User Guide to Thresholds and Classification - Environmental ...

196User Guide for Thresholds and ClassificationsOral ingestion causing sensitisationSubstances that are orally ingested that can cause a systemic allergic response (for example, antibiotics) arenot classified under subclass 6.5, because the hazard and classification criteria discussed below relatestrictly to contact and respiratory sensitisation.13.1.3. Weight of evidenceThe best quality data should be used as the fundamental basis for classification. Preferably, classificationshould be based on primary data sources. It is essential that test conditions be clearly and completelyarticulated.Data from internationally harmonised test methods are preferred for classification under this subclass. Datashould preferably be derived using Organisation for Economic Co-operation and Development (OECD) TestGuidelines or equivalent according to the principles of Good Laboratory Practice. When such data are notavailable, classification should be based on the best available data using a weight-of-evidence approach.See section 1.3 in chapter 1 for information about assessing data quality.See Appendix 13A for a detailed list of acceptable test methods for respiratory or contact sensitisation.13.2. Respiratory or contact sensitisation hazard and classification criteria13.2.1. Respiratory or contact sensitisation threshold criteriaSchedule 4 to the Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001 states:2 Minimum degrees of hazard(1) A substance with toxic properties is not hazardous for the purposes of the Act unless—…(i) data for the substance indicates positive evidence of respiratory sensitisation in animalsas a result of exposure to the substance; or(j) data for the substance indicates positive evidence of sensitisation by skin contact inanimals as a result of exposure to the substance of either—i. 30% or more sensitisation response in an adjuvant type test method; orii. 15% or more sensitisation response in a non-adjuvant type test; or(k) data for the substance, in the opinion of an expert, indicates evidence in humans ofspecific respiratory hypersensitivity (including asthma, rhinitis and alveolitis) as a result ofexposure to the substance; or(l) data for the substance, in the opinion of an expert, indicates evidence in humans ofsensitisation by skin contact as a result of exposure to the substance.January 2012 EPA0109