Table 6.

Summary of repeated dose oral toxicity studies of cocamidopropyl betaine (CAPB)

Subjects	Route/Period	Dose	Results	Refs.
Sprague- Dawley Rat (n = 10/sex/group)	Oral gavage/ 92 days (daily)	0, 250, 500, or 1000 mg/kg/day	Nonglandular gastritis in 6 male and 3 female rats in the 1000 mg/kg/day group, 2 male and 2 female rats in the 500 mg/kg/day group, not in the 250 mg/kg/day dose group (microscopic evaluations) NOEL: 250 mg/kg/day	[8]
Sprague- Dawley Rat (n = 8/sex/group)	Oral gavage/ 28 days	100, 500, 1000 mg/kg/day (30.6% active CAPB)	No clear relationship between dose and mortality	[27]
Sprague- Dawley Rat	Oral gavage/ 28 days (5 days/week)	0, 250, 500, or 1000 mg/kg/day	Edema in the mucosa of the nonglandular stomach in 1000 mg/kg/day group NOEL: 500 mg/kg/day	[8]