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3.7.3.: Classification criteria for mixtures

3.7.3.1. Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture
3.7.3.1.1. The mixture shall be classified as a reproductive toxicant when at least one ingredient has been classified as a Category 1A, Category 1B or Category 2 reproductive toxicant and is present at or above the appropriate generic concentration limit as shown in Table 3.7.2 for Category 1A, Category 1B and Category 2 respectively.
3.7.3.1.2. The mixture shall be classified for effects on or via lactation when at least one ingredient has been classified for effects on or via lactation and is present at or above the appropriate generic concentration limit as shown in Table 3.7.2 for the additional category for effects on or via lactation.


Table 3.7.2

Generic concentration limits of ingredients of a mixture classified as reproduction toxicants or for effects on or via lactation that trigger classification of the mixture

Ingredient classified as:

Generic concentration limits triggering classification of a mixture as:

Category 1 reproductive toxicant

Category 2 reproductive toxicant

Additional category for effects on or via lactation

Category 1A

Category 1B

Category 1A reproductive toxicant

≥ 0,3 %

[Note 1]

 

 

 

Category 1B reproductive toxicant

 

≥ 0,3 %

[Note 1]

 

 

Category 2 reproductive toxicant

 

 

≥ 3,0 %

[Note 1]

 

Additional category for effects on or via lactation

 

 

 

≥ 0,3 %

[Note 1]

Note:

The concentration limits in Table 3.7.2 apply to solids and liquids (w/w units) as well as gases (v/v units).

Note 1:

If a Category 1 or Category 2 reproductive toxicant or a substance classified for effects on or via lactation is present in the mixture as an ingredient at a concentration at or above 0,1 %, a SDS shall be available for the mixture upon request.

3.7.3.2. Classification of mixtures when data are available for the complete mixture
3.7.3.2.1. Classification of mixtures will be based on the available test data for the individual ingredients of the mixture using concentration limits for the ingredients of the mixture. 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 components. 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 reproduction test systems. Adequate documentation supporting the classification shall be retained and made available for review upon request.
3.7.3.3. Classification of mixtures when data are not available for the complete mixture: bridging principles
3.7.3.3.1. Subject to paragraph 3.7.3.2.1, where the mixture itself has not been tested to determine its reproductive 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 applicable bridging rules set out in section 1.1.3.