Cal. Code Regs. tit. 22 § 69403.1

Current through Register 2024 Notice Reg. No. 45, November 8, 2024
Section 69403.1 - Cardiovascular Toxicity
(a) The cardiovascular toxicity hazard trait is defined as the occurrence of adverse effects on the structure or function of the heart or the vascular system following exposure to a chemical substance.
(b) Toxicological endpoints for cardiovascular toxicity include but are not limited to observations indicating: structural effects associated with cell necrosis, cellular degeneration, proliferation, fibrosis, or inflammation of the heart or vasculature, atherosclerosis, thickening of arterial walls, or cardiac hypertrophy; functional effects such as arrhythmia or changes in rhythmicity or contractility of the heart, hypo- or hyper- tension, decreased cardiac output, alteration of vascular reactivity or vessel dilation or contraction; outcomes of structural or functional impairment including high blood pressure, myocardial infarct, or cardiac failure; epidemiological or laboratory animal observations of cardiovascular morbidity or mortality in association with chemical substance exposure.
(c) Other relevant cardiovascular toxicity data include but are not limited to: markers of systemic inflammation; alteration of the electrophysiology of isolated cardiomyocytes; dysregulation of cytokines; platelet activation and aggregation; perturbation of clotting; changes in cardiomyocytes gene expression involved in heart disease; alterations of cell signaling related to vascular or heart disease; in vitro measures of cardiovascular toxicity such as cytotoxicity to isolated vascular endothelial cells; structural or mechanistic similarity to other chemical substances that are toxic to the cardiovascular system.

Cal. Code Regs. Tit. 22, § 69403.1

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

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

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