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3.9.3.: Classification criteria for mixtures

3.9.3.1. Mixtures are classified using the same criteria as for substances, or alternatively as described below. As with substances, mixtures shall be classified for specific target organ toxicity following repeated exposure.
3.9.3.2. Classification of mixtures when data are available for the complete mixture
3.9.3.2.1. When reliable and good quality evidence from human experience or appropriate studies in experimental animals, as described in the criteria for substances, is available for the mixture (see 1.1.1.4), then the mixture shall be classified by weight of evidence evaluation of these data. Care shall be exercised in evaluating data on mixtures, that the dose, duration, observation or analysis, do not render the results inconclusive.
3.9.3.3. Classification of mixtures when data are not available for the complete mixture: bridging principles
3.9.3.3.1. Where the mixture itself has not been tested to determine its specific target organ toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging principles set out in section 1.1.3.
3.9.3.4. Classification of mixtures when data are available for all components or only for some components of the mixture
3.9.3.4.1. Where there is no reliable evidence or test data for the specific mixture itself, and the bridging principles cannot be used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this case, the mixture shall be classified as a specific target organ toxicant (specific organ specified), following single exposure, repeat exposure, or both when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ toxicant and is present at or above the appropriate generic concentration limit as laid out in Table 3.9.4 for Category 1 and 2 respectively.


Table 3.9.4

Generic concentration limits of ingredients of a mixture classified as a specific target organ toxicant that trigger classification of the mixture

Ingredient classified as:

Generic concentration limits triggering classification of the mixture as:

Category 1

Category 2

Category 1

Specific Target Organ Toxicant

Concentration ≥ 10 %

1,0 % ≤ concentration < 10 %

Category 2

Specific Target Organ Toxicant

 

Concentration ≥ 10 % [(Note 1)]

Note 1

If a Category 2 specific target organ toxicant is present in the mixture as an ingredient at a concentration ≥ 1,0 % a SDS shall be available for the mixture upon request.
3.9.3.4.2. These generic concentration limits and consequent classifications apply to repeated-dose target organ toxicants.
3.9.3.4.3. Mixtures shall be classified for either or both single- and repeated-dose toxicity independently.
3.9.3.4.4. Care shall be exercised when toxicants affecting more than one organ system are combined that the potentiation or synergistic interactions are considered, because certain substances can cause target organ toxicity at < 1 % concentration when other ingredients in the mixture are known to potentiate its toxic effect.