2.1 Subject to sections 2.8 and 2.9, for the purpose of establishing whether a material or substance is classified in a category or subcategory of a hazard class, the material or substance must be evaluated in accordance with established scientific principles, with respect to the criteria and requirements of each category or subcategory of the hazard class as set out in Parts 7 and 8, using available data of the following types, as applicable:
(a) in relation to the material or substance itself,
(i) results of testing or studies carried out in accordance with the test methods referred to in Part 7 or 8,
(ii) results of testing or studies carried out in accordance with generally accepted standards of good scientific practice at the time the test or study was carried out,
(b) except for Subparts 2 and 3 of Part 8, if the data of the types referred to in paragraph (a) are insufficient to evaluate the material or substance in accordance with the criteria and requirements set out in Parts 7 and 8, in relation to a material or substance that has similar properties,
8.6.1 A carcinogenic substance is classified in a category or subcategory of this hazard class in accordance with the following table:
TABLE
A substance in respect of which
[...]
(b) animal data establish a causal relationship between exposure to the substance and an increased incidence of malignant neoplasms or a combination of benign and malignant neoplasms in
(i) two or more species of animals, as demonstrated by one or more studies,
(ii) one species of animal, as demonstrated by two or more independent studies carried out at different times, in different laboratories or under different protocols, or
(iii) one species of animal, as demonstrated by a single study, if the neoplasms observed in the study are, based on established scientific principles, atypical in relation to the incidence, site, type or age at onset for the species of animal under study; or
8.7.3 (1) A mixture is classified in the category “Reproductive Toxicity — Category 1” or the subcategory “Reproductive Toxicity — Category 1A” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Reproductive Toxicity — Category 1A”, unless
(b) the mixture as a whole has been subjected to a reproductive toxicity study that determines that the mixture does not have adverse effects on sexual function and fertility or adverse effects on the development of the embryo, fetus or offspring, and a scientifically validated method was used and the study was performed in accordance with generally accepted standards of good scientific practice at the time it was carried out.
(2) A mixture is classified in the category “Reproductive Toxicity — Category 1” or the subcategory “Reproductive Toxicity — Category 1B” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Reproductive Toxicity — Category 1B”, and does not contain any ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Reproductive Toxicity — Category 1A”, unless
8.6.3 (1) A mixture is classified in the category “Carcinogenicity — Category 1” or the subcategory “Carcinogenicity — Category 1A” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Carcinogenicity — Category 1A”, unless
(b) the mixture as a whole has been subjected to a carcinogenicity study that determines that the mixture is not carcinogenic, and a scientifically validated method was used and the study was performed in accordance with generally accepted standards of good scientific practice at the time it was carried out.
(2) A mixture is classified in the category “Carcinogenicity — Category 1” or the subcategory “Carcinogenicity — Category 1B” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Carcinogenicity — Category 1B”, and does not contain any ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the subcategory “Carcinogenicity — Category 1A”, unless
8.7.5 (1) A mixture is classified in the category “Reproductive Toxicity — Effects on or via Lactation” if it contains at least one ingredient at a concentration equal to or greater than the concentration limit of 0.1% that is classified in the category “Reproductive Toxicity — Effects on or via Lactation”, unless
(b) the mixture as a whole has been subjected to a reproductive toxicity study that determines that the mixture does not have effects on or via lactation, and a scientifically validated method was used and the study was performed in accordance with generally accepted standards of good scientific practice at the time it was carried out.
