GMP-grade α-TEA lysine salt: a 28-Day oral toxicity and toxicokinetic study with a 28-Day recovery period in Beagle dogs

Table 1 Group assignment and dose levels

Group	Number of animals (M/F)	Test article	Nominal dose level (mg/kg/day)	Actual dose level^a	Number of animals for necropsy (M/F)
					Terminal (Day 29)	Recovery (Day 57)
1	6/6	Vehicle	0	0	4/4	2/2
2	4/4	α-TEA	100	130	4/4	-
3	6/6	α-TEA	300	390	4/4	2/2
4	6/6	α-TEA	1500	1950	4/4	2/2

^aDose levels have been corrected for lysine salt using a correction factor of 1.3
A total of 44 Beagle dogs (22 males and 22 females) received α-TEA lysine salt at different concentrations (0, 100, 300, 1500 mg/kg). Eight dogs from each group (4 females and 4 males) were necropsied at the end of dosing period (Day 29) or at the end of recovery period (Day 57)

ISSN: 1471-2407