Table 1. Reproduction and Ninety Day Oral Toxicity Study in Rats. (Wazeter, 1976).

      F0 Dietary Feed (ppm)  

F1

 
Parameters 0

10/sex

1000

10/sex

3000

10/sex

9000

10/sex

0

15/sex

1000

15/sex

3000

15/sex

6000

15/sex

  M F M F M F M F M F M F M F M F
Body Wt. (g)

(F0, wk. 17 F1, wk.13)

570 306 563 295 529 288 468 268 509 310 498 270 452 257 388 241
Food Consumption

(g/rat/day)

(F0, wk. 17 F1 wk.13)

26.5 26.7 27.5 20.5 26.8 20.2 26.5 22.1 25.8 19.0 25.3 16.4 25.0 15.5 21.9 14.9
Survival 10 10 10 10 10 10 10 10 14 15 15 15 15 13 15 13
Pregnancies per Mating

9/10

8/10

10/10

8/10

_

_

_

_

Gestation Survival

Index (%)

96

96

91

97

_

_

_

_

21 Day Survival

Index (%)

99

89

94

99

_

_

_

_

Mean Pup Wt.

(Day 0)

7.2

6.9

6.9

6.6

_

_

_

_

Mean Pup Wt.

(Day 21)

50.7

49.7

47.0(a)

44.5(b)

_

_

_

_

Relative Wt.

Testes

.67

.64

.65

.79

_

_

_

_

Relative Wt.

Ovaries

.46

.50

.47

.49

_

_

_

_

(a) Significantly lower than control group mean, p<0.05)

(b) Significantly lower than control group mean, p<0.01)

Notes: No compound-related gross lesions or variations in organ weights (liver, kidney, spleen testes, ovaries, heart, brain, thyroid, adrenals or pituitary) were observed. Indications of non-estrogenicity include no significant changes in pregnancies per mating, gestational or 21 day survival indexes or in relative weight of the testes and ovaries. There were no indications of estrogenicity in this study. The decreased mean pup weight (day 21) appear to be attributed to generalized maternal toxicity (reduced body weight). The ratio of pup weight to maternal body weight are equivalent at all dose levels.

The maternal and fetal NOEL for this study is 1000 ppm (50 mg/kg/day).