Hazardous Products Regulations (SOR/2015-17)

Marginal note:Human data — skin corrosion

• 8.2.2 (1) A substance for which human data demonstrate that it is a skin-corrosive substance is classified in the category “Skin Corrosion — Category 1”.

• Marginal note:Animal data — skin corrosion

  (2) A substance for which purposely generated animal data demonstrate that it is a skin-corrosive substance is classified in the category “Skin Corrosion — Category 1” and is, if the applicable data are available, further classified in accordance with the following table:

  	Column 1	Column 2
  Item	Subcategory	Criteria
  1	Skin Corrosion — Category 1A	A substance that, according to animal data acquired from a scientifically validated method, produces irreversible damage to the skin after an exposure of three minutes or less, and within one hour of observation, in at least one animal
  2	Skin Corrosion — Category 1B	A substance that, according to animal data acquired from a scientifically validated method, produces irreversible damage to the skin after an exposure of more than three minutes and up to and including one hour, and within 14 days of observation, in at least one animal
  3	Skin Corrosion — Category 1C	A substance that, according to animal data acquired from a scientifically validated method, produces irreversible damage to the skin after an exposure of more than one hour and up to and including four hours, and within 14 days of observation, in at least one animal

• Marginal note:Human or animal data — skin irritation

  (3) A substance for which there are human data or purposely generated animal data with respect to skin irritation is classified in the category “Skin Irritation — Category 2” in accordance with the following table:

  	Column 1	Column 2
  Item	Category	Criteria
  1	Skin Irritation — Category 2	A substance (a) that, according to human data, is skin-irritant; or (b) in respect of which animal data reveal (i) in the case of data acquired from a test performed in accordance with the OECD Guideline for the Testing of Chemicals, No. 404, entitled Acute Dermal Irritation/Corrosion, as amended from time to time, a mean score of ≥ 2.3 and ≤ 4.0 for erythema and eschar or for edema in at least two of three animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from gradings on three consecutive days after the onset of skin reactions, (ii) in the case of data acquired from a scientifically validated method, inflammation, namely, local alopecia, hyperkeratosis, hyperplasia and scaling, that persists to the end of the observation period specified by the method in at least two animals, or (iii) in the case of data acquired from a scientifically validated method, evidence of severe skin irritation in only one animal

• Marginal note:No classification

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

  • (a) there are human data or purposely generated animal data on the substance, acquired from a scientifically validated method, with respect to skin corrosion or skin irritation;

  • (b) the substance is not classified further to subsection (1), (2) or (3); and

  • (c) the data referred to in paragraph (a) demonstrate that it is neither a skin-corrosive substance nor a skin-irritant substance.

Marginal note:Other skin data from animals

8.2.3 A substance for which there are animal data on dermal exposure, acquired from a scientifically validated method, that have not been purposely generated and that demonstrate that the substance is skin-corrosive or skin-irritant is classified, respectively, in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2”.

Marginal note:In vitro or ex vivo data

8.2.4 A substance for which the data, in vitro or ex vivo, acquired from a scientifically validated method for the evaluation of skin corrosion or skin irritation demonstrate that the substance is skin-corrosive or skin-irritant is classified, respectively, in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2”.

Marginal note:pH

8.2.5 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 “Skin Corrosion — 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 skin-corrosive substance on the basis of its pH.

Marginal note:Structure-activity relationship — skin corrosion

• 8.2.6 (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 “Skin Corrosion — Category 1” is classified in that category.

• Marginal note:Structure-activity relationship — skin 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 “Skin Irritation — Category 2” is classified in that category.

Marginal note:Totality of available data

8.2.7 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 is skin-corrosive or skin-irritant is classified, respectively, in the category “Skin Corrosion — Category 1” or the category “Skin Irritation — Category 2”.

Classification of Mixtures

Marginal note:Order of provisions

8.2.8 The classification of a mixture as skin-corrosive or as skin-irritant in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.2.9 to 8.2.11.

Marginal note:Data available for mixture as a whole

• 8.2.9 (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 8.2.2 to 8.2.7, unless under subsection 8.2.2(4) the mixture need not be classified.

