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EC number: 701-028-2 | CAS number: -
Three of ten pregnant F0 parental females from the 1000 mg/kg/day group were found dead on Day 22 of gestation. These deaths may have been related to dystocia, since the dams appeared to be unable to deliver their normal appearing pups. In addition, absolute ovarian weights and ovarian weights relative to terminal body or brain weights were reduced in F0 females at 1000 mg/kg/day. No other consistent, treatment-related effects were observed. There was no evidence of F0 reproductive toxicity in males. The only evidences of F1 offspring toxicity pre- or postnatally were observed at 1000 mg/kg and were a reduced litter size on pnd 0 and 4, renal histopathology in F1 adult males and a significantly decreased paired epididymides weight, relative to terminal body weights in Fi male rats. This last finding is of uncertain toxicological significance, since there were no changes in epididymal weight in the F0 generation or in absolute organ weight in the F1 generation. No effects were seen on the developmental landmarks, including the time to vaginal opening or preputial separation, or estrous cycle normality or length. Therefore, under the conditions of this study in rats, the no observable adverse effect levels (NOAELs) for systemic parental toxicity and for reproductive and offspring toxicity were 200 mg/kg/day.
F0 Parental Reproductive Toxicity: Table 184.108.40.206 (attached to Chapter 1.11) presents a summary of F0 adult reproductive toxicity.
Precoital interval, days
Gestational length, days
Death due to dystocia on gd 22
No. implant sites/litter
% postimplantation loss/litter
No. total pups/litter, pnd 0
No. live pups/litter, pnd 0
No. dead pups/litter, pnd 0
No. females pregnant
No. litters on pnd 0
No. litters on pnd 21
a Indicated parameters were assessed in control and high dose animals only
b Presence of renal corticomedullary mineralization in two F1 males at 1000 mg/kg/day versus 0 at 0 mg/kg/day. F1 females exhibited the same findings with the same incidence and severity at both 0 and 1000 mg/kg/day.
---=No statistically significant difference
* =Statistically significantly different from control group value at p<0.05
NOAEL for systemic and reproductive toxicity from this study was 200 mg/kg/day.
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