Gas cylinders - Gases and gas mixtures - Determination of toxicity for the selection of cylinder valve outlets (ISO 10298:2018)

ISO 10298:2018 lists the best available acute-toxicity data of gases taken from a search of the current literature to allow the classification of gases and gas mixtures for toxicity by inhalation.

Gasflaschen - Gase und Gasgemische - Bestimmung der Toxizität zur Auswahl von Ventilausgängen (ISO 10298:2018)

In diesem Dokument sind die besten verfügbaren Daten zur akuten Toxizität von Gasen aufgeführt, die in einer Recherche der aktuellen Literatur entnommen wurden, um die Einstufung von Gasen und Gasgemischen hinsichtlich ihrer Toxizität durch Inhalation zu ermöglichen.

Bouteilles à gaz - Gaz et mélanges de gaz - Détermination de la toxicité pour le choix des raccords de sortie de robinets (ISO 10298:2018)

Plinske jeklenke - Plini in zmesi plinov - Določanje strupenosti za izbiro izhodnega priključka ventila na jeklenki (ISO 10298:2018)

General Information

Status
Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
07-Oct-2020
Completion Date
07-Oct-2020

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SLOVENSKI STANDARD
SIST EN ISO 10298:2020
01-december-2020

Plinske jeklenke - Plini in zmesi plinov - Določanje strupenosti za izbiro izhodnega

priključka ventila na jeklenki (ISO 10298:2018)

Gas cylinders - Gases and gas mixtures - Determination of toxicity for the selection of

cylinder valve outlets (ISO 10298:2018)
Gasflaschen - Gase und Gasgemische - Bestimmung der Toxizität zur Auswahl von
Ventilausgängen (ISO 10298:2018)

Bouteilles à gaz - Gaz et mélanges de gaz - Détermination de la toxicité pour le choix

des raccords de sortie de robinets (ISO 10298:2018)
Ta slovenski standard je istoveten z: EN ISO 10298:2020
ICS:
23.020.35 Plinske jeklenke Gas cylinders
71.100.20 Industrijski plini Gases for industrial
application
SIST EN ISO 10298:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10298:2020
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SIST EN ISO 10298:2020
EN ISO 10298
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2020
EUROPÄISCHE NORM
ICS 71.100.20
English Version
Gas cylinders - Gases and gas mixtures - Determination of
toxicity for the selection of cylinder valve outlets (ISO
10298:2018)

Bouteilles à gaz - Gaz et mélanges de gaz - Gasflaschen - Gase und Gasgemische - Bestimmung der

Détermination de la toxicité pour le choix des raccords Toxizität zur Auswahl von Ventilausgängen (ISO

de sortie de robinets (ISO 10298:2018) 10298:2018)
This European Standard was approved by CEN on 28 September 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10298:2020 E

worldwide for CEN national Members.
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SIST EN ISO 10298:2020
EN ISO 10298:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 10298:2020
EN ISO 10298:2020 (E)
European foreword

The text of ISO 10298:2018 has been prepared by Technical Committee ISO/TC 58 "Gas cylinders” of

the International Organization for Standardization (ISO) and has been taken over as EN ISO 10298:2020

by Technical Committee CEN/TC 23 “Transportable gas cylinders” the secretariat of which is held by

BSI.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by April 2021, and conflicting national standards shall be

withdrawn at the latest by April 2021.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 10298:2018 has been approved by CEN as EN ISO 10298:2020 without any modification.

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SIST EN ISO 10298:2020
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SIST EN ISO 10298:2020
INTERNATIONAL ISO
STANDARD 10298
Third edition
2018-02
Gas cylinders — Gases and gas
mixtures — Determination of toxicity
for the selection of cylinder valve
outlets
Bouteilles à gaz — Gaz et mélanges de gaz — Détermination de la
toxicité pour le choix des raccords de sortie de robinets
Reference number
ISO 10298:2018(E)
ISO 2018
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SIST EN ISO 10298:2020
ISO 10298:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 10298:2020
ISO 10298:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Determination of toxicity ............................................................................................................................................................................ 2

4.1 General ........................................................................................................................................................................................................... 2

4.2 Test method ............................................................................................................................................................................................... 2

4.2.1 Test procedure ................................................................................................................................................................... 2

4.2.2 Results for pure gases ........................................................................................................................................... ....... 2

4.3 Calculation method ............................................................................................................................................................................. 2

Annex A (informative) Selection of an LC value for a particular gas .............................................................................. 4

Annex B (informative) LC50 values for toxic gases and toxic vapours used in gas mixtures .....................7

Bibliography .............................................................................................................................................................................................................................12

© ISO 2018 – All rights reserved iii
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SIST EN ISO 10298:2020
ISO 10298:2018(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 documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on 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 the following

URL: www .iso .org/ iso/ foreword .html.
This document was prepared by ISO/TC 58 Gas cylinders, SC 2, Cylinder fittings.

