Hazardous Products Regulations (SOR/2015-17)

Regulations are current to 2017-12-11 and last amended on 2015-02-11. Previous Versions

Marginal note:Ingredient classified in Reproductive Toxicity — Category 1A or 1B

 A mixture is classified in the category “Reproductive Toxicity — 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 “Reproductive Toxicity — Category 1A” or in the subcategory “Reproductive Toxicity — Category 1B”, 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

 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
  •  (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

 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

 The following definitions apply in this Subpart.

narcotic effects

effets narcotiques

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

organe

organ includes any biological system. (organe)

respiratory tract irritation

irritation des voies respiratoires

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

toxicité pour certains organes cibles à la suite d’une exposition unique

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
  •  (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.

    TABLE

    ItemColumn 1Column 2
    CategoryCriteria
    1Specific 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

    2Specific Target Organ Toxicity — Single Exposure — Category 2A 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
    3Specific Target Organ Toxicity — Single Exposure — Category 3A 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:

    TABLE

    ItemColumn 1Column 2Column 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
    Toxic Effects on the Central Nervous System and Respiratory TractToxic Effects on Other Specific Target OrgansCategory of the “Specific Target Organ Toxicity — Single Exposure” Hazard Class
    1NoneItem 1Category 1
    2Item 1NoneCategory 1
    3Item 1Item 1Category 1
    4NoneItem 2Category 2
    5Item 2NoneCategory 2
    6Item 1Item 2Category 1
    7Item 2Item 1Category 1
    8Item 2Item 2Category 2
    9Item 3NoneCategory 3
    10Item 3Item 1Category 1 and Category 3
    11Item 3Item 2Category 2 and Category 3
 
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