Controlled Products Regulations (SOR/88-66)

Regulations are current to 2014-09-15 and last amended on 2010-02-23. Previous Versions

Untested Mixtures

 An untested mixture falls into Subdivision A of Division 2 of Class D — Poisonous and Infectious Material if it contains a product, material or substance that meets the criteria applicable to a pure substance or tested mixture referred to in

  • (a) any of sections 53 to 57, if the product, material or substance is present at a concentration of 0.1 per cent or more; or

  • (b) section 52, if the product, material or substance is present at a concentration of one per cent or more.

Subdivision B: Toxic Material

Pure Substances and Tested MixturesChronic Toxic Effects

 A pure substance or tested mixture falls into Subdivision B of Division 2 of Class D — Poisonous and Infectious Material if, in an animal assay for chronic toxic effects, it elicits a response of sufficient severity to threaten life or cause serious permanent impairment in a statistically significant proportion of the test population at

  • (a) a dose of more than 10 but not exceeding 100 milligrams per kilogram of body weight of the animal per day, when tested in accordance with

    • (i) OECD Test Guideline No. 408, “Subchronic Oral Toxicity — Rodent: 90-day”, dated May 12, 1981,

    • (ii) OECD Test Guideline No. 409, “Subchronic Oral Toxicity — Non-Rodent: 90-day”, dated May 12, 1981, or

    • (iii) the oral route test in OECD Test Guideline No. 452, “Chronic Toxicity Studies”, dated May 12, 1981;

  • (b) a dose of more than 20 but not exceeding 200 milligrams per kilogram of body weight of the animal per day, when tested in accordance with

    • (i) OECD Test Guideline No. 411, “Subchronic Dermal Toxicity: 90-day”, dated May 12, 1981, or

    • (ii) the dermal route test in OECD Test Guideline No. 452, “Chronic Toxicity Studies”, dated May 12, 1981; or

  • (c) a concentration of more than 25 but not exceeding 250 parts per million by volume of gas or vapour, or more than 10 but not exceeding 100 micrograms per litre or more than 10 but not exceeding 100 milligrams per cubic metre, of dust, mist or fume, when tested in accordance with

    • (i) OECD Test Guideline No. 413, “Subchronic Inhalation Toxicity: 90-day”, dated May 12, 1981, or

    • (ii) the inhalation route test in OECD Test Guideline No. 452, “Chronic Toxicity Studies”, dated May 12, 1981.

Skin or Eye Irritation

 A pure substance or tested mixture falls into Subdivision B of Division 2 of Class D — Poisonous and Infectious Material if, in an animal assay,

  • (a) it causes an effect graded at a mean of two or more for erythema formation or two or more for edema formation, when tested in accordance with OECD Test Guideline No. 404, “Acute Dermal Irritation/Corrosion”, dated May 12, 1981, as measured at any of the times specified in the test; or

  • (b) it causes an effect graded at a mean of two or more for corneal damage, one or more for iris damage or 2.5 or more for conjunctival swelling or redness, when tested in accordance with OECD Test Guideline No. 405, “Acute Eye Irritation/Corrosion”, dated May 12, 1981, as measured at any of the times specified in the test.

  • SOR/97-543, s. 24(F).

Skin Sensitization

 A pure substance or tested mixture falls into Subdivision B of Division 2 of Class D — Poisonous and Infectious Material if

  • (a) in an animal assay carried out in accordance with OECD Test Guideline No. 406, “Skin Sensitization”, dated May 12, 1981,

    • (i) it produces a response in 30 per cent or more of the test animals, when using one of the techniques incorporating the use of an adjuvant, or

    • (ii) it produces a response in 15 per cent or more of the test animals, when using one of the techniques not incorporating the use of an adjuvant; or

  • (b) evidence shows that it causes skin sensitization in persons following exposure in a work place.