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GB 30000.21-2013: Rules for classification and labelling of chemicals -- Part 21: Respiratory or skin sensitization
GB 30000.21-2013
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
Rules for classification and labelling of chemicals - Part 21:
Respiratory or skin sensitization
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. For skin sensitization, there
needs to be an induction phase, that allows the immune system to respond. If subsequent
exposure is sufficient to trigger a visible skin reaction (initiation phase), clinical
symptoms may develop. Therefore, predictive tests often follow this pattern, in which
there is an induction phase and the response to this phase is measured through a
standardized induction phase, typically using a patch test. Regional lymph node trials
that directly measure evoked responses are the exception. Evidence of skin sensitization
in humans is usually assessed by diagnostic patch test.
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:
a) Respiratory sensitization;
b) Skin sensitization.
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
5.2.1.1 Hazard category
5.2.1.1.1 In the case where the competent authority does not require subclassification
a) Data derived from clinical cases and appropriate pulmonary function tests related
to substance exposure, and they are corroborated by other supporting evidence,
including:
- In vivo immunological tests (e.g. skin prick tests);
- In vitro immunological tests (e.g. serum analysis);
- Studies in which the immunological mechanism of action has not yet been
confirmed, such as repeated low-level stimulation, pharmacologically
mediated effects, indicating other specific allergic reactions;
- Chemical structures related to substances known to cause respiratory allergies;
b) Data obtained from positive bronchial provocation tests, which are performed on
substances according to accepted criteria for determining specific
hypersensitivity reactions.
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. Relevant information includes factors present in the home and
workplace that contribute to worsening of the condition, the onset and progression of
the disease, the patient's family and medical history. The medical history shall also
include documentation of other allergic or respiratory conditions in early childhood and
a history of smoking.
5.2.1.2.5 A positive bronchial provocation test result alone provides sufficient evidence
for classification. However, it shall be recognized that many of the tests listed above
may have been carried out.
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:
- For example, determination of immunoglobulin E (Ig E) and other specific
immunological parameters in mice;
- Specific pulmonary responses in guinea pigs.
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.
2 The mechanism by which substances cause asthma symptoms is not fully understood so far. For precautionary
purposes, these substances may be considered respiratory sensitizers. However, if it can be proven based on the
evidence that these substances produce irritating effects and cause asthma symptoms only in people with bronchial
hyperreactivity, then they shall not be judged as respiratory sensitizers.
5.2.2.4 Specific matters
5.2.2.4.1 To classify substances, the weight of evidence method shall be used; the
evidence shall include any or all of the following:
a) Positive patch test data, usually from more than one hospital;
b) Epidemiological studies show that substances cause allergic contact dermatitis;
special attention shall be paid when a high proportion of contacts develop
characteristic symptoms, even if the number of cases is small;
c) Positive data from appropriate animal studies;
d) Positive data from experimental studies in humans;
e) Well-documented cases of allergic conta...