Hazardous Products Regulations (SOR/2015-17)

Classification in a Category or Subcategory of the Class

Classification of Substances

Marginal note:Categories or subcategories — Categories 1A, 1B and 2

• 8.7.1 (1) A substance that is toxic to reproduction is classified in a category or subcategory of this hazard class in accordance with the following table:

  	Column 1	Column 2	Column 3
  Item	Category	Subcategory	Criteria
  1	Reproductive Toxicity — Category 1	Reproductive Toxicity — Category 1A	A substance in respect of which human data demonstrate that exposure to the substance leads to adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring
  2	Reproductive Toxicity — Category 1	Reproductive Toxicity — Category 1B	A substance in respect of which animal data demonstrate that exposure of the animal to the substance leads to the following: (a) adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, in the absence of other toxic effects; or (b) adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, in the presence of other toxic effects, provided that such adverse effects are not considered to be a secondary non-specific consequence of the other toxic effects
  3	Reproductive Toxicity — Category 2		A substance in respect of which human or animal data support a positive association between exposure to the substance and adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, but do not support a conclusion, based on established scientific principles, that exposure to the substance leads to such effects, provided that such effects are not considered to be a secondary non-specific consequence of other toxic effects

• Marginal note:Category — effects on or via lactation

  (2) A substance that is toxic to reproduction is classified in the category of this hazard class in accordance with the following table:

  	Column 1	Column 2
  Item	Category	Criteria
  1	Reproductive Toxicity — Effects on or via Lactation	A substance that, according to human or animal data, has effects on or via lactation

Classification of Mixtures

Marginal note:Order of provisions

8.7.2 Subject to subsection 8.7.5(2), the classification of a mixture as a mixture that is toxic to reproduction in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.7.3 to 8.7.6.

Marginal note:Ingredient classified in Category 1 or 1A

• 8.7.3 (1) A mixture is classified in the category “Reproductive Toxicity — Category 1” or the subcategory “Reproductive Toxicity — 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 “Reproductive Toxicity — Category 1A”, unless

  • (a) there are data for the mixture as a whole that demonstrate conclusively, based on established scientific principles, that the mixture has adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, in which case the mixture is classified as a mixture that is toxic to reproduction in accordance with subsection 8.7.1(1); or

  • (b) the mixture as a whole has been subjected to a reproductive toxicity study that determines that the mixture does not have adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, and a scientifically validated method was used and the study 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 1 or 1B

  (2) A mixture is classified in the category “Reproductive Toxicity — Category 1” or the subcategory “Reproductive Toxicity — Category 1B” 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 “Reproductive Toxicity — Category 1B”, and does not contain any ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Reproductive Toxicity — Category 1A”, unless

  • (a) there are data for the mixture as a whole that demonstrate conclusively, based on established scientific principles, that the mixture has adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, in which case the mixture is classified as a mixture that is toxic to reproduction in accordance with subsection 8.7.1(1); or

  • (b) the mixture as a whole has been subjected to a reproductive toxicity study that determines that the mixture does not have adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, and a scientifically validated method was used and the study was performed in accordance with generally accepted standards of good scientific practice at the time it was carried out.

Marginal note:Ingredient classified in Reproductive Toxicity — Category 2

8.7.4 A mixture is classified in the category “Reproductive Toxicity — Category 2” 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 “Reproductive Toxicity — Category 2”, unless

• (a) there are data for the mixture as a whole that demonstrate conclusively, based on established scientific principles, that the mixture has adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, in which case the mixture is classified as a mixture that is toxic to reproduction in accordance with subsection 8.7.1(1); or

• (b) the mixture as a whole has been subjected to a reproductive toxicity study that determines that the mixture does not have adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, and a scientifically validated method was used and the study was performed in accordance with generally accepted standards of good scientific practice at the time it was carried out.

Marginal note:Ingredient classified in Reproductive Toxicity — Effects on or via Lactation

• 8.7.5 (1) A mixture is classified in the category “Reproductive Toxicity — Effects on or via Lactation” 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 “Reproductive Toxicity — Effects on or via Lactation”, unless

  • (a) there are data for the mixture as a whole that demonstrate conclusively, based on established scientific principles, that the mixture has effects on or via lactation, in which case the mixture is classified as a mixture that is toxic to reproduction in accordance with subsection 8.7.1(2); or

  • (b) the mixture as a whole has been subjected to a reproductive toxicity study that determines that the mixture does not have effects on or via lactation, and a scientifically validated method was used and the study was performed in accordance with generally accepted standards of good scientific practice at the time it was carried out.

