Controlled Products Regulations

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

• (a) there is epidemiological evidence that shows a causal connection between exposure of persons to the substance or mixture and heritable genetic effects; or

• (b) there is evidence of mutagenicity in mammalian germ cells in vivo as shown by

  • (i) positive results in a study that measures mutations transmitted to offspring, or

  • (ii) positive results in an in vivo study showing chemical interaction with the genetic materials of mammalian germ cells and positive results in an in vivo study assessing either gene mutation or chromosomal aberration in somatic cells.

(2) The evidence referred to in paragraph (1)(b) shall be obtained

• (a) in accordance with test methods described in the “Introduction to the OECD Guidelines on Genetic Toxicology Testing and Guidance on the Selection and Application of Assays”, dated March 1, 1987, published in the Third Addendum to the OECD Guidelines for Testing of Chemicals; and

• (b) using testing strategies described in the Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals, dated 1986, published under the authority of the Minister of National Health and Welfare and the Minister of the Environment.