DfE Skin Sensitization

3.8 SKIN SENSITIZATION

Criteria

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

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].