SIST-TS CEN ISO/TS 5387:2024

SLOVENSKI STANDARD
kSIST-TS FprCEN ISO/TS 5387:2024
01-julij-2024
Nanotehnologije - Merjenje mase nanomaterialov pri obremenitvi pljuč z
nanomateriali z inhalacijskimi testi strupenosti (ISO/TS 5387:2023)
Nanotechnologies - Lung burden mass measurement of nanomaterials for inhalation
toxicity tests (ISO/TS 5387:2023)
Nanotechnologies - Mesure de la masse de la charge pulmonaire des nanomatériaux
pour les études de toxicité par inhalation (ISO/TS 5387:2023)
Ta slovenski standard je istoveten z: FprCEN ISO/TS 5387
ICS:
07.120 Nanotehnologije Nanotechnologies
kSIST-TS FprCEN ISO/TS 5387:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

kSIST-TS FprCEN ISO/TS 5387:2024

kSIST-TS FprCEN ISO/TS 5387:2024
TECHNICAL ISO/TS
SPECIFICATION 5387
First edition
2023-10
Nanotechnologies — Lung burden
mass measurement of nanomaterials
for inhalation toxicity tests
Nanotechnologies — Mesure de la masse de la charge pulmonaire des
nanomatériaux pour les études de toxicité par inhalation
Reference number
ISO/TS 5387:2023(E)
kSIST-TS FprCEN ISO/TS 5387:2024
ISO/TS 5387:2023(E)
© ISO 2023
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Published in Switzerland
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kSIST-TS FprCEN ISO/TS 5387:2024
ISO/TS 5387:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 4
5 Use of lung burden measurements for risk assessment of nanomaterials .4
6 Inhalation exposure and tissue sampling to determine lung burden .5
6.1 Inhalation exposure . 5
6.2 Lung burden evaluation in single or multiple lobes . 5
6.3 Post-exposure observation points . 6
7 Available methods for lung burden measurements . 7
7.1 General . 7
7.2 Carbon nanomaterials . 8
7.3 Metal-based nanomaterials . 8
7.4 Polymeric nanomaterials and others . 9
8 Application of lung burden data to toxicokinetics of nanomaterials .9
8.1 General . 9
8.2 Sampling points . 9
8.3 Particle lung clearance and retention kinetics . 10
8.3.1 General . 10
8.3.2 One-compartment first-order clearance model . 10
8.3.3 Two-compartment first-order model . 11
Annex A (informative) Option A for test scheme for 28-d and 90-d studies — Gases,
vapours, liquid aerosols, and fast dissolution solid aerosols.15
Annex B (informative) Option B for test schemes for 28-d and 90-d studies — Poorly
soluble aerosols .16
Annex C (informative) Lung burden measurement methods .17
Bibliography .21
iii
kSIST-TS FprCEN ISO/TS 5387:2024
ISO/TS 5387:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 229, Nanotechnologies.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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kSIST-TS FprCEN ISO/TS 5387:2024
ISO/TS 5387:2023(E)
Introduction
Inhalation is a primary route of exposure to aerosolized nanomaterials and therefore appropriate
inhalation toxicity tests are required to address risk assessment needs for these materials. For this
reason, the Organisation for Economic Cooperation and Development (OECD) recently updated its
inhalation toxicity test guidelines 412 (subacute) and 413 (subchronic) to make them applicable to
[1][2]
nanomaterials. These revised test guidelines require post-exposure lung burden measurements
to be undertaken when a range-finding study or other relevant information suggests that inhaled test
nanomaterials are poorly soluble with low dissolution rate and likely to be retained in the lung. The
measurements of lung burden inform on pulmonary deposition and retention of nanomaterials in the
lung. At least three lung burden measurements are needed to evaluate clearance kinetics.
This document gives information on how to derive clearance kinetic parameter values using lung
[1] [2]
burden measurement data. This document complements OECD TG 412 and OECD TG 413 . As
References [1], [2] and [3] only provide limited information on methods for lung burden measurement
for nanomaterials or the derivation of lung clearance kinetics, this document provides useful supporting
[1] [2]
information for conducting inhalation studies based on OECD TG 412 and OECD TG 413 .
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kSIST-TS FprCEN ISO/TS 5387:2024

kSIST-TS FprCEN ISO/TS 5387:2024
TECHNICAL SPECIFICATION ISO/TS 5387:2023(E)
Nanotechnologies — Lung burden mass measurement of
nanomaterials for inhalation toxicity tests
1 Scope
The document provides information on the measurement of nanomaterial mass in tissue after inhalation
exposure, which can inform on lung clearance behaviour and translocation.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 80004 (all parts), Nanotechnologies – Vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in the ISO 80004 series and the
following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
aerodynamic diameter
diameter of a spherical particle with a density of 1 000 kg/m that has the same settling velocity as the
particle under consideration
Note 1 to entry: Aerodynamic diameter is related to the inertial properties of aerosol (3.2) particles and is
generally used to describe particles larger than approximately 100 nm.
[4]
[SOURCE: ISO/TR 27628:2007, 2.2 ]
3.2
aerosol
metastable suspension of solid or liquid particles in a gas
[4]
[SOURCE: ISO/TR 27628:2007, 2.3 ]
3.3
mass median aerodynamic diameter
MMAD
calculated aerodynamic diameter (3.1) which divides the particles of a measured aerosol (3.2)
distribution in half based on the mass of the particles where fifty percent of the particles by mass will
be larger than the median diameter and fifty per cent of the particles will be smaller than the median
[11]
[SOURCE: EPA IRIS Glossary ]
kSIST-TS FprCEN ISO/TS 5387:2024
ISO/TS 5387:2023(E)
3.4
manufactured nanomaterial
nanomaterial (3.8) intentionally produced for commercial purposes to have selected properties or
composition
[SOURCE: ISO 80004-1:2023, 3.1.9, modified — "for commercial purposes" has been added to the
definition.]
3.5
mixture
mixture composed of two or more substances in which they do not react
Note 1 to entry: A solution is a mixture as well.
[8]
[SOURCE: GHS, 2011 ]
3.6
mobility
propensity for an aerosol (3.2) particle to move in response to an external influence, such as an
electrostatic field, thermal field or by diffusion
[4]
[SOURCE: ISO/TR 27628:2007, 2.9 , modified — the domain "" has been removed.]
3.7
nanofibre
nano-object with two similar external dimensions in the nanoscale and the third dimension significantly
larger
Note 1 to entry: A nanofibre can be flexible or rigid.
Note 2 to entry: The two similar external dimensions are considered to differ in size by less than three times and
the significantly larger external dimension is considered to differ from the other two by more than three times.
Note 3 to entry: The largest external dimension is not necessarily in the nanoscale.
[SOURCE: ISO 80004-1:2023, 3.3.5, modified — Notes 1 and 2 to entry have been added.]
3.8
nanomaterial
material with any external dimension in the nanoscale or
...