Table 2.

Incidences of Alveolar/Bronchiolar Tumors in Mice in the 2-Year Inhalation Study of Antimony Trioxide (NTP TR 590).^#

	Chamber Control	3 mg/m3	10 mg/m3	30 mg/m3
Males
Alveolar/bronchiolar adenomas, multiple
	3	3	2	4
Alveolar/bronchiolar adenomas (including multiples)a
	10/50 (20%)	14/50 (28%)	9/50 (18%)	14/50 (28%)
Poly-3 testb	P=0.190	P=0.165	P=0.592	P=0.129
Alveolar/bronchiolar carcinomas, multiple
	0	5*	6**	11**
Alveolar/bronchiolar carcinomas (including multiples)c
	4/50 (8%)	18/50 (36%)	20/50 (40%)	27/50 (54%)
Poly-3 test	P<0.001	P<0.001	P<0.001	P<0.001
Alveolar/bronchiolar adenomas or carcinomas (combined)d
	13/50 (26%)	29/50 (58%)	28/50 (56%)	34/50 (68%)
Poly-3 test	P<0.001	P<0.001	P<0.001	P<0.001
Females
Alveolar/bronchiolar adenomas, multiple
	0	3	3	1
Alveolar/bronchiolar adenomas (including multiples)e
	1/50 (2%)	10/50 (20%)	19/50 (38%)	8/50 (16%)
Poly-3 test*	P=0.137	P=0.003	P<0.001	P=0.009
Alveolar/bronchiolar carcinomas, multiples
	0	7**	6*	4*
	0/50 (0%)	0/50 (0%)	0/50 (0%)	0/50 (0%)
Alveolar/bronchiolar carcinomas (including multiples)f
	2/50 (4%)	14/50 (28%)	11/50 (22%)	11/50 (22%)
Poly-3 test	P=0.065	P<0.001	P=0.003	P=0.002
Alveolar/bronchiolar adenomas or carcinomas (combined)g
	3/50 (6%)	22/50 (44%)	27/50 (54%)	18/50 (36%)
Poly-3 test	P=0.019	P<0.001	P<0.001	P<0.001

^*Significantly different (P ≤ 0.05) from the chamber control group by the Fisher exact test (interim evaluation) or the Poly-3 test (2-year study).

^**P ≤ 0.01.

^aHistorical incidence for 2-year inhalation studies with chamber control groups (mean ± standard deviation): 35/250 (14.0% ± 3.7%), range 10%–20%; all routes: 83/550 (15.1% ± 5.9%), range 8%–26%.

^bBeneath the chamber control incidence is the P value associated with the trend test. Beneath the exposed group incidence are the P values corresponding to pairwise comparisons between the chamber controls and that exposed group. The Poly-3 test accounts for differential mortality in animals that do not reach terminal kill.

^cHistorical incidence for inhalation studies: 42/250 (16.8% ± 5.4%), range 8%–22%; all routes: 75/550 (13.6% ± 6.4%), range 4%–22%.

^dHistorical incidence for inhalation studies: 69/250 (27.6% ± 2.6%), range 26%–32%; all routes: 147/550 (26.7% ± 6.5%), range 16%–38%.

^eHistorical incidence for inhalation studies: 12/249 (4.8% ± 2.7%), range 2%–8%; all routes: 27/549 (4.9% ± 3.5%), range 0%– 10%.

^fHistorical incidence for inhalation studies: 17/249 (6.8% ± 3.7%), range 2%–10%; all routes: 24/549 (4.4% ± 3.5%), range 0%– 10%.

^gHistorical incidence for inhalation studies: 28/249 (11.3% ± 5.5%), range 6%–18%; all routes: 50/549 (9.1% ± 5.2%), range 2%– 18%.

^#Table #22 from the NTP Technical Report on the Toxicology and Carcinogenesis Studies of Antimony Trioxide (Technical Report 590)