Hazardous Products Regulations (SOR/2015-17)

SUBPART 3Serious Eye Damage/Eye Irritation

Definitions

Marginal note:Definitions

8.3 The following definitions apply in this Subpart.

eye irritation

eye irritation means the production of changes in the eye after exposure of the eye to a mixture or substance that are fully reversible within an observation period of 21 days after that exposure. (irritation oculaire)

serious eye damage

serious eye damage means the production of tissue damage in the eye or serious physical decay of vision, occurring after exposure of the eye to a mixture or substance,

• (a) for which data demonstrate that it is irreversible; or

• (b) that is not fully reversible within an observation period of 21 days after that exposure. (lésion oculaire grave)

Classification in a Category or Subcategory of the Class

Classification of Substances

Marginal note:Order of provisions

8.3.1 The classification of a substance that causes serious eye damage or eye irritation in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.3.2 to 8.3.7, unless, after applying subsections 8.3.2(1) to (4), the substance is not classified further to subsection 8.3.2(5).

Marginal note:Human or animal data — serious eye damage

• 8.3.2 (1) A substance for which there are human data or purposely generated animal data with respect to serious eye damage is classified in the category of this hazard class in accordance with the following table:

  	Column 1	Column 2
  Item	Category	Criteria
  1	Serious Eye Damage — Category 1	A substance (a) that, according to human data, causes serious eye damage; (b) that, according to animal data acquired from a scientifically validated method from at least one animal, produces effects on the cornea, iris or conjunctiva (i) that are irreversible as demonstrated by data, or (ii) that are not fully reversible within an observation period of 21 days; or (c) in respect of which animal data acquired from tests performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 405, entitled Acute Eye Irritation/Corrosion, as amended from time to time, demonstrate a positive response in at least two of three animals, and the mean score calculated following gradings at 24, 48 and 72 hours after instillation of the substance, is (i) in the case of corneal opacity, ≥ 3, or (ii) in the case of iritis, > 1.5

• Marginal note:Human data — eye irritation

  (2) A substance for which human data demonstrate that it causes eye irritation is classified in the category “Eye Irritation — Category 2”.

• Marginal note:Animal data — eye irritation

  (3) A substance for which purposely generated animal data demonstrate that it causes eye irritation is classified in the category “Eye Irritation — Category 2” and is, if the applicable data are available, further classified in the appropriate subcategory in accordance with the following table:

  	Column 1	Column 2	Column 3
  Item	Category	Subcategory	Criteria
  1	Eye Irritation — Category 2	Eye Irritation — Category 2A	A substance that is not classified in the category “Serious Eye Damage — Category 1” and in respect of which animal data acquired from tests performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 405, entitled Acute Eye Irritation/Corrosion, as amended from time to time, demonstrate in at least two of three animals a positive response that fully reverses within an observation period of more than seven days but not more than 21 days, and the mean score calculated following gradings at 24, 48 and 72 hours after instillation of the substance, is (a) in the case of corneal opacity, ≥ 1; (b) in the case of iritis, ≥ 1; (c) in the case of conjunctival redness, ≥ 2; or (d) in the case of conjunctival edema (chemosis), ≥ 2
  2	Eye Irritation — Category 2	Eye Irritation — Category 2B	A substance that is not classified in the category “Serious Eye Damage — Category 1” and in respect of which animal data acquired from tests performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 405, entitled Acute Eye Irritation/Corrosion, as amended from time to time, demonstrate in at least two of three animals a positive response that fully reverses within an observation period of seven days, and the mean score calculated following gradings at 24, 48 and 72 hours after instillation of the substance, is (a) in the case of corneal opacity, ≥ 1; (b) in the case of iritis, ≥ 1; (c) in the case of conjunctival redness, ≥ 2; or (d) in the case of conjunctival edema (chemosis), ≥ 2

• Marginal note:Skin corrosion data

  (4) A substance that is classified in the category “Skin Corrosion — Category 1” in accordance with subsections 8.2.2(1) and (2) is also classified in the category “Serious Eye Damage — Category 1” of this hazard class.

• Marginal note:No classification

  (5) A substance that meets the following conditions need not be classified in any category of this hazard class:

  • (a) the substance is not classified further to subsections (1) to (4); and

  • (b) human data or purposely generated animal data on the substance, acquired from a scientifically validated method, with respect to serious eye damage or eye irritation, demonstrate that the substance does not cause serious eye damage or eye irritation.

