User Guide to Thresholds and Classification - Environmental ...

211User Guide for Thresholds and Classificationsand under the control of the same manufacturer, unless there is reason to believe there is significantvariation in composition such that the germ cell mutagenic potential of the batch has changed. If the latteroccurs, a new classification is necessary.c. Substantially similar mixturesGiven:i. two mixtures: (A + B) and (C + B);ii.iii.iv.the concentration of mutagen ingredient B is the same in both mixtures;the concentration of ingredient A in mixture (A + B) equals that of ingredient C in mixture (C + B);anddata on toxicity for ingredients A and C are available and substantially equivalent; that is, they are inthe same hazard category and are not expected to affect the germ cell mutagenicity of ingredient B;thenif mixture (A + B) has already been classified by testing, mixture (C + B) can be assigned the samecategory.d. AerosolsA hazard classification may be assigned for mutagenicity for aerosol products. The classification shouldalso take into account the propellant in the aerosol.14.3.3. Classification of mixtures when data are available for all or some ingredients of themixtureA mixture will be classified as a mutagen when at least one ingredient has been classified as a category6.6A or 6.6B mutagen and is present at or above the appropriate hazard cut-off value or concentration limitmentioned in Table 14.1 for category 6.6A and 6.6B respectively.Table 14.1: Cut-off values or concentration limits of ingredients of a mixture classified as mutagenic that wouldtrigger classification of the mixtureIngredient classified ascategoryCut-off value or concentration limit triggeringclassification of a mixture as category6.6A 6.6B6.6A mutagen 0.1% –6.6B mutagen – 1%ReferencesEC 1967. General classification and labelling requirements for dangerous substances and preparations.Council Directive 67/548/EEC of 27 June 1967 on the Approximation of Laws, Regulations andAdministrative Provisions Relating to the Classification, Packaging and Labelling of Dangerous Substances.European Commission, Annex VI. http://ec.europa.eu/environment/dansub/consolidated_en.htm.January 2012 EPA0109