Division II.6.3.6.4

Exposure to certain genotoxic substances is known to be associated with carcinogenesis and consequently, clearly positive findings in genotoxicity tests shall be considered to indicate that the substance may be carcinogenic. In addition, because germ cell mutations are known to be associated with disease, clearly positive findings in genotoxicity tests shall be considered to indicate that the substance may induce heritable disease (reproductive toxicity).