Marginal note:Other animal data — eye or skin exposure

8.3.3 A substance for which there are animal data on eye exposure that demonstrate, or animal data on skin exposure that support the conclusion, that the substance causes serious eye damage or eye irritation is classified in the category “Serious Eye Damage — Category 1” or the category “Eye Irritation — Category 2”, and, in the latter case, if the applicable data are available, the substance is further classified in the subcategory “Eye Irritation — Category 2A” or in the subcategory “Eye Irritation — Category 2B”.

Marginal note:In vitro or ex vivo data — serious eye damage

• 8.3.4 (1) A substance for which the data, in vitro or ex vivo, acquired from a scientifically validated method for the evaluation of serious eye damage demonstrate that the substance causes serious eye damage is classified in the category “Serious Eye Damage — Category 1”.

• Marginal note:In vitro or ex vivo data — eye irritation

  (2) A substance for which the data, in vitro or ex vivo, acquired from a scientifically validated method for the evaluation of eye irritation demonstrate that the substance causes eye irritation is classified in the category “Eye Irritation — Category 2” and, if the applicable data are available, the substance is further classified in the subcategory “Eye Irritation — Category 2A” or in the subcategory “Eye Irritation — Category 2B”.

Marginal note:pH

8.3.5 A substance for which the pH is less than or equal to two or equal to or greater than 11.5 is classified in the category “Serious Eye Damage — Category 1”, unless an assessment of alkali or acid reserve performed in accordance with established scientific principles supports the conclusion that it need not be classified as a substance that causes serious eye damage on the basis of its pH.

Marginal note:Structure-activity relationship — serious eye damage

• 8.3.6 (1) A substance for which a structure-activity relationship, established in accordance with established scientific principles, supports the conclusion that the substance must be classified in the category “Serious Eye Damage — Category 1” is classified in that category.

• Marginal note:Structure-activity relationship — eye irritation

  (2) A substance for which a structure-activity relationship, established in accordance with established scientific principles, supports the conclusion that the substance must be classified in the category “Eye Irritation — Category 2” is classified in that category and, if the applicable data are available, the substance is further classified in the subcategory “Eye Irritation — Category 2A” or in the subcategory “Eye Irritation — Category 2B”.

Marginal note:Totality of available data

8.3.7 A substance for which an evaluation of the totality of available data, performed in accordance with established scientific principles, supports the conclusion that the substance causes serious eye damage or eye irritation is classified in the category “Serious Eye Damage — Category 1” or the category “Eye Irritation — Category 2” and, in the latter case, if the applicable data are available, the substance is further classified in the subcategory “Eye Irritation — Category 2A” or in the subcategory “Eye Irritation — Category 2B”.

Classification of Mixtures

Marginal note:Order of provisions

8.3.8 The classification of a mixture as a mixture that causes serious eye damage or eye irritation in a category of this hazard class must proceed in accordance with the order of sections 8.3.9 to 8.3.11.

Marginal note:Data available for mixture as a whole

• 8.3.9 (1) If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, the mixture must be classified in accordance with the order of sections 8.3.2 to 8.3.7 unless, under subsection 8.3.2(5), the mixture need not be classified.

• Marginal note:Data available for mixture as a whole — sections 8.3.10 and 8.3.11

  (2) If data of the types referred to in subparagraphs 2.1(a)(i) to (iv) are available for the mixture as a whole, but the mixture cannot be classified further to subsections 8.3.2(1) to (4) or sections 8.3.3 to 8.3.7, its classification in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.3.10 and 8.3.11.

Marginal note:Data available for use of bridging principles

8.3.10 If data are available to enable the characterization of the mixture as a mixture that causes serious eye damage or eye irritation, in accordance with the bridging principles referred to in subsections 2.3(3) to (8), the mixture must be classified in a category or subcategory of this hazard class in accordance with those subsections.

Marginal note:Data available for ingredients

• 8.3.11 (1) Subject to subsection (3), a mixture that contains one or more ingredients that are classified in the category “Serious Eye Damage — Category 1”, the category “Eye Irritation — Category 2”, the subcategory “Eye Irritation — Category 2A” or the subcategory “Eye Irritation — Category 2B” is classified in a category or subcategory of this hazard class in accordance with subsection (2), subject to the following:

  • (a) ingredients that are classified in the category “Serious Eye Damage — Category 1”, the category “Eye Irritation — Category 2”, the subcategory “Eye Irritation — Category 2A” or the subcategory “Eye Irritation — Category 2B” and are present in the mixture at a concentration equal to or greater than the concentration limit of 1.0% must be included in the calculation of the sum of concentrations of ingredients; and

  • (b) ingredients that are classified in the category “Serious Eye Damage — Category 1”, the category “Eye Irritation — Category 2”, the subcategory “Eye Irritation — Category 2A” or the subcategory “Eye Irritation — Category 2B” and are present in the mixture at a concentration of less than the concentration limit of 1.0% must be included in the calculation of the sum of concentrations of ingredients only if there is evidence that, at the concentration at which they are present, the ingredients are substances that cause serious eye damage or eye irritation.

