidance on photosafety evaluation of pharmaceuticals
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EMA
Description:
EMA guideline on non-clinical local tolerance testing of medicinal products
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EMA
Description:
EMA reflection paper on the data requirements for intravenous iron-based nano-colloidal products
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EMA
Description:
EMA guideline on the chemistry of active substances
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
EMA
Description:
EMA guideline on the chemical and pharmaceutical quality in clinical trials
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA guideline on the environmental risk assessment of medicinal products for human use
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA guideline on reproductive toxicology for human pharmaceuticals
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
European Parliament
Description:
European regulation on medical devices (Regulation (EU) 2017/745)
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
SCENIHR
Description:
SCENIHR guidance on nanomaterials in medical devices
URL(s):
Open URL (2/27/2023 12:00:00 AM)
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Reference name:
ISO
Description:
ISO guidance on immunotoxicology testing of medical devices
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
ISO
Description:
ISO guidance on tests for in vitro cytotoxicity of medical devices
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
ISO
Description:
ISO guidance on tests for genotoxicity, carcinogenicity and reproductive toxicity of medical devices
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
ISO
Description:
ISO guidance on tests for systemic toxicity of medical devices
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
ISO
Description:
ISO guidance on biological evaluation of nanomaterials in medical devices
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
ISO
Description:
ISO guidance on tests for skin sensitization of medical devices
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
ISO
Description:
ISO guidance on tests for irritation of medical devices
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
European Parliament
Description:
European regulation on veterinary medicinal products (Regulation (EU) 2019/6)
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
European Parliament
Description:
Amendment of Annex II of the European regulation on veterinary medicinal products (Delegated Regulation (EU) 2021/805)
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA guidance on reproduction testing of residues of veterinary drugs in human food
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA guidance on repeated-dose 90 day toxicity testing of residues of veterinary drugs in human food
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA guidance on repeated-dose chronic toxicity testing of residues of veterinary drugs in human food
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA guidance on environmental impact assessment for veterinary medicinal products
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA guidance on human carcinogenicity testing of veterinary drugs
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA guidance on a testing approach for residues of veterinary drugs in human food
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA guidance on determining fate of veterinary medicinal products in manure
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA guidance on genotoxicity testing of residues of veterinary drugs in human food
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
EMA
Description:
EMA advice on implementing the European regulation on veterinary medicinal products
URL(s):
Open URL (2/27/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
The OECD Guidelines for the Testing of Chemicals is a collection of most relevant internationally agreed testing methods used by government, industry and independent laboratories to identify and characterise potential hazards of chemicals. They are a set of tools for professionals, used primarily in regulatory safety testing and subsequent chemical and chemical product notification, chemical registration and in chemical evaluation. They can also be used for the selection and ranking of candidate chemicals during the development of new chemicals and products and in toxicology research.
URL(s):
oecd (2/28/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
This Test Guideline (TG) describes a harmonised procedure to determine the Volume Specific Surface Area (VSSA) of powdered solid manufactured nanomaterials (MNs). The VSSA (in m2/cm3) of a material is calculated by multiplying its mass specific surface area (in m2/g) with its skeletal density (in g/cm3). The determination of the external and internal (mass) specific surface area (SSA) of powdered solid MNs is done by the Brunauer, Emmett and Teller (BET) method. This TG also provides instructions on how to determine the skeletal density (ρ) of the MN by gas pycnometry.
URL(s):
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G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
This Test Guideline, covering nanomaterials spanning from 1 nm to 1000 nm, is intended for particle size and particle size distribution measurements of nanomaterials. The TG includes the following methods: Atomic Force Microscopy (AFM), Centrifugal Liquid Sedimentation (CLS)/Analytical Ultracentrifugation (AUC), Dynamic Light Scattering (DLS), Differential Mobility Analysis System (DMAS), (Nano)Particle Tracking Analysis (PTA/NTA), Small Angle X-Ray Scattering (SAXS), Scanning Electron Microscopy (SEM), and Transmission Electron Microscopy (TEM). For measuring the diameter and length of fibres, analysing images captured with electron microscopy is currently the only method available.
