CELEX 02008R1272 · v20250901

3.3. Serious eye damage/eye irritation

3.3.1.1.

Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, which is not fully reversible, occurring after exposure of the eye to a substance or mixture.

Eye irritation means the production of changes in the eye, which are fully reversible, occurring after the exposure of the eye to a substance or mixture.

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3.3.1.2.

In a tiered approach, emphasis shall be placed upon existing human data, followed by existing animal data, followed by in vitro data, and then other sources of information. Classification results directly when the data satisfy the criteria. In other cases, classification of a substance or a mixture is made on the basis of the weight of evidence within a tier. In a total weight of evidence approach all available information bearing on the determination of serious eye damage/eye irritation is considered together, including the results of appropriate validated in vitro tests, relevant animal data, and human data such as epidemiological and clinical studies and well-documented case reports and observations (see Annex I, Part 1, Section 1.1.1.3).

3.3.2. Classification criteria for substances

Substances are allocated to one of the categories within this hazard class, Category 1 (serious eye damage) or Category 2 (eye irritation), as follows:

(a)

Category 1 (serious eye damage):

substances that have the potential to seriously damage the eyes (see Table 3.3.1).

(b)

Category 2 (eye irritation):

substances that have the potential to induce reversible eye irritation (see Table 3.3.2).

3.3.2.1. Classification based on standard animal test data

3.3.2.1.1. Serious eye damage (Category 1)

3.3.2.1.1.1. A single hazard category (Category 1) is adopted for substances that have the potential to seriously damage the eyes. This hazard category includes as criteria the observations listed in Table 3.3.1. These observations include animals with grade 4 cornea lesions and other severe reactions (e.g. destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight. In this context, persistent lesions are considered those which are not fully reversible within an observation period of normally 21 days. Hazard classification as Category 1 also contains substances fulfilling the criteria of corneal opacity ≥ 3 or iritis > 1,5 observed in at least 2 of 3 tested animals, because severe lesions like these usually do not reverse within a 21-day observation period.

3.3.2.1.1.2. The use of human data is discussed in Section 3.3.2.2 and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.

Table 3.3.1

Serious eye damage ()

3.3.3. Classification criteria for mixtures

3.3.3.1. Classification of mixtures when data are available for the complete mixture

3.3.3.1.1.

The mixture shall be classified using the criteria for substances, and taking into account the tiered approach to evaluate data for this hazard class.

3.3.3.1.2.

When considering testing of the mixture classifiers are encouraged to use a tiered weight of evidence approach as included in the criteria for classification of substances for skin corrosion and serious eye damage/eye irritation to help ensure an accurate classification, as well as to avoid unnecessary animal testing. In the absence of any other information, a mixture is considered to cause serious eye damage (Category 1) if it has a pH ≤ 2 or ≥ 11,5. However, if consideration of acid/alkali reserve suggests the mixture may not cause serious eye damage despite the low or high pH value, this needs to be confirmed by other data, preferably data from an appropriate validated in vitro test.

3.3.3.2. Classification of mixtures when data are not available for the complete mixture: bridging principles

3.3.3.2.1.

Where the mixture itself has not been tested to determine its skin corrosivity or potential to cause serious eye damage/eye irritation, 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.

3.3.3.3. Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture

3.3.3.3.1.

In order to make use of all available data for purposes of classifying the serious eye damage/eye irritation properties of the mixtures, the following assumption has been made and is applied where appropriate in the tiered approach:

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.

3.3.3.3.2.

In general, the approach to classification of mixtures as seriously damaging to the eye/eye irritant when data are available on the ingredients, but not on the mixture as a whole, is based on the theory of additivity, such that each skin corrosive or serious eye damaging/eye irritant ingredient contributes to the overall serious eye damage/eye irritation properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for skin corrosive and serious eye damaging ingredients when they are present at a concentration below the generic concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as eye irritant. The mixture is classified as seriously damaging to the eye or eye irritant when the sum of the concentrations of such ingredients exceeds a concentration limit.

3.3.3.3.3.

Table 3.3.3 provides the generic concentration limits to be used to determine if the mixture shall be classified as seriously damaging to the eye or as eye irritant.

