ISO/TS 5387:2023

Nanotechnologies — Lung burden mass measurement of nanomaterials for inhalation toxicity tests

The document provides information on the measurement of nanomaterial mass in tissue after inhalation exposure, which can inform on lung clearance behaviour and translocation.

Nanotechnologies — Mesure de la masse de la charge pulmonaire des nanomatériaux pour les études de toxicité par inhalation

General Information

• Status: Published
• Publication Date: 26-Oct-2023
• ICS: 07.120 - Nanotechnologies
• Technical Committee: ISO/TC 229 - Nanotechnologies
• Drafting Committee: ISO/TC 229 - Nanotechnologies
• Current Stage: 6060 - International Standard published
• Start Date: 27-Oct-2023
• Due Date: 21-Aug-2023
• Completion Date: 27-Oct-2023

Standards Content (Sample)

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)
© ISO 2023

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ISO/TS 5387:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2023 – All rights reserved

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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 .
...

FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 5387
ISO/TC 229
Nanotechnologies — Lung burden
Secretariat: BSI
mass measurement of nanomaterials
Voting begins on:
2023-07-20 for inhalation toxicity tests
Voting terminates on:
Nanotechnologies — Mesure de la masse de la charge pulmonaire des
2023-09-14
nanomatériaux pour les études de toxicité par inhalation
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/DTS 5387:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 1 ----------------------
ISO/DTS 5387:2023(E)
FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 5387
ISO/TC 229
Nanotechnologies — Lung burden
Secretariat: BSI
mass measurement of nanomaterials
Voting begins on:
for inhalation toxicity tests
Voting terminates on:
Nanotechnologies — Mesure de la masse de la charge pulmonaire des
nanomatériaux pour les études de toxicité par inhalation
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/DTS 5387:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 2 ----------------------
ISO/DTS 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 .
...

ISO/DTS 5387:2023(E)
ISO TC 229/WG 3
Date: 2023-01-13
Secretariat: BSI
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
First edition
Date: 2023-07-05

---------------------- Page: 1 ----------------------
ISO/DTS 5387:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of
this publication may be reproduced or utilized otherwise in any form or by any means, electronic or
mechanical, including photocopying, or posting on the internet or an intranet, without prior written
permission. Permission can be requested from either ISO at the address below or ISO’sISO's member body in
the country of the requester.
ISO Copyright Office
CP 401 • CH. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: [e-mail] [e-mail]
Website: www.iso.orgwww.iso.org
Published in Switzerland.
ii © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/DTS 5387:2023(E)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 7
5 Use of lung burden measurements for risk assessment of nanomaterials . 7
6 Inhalation exposure and tissue sampling to determine lung burden . 8
6.1 Inhalation exposure . 8
6.2 Lung Burden Evaluation in Single or Multiple Lobes . 8
6.3 Post-exposure Observation Points . 9
7 Available methods for lung burden measurements . 10
7.1 General . 10
7.2 Carbon nanomaterials . 10
7.3 Metal-based nanomaterials . 11
7.4 Polymeric nanomaterials and others . 12
8 Application of lung burden data to toxicokinetics of nanomaterials . 12
8.1 General . 12
8.2 Sampling points . 12
8.3 Particle lung clearance and retention kinetics . 12
8.3.1 General . 12
8.3.2 One-compartment first-order clearance model . 13
8.3.3 Two-compartment first-order model . 14
Annex A (informative) Test scheme for 28-d study (TG 412) . 17
Annex B (informative) Test scheme for 90-d study (TG 413) . 18
Annex C (informative) Lung burden measurement methods . 21
Bibliography . 27
© ISO 2023 – All rights reserved iii

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