GB 30000.21-2013Rules for classification and labelling of chemicals - Part 21: Respiratory or skin sensitization (English PDF)

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.

5.3 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

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.