Table 5. MTD study in mice, PO administration: Observations.
| Treatment | Vehicle a | C16 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 10 mL/kg | 10 mg/kg | 30 mg/kg | 100 mg/kg | 300 mg/kg | ||||||
| Sex | M | F | M | F | M | F | M | F | M | F |
| Behavioral b,c | none | none | none | none | none | none | Yes: A,C | Yes: B,C | Yes: A | Yes: A |
| Neurologic c | none | none | none | none | none | none | none | none | none | none |
| Autonomic c | none | none | none | none | none | none | none | none | none | none |
| Deaths | 0/2 | 0/2 | 0/2 | 0/2 | 0/2 | 0/2 | 0/2 | 0/2 | 0/2 | 0/2 |
| Necropsy: gross findings d | none | none | none | none | none | none | none | none | none | none |
| Weigt increase (%) e | 21±0 | 4±6 | 25±3 | 2±3 | 18±3 | 6±3 | 25±1 | 8±1 | 17±0 | 7±3 |
a Vehicle: 10% Solutol HS-15 / 90% PEG 600.
b Behavioral changes: A: Irritability: vocalization, 1/2; B: Irritability: vocalization, 2/2; C: Slightly increased touch, 1/2.
c Observations made over the first 60 min.
d Necropsy 72 h post dosing.
e Over 72 h (average±SD)