Hazardous Products Regulations (SOR/2015-17)

Classification of Mixtures

Marginal note:Order of provisions

• 8.1.2 (1) The classification of a mixture as an acute toxicant in a category of this hazard class must proceed in accordance with the order of sections 8.1.3 to 8.1.6.

• Marginal note:Concentrations for the purpose of classification

  (2) Only ingredients present at concentrations equal to or greater than the concentration limit of 1.0% — w/w for solids, liquids, dusts, mists and vapours and v/v for gases — must be considered for the purpose of classification.

Marginal note:Data available for mixture as a whole

8.1.3 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 an acute toxicant in accordance with section 8.1.1.

Marginal note:Data available for use of bridging principles

8.1.4 If data are available to enable the characterization of the mixture as an acute toxicant, 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 all ingredients

8.1.5 If data are available for all ingredients in the mixture, the mixture must be classified as an acute toxicant in accordance with section 8.1.1 using the ATE of the mixture that is determined in respect of each applicable route of exposure by the following formula:

where

ATE_mix

is the ATE of the mixture determined using this formula;

C_i

is the concentration of ingredient i;

n

is the number of ingredients and i is running from 1 to n;

ATE_i

is the ATE of ingredient i, which is either

• (a) the LD₅₀ or the LC₅₀ based on or converted to a four-hour exposure period, for i, or

• (b) if the LD₅₀ or the LC₅₀ is unavailable, the acute toxicity point estimate established for i in accordance with the table to section 8.1.7; and

i

is each ingredient in the mixture with

• (a) an ATE within the ranges set out in the applicable table to subsection 8.1.1(3),

• (b) an oral or dermal LD₅₀ greater than 2000 mg/kg body weight but less than or equal to 5000 mg/kg body weight, or

• (c) an LC₅₀ based on or converted to a four-hour exposure period within a range having an amplitude comparable to the one in paragraph (b).

Marginal note:Data not available for all ingredients

8.1.6 If the ATE is not available for one or more ingredients of the mixture, the mixture must be classified as an acute toxicant in accordance with section 8.1.1 using the ATE of the mixture that is determined in respect of each applicable route of exposure according to the following:

• (a) if data permit the ATE to be estimated for each of those ingredients in accordance with established scientific principles, the formula in section 8.1.5 must be used;

• (b) if data do not permit the ATE to be estimated for an ingredient in accordance with established scientific principles, and the concentration of the ingredient in the mixture is equal to or greater than the concentration limit of 1.0%, the mixture is classified based only on the ingredients having an ATE, such that

  • (i) if the total concentration of all ingredients with unknown acute toxicity is less than or equal to 10.0% of the mixture, the formula in section 8.1.5 must be used, or

  • (ii) if the total concentration of all ingredients with unknown acute toxicity is greater than 10.0% of the mixture, the following formula must be used:

    

    where

    ATE_mix

    is the ATE of the mixture determined using this formula,

    C_i

    is the concentration of ingredient i,

    C_unknown

    is the concentration of ingredients i with unknown ATE values,

    n

    is the number of ingredients and i is running from 1 to n,

    ATE_i

    is the ATE of ingredient i, which is either

    • (a) the LD₅₀ or the LC₅₀ based on or converted to a four-hour exposure period, for i, or

    • (b) if the LD₅₀ or the LC₅₀ is unavailable, the acute toxicity point estimate established for i in accordance with the table to section 8.1.7, and

    i

    is each ingredient in the mixture with

    • (a) an ATE within the ranges set out in the applicable table to subsection 8.1.1(3),

    • (b) an oral or dermal LD₅₀ greater than 2000 mg/kg body weight but less than or equal to 5000 mg/kg body weight, or

    • (c) an LC₅₀ based on or converted to a four-hour exposure period within a range having an amplitude comparable to the one in paragraph (b).

Marginal note:Conversion from range to point estimate

• 8.1.7 (1) If a formula in section 8.1.5 or 8.1.6 is used, an acute toxicity point estimate must be determined, in accordance with the table to subsection (2), for each ingredient for which only that ingredient’s classification category or experimentally obtained acute toxicity range is available.

• Marginal note:More than one range

  (2) If the experimentally obtained acute toxicity range for an ingredient does not fall entirely within any of the ranges set out in column 2 of the following table, the converted acute toxicity point estimate for that ingredient for the purposes of column 3 is the lowest value of the experimentally obtained acute toxicity range.

  	Column 1	Column 2	Column 3
  Item	Exposure Routes	Classification Category and Associated Experimentally Obtained Acute Toxicity Range Minimum and Maximum Values	Converted Acute Toxicity Point Estimate
  1	Oral (mg/kg body weight)	0 < Category 1 ≤ 5 5 < Category 2 ≤ 50 50 < Category 3 ≤ 300 300 < Category 4 ≤ 2000	0.5 5 100 500
  2	Dermal (mg/kg body weight)	0 < Category 1 ≤ 50 50 < Category 2 ≤ 200 200 < Category 3 ≤ 1000 1000 < Category 4 ≤ 2000	5 50 300 1100
  3	Inhalation (gases) (ppmV)	0 < Category 1 ≤ 100 100 < Category 2 ≤ 500 500 < Category 3 ≤ 2500 2500 < Category 4 ≤ 20 000	10 100 700 4500
  4	Inhalation (vapours) (mg/l)	0 < Category 1 ≤ 0.5 0.5 < Category 2 ≤ 2.0 2.0 < Category 3 ≤ 10.0 10.0 < Category 4 ≤ 20.0	0.05 0.5 3 11
  5	Inhalation (dust/mist) (mg/l)	0 < Category 1 ≤ 0.05 0.05 < Category 2 ≤ 0.5 0.5 < Category 3 ≤ 1.0 1.0 < Category 4 ≤ 5.0	0.005 0.05 0.5 1.5

SUBPART 2Skin Corrosion/Irritation

Definitions

Marginal note:Definitions

8.2 The following definitions apply in this Subpart.

skin corrosion

skin corrosion means the production of irreversible damage to the skin, namely, visible necrosis through the epidermis and into the dermis, occurring after exposure to a mixture or substance, and includes ulcers, bleeding, bloody scabs and, within a 14-day observation period, discoloration due to blanching of the skin, complete areas of alopecia, and scars. (corrosion cutanée)

skin-corrosive

skin-corrosive means, in relation to a mixture or substance, liable to cause skin corrosion. (corrosif pour la peau)

skin-irritant

skin-irritant means, in relation to a mixture or substance, liable to cause skin irritation. (irritant pour la peau)

skin irritation

skin irritation means the production of reversible damage to the skin occurring after exposure to a mixture or substance. (irritation cutanée)

Classification in a Category or Subcategory of the Class

Classification of Substances

Marginal note:Order of provisions

8.2.1 The classification of a skin-corrosive substance or a skin-irritant substance in a category or subcategory of this hazard class must proceed in accordance with the order of sections 8.2.2 to 8.2.7, unless, after applying subsections 8.2.2(1) to (3), the substance is not classified further to subsection 8.2.2(4).