DfE Respiratory Sensitization





Chemicals that carry the EU Risk Phrase R42: “May cause sensitization by inhalation” [16] shall not pass the Criteria. Chemicals that are considered that are considered Category 1 – “Respiratory Sensitizer” (either Category 1A and 1B) under GHS criteria [74] shall not pass the Criteria.


Table 9 – Authoritative Lists and GHS Criteria


Authoritative Body

Does not pass DfE Criteria

EU Risk Phrase [16]

Risk Phrase R42: “May cause sensitization by inhalation”

Globally Harmonized System (GHS) [74]

Category 1 – Respiratory Sensitizer



Data Requirements


Chemicals with new data not yet reviewed by authoritative bodies will be evaluated under these Criteria. 

Public literature, EPA-confidential data, and lists of chemicals of potential concern will be screened. Chemicals designated as sensitizer-induced asthmagens (“Rs”) on the specified list below will require supplemental review. All relevant data and information used to designate a chemical as a sensitizer-induced asthmagen (“Rs”) on the specified list will be considered when reviewing the chemical against the respiratory sensitization criteria.

  1. 1. Association of Occupational and Environmental Clinics (AOEC) Exposure Code List [75].

    Acknowledging that recognized animal models for the testing of respiratory hypersensitivity are not available at present, data on respiratory sensitization will normally be based on human evidence.  Chemicals associated with hypersensitivity after appropriate clinical testing may not pass the Criteria. See GHS guidance for further details. 


    Data Interpretation


    The following sources should be consulted for additional information:


     EU Dangerous Substances Directive, http://ecb.jrc.ec.europa.eu/documentation/. To access the list of substances carrying Risk Phrases, click on “CLASSIFICATION-LABELLING”, then “DIRECTIVE 67-548-EEC”, then “ANNEX I OF DIRECTIVE 67-548-EEC”, and then either of the files listed as: “Annex I of Directive 67548EEC”. [25];

     EU Dangerous Preparations Directive Article 6 and Annex II (1999/45/EC and subsequent updates/amendments) [26-28];

     GHS Ch 3.4 Respiratory and Skin Sensitization [74], and

     Association of Occupational and Environmental Clinics Exposure Code List, available from: http://www.aoecdata.org/Default.aspx [75].



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