Respiratory or skin sensitization

A respiratory sensitizer is a substance that will induce hypersensitivity of the airways following inhalation of the substance . 

Substances shall be classified as respiratory sensitizers (Category 1) in accordance with the criteria given below  

1 Evidence that a substance can induce specific respiratory hypersensitivity will normally be based on human experience. In this context, hypersensitivity is normally seen as asthma, but other hypersensitivity reactions such as rhinitis/conjunctivitis and alveolitis are also considered. The condition will have the clinical character of an allergic reaction. However, immunological mechanisms do not have to be demonstrated. 

2 When considering the human evidence, it is necessary for a decision on classification to take into account, in addition to the evidence from the cases  

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OECD has also published a document on a Harmonised integrated classification system for human health and environmental hazards of chemical substances and mixtures (OECD 2001b). Chapter 2.4 addresses a harmonized system for the classification of chemicals, which cause respiratory or skin sensitization. 

Reactive dyes that caused respiratory or skin sensitization in workers on occupational exposure were compiled by ETAD [13], In the EU these dyes, which are all listed in the European Inventory of Existing Chemical Substances (EINECS), should be labeled accordingly (Table 8.1). 

The mixture should be classified as a respiratory or skin sensitizer when at least one ingredient has been classified as a respiratory or skin sensitizer and is present at or above the appropriate cutoff value/concentration limit for the specific endpoint as shown in Table 3.4.1 for solid/liquid and gas respectively. 

Table 3.4.2 Respiratory or skin sensitization label elements.

Health hazards Acute toxicity, skin irritation/cor-rosion, eye irritation/corrosion, respiratory or skin sensitization, mutagenicity, carcinogenicity, toxic to reproduction, target organ toxicity. 

May cause respiratory or skin sensitization. Acute oral toxicity (LD50) 2000 mg/kg [Rat]. 

Acute toxicity Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitization Germ cell mutagenicity Carcinogenicity... 

A.4.1.5 The hazard class respiratory or skin sensitization is differentiated into ... 

Respiratory or skin sensitization Respiratory sensitization Skin sensitization Germ cell mutagenicity... 

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