Hazardous Products Regulations (SOR/2015-17)

Regulations are current to 2018-10-24 and last amended on 2018-04-04. Previous Versions

PART 8Health Hazard Classes (continued)

SUBPART 5Germ Cell Mutagenicity

Definitions

Marginal note:Definitions

 The following definitions apply in this Subpart.

genotoxicity

génotoxicité

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

mutagène des cellules germinales

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)

mutagenic

mutagène

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

mutagénicité

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

mutation

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

 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:

TABLE

ItemColumn 1Column 2Column 3
CategorySubcategoryCriteria
1Germ Cell Mutagenicity — Category 1Germ Cell Mutagenicity — Category 1AA substance that, according to data from human epidemiological studies, induces heritable mutations in germ cells
2Germ Cell Mutagenicity — Category 1Germ Cell Mutagenicity — Category 1B

A substance in respect of which

  • (a) data acquired from in vivo heritable germ cell mutagenicity tests in mammals demonstrate positive results;

  • (b) data acquired from in vivo somatic cell mutagenicity tests in mammals demonstrate positive results and there is evidence that the substance has the potential to cause mutations to germ cells, such as

    • (i) in germ cells, positive in vivo mutagenicity test results or positive in vivo genotoxicity test results, or

    • (ii) evidence that the substance or any of its metabolites is able to interact with the genetic material of germ cells; or

  • (c) data on human germ cells demonstrate mutagenic effects, with or without demonstrating transmission to offspring, including an increase in the frequency of aneuploidy in sperm of men exposed to the substance

3Germ Cell Mutagenicity — Category 2

A substance in respect of which

  • (a) data acquired from in vivo somatic cell mutagenicity tests in mammals demonstrate positive results;

  • (b) data acquired from in vivo somatic cell genotoxicity tests demonstrate positive results and data acquired from in vitro mutagenicity tests demonstrate positive results; or

  • (c) data acquired from in vitro mutagenicity tests in mammalian cells demonstrate positive results and the substance has a structure-activity relationship with germ cell mutagens classified in the subcategory “Germ Cell Mutagenicity — Category 1A”

Classification of Mixtures

Marginal note:Order of provisions

 The classification of a mixture as a germ cell mutagen in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.5.3 to 8.5.5.

Marginal note:Ingredient classified in Category 1A or 1B

 A mixture is classified in the category “Germ Cell Mutagenicity — 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 subcategory “Germ Cell Mutagenicity — Category 1A” or in the subcategory “Germ Cell Mutagenicity — Category 1B”, unless

  • (a) there are data for the mixture as a whole that demonstrate conclusively, based on established scientific principles, that the mixture is a germ cell mutagen, in which case the mixture is classified as a germ cell mutagen in accordance with section 8.5.1; or

  • (b) the mixture as a whole has been subjected to an in vivo heritable germ cell mutagenicity test that determines that the mixture is not a germ cell mutagen, and a scientifically validated method was used and the test was performed in accordance with generally accepted standards of good scientific practice at the time it was carried out.

Marginal note:Ingredient classified in Category 2

 A mixture is classified in the category “Germ Cell Mutagenicity — Category 2” if 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 category “Germ Cell Mutagenicity — Category 2”, unless

  • (a) there are data for the mixture as a whole that demonstrate conclusively, based on established scientific principles, that the mixture is a germ cell mutagen, in which case the mixture is classified as a germ cell mutagen in accordance with section 8.5.1; or

  • (b) the mixture as a whole has been subjected to an in vivo heritable germ cell mutagenicity test that determines that the mixture is not a germ cell mutagen, and a scientifically validated method was used and the test was performed in accordance with generally accepted standards of good scientific practice at the time it was carried out.

Marginal note:Data available for use of bridging principles

 If data are available to enable the characterization of the mixture as a germ cell mutagen, in accordance with the bridging principles referred to in subsections 2.3(3), (4) and (7), the mixture must be classified in accordance with those subsections.

SUBPART 6Carcinogenicity

Definition

Definition of carcinogenic

 In this Subpart, carcinogenic means, in relation to a mixture or substance, liable to lead to cancer or increase the incidence of cancer.

Classification in a Category or Subcategory of the Class

Classification of Substances

Marginal note:Categories

 A carcinogenic substance is classified in a category or subcategory of this hazard class in accordance with the following table:

TABLE

ItemColumn 1Column 2Column 3
CategorySubcategoryCriteria
1Carcinogenicity — Category 1Carcinogenicity — Category 1AA substance in respect of which human data establish a causal relationship between exposure to the substance and the development of cancer
2Carcinogenicity — Category 1Carcinogenicity — Category 1B

A substance in respect of which

  • (a) human data establish a causal relationship between exposure to the substance and the development of cancer, but there are additional data that do not support, based on established scientific principles, the conclusion that the substance is the causative agent;

  • (b) animal data establish a causal relationship between exposure to the substance and an increased incidence of malignant neoplasms or a combination of benign and malignant neoplasms in

    • (i) two or more species of animals, as demonstrated by one or more studies,

    • (ii) one species of animal, as demonstrated by two or more independent studies carried out at different times, in different laboratories or under different protocols, or

    • (iii) one species of animal, as demonstrated by a single study, if the neoplasms observed in the study are, based on established scientific principles, atypical in relation to the incidence, site, type or age at onset for the species of animal under study; or

  • (c) human data support a positive association between exposure to the substance and the development of cancer, and animal data support a positive association between exposure to the substance and an increased incidence of malignant or benign neoplasms, but the data supporting either positive association do not support a conclusion of a causal relationship, based on established scientific principles

3Carcinogenicity — Category 2

A substance in respect of which

  • (a) human data support a positive association between exposure to the substance and the development of cancer, but do not support a conclusion of a causal relationship, based on established scientific principles; or

  • (b) animal data support a positive association between exposure to the substance and an increased incidence of malignant or benign neoplasms, but do not support a conclusion of a causal relationship, based on established scientific principles

 
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