Controlled Products Regulations

59 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.