User Guide to Thresholds and Classification - Environmental ...

180User Guide for Thresholds and ClassificationsData from internationally harmonised test methods are preferred for classification under this subclass.Preferably, data should be derived using Organisation for Economic Co-operation and Development 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 above in chapter 1 for information about assessing data quality.See Appendix 12A below for a detailed list of acceptable test methods for eye corrosion or irritancy.12.1.3. Synergistic and antagonistic effectsIf the applicant is aware of any available information about possible synergistic effects that may enhance theirritancy of the substance as a mixture, this must be considered.If the applicant is aware of any available information that antagonistic effects may occur such that thesubstance as a mixture classification is lower than indicated from the calculated value, this should be noted.For example, the encapsulation of a substance as a mixture can lower the corrosivity or irritancy of thesubstance.12.2. Eye corrosion or irritation hazard and classification criteria12.2.1. Eye corrosion or irritation threshold criteriaEye corrosionSchedule 5 to the Hazardous Substances (Minimum Degrees of Hazard) Regulations 2001 states:2 Minimum degrees of hazard(1) A substance with corrosive properties is not hazardous for the purposes of the Act unless—…(b) data for the substance indicates that the substance has a pH level of 2 or less, or 11.5 ormore; or(c) data for the substance indicates destruction of dermal tissue, being visible necrosis throughthe epidermis and into the dermis, as a result of exposure to the substance, that has notfully reversed within an observation period of 14 days; or(d) data for the substance indicates destruction of ocular tissue being adverse effects on thecornea, iris, or conjunctiva, as a result of exposure to the substance, that has not fullyreversed within an observation period of 21 days; or(e) data for the substance indicates a mean Draize score of 3 or more for the eye irritationeffect known as corneal opacity, as a result of exposure to the substance; or(f) data for the substance indicates a mean Draize score of 1.5 or more for the eye irritationeffect known as iritis, as a result of exposure to the substance.Eye irritationJanuary 2012 EPA0109