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3.5.3.: Classification criteria for mixtures

3.5.3.1. Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture
3.5.3.1.1. The mixture shall be classified as a mutagen when at least one ingredient has been classified as a Category 1A, Category 1B or Category 2 mutagen and is present at or above the appropriate generic concentration limit as shown in Table 3.5.2 for Category 1A, Category 1B and Category 2 respectively.


Table 3.5.2

Generic concentration limits of ingredients of a mixture classified as germ cell mutagens that trigger classification of the mixture

Ingredient classified as:

Concentration limits triggering classification of a mixture as:

Category 1 mutagen

Category 2 mutagen

Category 1A

Category 1B

Category 1A mutagen

≥ 0,1 %

Category 1B mutagen

≥ 0,1 %

Category 2 mutagen

≥ 1,0 %

Note

The concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units).
3.5.3.2. Classification of mixtures when data are available for the complete mixture
3.5.3.2.1. Classification of mixtures will be based on the available test data for the individual ingredients of the mixture using concentration limits for the ingredients classified as germ cell mutagens. On a case-by-case basis, test data on mixtures may be used for classification when demonstrating effects that have not been established from the evaluation based on the individual ingredients. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations, sensitivity and statistical analysis of germ cell mutagenicity test systems. Adequate documentation supporting the classification shall be retained and made available for review upon request.
3.5.3.3. Classification of mixtures when data are not available for the complete mixture: bridging principles
3.5.3.3.1. Where the mixture itself has not been tested to determine its germ cell mutagenicity hazard, but there are sufficient data on the individual ingredients and similar tested mixtures (subject to paragraph 3.5.3.2.1), to adequately characterise the hazards of the mixture, these data shall be used in accordance with the applicable bridging rules set out in section 1.1.3.