TABLE 14.
Incidence of fetuses/litters with malformations in the rabbit after oral administration of DDAC
| Fetal malformations | DDAC dose level (mg/kg/day) | |||
|---|---|---|---|---|
| 0 (control) | 1 | 3 | 10 | |
| Number examined externally | 120/14a | 117/13 | 143/15 | 81/9 |
| Lateral scoliosis, clubbed hindlimbs, short tail | 0/0 | 0/0 | 0/0 | 1/1b |
| Forelimb joint rigid | 0/0 | 0/0 | 0/0 | 2/1 |
| Gastroschisis | 0/0 | 1/1 | 1/1 | 0/0 |
| Dome‐shaped head and microglossia | 0/0 | 0/0 | 1/1 | 0/0 |
| Number examined viscerally | 120/14 | 117/13 | 143/15 | 81/9 |
| Dilated lateral ventricle (brain) with tissue depression | 1/1 | 4/1 | 5/5 | 1/1b |
| Kidney absent (unilateral) | 0/0 | 0/0 | 0/0 | 1/1b |
| Urinary bladder absent | 1/1 | 0/0 | 0/0 | 0/0 |
| Gall bladder absent | 0/0 | 2/1c | 1/1 | 0/0 |
| Uterine horn and ovary absent | 0/0 | 1/1c | 0/0 | 0/0 |
| Number examined skeletally | 120/14 | 117/13 | 143/15 | 81/9 |
| Vertebral segments (thoracic to caudal) and ribs fused, absent, and/or malformed | 0/0 | 0/0 | 0/0 | 1/1b |
| Lateral scoliosis without associated vertebral and rib malformations | 2/2d | 0/0 | 0/0 | 1/1 |
| Sternebrae duplicated | 1/1d | 0/0 | 1/1 | 0/0 |
| Total number with malformations | 11/6 | 7/3 | 13/7 | 7/5 |
Abbreviation: DDAC, didecyl dimethyl ammonium chloride.
a
Data are presented as number of fetuses/number of litters.
b
The same fetus exhibited the external, visceral, and skeletal malformations.
c
Findings occurred in the same litter/fetus.
d
Findings occurred in the same litter/fetus.