Hazardous Products Regulations (SOR/2015-17)

SUBPART 4Respiratory or Skin Sensitization

Definitions

Marginal note:Definitions

8.4 The following definitions apply in this Subpart.

respiratory sensitization

respiratory sensitization means the production of hypersensitivity of the airways occurring after inhalation of a mixture or substance. (sensibilisation respiratoire)

respiratory sensitizer

respiratory sensitizer means a mixture or substance that is liable to lead to hypersensitivity of the airways following inhalation. (sensibilisant respiratoire)

skin sensitization

skin sensitization means the production of an allergic response occurring after skin contact with a mixture or substance. (sensibilisation cutanée)

skin sensitizer

skin sensitizer means a mixture or substance that is liable to lead to an allergic response following skin contact. (sensibilisant cutané)

Classification in a Category or Subcategory of the Class

Classification of Substances

Marginal note:Respiratory sensitizer — category

• 8.4.1 (1) A substance that is a respiratory sensitizer is classified in the category of this hazard class in accordance with the following table:

  	Column 1	Column 2
  Item	Category	Criteria
  1	Respiratory Sensitizer — Category 1	A substance (a) that, according to human data, leads to specific respiratory hypersensitivity; or (b) in respect of which animal data acquired from scientifically validated methods for the evaluation of respiratory sensitization demonstrate positive results

• Marginal note:Respiratory sensitizer — subcategories

  (2) A substance classified in the category “Respiratory Sensitizer — Category 1” under subsection (1) is, if the applicable data are available, further classified in the subcategory “Respiratory Sensitizer — Category 1A” or in the subcategory “Respiratory Sensitizer — Category 1B” in accordance with the following table:

  	Column 1	Column 2	Column 3
  Item	Category	Subcategory	Criteria
  1	Respiratory Sensitizer — Category 1	Respiratory Sensitizer — Category 1A	A substance (a) that, according to human data, leads to a high frequency of occurrence of respiratory sensitization; or (b) in respect of which animal data support the probability of a high respiratory sensitization rate in humans
  2	Respiratory Sensitizer — Category 1	Respiratory Sensitizer — Category 1B	A substance (a) that, according to human data, leads to a low to moderate frequency of occurrence of respiratory sensitization; or (b) in respect of which animal data support the probability of a low to moderate respiratory sensitization rate in humans

• Marginal note:Skin sensitizer — category

  (3) A substance that is a skin sensitizer is classified in the category of this hazard class in accordance with the following table:

  	Column 1	Column 2
  Item	Category	Criteria
  1	Skin Sensitizer — Category 1	A substance (a) that, according to human data, leads to skin sensitization; or (b) in respect of which animal data acquired from scientifically validated methods for the evaluation of skin sensitization demonstrate positive results

• Marginal note:Skin sensitizer — subcategories

  (4) A substance classified in the category “Skin Sensitizer — Category 1” under subsection (3) is, if the applicable data are available, further classified in the subcategory “Skin Sensitizer — Category 1A” or in the subcategory “Skin Sensitizer — Category 1B” in accordance with the following table:

  	Column 1	Column 2	Column 3
  Item	Category	Subcategory	Criteria
  1	Skin Sensitizer — Category 1	Skin Sensitizer — Category 1A	A substance (a) that, according to human data, leads to a high frequency of occurrence of skin sensitization; or (b) in respect of which animal data acquired from scientifically validated methods for the evaluation of skin sensitization support the probability of a high skin sensitization rate in humans
  2	Skin Sensitizer — Category 1	Skin Sensitizer — Category 1B	A substance (a) that, according to human data, leads to a low to moderate frequency of occurrence of skin sensitization; or (b) in respect of which animal data acquired from scientifically validated methods for the evaluation of skin sensitization support the probability of a low to moderate skin sensitization rate in humans

Classification of Mixtures

Marginal note:Order of provisions

8.4.2 The classification of a mixture as a respiratory sensitizer or a skin sensitizer, or both, in one or more categories of this hazard class must proceed in accordance with the order of sections 8.4.3 to 8.4.5.

