Children’s Sleepwear Regulations (SOR/2016-169)

1 Acute oral toxicity must be assessed in accordance with OECD Test No. 401, “Acute Oral Toxicity”, published May 12, 1981 in the OECD Guidelines for Testing of Chemicals.

2 Acute dermal toxicity must be assessed in accordance with OECD Test No. 402, “Acute Dermal Toxicity”, published May 12, 1981 in the OECD Guidelines referred to in section 1.

3 Dermal irritation must be assessed in accordance with OECD Test No. 404, “Acute Dermal Irritation/Corrosion”, published May 12, 1981 in the OECD Guidelines referred to in section 1.

4 Dermal sensitisation must be assessed in accordance with OECD Test No. 406, “Skin Sensitisation”, published May 12, 1981 in the OECD Guidelines referred to in section 1.

5 Mutagenicity must be assessed in accordance with the “OECD Guidelines on Genetic Toxicology Testing and Guidance on the Selection and Application of Assays”, published May 15, 1986 by OECD, which include the tests referred to in paragraphs (a) to (c), as well as in accordance with the third level of concern (LOC III) of the federal “Guidelines on the Use of Mutagenicity Tests in the Toxicological Evaluation of Chemicals”, published by Health and Welfare Canada and Environment Canada in 1986, in regard to the tests referred to in paragraph (d):

• (a) to test in vitro gene mutation:

  • (i) OECD Test No. 471, “Genetic Toxicology: Salmonella typhimurium, Reverse Mutation Assay”, published May 26, 1983 in the OECD Guidelines referred to in section 1,

  • (ii) OECD Test No. 476, “Genetic Toxicology: In vitro Mammalian Cell Gene Mutation Tests”, published April 4, 1984 in the OECD Guidelines referred to in section 1, or

  • (iii) OECD Test No. 480, “Genetic Toxicology: Saccharomyces cerevisiae, Gene Mutation Assay”, adopted October 23, 1986 by the OECD and included in the OECD Guidelines referred to in section 1;

• (b) to test in vitro mammalian chromosomal aberrations with the exclusion of sister chromatid exchange and micronuclei: OECD Test No. 473, “Genetic Toxicology: In vitro Mammalian Cytogenetic Test”, published May 26, 1983 in the OECD Guidelines referred to in section 1;

• (c) to test in vivo mammalian chromosomal aberrations excluding sister chromatid exchange:

  • (i) OECD Test No. 474, “Genetic Toxicology: Micronucleus Test”, published May 26, 1983 in the OECD Guidelines referred to in section 1, or

  • (ii) OECD Test No. 475, “Genetic Toxicology: In Vivo Mammalian Bone Marrow Cytogenetic Test — Chromosomal Analysis”, published April 4, 1984 in the OECD Guidelines referred to in section 1; and

• (d) to test in vivo mammalian gene mutation or other indicator tests in a second somatic tissue or species:

  • (i) test as specified by J. W. Allen, C. F. Shuler, R. W. Mendes and S. A. Latt in the paper entitled “A simplified technique for in vivo analysis of sister-chromatid exchanges using 5-bromodeoxyuridine tablets”, published in the Journal of Cytogenetics and Cell Genetics, Vol. 18, 1977, pp. 231-237, or

  • (ii) test as specified by J. C. Mirsalis and B. E. Butterworth in the paper entitled “Detection of unscheduled DNA synthesis in hepatocytes isolated from rats treated with genotoxic agents: an in vivo-in vitro assay for potential carcinogens and mutagens”, published in Carcinogenesis, Vol. 1, July 1980, pp. 621-625.

6 Tumorigenicity by the oral route must be assessed in accordance with OECD Test No. 451, “Carcinogenicity Studies”, published May 12, 1981 in the OECD Guidelines referred to in section 1.