• Marginal note:Classification — mixture

  (2) A mixture is classified in a category of this hazard class in accordance with the following:

  • (a) if the sum of concentrations of ingredients classified in the category “Serious Eye Damage — Category 1”, the category “Skin Corrosion — Category 1”, the subcategory “Skin Corrosion – Category 1A”, the subcategory “Skin Corrosion – Category 1B” and the subcategory “Skin Corrosion – Category 1C” is equal to or greater than 3.0%, the mixture is classified in the category “Serious Eye Damage — Category 1”;

  • (b) if the sum of concentrations of ingredients classified in the category “Serious Eye Damage — Category 1”, the category “Skin Corrosion — Category 1”, the subcategory “Skin Corrosion – Category 1A”, the subcategory “Skin Corrosion – Category 1B” and the subcategory “Skin Corrosion – Category 1C” is equal to or greater than 1.0% but less than 3.0%, the mixture is classified in the category “Eye Irritation — Category 2”;

  • (c) if the sum of concentrations of ingredients classified in the category “Eye Irritation — Category 2” is equal to or greater than 10.0%, the mixture is classified in the category “Eye Irritation — Category 2”;

  • (c.1) if the sum of concentrations of ingredients classified in the subcategory “Eye Irritation — Category 2A” is equal to or greater than 10.0%, and the mixture does not contain any ingredients classified in the category “Eye Irritation — Category 2” or the subcategory “Eye Irritation — Category 2B”, the mixture is classified in the category “Eye Irritation — Category 2” or the subcategory “Eye Irritation — Category 2A”;

  • (c.2) if the sum of concentrations of ingredients classified in the subcategory “Eye Irritation — Category 2B” is equal to or greater than 10.0% and the mixture does not contain any ingredients classified in the category “Eye Irritation — Category 2” or the subcategory “Eye Irritation — Category 2A”, the mixture is classified in the category “Eye Irritation — Category 2” or the subcategory “Eye Irritation — Category 2B”;

  • (c.3) if the sum of the concentrations of ingredients set out in two or more of the following subparagraphs is equal to or greater than 10.0%, the mixture is classified in the category “Eye Irritation — Category 2”:

    • (i) ingredients classified in the category “Eye Irritation — Category 2”,

    • (ii) ingredients classified in the subcategory “Eye Irritation — Category 2A”, and

    • (iii) ingredients classified in the subcategory “Eye Irritation — Category 2B”; or

  • (d) if the sum of the results of the following subparagraphs is equal to or greater than 10.0%, the mixture is classified in the category “Eye Irritation — Category 2”:

    • (i) 10 times the total of the sum of concentrations of ingredients classified in the category “Serious Eye Damage — Category 1” and the sum of concentrations of ingredients classified in the category “Skin Corrosion — Category 1”, ingredients classified in the subcategory “Skin Corrosion — Category 1A”, ingredients classified in the subcategory “Skin Corrosion — Category 1B” and ingredients classified in the subcategory “Skin Corrosion — Category 1C”, and

    • (ii) the sum of concentrations of ingredients classified in the category “Eye Irritation — Category 2”, ingredients classified in the subcategory “Eye Irritation — Category 2A” and ingredients classified in the subcategory “Eye Irritation — Category 2B”.

• Marginal note:Mixtures containing particular ingredients

  (3) A mixture is classified in a category of this hazard class in accordance with the following table if the mixture contains one or more substances, such as acids, bases, inorganic salts, aldehydes, phenols or surfactants, which could cause serious eye damage or eye irritation at concentrations below the concentration limits set out in subsection (2) and at least one ingredient with a concentration that is above the concentration limits set out below:

  	Column 1	Column 2	Column 3
  Item	Category	Ingredient	Concentration Limits
  1	Serious Eye Damage — Category 1	Acid with pH ≤ 2	≥ 1.0%
  2	Serious Eye Damage — Category 1	Base with pH ≥ 11.5	≥ 1.0%
  3	Serious Eye Damage — Category 1	Other ingredients classified in the category “Serious Eye Damage — Category 1”	≥ 1.0%
  4	Eye Irritation — Category 2	Other ingredients classified in the category “Eye Irritation — Category 2”, including acids and bases	≥ 3.0%