Hazardous Products Regulations (SOR/2015-17)

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

Classification of Mixtures

Marginal note:Order of provisions
  •  (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

 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

 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

 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:

ATE subscript mix is equal to 100 divided by, opening square bracket, the summation, represented by the capital sigma symbol, from n, of the series capital C, subscript i, divided by ATE, subscript i, closing square bracket.

where

ATEmix
is the ATE of the mixture determined using this formula;
Ci
is the concentration of ingredient i;
n
is the number of ingredients and i is running from 1 to n;
ATEi
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

 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:

      ATE subscript mix is equal to the quotient of the numerator of 100 minus, opening parenthesis, the summation, represented by the capital sigma symbol, of the series capital C, subscript unknown, if the value of C is greater than 10.0%, closing parenthesis, divided by the following denominator: opening square bracket, the summation, represented by the symbol capital sigma, from n, of the series capital C, subscript i, divided by ATE, subscript i, closing square bracket.

      where

      ATEmix
      is the ATE of the mixture determined using this formula,
      Ci
      is the concentration of ingredient i,
      Cunknown
      is the concentration of ingredients i with unknown ATE values,
      n
      is the number of ingredients and i is running from 1 to n,
      ATEi
      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

 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 following table, for each ingredient for which only that ingredient’s classification category or experimentally obtained acute toxicity range is available:

TABLE

ItemColumn 1Column 2Column 3
Exposure RoutesClassification Category and Associated Experimentally Obtained Acute Toxicity Range Minimum and Maximum ValuesConverted Acute Toxicity Point Estimate
1Oral (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
2Dermal (mg/kg body weight)
  • 0 < Category 1 ≤ 50
  • 50 < Category 2 ≤ 200
  • 200 < Category 3 ≤ 1000
  • 1000 < Category 4 ≤ 2000
  • 5
  • 50
  • 300
  • 1100
3Inhalation (gases) (ppmV)
  • 0 < Category 1 ≤ 100
  • 100 < Category 2 ≤ 500
  • 500 < Category 3 ≤ 2500
  • 2500 < Category 4 ≤ 20 000
  • 10
  • 100
  • 700
  • 4500
4Inhalation (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
5Inhalation (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
 
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