GB 30000.21-2013 PDF English
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Rules for classification and labelling of chemicals - Part 21: Respiratory or skin sensitization
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GB 30000.21-2013: Rules for classification and labelling of chemicals - Part 21: Respiratory or skin sensitization
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB30000.21-2013
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 13.300
A 80
Replacing GB 20595-2006
Rules for classification and labelling of chemicals - Part 21.
Respiratory or skin sensitization
Issued on. OCTOBER 10, 2013
Implemented on. NOVEMBER 01, 2014
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine of PRC;
National Standardization Administration.
Table of Contents
Foreword... 3
1 Scope... 6
2 Normative references... 6
3 Terms and definitions... 6
4 General instructions... 7
5 Classification criteria... 7
6 Decision logic... 15
7 Labels... 15
Appendix A (Informative) Decision logic for respiratory or skin sensitizer... 18
Appendix B (Normative) Assignment of label elements for respiratory or skin
sensitizers... 21
Appendix C (Normative) Classification criteria and labeling elements for respiratory or
skin sensitizers... 22
Appendix D (Informative) Hazard statements and precautionary statements for
respiratory or skin sensitizers... 25
1 Scope
This Part of GB 30000 specifies the terms and definitions, general descriptions,
classification standards, judgment logic, labels for chemicals with respiratory or skin
sensitization.
This Part applies to the classification and labeling of chemicals, which have respiratory
or skin sensitization, in accordance with the United Nations' Globally Harmonized
System of Classification and Labeling of Chemicals (hereinafter referred to as GHS).
2 Normative references
The following documents are essential to the application of this document. For the dated
documents, only the versions with the dates indicated are applicable to this document;
for the undated documents, only the latest version (including all the amendments) is
applicable to this standard.
GB 13690 General rule for classification and hazard communication of chemicals
GB 16483 General rules to drafting safety data sheet for dangerous chemicals
United Nations "Recommendations on the Transport of Dangerous Goods - Model
Regulations" (17th Revised Edition)
United Nations "Globally Harmonized System of Classification and Labeling of
Chemicals" (Fourth Revised Edition)
3 Terms and definitions
The terms and definitions as defined in GB 13690, as well as the following terms and
definitions, apply to this document.
3.1
Respiratory sensitizer
Substances that can cause respiratory allergies if inhaled.
3.2
Skin sensitizer
Substances that can cause allergies after skin exposure.
4 General instructions
4.1 Sensitization includes two stages. The first stage is when an individual is exposed
to a certain allergen and induces a specific immune memory; the second stage is
triggering, that is, an allergic individual develops cell-mediated or antibody-mediated
allergic reactions due to exposure to a certain allergen.
4.2 As far as respiratory sensitization is concerned, induction is followed by a triggering
phase, which is the same characteristic as skin sensitization.
4.3 For skin sensitization and respiratory sensitization, the amount required for
induction is generally lower than the amount required for triggering.
4.4 The hazard category "Respiratory or skin sensitization" is divided into.
5 Classification criteria
5.1 General principles
General principles for classification and labeling of respiratory or skin sensitization are
provided in GB 13690.
5.2 Substance classification criteria
5.2.1 Respiratory sensitizers
5.2.1.2 Human evidence
5.2.1.2.1 Evidence that a substance may cause specific respiratory allergic reactions is
generally based on human experience. In this context, allergic reactions usually
manifest as asthma, but can also be combined with other allergic reactions such as
rhinitis/conjunctivitis and alveolitis. Symptoms shall have clinical features of allergic
reaction. However, immunological mechanisms do not necessarily have to be proven.
5.2.1.2.2 When making judgments based on human evidence, classification decisions
need to incorporate, in addition to case evidence.
5.2.1.2.4 The clinical case shall include both medical and occupational history, to
determine the relationship between exposure to specific substances and respiratory
allergic reactions.
5.2.1.3 Animal studies
Data obtained from appropriate animal studies 1) indicating that a substance has the
potential to cause 2) sensitization in humans by respiration include.
5.2.2 Skin sensitizers
1 There is currently no recognized and effective animal model for testing respiratory allergic reactions. In some
cases, data from animal studies can provide important information in the weight of evidence assessment.
5.2.2.1 Hazard category
5.2.2.2 Human evidence
5.3 Classification criteria for mixtures
5.3.1 Classification of mixtures when data on the entire mixture are available
Where a mixture possesses reliable, high-quality evidence from human experience or
appropriate experimental animal studies, as described in the material standard, the
mixture may be classified based on an assessment of the weight of evidence of these
data. Care shall be taken when evaluating mixture data, so that doses used do not
produce ambiguous results.
5.3.2 Classification of mixtures without data on the mixture as a whole. bridging
principle
6 Decision logic
The decision logic is for reference only. See Appendix A for the decision logic. It is
particularly recommended that those responsible for classification study Chapter 5
before and during the use of decision logic.
7 Labels
7.1 Overview
7.1.1 Hazard category labels for respiratory or skin sensitization are listed in the
specified order of pictograms, signal words, hazard statements. The types or categories
of hazards covered by the "Model Regulations" shall be listed in the label with the
designated corresponding graphic symbol for each category.
7.1.2 See Appendix C for classification and labeling elements related to respiratory tract
or skin sensitization.
7.1.3 The information required on the label includes hazard pictograms, signal words,
hazard statements, precautionary statements, product identifiers, supplier logos, etc.
7.2 Hazard pictograms
Hazard pictograms specified by GHS shall use black symbols with a white background;
the red frame shall be wide enough to be eye-catching.
7.3 Signal words
Signal words are words on labels used to indicate the relative severity of a hazard and
to alert readers to potential hazards. The signal words "Danger" and "Warning" are used
to classify different hazard categories for respiratory or skin sensitization. Use the
signal word "Danger" for Category 1, Category 1A, Category 1B respiratory sensitizers.
Use the signal word "Warning" for Category 1, Category 1A, Category 1B skin
sensitizers.
7.4 Hazard statements
Hazard statement means a phrase assigned to a hazard type and category that describes
the hazardous nature of a chemical and, where appropriate, its degree of hazard. See
Appendix C and Appendix D for hazard statements and precautionary statements for
respiratory or skin sensitizers.
7.5 Precautionary statements
A precautionary statement is a word (and/or pictogram) used to describe recommended
measures to minimize or prevent adverse effects resulting from exposure to a hazardous
product or improper storage or handling of a hazardous product. To meet GHS
requirements, there are five categories of precautionary statements. General,
precautionary, emergency, storage, disposal.
7.6 Product identifier
7.7 Supplier identification
The name, address, telephone number of the manufacturer or supplier of the substance
or mixture shall be provided on the label.
7.8 Label examples
See Appendix E for examples of respiratory or skin sensitization labels.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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