Rules for classification and labelling of chemicals — Part 20: Serious eye damage/eye irritation
1 Scope
This part of GB 30000 stipulates the terms and definitions, classification standards, judgment logic and labels of chemicals with serious eye damage/eye irritation.
This part is applicable to the classification and labelling of carcinogenic chemicals according to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (hereinafter referred to as “GHS”).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 13690 General rule for classification and hazard communication of chemicals
GB 2013 Rules for classification and labelling of chemicals — Part 19: Skin corrosive/irritation
United Nations Globally Harmonized System of Classification and labelling of Chemicals (Rev.4)
United Nations Recommendations on the transport of dangerous goods: Model regulations (Rev.17)
3 Terms and definitions
For the purposes of this document, the term and definition given in GB 13690 and the following apply.
3.1
serious eye damage
the situation of tissue damage in the eye or severe visual deterioration, caused in the application of a test substance to the anterior surface of the eye, which cannot fully recovered within 21 days of exposure
3.2
eye irritation
the situation of changes in the eye caused in the application of a test substance to the anterior surface of the eye, which can be fully recovered within 21 days of exposure
4 Classification standards
4.1 General principles
See GB 13690 for general principles of classification and labelling of serious eye damage/eye irritation
4.2 Classification standards for substances
4.2.1 Tiered tests and evaluation schemes shall be used to combine existing information on serious visual tissue damage and eye irritation (including data from previous human or animal experiences), as well as structure-activity relationship (SAR) with effective in vitro test results to avoid unnecessary animal tests.
4.2.2 Recommendations for classification of eye irritation and serious eye damage include elements that have been harmonized and used by all competent departments, as well as optional subcategories that will only be used by some competent departments (e.g., the regulatory departments that classify pesticides).
4.2.3 All available information on the test substance shall be reviewed prior to any in vivo serious eye damage/eye irritation test. From the existing data, it is often preliminarily determined whether a substance will cause serious (i.e., irreversible) eye damage. If the test substance can be classified in this way, no test is required. The tiered test strategy of serious eye damage and eye irritation shall be used to evaluate the existing information of the test substance or new unstudied substances.
4.2.4 Before conducting the test, the following factors shall be combined when determining the serious eye damage or irritation potential of the substance. First of all, we shall analyze the accumulated human and animal experience, for they can provide information directly related to eye effects. In some cases, sufficient information may be obtained from structurally related compounds to make a determination of hazard category. Similarly, some cases like pH ≤ 2 and pH ≥ 11.5 may also cause serious eye damage, especially when they are associated with significant buffering capacity. Such substances may produce significant effects on eyes. Before evaluating serious eye damage/eye irritation, the possible skin corrosivity shall be evaluated to avoid testing for the local effects on eyes with skin corrosive substances. Classification may be carried out using in vitro alternative tests that have been validated and approved.
4.2.5 All the above available information of a substance shall be used in determining whether in vivo eye irritation testing is required. Although it is possible to obtain information from a single parameter evaluation within a tier (e.g., caustic alkali with a limit pH value shall be regarded as a local corrosive), it is still valuable in considering the integrity of the existing information and weighing the entire evidence. This is especially true when information on some but not all parameters are available. In general, primary focus shall be placed on expert judgment considering human experience of related substances, followed by test results of skin irritation testing and of reliable alternative methods. Animal testing with corrosive substances shall be avoided as much as possible.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification standards
5 Judgment logic
6 Labelling
Annex A (Informative) Judgment logic
Annex B (Normative) Allocation of label elements
Annex C (Normative) Classification standards and label elements of serious eye damage/eye irritation
Annex D (Informative) Hazard statements and precautionary statements of serious eye damage/eye irritation
Annex E (Informative) Examples of labels for severe eye damage/eye irritation
