Table 6.
Historical Control Data for Puberty Onset Endpoints in Sprague-Dawley Rats for Studies Conducted from 2007 to 2013a, b
| Company A EDSP studies | Company A Reproductive studies | Company B EDSP studies | Company B Reproductive studies | Company C EDSP studies | Company C Reproductive studies | Performance criteria (OPPTS 890.1500 and 890.1450) | |
|---|---|---|---|---|---|---|---|
| Preputial separation | |||||||
| Age (days) | 45.0 (0.9) | 45.0 (1.3) | 42.2 (0.9) | 46.3 (1.2) | 44.0 (0.80) | 44.6 (0.58) | 43.1 (39.8–46.5)c |
| Body weight at achievement | 220.7 (12.1) | 231.2 (12.4) | 224.6 (10.8) | 239.0 (12.2) | 207.2 (8.2) | 245.9 (10.1) | 222.2 (188.277–256.169)d |
| Vaginal patency | |||||||
| Age (days) | 35.6 (1.1) | 33.2 (1.0) | 32.8 (1.2) | 32.8 (0.9) | 34.6 (1.0) | 32.4 (1.0) | 33.2 (30.7–35.6)c |
| Body weight at achievement | 124.1 (7.7) | 110.6 (5.5) | 119.6 (9.6) | 105.4 (7.0) | 113.4 (5.0) | 116.2 (5.9) | 116.6 (101.71–131.44)d |
| Sample size (no. of studies) | 9 | 165 | 3 | 86 | 7–8 | 8 | |
a
Comparison of laboratory mean values versus performance criteria means (ranges) as specified in the pubertal assay test guidelines.
b
Values are means (standard deviations) for each laboratory and study type.
c
Age at preputial separation or vaginal opening in Sprague-Dawley rats based on the performance criteria specified in the OPPTS 890.1450 and 890.1500 test guidelines.
d
Body weight at preputial separation or vaginal opening in Sprague-Dawley rats based on the performance criteria specified in the OPPTS 890.1450 and 890.1500 test guidelines.