§ 69403.7. Hepatotoxicity and Digestive System Toxicity.

(a) The hepatotoxicity and digestive system toxicity hazard trait is defined as the occurrence of adverse effects on the structure or function of the liver, gall bladder, or gastrointestinal tract following exposure to a chemical substance.

(b) Toxicological endpoints for hepatotoxicity and digestive system toxicity include, but are not limited to those indicating: liver damage; fatty liver; hepatitis; canicular cholestasis; vascular changes; steatosis; bile duct damage; gall bladder disease; gastrointestinal tract dysfunction including emesis and acid reflux disorder; sinusoidal damage; cirrhosis; inflammation or hyperplasia of the gastrointestinal epithelium.

(c) Other relevant hepatotoxicity and gastrointestinal toxicity data include but are not limited to those indicating: elevated pro-inflammatory cytokines, induction or inhibition of xenobiotic metabolizing enzymes; generation of reactive metabolites; disruption of glucose or glycogen metabolism; impaired or unbalanced serum protein production; in vitro indicators of hepatotoxicity; structural or mechanistic similarity to other chemical substances that are hepatotoxic or cause digestive system toxicity.

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.