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Hazardous Products Regulations (SOR/2015-17)

Regulations are current to 2022-05-16 and last amended on 2020-03-18. Previous Versions

PART 8Health Hazard Classes (continued)

SUBPART 1Acute Toxicity (continued)

Classification in a Category of the Class (continued)

Marginal note:Conversion from range to point estimate

 If a formula in section 8.1.5 or 8.1.6 is used, an acute toxicity point estimate must be determined, in accordance with the following table, for each ingredient for which only that ingredient’s classification category or experimentally obtained acute toxicity range is available:

TABLE

Column 1Column 2Column 3
ItemExposure RoutesClassification Category and Associated Experimentally Obtained Acute Toxicity Range Minimum and Maximum ValuesConverted Acute Toxicity Point Estimate
1Oral (mg/kg body weight)
  • 0 < Category 1 ≤ 5
  • 5 < Category 2 ≤ 50
  • 50 < Category 3 ≤ 300
  • 300 < Category 4 ≤ 2000
  • 0.5
  • 5
  • 100
  • 500
2Dermal (mg/kg body weight)
  • 0 < Category 1 ≤ 50
  • 50 < Category 2 ≤ 200
  • 200 < Category 3 ≤ 1000
  • 1000 < Category 4 ≤ 2000
  • 5
  • 50
  • 300
  • 1100
3Inhalation (gases) (ppmV)
  • 0 < Category 1 ≤ 100
  • 100 < Category 2 ≤ 500
  • 500 < Category 3 ≤ 2500
  • 2500 < Category 4 ≤ 20 000
  • 10
  • 100
  • 700
  • 4500
4Inhalation (vapours) (mg/l)
  • 0 < Category 1 ≤ 0.5
  • 0.5 < Category 2 ≤ 2.0
  • 2.0 < Category 3 ≤ 10.0
  • 10.0 < Category 4 ≤ 20.0
  • 0.05
  • 0.5
  • 3
  • 11
5Inhalation (dust/mist) (mg/l)
  • 0 < Category 1 ≤ 0.05
  • 0.05 < Category 2 ≤ 0.5
  • 0.5 < Category 3 ≤ 1.0
  • 1.0 < Category 4 ≤ 5.0
  • 0.005
  • 0.05
  • 0.5
  • 1.5

SUBPART 2Skin Corrosion/Irritation

Definitions

Marginal note:Definitions

 The following definitions apply in this Subpart.

skin corrosion

skin corrosion means the production of irreversible damage to the skin, namely, visible necrosis through the epidermis and into the dermis, and includes ulcers, bleeding, bloody scabs and, within a 14-day observation period, discoloration due to blanching of the skin, complete areas of alopecia, and scars. (corrosion cutanée)

skin-corrosive

skin-corrosive means, in relation to a mixture or substance, liable to cause skin corrosion. (corrosif pour la peau)

skin-irritant

skin-irritant means, in relation to a mixture or substance, liable to cause skin irritation. (irritant pour la peau)

skin irritation

skin irritation means the production of reversible damage to the skin. (irritation cutanée)

Classification in a Category or Subcategory of the Class

Classification of Substances

Marginal note:Order of provisions

 The classification of a skin-corrosive substance or a skin-irritant substance in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.2.2 to 8.2.7, unless, after applying subsections 8.2.2(1) to (3), the substance is not classified further to subsection 8.2.2(4).

Marginal note:Human data — skin corrosion

  •  (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:

    TABLE

    Column 1Column 2
    ItemSubcategoryCriteria
    1Skin Corrosion — Category 1AA 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 of three animals
    2Skin Corrosion — Category 1BA 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 of three animals
    3Skin Corrosion — Category 1CA 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 of three animals
  • 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:

    TABLE

    Column 1Column 2
    ItemCategoryCriteria
    1Skin 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

 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

 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

 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

  •  (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

 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

 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

  •  (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

 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

  •  (1) Subject to subsection (3), a mixture that contains one or more ingredients that are classified in the category “Skin Corrosion — Category 1” 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” 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” 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”;

    • (b) if the sum of concentrations of ingredients classified in the category “Skin Corrosion — Category 1” 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”, 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:

    TABLE

    Column 1Column 2Column 3
    ItemCategoryIngredientConcentration Limits
    1Skin Corrosion — Category 1Acid with pH ≤ 2≥ 1.0%
    2Skin Corrosion — Category 1Base with pH ≥ 11.5≥ 1.0%
    3Skin Corrosion — Category 1Other ingredients classified in the category “Skin Corrosion — Category 1”≥ 1.0%
    4Skin Irritation — Category 2Other ingredients classified in the category “Skin Irritation — Category 2”, including acids and bases≥ 3.0%
 
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