3.3.3.3.4.1.

Particular care must be taken when classifying certain types of mixtures containing substances such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in Sections 3.3.3.3.1 and 3.3.3.3.2 might not work given that many such substances are seriously damaging to the eye/eye irritant at concentrations < 1 %.

3.3.3.3.4.2.

For mixtures containing strong acids or bases the pH shall be used as classification criterion (see Section 3.3.3.1.2) since pH will be a better indicator of serious eye damage (subject to consideration of acid/alkali reserve) than the generic concentration limits in Table 3.3.3.

3.3.3.3.4.3.

A mixture containing skin corrosive or serious eye damaging/eye irritating ingredients that cannot be classified based on the additivity approach (Table 3.3.3) due to chemical characteristics that make this approach unworkable, shall be classified as Serious Eye Damage (Category 1) if it contains ≥ 1 % of a skin corrosive or serious eye damaging ingredient and as Eye Irritation (Category 2) when it contains ≥ 3 % of an eye irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 3.3.3 does not apply is summarised in Table 3.3.4.

3.3.3.3.5.

On occasion, reliable data may show that the effects of serious eye damage/eye irritation of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4 in Section 3.3.3.3.6. In these cases the mixture shall be classified according to those data (see also Articles 10 and 11). On other occasions, when it is expected that the skin corrosion/irritation hazards or the effects of serious eye damage/eye irritation of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4, testing of the mixture shall be considered. In those cases, the tiered weight of evidence approach shall be applied.

3.3.3.3.6.

If there are data showing that (an) ingredient(s) may be corrosive to the skin or seriously damaging to the eye/eye irritating at a concentration of < 1 % (corrosive to the skin or seriously damaging to the eye) or < 3 % (eye irritant), the mixture shall be classified accordingly.

Table 3.3.3

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/eye irritation where the additivity approach applies

Sum of ingredients classified as:	Concentration triggering classification of a mixture as:
	Serious eye damage	Eye irritation
	Category 1	Category 2
Skin corrosion Sub-Category 1A, 1B, 1C or Category 1 + Serious eye damage (Category 1) ()	≥ 3 %	≥ 1 % but < 3 %
Eye irritation (Category 2)		≥ 10 %
10 × (Skin corrosion Sub-Category 1A, 1B, 1C or Skin corrosion Category 1 + Serious eye damage (Category 1)) + Eye irritation (Category 2)		≥ 10 %
(1) If an ingredient is classified as both Skin Corrosion Sub-Category 1A, 1B, 1C or Category 1 and Serious Eye Damage (Category 1), its concentration is considered only once in the calculation.

Table 3.3.4

Generic concentration limits of ingredients that trigger classification of the mixture as serious eye damage (Category 1) or eye irritation (Category 2), where the additivity approach does not apply

Ingredient	Concentration	Mixture classified as:
Acid with pH ≤ 2	≥ 1 %	Serious eye damage (Category 1)
Base with pH ≥ 11,5	≥ 1 %	Serious eye damage (Category 1)
Other ingredient classified as skin corrosion (Sub-Category 1A, 1B, 1C or Category 1) or serious eye damage (Category 1)	≥ 1 %	Serious eye damage (Category 1)
Other ingredient classified as eye irritation (Category 2)	≥ 3 %	Eye irritation (Category 2)

3.3.4. Hazard Communication

3.3.4.1.

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.3.5.

Table 3.3.5

Label elements for serious eye damage/eye irritation ()

Classification	Category 1	Category 2
GHS Pictograms
Signal Word	Danger	Warning
Hazard Statement	H318: Causes serious eye damage	H319: Causes serious eye irritation
Precautionary Statement Prevention	P280	P264 P280
Precautionary Statement Response	P305 + P351 + P338 P310	P305 + P351 + P338 P337 + P313
Precautionary Statement Storage
Precautionary Statement Disposal
(1) Where a chemical is classified as skin corrosion Sub-Category 1A, 1B, 1C or Category 1, labelling for serious eye damage/eye irritation can be omitted as this information is already included in the hazard statement for skin corrosion Category 1 (H314).

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3.3. Serious eye damage/eye irritation