URL(s):
Open URL (2/28/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
This test guideline describes a test procedure to gain information on dispersion stability of manufactured nanomaterials in simulated environmental media. The main purpose of this guideline is to assess the ability of a nanomaterial to attain a colloidal dispersion and to conserve this dispersion under environmentally relevant conditions. The test procedure involves a dispersion of the nanomaterial with the aid of a calibrated sonication procedure and the determination of the mass concentration of the nanomaterial in a set of test vials while the particles undergo homoagglomeration and settling in environments of different hydrochemistry.
URL(s):
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G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
This revised Test Guideline 412 (TG 412) has been designed to fully characterize test article toxicity by the inhalation route following repeated exposure for a limited period of time (28 days), and to provide data for quantitative inhalation risk assessments. It was updated in 2017 to enable the testing and characterisation of effects of nanomaterials tested. Groups of at least 5 male and 5 female rodents are exposed 6 hours per day for 28 days to a) the test chemical at three or more concentration levels, b) filtered air (negative control), and/or c) the vehicle (vehicle control). Animals are generally exposed 5 days per week but exposure for 7 days per week is also allowed. Males and females are always tested, but they may be exposed at different concentration levels if it is known that one sex is more susceptible to a given test article. This guideline allows the study director the flexibility to include satellite (reversibility) groups, bronchoalveolar lavage (BAL), lung burden (LB) for particles, neurologic tests, and additional clinical pathology and histopathological evaluations in order to better characterize the toxicity of a test chemical.
URL(s):
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G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
"This revised Test Guideline 413 (TG 413) has been designed to fully characterize test article toxicity by the inhalation route following repeated exposure for a period of 90 days, and to provide data for quantitative inhalation risk assessments. It was updated in 2017 to enable the testing and characterisation of effects of nanomaterials tested.
Groups of at least 10 male and 10 female rodents are exposed 6 hours per day for 90 days to a) the test chemical at three or more concentration levels, b) filtered air (negative control), and/or c) the vehicle (vehicle control). Animals are generally exposed 5 days per week but exposure for 7 days per week is also allowed. Males and females are always tested, but they may be exposed at different concentration levels if it is known that one sex is more susceptible to a given test chemical. The results of the study include measurement and daily and detailed observations (haematology and clinical chemistry), as well as ophthalmology, gross pathology, organ weights, and histopathology. This Test Guideline allows the flexibility to include satellite (reversibility) groups, interim sacrifices, bronchoalveolar lavage (BAL), lung burden (LB) for particles, neurologic tests, and additional clinical pathology and histopathological evaluations in order to better characterize the toxicity of a test chemical."
URL(s):
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G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
- Evaluation of Tools and Models for Assessing Occupational and Consumer Exposure to Manufactured Nanomaterials; Part III: Performance testing results of tools/models for consumer exposure
URL(s):
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G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
- Evaluation of Tools and Models for Assessing Occupational and Consumer Exposure to Manufactured Nanomaterials; Part II: Performance testing results of tools/models for occupational exposure (Annex 1)
URL(s):
Open URL (2/28/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
- Evaluation of Tools and Models for Assessing Occupational and Consumer Exposure to Manufactured Nanomaterials; Part I: Compilation of tools/models and analysis for further evaluation
URL(s):
Open URL (2/28/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
- Evaluation of Tools and Models Used for Assessing Environmental Exposure to Manufactured Nanomaterials; Functional Assessment and Statistical Analysis of Nano-Specific Environmental Exposure Tools and Models; Annex 1
URL(s):
Open URL (2/28/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
In this document, the in vitro and in vivo systems that are used to measure biodurability in biological and environmental systems, are presented for the pristine NMs of the OECD sponsorship programme.
URL(s):
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G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
The outcome of this project is an increased understanding of the details and scope of different regulatory risk assessments for manufactured nanomaterials by comparing and contrasting the conditions, assumptions, and levels of uncertainties of approaches utilised in different jurisdictions. Best practices could be identified that could be adopted by other countries
URL(s):
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G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
The present report summarises the information extracted from dossiers, presents the evaluation of the information extracted from the dossiers, and identifies potential next steps (e.g. where modification of existing TGs, or proposals of new TGs or Guidance Documents (GDs) could be appropriate). The recommendations and observations presented in this report are only based on the information extracted from the dossiers and recent publications on specific TGs.
