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3.4.3.: Classification criteria for mixtures

3.4.3.1. Classification of mixtures when data are available for the complete mixture
3.4.3.1.1. 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, then the mixture can be classified by weight of evidence evaluation of these data. Care shall be exercised in evaluating data on mixtures, that the dose used does not render the results inconclusive.
3.4.3.2. Classification of mixtures when data are not available for the complete mixture: bridging principles
3.4.3.2.1. Where the mixture itself has not been tested to determine its sensitising properties, 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 rules set out in section 1.1.3.
3.4.3.3. Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture
3.4.3.3.1. The mixture shall be classified as a respiratory or skin sensitiser when at least one ingredient has been classified as a respiratory or skin sensitiser and is present at or above the appropriate generic concentration limit as shown in ►M2  Table 3.4.5  ◄ for solid/liquid and gas respectively.
3.4.3.3.2. Some substances that are classified as sensitisers may elicit a response, when present in a mixture in quantities below the concentrations established in ►M2  Table 3.4.5 ◄ , in individuals who are already sensitised to the substance or mixture (see Note 1 to ►M2  Table 3.4.6 ◄ ).


Table 3.4.5

Generic concentration limits of components of a mixture classified as either respiratory sensitisers or skin sensitisers that trigger classification of the mixture

Component classified as:

Generic concentration limits triggering classification of a mixture as:

Respiratory sensitiser

Category 1

Skin sensitiser

Category 1

Solid/liquid

Gas

All physical states

Respiratory sensitiser

Category 1

≥ 1,0 %

≥ 0,2 %

 

Respiratory sensitiser

Sub-category 1A

≥ 0,1 %

≥ 0,1 %

 

Respiratory sensitiser

Sub-category 1B

≥ 1,0 %

≥ 0,2 %

 

Skin sensitiser

Category 1

 

 

≥ 1,0 %

Skin sensitiser

Sub-category 1A

 

 

≥ 0,1 %

Skin sensitiser

Sub-category 1B

 

 

≥ 1,0 %


Table 3.4.6

Concentration limits for elicitation of components of a mixture

Component classified as:

Concentration limits for elicitation

Respiratory sensitiser

Category 1

Skin sensitiser

Category 1

Solid/liquid

Gas

All physical states

Respiratory sensitiser

Category 1

≥ 0,1 % (Note 1)

≥ 0,1 % (Note 1)

 

Respiratory sensitiser

Sub-category 1A

≥ 0,01 % (Note 1)

≥ 0,01 % (Note 1)

 

Respiratory sensitiser

Sub-category 1B

≥ 0,1 % (Note 1)

≥ 0,1 % (Note 1)

 

Skin sensitiser

Category 1

 

 

≥ 0,1 % (Note 1)

Skin sensitiser

Sub-category 1A

 

 

≥ 0,01 % (Note 1)

Skin sensitiser

Sub-category 1B

 

 

≥ 0,1 % (Note 1)

Note 1:

This concentration limit for elicitation is used for the application of the special labelling requirements of section 2.8 of Annex II to protect already sensitised individuals. A SDS is required for the mixture containing a component at or above this concentration. For sensitising substances with specific concentration limit lower than 0,1 %, the concentration limit for elicitation should be set at one tenth of the specific concentration limit.