Hazardous Products Regulations (SOR/2015-17)

PART 8Health Hazard Classes

SUBPART 1Acute Toxicity

Definitions

Marginal note:Definitions

8.1 The following definitions apply in this Subpart.

acute toxicant

acute toxicant means a mixture or substance that is liable to cause acute toxicity, or a mixture or substance that, upon contact with water, releases a gaseous substance that is liable to cause acute toxicity. (toxique aigu)

acute toxicity

acute toxicity refers to serious adverse health effects, including death, occurring following

• (a) oral or dermal administration of a single dose of a mixture or substance, or multiple doses given within 24 hours; or

• (b) an inhalation exposure to a mixture or substance of four hours or of a duration that is converted to four hours in accordance with subsection 8.1.1(4). (toxicité aiguë)

dust

dust means solid particles that are suspended in a gas, usually air. (poussières)

mist

mist means liquid droplets that are suspended in the air. (brouillard)

Classification in a Category of the Class

Classification of Substances

Marginal note:LD₅₀ or LC₅₀ — associated range

• 8.1.1 (1) An acute toxicant that is a substance is classified, with respect to each applicable route of exposure, in a category of this hazard class in accordance with the tables to subsection (3) if it has an LD₅₀ by the oral or dermal exposure route, or an LC₅₀ by the inhalation exposure route, that falls into one of the ranges indicated in the applicable table to that subsection.

• Marginal note:Contact with water — gaseous substance

  (2) If an acute toxicant that is a substance is not classified in accordance with subsection (1) with respect to the inhalation route of exposure in a category of this hazard class in accordance with Table 3 to subsection (3) and, upon contact with water, the acute toxicant releases a gaseous substance that has an LC₅₀ that falls into one of the ranges indicated in that table, it is classified in accordance with that table with regard to that range.

• Marginal note:LD₅₀ or LC₅₀ not available

  (3) If an LD₅₀ by the oral or dermal exposure route or an LC₅₀ by the inhalation exposure route is not available, an acute toxicity point estimate must be established in accordance with the table to section 8.1.7, and the acute toxicant must be classified based on that acute toxicity point estimate, with respect to each applicable route of exposure, in a category of this hazard class in accordance with the following tables:

  	Column 1	Column 2
  Item	Category	Ranges for LD50 or for Acute Toxicity Point Estimates (mg/kg body weight)
  1	Acute Toxicity (Oral) — Category 1	≤ 5
  2	Acute Toxicity (Oral) — Category 2	> 5 and ≤ 50
  3	Acute Toxicity (Oral) — Category 3	> 50 and ≤ 300
  4	Acute Toxicity (Oral) — Category 4	> 300 and ≤ 2000

  	Column 1	Column 2
  Item	Category	Ranges for LD50 or for Acute Toxicity Point Estimates (mg/kg body weight )
  1	Acute Toxicity (Dermal) — Category 1	≤ 50
  2	Acute Toxicity (Dermal) — Category 2	> 50 and ≤ 200
  3	Acute Toxicity (Dermal) — Category 3	> 200 and ≤ 1000
  4	Acute Toxicity (Dermal) — Category 4	> 1000 and ≤ 2000

  	Column 1	Column 2	Column 3	Column 4
  		Ranges for LC50 or for Acute Toxicity Point Estimates
  Item	Category	Gases (ppmV)	Vapours (mg/l)	Dusts and Mists (mg/l)
  1	Acute Toxicity (Inhalation) — Category 1	≤ 100	≤ 0.5	≤ 0.05
  2	Acute Toxicity (Inhalation) — Category 2	> 100 and ≤ 500	> 0.5 and ≤ 2	> 0.05 and ≤ 0.5
  3	Acute Toxicity (Inhalation) — Category 3	> 500 and ≤ 2500	> 2 and ≤ 10	> 0.5 and ≤ 1
  4	Acute Toxicity (Inhalation) — Category 4	> 2500 and ≤ 20 000	> 10 and ≤ 20	> 1 and ≤ 5

• Marginal note:One-hour exposure period

  (4) For the purposes of Table 3 to subsection (3), the LC₅₀ is based on a four-hour exposure period. If existing acute inhalation toxicity data have been generated according to a one-hour exposure period, the LC₅₀ for gases and vapours must be divided by two, and the LC₅₀ for dusts and mists must be divided by four.

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