URL(s):
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G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
This document includes a detailed description of a procedure for measuring the net removal extent (NR) to which a MN distributes between activated sludge and water in wastewater treatment systems. The goal of this test is to provide sufficient information to predict the removal of a test MN in a wastewater treatment facility through association with sludge.
URL(s):
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G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
OECD
Description:
This report summarize the outcomes of a meeting having the purpose to have a common understanding of which specific aspects are to be considered in a regulatory context when applying grouping and read-across for hazard assessment of manufactured nanomaterials (MNs).
URL(s):
Open URL (2/28/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
ISO
Description:
ISO 21505:2017 describes the context in which the governance of projects, programmes and portfolios is conducted and provides guidance for the governance of projects, programmes and portfolios. ISO 21505:2017 can also be used for assessment, assurance or verification of the governance function for projects, programmes or portfolios. ISO 21505:2017 is intended for governing bodies and executive and senior management who influence, impact or make decisions regarding the governance of projects, programmes and portfolios. It is also intended to provide guidance to those who direct projects, programmes and portfolios, such as sponsors, steering committees, portfolio owners and the project management office. It also can be used by project, programme and portfolio managers, as well as stakeholders involved in the development and implementation of projects, programmes and portfolios. Other audiences who can have an interest in this topic include those advising, informing, assisting or working within projects, programmes and portfolios.
URL(s):
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G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
ISO
Description:
This Technical Report provides guidance on the development of content for, and consistency in, the communication of information on safety, health and environmental matters in safety data sheets (SDS) for substances classified as manufactured nanomaterials and for chemical products containing manufactured nanomaterials. It provides supplemental guidance to ISO 11014:2009[1] on the preparation of SDSs generally, addressing the preparation of an SDS for both manufactured nanomaterials with materials and mixtures containing manufactured nanomaterials.
URL(s):
Open URL (2/28/2023 12:00:00 AM)
G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
ISO
Description:
"ISO/TS 12901-2:2014 describes the use of a control banding approach for controlling the risks associated with occupational exposures to nano-objects, and their aggregates and agglomerates greater than 100 nm (NOAA), even if knowledge regarding their toxicity and quantitative exposure estimations is limited or lacking.
The ultimate purpose of control banding is to control exposure in order to prevent any possible adverse effects on workers' health. The control banding tool described here is specifically designed for inhalation control. Some guidance for skin and eye protection is given in ISO/TS 12901‑1.
ISO/TS 12901-2:2014 is focused on intentionally produced nano-objects such as nanoparticles, nanopowders, nanofibres, nanotubes, nanowires, as well as of aggregates and agglomerates of the same. As used in ISO/TS 12901-2:2014, the term ""NOAA"" applies to such components, whether in their original form or incorporated in materials or preparations from which they could be released during their lifecycle.
ISO/TS 12901-2:2014 is intended to help businesses and others, including research organizations engaged in the manufacturing, processing or handling of NOAA, by providing an easy-to-understand, pragmatic approach for the control of occupational exposures."
URL(s):
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G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
CEN/TS
Description:
This Technical Specification provides a guidance for the responsible development of nanotechnologies taking into account: - Board Accountability; - Stakeholder Involvement; - Worker Health and Safety; - Benefits to and Risks for Public Health, Safety and the Environment; - Wider Social and Ethical Implications and Impacts; - Engagement with Business Partners; - Transparency and Disclosure. NOTE 1 This Technical Specification contributes to social responsibility as defined in ISO 26000:2010. NOTE 2 Nanotechnology activities include industrial production, R&D, services, and marketing of products. This Technical Specification neither covers labelling and advertising aspects nor is it intended for certification purposes, nor does it imply any legally binding agreements. This Technical Specification intends to cover nanotechnology activities involving manufactured nanomaterials, and where relevant incidental nanomaterials.
URL(s):
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G R D W C X E H T F S FS F1 F2 F3 F4 F5 F6 F7 XS X1 X2 X3 X4 X5 LS L1 L2 L3 L4
Reference name:
eREACHnano
Description:
This e-REACH Guidance is a comprehensive E-learning tool informing on the background and requirements for REACH registration of a nanomaterial at ECHA (The European Chemicals Agency).
URL(s):
eREACHnano (2/28/2023 12:00:00 AM)
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