§ 69402.1. Carcinogenicity.

(a) The carcinogenicity hazard trait is defined as the occurrence of increased incidence, reduced latency, or increased severity or multiplicity in neoplasia following exposure to a chemical substance.

(b) Toxicological endpoints for carcinogenicity include, but are not limited to those indicating malignant or benign neoplasia or pre-neoplasia of alimentary, cardiovascular, endocrine, genital, hematopoietic, integumentary, musculoskeletal, nervous, respiratory, special senses, or urinary systems as well as any other systemic neoplastic lesions observed in human or animal studies.

(c) Other relevant carcinogenicity data include but are not limited to data on: mechanisms of carcinogenesis such as exposure-related modifications to the physiology or response of cells, tissues and organs (for example, mitogenesis, compensatory cell division, hyperplasia, or signaling pathways used by cells to manage critical processes related to increased risk for cancer); changes in key cellular structures at the molecular level such as mutation and other genotoxicity endpoints; epigenetic changes associated with increased cancer risk; structural similarity to other carcinogenic chemical substances.

HISTORY

1. New section filed 12-20-2011; operative 1-29-2012 (Register 2011, No. 51).

Note

Note: Authority cited: Sections 25256.1 and 59012, Health and Safety Code. Reference: Sections 25256.1 and 59012, Health and Safety Code.