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Classification

Serious damage to eyes / Eye irritation

Mixture's pH

According to 3.3.3.1.2 of Annex I to CLP "... a mixture is considered to cause serious eye damage (Category 1) if it has a pH ≤ 2 or a pH ≥ 11.5 ...". Therefore, if a mixture as a whole has such extreme pH it is classified as 'Eye Dam. 1'.

Non-additivity approach

The generic cut-off value for Serious eye damage/irritation is 1 % (CLP, Annex I, Table 1.1). This means that if mixture consists of substances classified as Serious eye damage or Serious eye irritation each present at a concentration below 1 % and even if the sum of their concentrations is above 1 % the mixture will not be classified for Serious eye damage/irritation.

Other hand, in case of acids, bases, inorganic salts, aldehydes, phenols and surfactants such approach is not applicable, because many such substances are seriously damaging to the eye/eye irritant at concentrations < 1 %. A mixture containing such ingredients cannot be classified on the basis of the additivity approach. In this case Serious eye damage/irritation is calculated based on approach described in Annex I, 3.3.3.3.4.3 and Table 3.3.4 to CLP.

In the table below generic concentration limits of ingredients that trigger classification of the mixture as Serious eye damage/irritation are presented.

Ingredient Concentration in mixture Mixture classified as
Acid with pH ≤ 2 ≥ 1 % Eye Dam. 1
Base with pH ≥ 11.5 ≥ 1 % Eye Dam. 1
Other ingredient classified as skin corrosion (sub-category 1A, 1B, 1C or Category 1) or serious eye damage (Category 1) ≥ 1 % Eye Dam. 1
Other ingredient classified as eye irritation (Category 2) ≥ 3 % Eye Irrit. 2

Additivity approach

The table below represents generic concentration limits of ingredients classified as Skin corrosion (Category 1, 1A, 1B or 1C) and/or Serious eye damage (Category 1) or Eye irritation (Category 2) that trigger classification of the mixture as Serious eye damage or Eye irritation where the additivity approach applies (CLP, Annex I, Table 3.3.3):

Sum of ingredients classified as Concentration triggering classification of a mixture as
Sum of ingredients classified as Eye Dam. 1 Eye Irrit. 2
Skin Corr. 1A +
Skin Corr. 1B +
Skin Corr. 1C +
Skin Corr. 1 +   
Eye Dam. 1      
(see note)
≥ 3 % ≥ 1 % but < 3 %
Eye Irrit. 2 ≥ 10 %
10 × (Skin Corr. 1A +
          Skin Corr. 1B +
          Skin Corr. 1C +
       Skin Corr. 1 +
     Eye Dam. 1)
+
 Eye Irrit. 2
≥ 10 %

Note.

If an ingredient is classified as both:

Skin Corrosion sub-category 1A or 1B or 1C or Category 1   and
Serious Eye Damage Category 1

its concentration is considered only once in the calculation.

The below approach should be used to calculate Serious eye damage:

To classify mixture as Eye Dam. 1 concentration of ingredients with
- 'Skin Corr. 1'     and
- 'Skin Corr. 1A'   and
- 'Skin Corr. 1B'   and
- 'Skin Corr. 1C'   and
- 'Eye Dam. 1'
are added. If their sum is ≥ 3 % the mixture is classified as 'Eye Dam. 1'.

The below approach should be used to calculate Eye irritation:

If the sum of all ingredients with 'Eye Irrit. 2' is ≥ 10 % the mixture is classified as Eye Irrit. 2 .
If mixture contains ingredients classified as Skin corrosion (sub-)categories 1A, 1B, 1C or 1 and Serious eye damage category 1 their concentration values must be summed and multiplied by 10. Additionally, if mixture contains ingredients with Eye irritation category 2 their concentration values (without multiplication) should be added. If final sum value is ≥ 10 % the mixture is classified as Eye Irrit. 2 .

For calculation the serious eye damage/eye irritation properties of the mixtures, only 'relevant ingredients' are taken into account.

The 'relevant ingredients' of a mixture are those which are present in concentrations ≥ 1 % (w/w for solids, liquids, dusts, mists and vapours and v/v for gases), unless there is a presumption (e.g. in the case of skin corrosive ingredients) that an ingredient present at a concentration < 1 % can still be relevant for classifying the mixture for serious eye damage/eye irritation (CLP, Annex I, 3.3.3.3.1).

If mixture contains an ingredient classified as 'Eye Dam. 1' or 'Eye Irrit. 2' at concentration below 1 % such ingredient is not taken into account because:
− its concentration is below cut-off limit 1 %(CLP, Annex I, table 1.1),
− it is not a 'relevant ingredient'.
If mixture contains an ingredient classified as 'Skin Corr. 1A' or 'Skin Corr. 1B' or 'Skin Corr. 1C' or 'Skin Corr. 1' at concentration < 1 % such ingredient is not taken into account because:
− it is not a 'relevant ingredient'.

Hierarchy of hazard categories

Hazard
Serious eye damage, category 1 (Eye Dam. 1: H318)
Eye irritation, category 2 (Eye Irrit. 2: H319)

A more severe classification for a mixture overrides a less severe classification. For example, if ingredients of a mixture lead to classification both as serious eye damage category 1 (Eye Dam. 1) and eye irritation category 2 (Eye Irrit. 2) the category ''Eye Dam. 1' must be selected.

In accordance to Article 27 and Part 1 of Annex III to CLP, if the hazard statement H314 'Causes severe skin burns and eye damage' is assigned, the hazard statement H318 'Causes serious eye damage' does not need to be indicated in hazard communication (label, section 2.2 of safety data sheet). Taking into account the above and Guidance on the Application of the CLP Criteria, Version 5.0 July 2017, section 3.3.2.4, if a mixture is classified both as:

Skin Corr. 1 or 1A or 1B or 1C (H314 - Causes severe skin burns and eye damage)
and
Eye Dam. 1 (H318 - Causes serious eye damage)

the statement H318 may be omitted because of redundancy.

To select pictogram, signal word, hazard and precautionary statements please refer to Annex I, part 3, Table 3.3.5 of Regulation (EC) no 1272/2008 (CLP).

Example 1
Example 2
Example 3
Example 4
Example 5
Example 6
Example 7
Example 8

See also Example 3  in section Examples.