Table 2. Reproduction and Ninety Day Feeding Study in Rats. (Goldenthal, 1978).

Parameters Dietary Feed (ppm)

FO F1

  0

10/sex

100

10/sex

250

10/sex

500

10/sex

750

10/sex

1000

10/sex

0

15/sex

100

15/sex

250

15/sex

500

15/sex

750

15/sex

1000

15/sex

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

(FO, wk18 F1, wk13)

532 292 549 293 537 298 534 295 511 281 500 292 456 245 474 261 480 276 452 254 426 240 462 246
Food Consumption

(g/rat/day)

(FO,wk18 F1, wk13)

25.8 17.1 26.3 19.6 26.6 20.2 25.3 19.3 25.2 22.4 25.9 19.8 22.2 14.4 24.5 16.1 24.8 17.3 22.7 14.9 21.2 13.7 22.8 14.7
Survival 10 10 10 10 10 10 10 10 10 10 10 10 15 14 15 15 15 15 15 12 15 10 15 12
Pregnancies per Mating 7/10 10/10 10/10 10/10 10/10 10/10 - - - - - -
Gestation Survival Index (%) 100 100 98 98 99 98 - - - - - -
21 Day Survival Index (%) - - - - - - 98 99 96 96 92 95
Mean Pup Wt.

(Day 0)

- - - - - - 6.5 6.5 6.5 6.4 6.4 6.4
Mean Pup Wt.

(Day 21)

- - - - - - 39.3 39.8 41.6 40.3 43.1(a) 38.3
Relative Wt.

Testes

- - - - - - 7.49 7.10 7.06 7.42 7.96 7.54
Relative Wt.

Ovaries

- - - - - - 0.58 0.64 0.57 0.60 0.59 0.65

(a) Significantly higher than control group mean (p <0.05)

Notes: No compound-related gross lesions or variations in organ weights (liver, kidney, spleen, testes, ovaries, heart, brain, thyroid, adrenals and 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 or ovaries. There were no indications of estrogenicity in this study.  The maternal and fetal NOEL for this study is 1000 ppm (50 mg/kg/day).