This third edition cancels and replaces the second edition (ISO 10298:2010), which has been technically

revised.
The main changes compared to the previous edition are as follows:
— The Scope and Clause 4 have been clarified.

— The terms and definitions in Clause 3 have been changed and, in particular, the reference to FTSC

codes (that were in ISO 5145) was changed to ISO 14456.
— Some LC50 values have been updated.
iv © ISO 2018 – All rights reserved
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SIST EN ISO 10298:2020
ISO 10298:2018(E)
Introduction

ISO 5145 specifies the dimensions of different valve outlets for different compatible gas groups. These

compatible gas groups are determined according to practical criteria defined in ISO 14456.

These criteria are based on certain physical, chemical, toxic and corrosive properties of the gases. In

particular, the tissue corrosiveness is considered in this document.

The aim of this document is to assign for each gas a classification category that takes into account the

toxicity by inhalation of the gas. For gas mixtures containing toxic components a calculation based on

the method specified in the GHS is proposed.

Since the publication of the first edition of ISO 10298, this International Standard has been used for other

purposes than the selection of cylinder valve outlets, e.g. providing toxicity data for the classification

of gas and gas mixtures according to the international transport regulations and according to the

classification of dangerous substances regulations, which since 2003 is under the umbrella of the

Globally Harmonized System (GHS).
© ISO 2018 – All rights reserved v
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SIST EN ISO 10298:2020
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SIST EN ISO 10298:2020
INTERNATIONAL STANDARD ISO 10298:2018(E)
Gas cylinders — Gases and gas mixtures — Determination
of toxicity for the selection of cylinder valve outlets
1 Scope

This document lists the best available acute-toxicity data of gases taken from a search of the current

literature to allow the classification of gases and gas mixtures for toxicity by inhalation.

2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online Browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
lethal concentration 50

concentration of a substance in air exposure to which, for a specified length of time, it is expected to

cause the death of 50 % of the entire defined experimental animal population after a defined time period

Note 1 to entry: See Annex A for the selection of this LC value.
3.2
toxicity level
level of toxicity of gases and gas mixtures
Note 1 to entry: In ISO 14456, the toxicity level is divided into three groups:
— Subdivision 1: non toxic [LC > 5 000 ppm (volume fraction)]

— Subdivision 2: toxic [200 ppm (volume fraction) < LC ≤ 5 000 ppm (volume fraction)]

— Subdivision 3: very toxic [LC ≤ 200 ppm (volume fraction)]
These subdivisions are sometimes used in transport regulations.
where
LC values correspond to 1 h exposure to gas;
ppm (volume fraction) indicates parts per million, by volume.
Note 2 to entry: In the GHS, the inhalation toxicity levels are:
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SIST EN ISO 10298:2020
ISO 10298:2018(E)
Category 1: Fatal if inhaled 0 ppm < LC ≤ 100 ppm (volume fraction)

Category 2: Fatal if inhaled 100 ppm (volume fraction) < LC ≤ 500 ppm (volume fraction)

Category 3: Toxic if inhaled 500 ppm (volume fraction) < LC ≤ 2 500 ppm (volume fraction)

Category 4: Harmful if inhaled 2 500 ppm (volume fraction) < LC ≤ 20 000 ppm (volume fraction)

Note 3 to entry: In GHS, the LC values correspond to 4 hours exposure. Consequently, the LC50 values given in

Annex B (see 4.2.2) need to be divided by 2 (i.e. 41/ ). The reasoning behind the division by 2 is given in A.2.

3.3
lethal dose 50

amount of a material, given all at once, which causes the death of 50 % of a group of test animals

3.4
lethal concentration low value

lowest concentration of a substance in air, other than the LC , which was reported in the original

reference paper as having caused death in humans or animals
4 Determination of toxicity
4.1 General

Toxicity may be determined through a test method (4.2) for gas mixtures where the data for the

components exist, or through a calculation method (4.3).

