Hazardous Products Regulations (SOR/2015-17)

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

Classification of Mixtures

Marginal note:Order of provisions

8.8.2 The classification of a mixture as a mixture that causes specific target organ toxicity arising from a single exposure in a category of this hazard class must proceed in accordance with the order of sections 8.8.3 to 8.8.5.

Marginal note:Data available for mixture as a whole

8.8.3 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 mixture that causes specific target organ toxicity arising from a single exposure in accordance with section 8.8.1.

Marginal note:Data available for use of bridging principles

8.8.4 If data are available to enable the characterization of the mixture as a mixture that causes specific target organ toxicity arising from a single exposure, in accordance with the bridging principles referred to in subsections 2.3(3) to (8), the mixture must be classified in one or more categories of this hazard class, based on the table to subsection 8.8.1(2), in accordance with those subsections.

Marginal note:Data available for ingredients — Category 1, 2 or 3

• 8.8.5 (1) A mixture that contains one or more ingredients that are classified as a substance that causes specific target organ toxicity arising from a single exposure is classified as follows:

  • (a) in the category “Specific Target Organ Toxicity — Single Exposure — Category 1”, 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 “Specific Target Organ Toxicity — Single Exposure — Category 1”;

  • (b) in the category “Specific Target Organ Toxicity — Single Exposure — 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 “Specific Target Organ Toxicity — Single Exposure — Category 2”;

  • (c) in the category “Specific Target Organ Toxicity — Single Exposure — Category 3”, if it contains at least one ingredient that is classified in the category “Specific Target Organ Toxicity — Single Exposure — Category 3” that is

    • (i) at a concentration equal to or greater than the concentration at which the effect is elicited, if known, or

    • (ii) at a concentration equal to or greater than the concentration limit of 20.0%; or

    • (iii) [Repealed, SOR/2022-272, s. 55]

  • (d) in the category “Specific Target Organ Toxicity — Single Exposure — Category 3”, if it contains at least two ingredients that are classified in that category which are present individually at a concentration of 1.0% or more and

    • (i) such ingredients individually cause a transient narcotic effect, and the sum of their concentrations is equal to or greater than the concentration limit of 20.0%, or

    • (ii) such ingredients individually cause transient respiratory tract irritation, and the sum of their concentrations is equal to or greater than the concentration limit of 20.0%.

• Marginal note:Data available for ingredients — Categories 1 and 3 or 2 and 3

  (2) Despite subsection 2.2(3), a mixture that has been classified in accordance with paragraph (1)(a) or (b) and meets the criteria of paragraph (1)(c) is also classified in the category “Specific Target Organ Toxicity — Single Exposure — Category 3”.

SUBPART 9Specific Target Organ Toxicity — Repeated Exposure

Definitions

Marginal note:Definitions

8.9 The following definitions apply in this Subpart.

organ

organ includes any biological system. (organe)

specific target organ toxicity arising from repeated exposure

specific target organ toxicity arising from repeated exposure means specific toxic effects on target organs that arise from repeated 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’expositions répétées)

Classification in a Category of the Class

Classification of Substances

Marginal note:Categories

8.9.1 A substance that causes specific target organ toxicity arising from repeated exposure is classified in a category of this hazard class in accordance with the following table:

Classification of Mixtures

Marginal note:Order of provisions

8.9.2 The classification of a mixture as a mixture that causes specific target organ toxicity arising from repeated exposure in a category of this hazard class must proceed in accordance with the order of sections 8.9.3 to 8.9.5.

Marginal note:Data available for mixture as a whole

8.9.3 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 mixture that causes specific target organ toxicity arising from repeated exposure in accordance with section 8.9.1.

Marginal note:Data available for use of bridging principles

8.9.4 If data are available to enable the characterization of the mixture as a mixture that causes specific target organ toxicity arising from repeated exposure, 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.