• Marginal note:Data available for mixture as a whole — sections 8.2.10 and 8.2.11

  (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 8.2.2(1) to (3) or sections 8.2.3 to 8.2.7, its classification in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.2.10 and 8.2.11.

Marginal note:Data available for use of bridging principles

8.2.10 If data are available to enable the characterization of the mixture as a skin-corrosive mixture or a skin-irritant mixture, 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

• 8.2.11 (1) Subject to subsection (3), a mixture that contains one or more ingredients that are classified in the category “Skin Corrosion — Category 1”, the subcategory “Skin Corrosion — Category 1A”, the subcategory “Skin Corrosion — Category 1B”, the subcategory “Skin Corrosion — Category 1C” or the category “Skin Irritation — Category 2” 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 “Skin Corrosion — Category 1”, the subcategory “Skin Corrosion — Category 1A”, the subcategory “Skin Corrosion — Category 1B”, the subcategory “Skin Corrosion — Category 1C” or the category “Skin Irritation — Category 2” 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 “Skin Corrosion — Category 1”, the subcategory “Skin Corrosion — Category 1A”, the subcategory “Skin Corrosion — Category 1B”, the subcategory “Skin Corrosion — Category 1C” or the category “Skin Irritation — Category 2” 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 skin-corrosive substances or skin-irritant substances.

• 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 “Skin Corrosion — Category 1” is equal to or greater than 5.0%, the mixture is classified in the category “Skin Corrosion — Category 1”;

  • (a.1) if the sum of concentrations of ingredients classified in the subcategory “Skin Corrosion — Category 1A” is equal to or greater than 5.0%, and the mixture does not contain any ingredients classified in the category “Skin Corrosion — Category 1”, the subcategory “Skin Corrosion — Category 1B”, or the subcategory “Skin Corrosion — Category 1C”, the mixture is classified in the category “Skin Corrosion — Category 1” or the subcategory “Skin Corrosion — Category 1A”;

  • (a.2) if the sum of concentrations of ingredients classified in the subcategory “Skin Corrosion — Category 1B” is equal to or greater than 5.0%, and the mixture does not contain any ingredients classified in the category “Skin Corrosion — Category 1”, the subcategory “Skin Corrosion — Category 1A”, or the subcategory “Skin Corrosion — Category 1C”, the mixture is classified in the category “Skin Corrosion — Category 1” or the subcategory “Skin Corrosion — Category 1B”;

  • (a.3) if the sum of concentrations of ingredients classified in the subcategory “Skin Corrosion — Category 1C” is equal to or greater than 5.0%, and the mixture does not contain any ingredients classified in the category “Skin Corrosion — Category 1”, the subcategory “Skin Corrosion — Category 1A”, or the subcategory “Skin Corrosion — Category 1B”, the mixture is classified in the category “Skin Corrosion — Category 1” or the subcategory “Skin Corrosion — Category 1C”;

  • (a.4) if the sum of the concentrations of ingredients set out in two or more of the following subparagraphs is equal to or greater than 5.0%, the mixture is classified in the category “Skin Corrosion ─ Category 1”:

    • (i) ingredients classified in the category “Skin Corrosion ─ Category 1”,

    • (ii) ingredients classified in the subcategory “Skin Corrosion ─ Category 1A”,

    • (iii) ingredients classified in the subcategory “Skin Corrosion ─ Category 1B”, and

    • (iv) ingredients classified in the subcategory “Skin Corrosion ─ Category 1C”;

  • (b) if 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” is equal to or greater than 1.0% but less than 5.0%, the mixture is classified in the category “Skin Irritation — Category 2”;

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

    • (i) 10 times 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 “Skin Irritation — Category 2”.

• 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 it contains one or more substances, such as acids, bases, inorganic salts, aldehydes, phenols or surfactants, which could be corrosive or irritant 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	Skin Corrosion — Category 1	Acid with pH ≤ 2	≥ 1.0%
  2	Skin Corrosion — Category 1	Base with pH ≥ 11.5	≥ 1.0%
  3	Skin Corrosion — Category 1	Other ingredients classified in the category “Skin Corrosion — Category 1”	≥ 1.0%
  4	Skin Irritation — Category 2	Other ingredients classified in the category “Skin Irritation — Category 2”, including acids and bases	≥ 3.0%