For reasons of animal welfare, inhalation toxicity tests geared only for the classification of gas

mixtures should be avoided if the toxicity of each of the components is available. In this case, toxicity is

determined in accordance with 4.3.
4.2 Test method
4.2.1 Test procedure

When new toxicity data are being considered for inclusion in this document, an internationally

[43]
recognized test method such as OECD TG 403 should be used.
NOTE For this document, LC is equivalent to 1 h exposure to albino rats.
4.2.2 Results for pure gases

The toxicity of pure gases is listed in Annex B, in which LC values correspond to 1 h exposure. Some of

these values have been estimated in accordance with Annex A.
4.3 Calculation method
The LC value of a gas mixture is calculated using Formula 1:
LC = (1)
50i
where
C is the mole fraction of the ith toxic component present in the gas mixture;

LC is the lethal concentration of the ith toxic component [LC < 5 000 ppm (by volume)].

50i 50
2 © ISO 2018 – All rights reserved
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SIST EN ISO 10298:2020
ISO 10298:2018(E)

After the LC of the gas mixture has been calculated, this mixture is classified in accordance with 3.2.

NOTE Potential synergistic effects are not considered in Formula 1.
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SIST EN ISO 10298:2020
ISO 10298:2018(E)
Annex A
(informative)
Selection of an LC value for a particular gas
A.1 General

When collecting data from the open literature on the acute inhalation toxicity of gases, some difficulties

are experienced. For example, taking into account the very early years of publication, one cannot expect

to get results of standardized tests. Moreover, data from reporting sources have to be validated with

respect to their details in handling and summarizing information. Furthermore, there is a lack of

information on inhalation toxicity for several gases. Thus, particular attention is needed to incorporate

all the available facts to complete the toxicological characteristics of gases.
A.2 Time adjustment

In inhalation toxicity tests, the dose-response relationship can be described by Formula A.1:

W = c ⋅ t (A.1)
where

W is a constant which is specific for any given effect, e.g. the deaths of 50 % of the animals

exposed;

c ⋅ t is the applied dose expressed as the product of concentration and exposure time.

This equation, called Haber's rule, is applicable as long as the biological half-life of the substance in

question is reasonably longer than the exposure time.

For gases and vapours with appreciable rates of detoxification or excretion over the time in question,

it was found that the relationship between concentration and time is better described by Formula A.2.

0,5
W = c ⋅ t (A.2)

When extrapolating from 4 h to 1 h, Formula A.2 predicts lower LC values than does Haber's rule. To

be on the safe side, this principle was applied by the UN Transport Recommendations in adopting the

conversion factor 2 (i.e. 41/ ) to allow classification of materials on the basis of 1 h LC data. On the

other hand, Haber's rule predicts a lower LC when going from a 1-h to a 4-h LC . To make use of all

50 50

the available data on acute inhalation toxicity under the different exposure schemes, a more generalized

version was applied.
Using 1 h as the point of reference,
— going up from shorter periods, linear extrapolation was preferred;
— coming down from longer periods, the conversion factor xhh/1 was used.

However, test results for a period less than 0,5 h were not used, as this was deemed unreliable.

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SIST EN ISO 10298:2020
ISO 10298:2018(E)
A.3 Choice of animal

Since data on humans, if available, are usually not sufficient to derive any dose-response relationship,

laboratory animals are used to investigate the toxicity of substances on warm-blooded animals.

Unless there are counter indications, such as extraordinarily high or low susceptibility of the rat

compared to other animals or humans, the rat is the preferred species in the most common toxicity

tests. Therefore, LC data in rats are the most likely to be found. If they are missing, data from animals

close to the rat in body weight are evaluated.
A.4 Adjustment for effects

Instead of LC , often the term LC is found in the reporting literature and in databases.

50 LO

Unfortunately, the use of this term is not consistent enough to make any assumptions as to whether

the LC is below or above that value. Nevertheless, it seems reasonable to make the same use of the

LC as if it were information about an approximate lethal concentration (ALC). For the classification of

gases, no higher precision is required, but the calculation formula for gas mixtures requires a definite

LC value to be set. Another LC value has been taken
...

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