TABLE 12.

Summary of tumour incidences in rats in the NTP (2014) study.

	0 mg/kg bw a	250 mg/kg bw	500 mg/kg bw	1000 mg/kg bw
Females – Uterus b
Atypical endometrial hyperplasia	2 c	13 d	11 d	13 d
Adenoma	3	2	4	6
Adenocarcinoma	4I	10	15 d	16 d
MMMT	0	4	0	2
Adenoma, adenocarcinoma or MMMT (combined) e	6 f	11	16 d	19 d
Males – Testis
Interstitial cell adenoma	0	0	1	3

Abbreviation: MMMT, Malignant mixed Müllerian tumour.

^a Groups of 50 rats were dosed by gavage 5 days per week for 2 years (averaged doses = 0, 179, 357, 714 mg/kg bw per day).

^b Based on original transverse review and additional longitudinal review, combined.

^c Statistically significant trend at p ≤ 0.05.

^d Statistically significant at p ≤ 0.01 in pairwise comparisons with the control group.

^e One of 5 peer reviewers did not agree that MMMT should be combined with uterine epithelial tumours.

^f Statistically significant trend at p ≤ 0.01.