• Marginal note:Classification in Category 1A, 1B or 2 and in Reproductive Toxicity — Effects on or via Lactation

  (2) Despite subsection 2.2(3), a mixture that has been classified in accordance with section 8.7.3 or 8.7.4 and meets the criteria of subsection (1) is also classified in the category “Reproductive Toxicity — Effects on or via Lactation”.

Marginal note:Data available for use of bridging principles

8.7.6 If data are available to enable the characterization of the mixture as toxic to reproduction 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, in the following categories:

• (a) “Reproductive Toxicity — Category 1”;

• (b) “Reproductive Toxicity — Category 2”;

• (c) “Reproductive Toxicity — Effects on or via Lactation”;

• (d) both “Reproductive Toxicity — Category 1” and “Reproductive Toxicity — Effects on or via Lactation”; or

• (e) both “Reproductive Toxicity — Category 2” and “Reproductive Toxicity — Effects on or via Lactation”.

SUBPART 8Specific Target Organ Toxicity — Single Exposure

Definitions

Marginal note:Definitions

8.8 The following definitions apply in this Subpart.

narcotic effects

narcotic effects means central nervous system depression that

• (a) in humans, may present as drowsiness, narcosis, reduced alertness, loss of reflexes, lack of coordination, vertigo, severe headache or nausea and may lead to reduced judgment, dizziness, irritability, fatigue, impaired memory function, deficits in perception or coordination, prolonged reaction time or sleepiness; and

• (b) in animals, may be observed as lethargy, lack of coordination righting reflex, narcosis or ataxia. (effets narcotiques)

organ

organ includes any biological system. (organe)

respiratory tract irritation

respiratory tract irritation means localized redness, edema, pruritis or irritant effects in the respiratory tract that impair its function, whether or not accompanied by cough, pain, choking, breathing difficulties or other respiratory symptoms. (irritation des voies respiratoires)

specific target organ toxicity arising from a single exposure

specific target organ toxicity arising from a single exposure means specific, non-lethal toxic effects on target organs that arise from a single exposure to a mixture or substance, including all health effects liable to impair function of the body or any of its parts, whether reversible or irreversible, immediate or delayed, but excludes effects resulting from health hazards addressed by Subparts 1 to 7 and 10 of this Part. (toxicité pour certains organes cibles à la suite d’une exposition unique)

Classification in a Category of the Class

Classification of Substances

Marginal note:Two evaluations

• 8.8.1 (1) In order to establish the classification of a substance that causes specific target organ toxicity arising from a single exposure in one or more categories of this hazard class, the substance must be evaluated in accordance with all the criteria set out in column 2 of the following table, in relation to toxic effects on

  • (a) the central nervous system and respiratory tract; and

  • (b) other specific target organs.

  	Column 1	Column 2
  Item	Category	Criteria
  1	Specific Target Organ Toxicity — Single Exposure — Category 1	A substance that (a) according to human data, causes specific target organ toxicity arising from a single exposure; or (b) according to animal data, causes specific target organ toxicity arising from a single exposure at low exposure concentrations, within the concentration value ranges set out for Category 1 in Table 3.8.1 of the GHS
  2	Specific Target Organ Toxicity — Single Exposure — Category 2	A substance that, according to animal data, causes specific target organ toxicity arising from a single exposure at moderate exposure concentrations, within the concentration value ranges set out for Category 2 in Table 3.8.1 of the GHS
  3	Specific Target Organ Toxicity — Single Exposure — Category 3	A substance in respect of which data demonstrate that a single exposure to the substance generates transient narcotic effects or transient respiratory tract irritation

• Marginal note:Classification

  (2) Following the evaluations referred to in subsection (1), the substance is classified in one or more categories of this hazard class, based on the results of the evaluations of its toxic effects as set out in columns 1 and 2 of the following table, in accordance with the corresponding category set out in column 3:

  	Column 1	Column 2	Column 3
  	Item Number of the Table to Subsection (1) that is Associated with the Criteria in Column 2 of that Table that are Determined to Have Been Met as a Result of the Evaluation of the Following:		Classification
  Item	Toxic Effects on the Central Nervous System and Respiratory Tract	Toxic Effects on Other Specific Target Organs	Category of the “Specific Target Organ Toxicity — Single Exposure” Hazard Class
  1	None	Item 1	Category 1
  2	Item 1	None	Category 1
  3	Item 1	Item 1	Category 1
  4	None	Item 2	Category 2
  5	Item 2	None	Category 2
  6	Item 1	Item 2	Category 1
  7	Item 2	Item 1	Category 1
  8	Item 2	Item 2	Category 2
  9	Item 3	None	Category 3
  10	Item 3	Item 1	Category 1 and Category 3
  11	Item 3	Item 2	Category 2 and Category 3