DfE Skin Sensitization





Chemicals that carry the EU Risk Phrase R43: “May cause sensitization by skin contact” [16] shall not pass the Criteria. Chemicals that are considered that are considered Category 1 – “Skin Sensitizer” (either Category 1A and 1B) under GHS criteria [74] shall not pass the Criteria.


Table 10 – Authoritative Lists and GHS Criteria


Authoritative Body

Does not pass DfE Criteria

EU Risk Phrase [16]

R43: “May cause sensitization by skin contact”


Globally Harmonized System (GHS) [74]

Category 1 – Skin Sensitizer


Data Requirements


All available data, measured and/or estimated, for the chemical and/or a suitable analog will be reviewed against GHS criteria using a weight-of-evidence approach. 


Preferred Test Methods for GHS Review


 OECD Test Guideline 406: Skin Sensitization [76]

 OECD Test Guideline 429: Skin Sensitization: Local Lymph Node Assay [77]

 OPPTS Harmonized Guideline 870.2600: Skin Sensitization [78]


Data Interpretation  


 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].

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