Marginal note:Data available for mixture as a whole

8.4.3 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 as a respiratory sensitizer or a skin sensitizer, or both, in accordance with section 8.4.1.

Marginal note:Data available for use of bridging principles

8.4.4 If data are available to enable the characterization of the mixture as a respiratory sensitizer or a skin sensitizer, or both, in accordance with the bridging principles referred to in subsections 2.3(3) to (8), the mixture must be classified in a category of this hazard class in accordance with those subsections.

Marginal note:Data available for ingredients

8.4.5 A mixture is classified as a respiratory sensitizer or as a skin sensitizer, or both, as the case may be, in accordance with the following:

• (a) as a respiratory sensitizer,

  • (i) in the category “Respiratory Sensitizer — Category 1”, if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the category “Respiratory Sensitizer — Category 1”,

  • (ii) in the subcategory “Respiratory Sensitizer — Category 1A”, if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Respiratory Sensitizer — Category 1A”, or

  • (iii) in the subcategory “Respiratory Sensitizer — Category 1B”, if it does not contain ingredients classified in the subcategory “Respiratory Sensitizer — Category 1A” at a concentration equal to or greater than the concentration limit of 0.1% and

    • (A) it contains at least one ingredient that is a solid or a liquid at a concentration equal to or greater than the concentration limit of 1.0% that is classified in the subcategory “Respiratory Sensitizer — Category 1B”, or

    • (B) it contains at least one ingredient that is a gas at a concentration equal to or greater than the concentration limit of 0.2% that is classified in the subcategory “Respiratory Sensitizer — Category 1B”; or

• (b) as a skin sensitizer,

  • (i) in the category “Skin Sensitizer — Category 1”, if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the category “Skin Sensitizer — Category 1”,

  • (ii) in the subcategory “Skin Sensitizer — Category 1A”, if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Skin Sensitizer — Category 1A”, or

  • (iii) in the subcategory “Skin Sensitizer — Category 1B”, if it does not contain ingredients classified in the subcategory “Skin Sensitizer — Category 1A” at a concentration equal to or greater than the concentration limit of 0.1% and it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 1.0% that is classified in the subcategory “Skin Sensitizer — Category 1B”.

SUBPART 5Germ Cell Mutagenicity

Definitions

Marginal note:Definitions

8.5 The following definitions apply in this Subpart.

genotoxicity

genotoxicity means the alteration of the structure, information content or segregation of DNA by an agent or process, including those agents or processes that cause DNA damage by interfering with normal replication processes or that in a non-physiological manner temporarily alter its replication. (génotoxicité)

germ cell mutagen

germ cell mutagen means a mixture or substance that is liable to lead to an increased occurrence of mutations in the germ cells of a population. (mutagène des cellules germinales)

germ cell mutagenicity

germ cell mutagenicity means an increased occurrence of heritable gene mutations, including heritable structural and numerical chromosome aberrations in germ cells, occurring after exposure to a mixture or substance. (mutagénicité sur les cellules germinales)

mutagenic

mutagenic means, in relation to a mixture or substance, liable to lead to an increased occurrence of mutations in populations of cells or organisms. (mutagène)

mutagenicity

mutagenicity means an increased occurrence of mutations in populations of cells or organisms. (mutagénicité)

mutation

mutation means a permanent change in the amount or structure of the genetic material in a cell and includes

• (a) the heritable genetic changes that may be manifested at the phenotypic level; and

• (b) the underlying DNA modifications when known, including specific base pair changes and chromosomal translocations. (mutation)

Classification in a Category or Subcategory of the Class

Classification of Substances

Marginal note:Categories

8.5.1 A substance that is a germ cell mutagen is classified in a category or subcategory of this hazard class in accordance with the following table: