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low and high-dose groups, respectively) within 217-360 days (total dose up to 390 mg/kg) (Druckrey
et al., 1968, 1970).
Weekly intravenous injections of a 2% solution of 1,3-propane sultone in water at doses of 10, 20 or
40 mg/kg (total doses 300, 570 and 560 mg/kg, respectively) were administered to groups of 10 BD
rats (the 40 mg/kg group treatment was suspended after 16 weeks due to tail vein sclerosis) (Druckrey
et al., 1970). Three animals in the 40 mg/kg group died of tumors after 280-410 days (sarcoma of the
mediastinum with right lung and kidney metastases, glial-mesodermal mixed tumor of the brain,
neurosarcoma); 2/12 and 3/8 animals respectively in the 10 and 20 mg/kg groups died of tumors (10
mg/kg group: ganglioneuroma, neurocytoma; 20 mg/kg group: nephroblastoma, ileocaecal carcinoma,
glial-mesodermal mixed tumor of the brain and mammary carcinoma) after 381-492 days. In the same
study, a single intravenous injection of 1,3-propane sultone (150 mg/kg) induced tumors at various sites
resulting in mortality within 459 days in 10/32 BD rats. Single intravenous injections of 20 or 60 mg/kg
1,3-propane sultone administered to pregnant BD rats on gestation day 15 resulted in malignant
neurogenic tumors in 3/25 offspring born to the 20 mg/kg group, and in malignant tumors in 4/14
offspring (2 neurogenic tumors, 1 pancreatic tumor, 1 ovarian tumor) born to the 60 mg/kg group.
Female ICR/Ha Swiss mice (30/group) given weekly subcutaneous injections of 0.3 mg 1,3-propane
sultone in 50 µl distilled water developed tumors in 21/30 mice at the injection site (1 papilloma, 7
adenoacanthomas, 12 sarcomas, 1 undifferentiated carcinoma) within 63 weeks, compared to 0/30
controls after 78 weeks (Van Duuren et al., 1971).
Male and female Charles River CD rats (26/sex/group) were exposed to an aqueous solution of 1,3-
propane sultone by gavage twice weekly at doses of 28 mg/kg body weight for 60 weeks and 56 mg/kg
for 32 weeks (Ulland et al., 1971; Weisburger et al., 1981). Control groups (32/sex) were also
included; however, only 6 animals/sex were killed and necropsied at 61 weeks. Tumor types induced
by 1,3-propane sultone are listed in Table 1.
Table 1: 1,3-propane sultone-induced tumor incidences in male and female CD rats
Exposure group (mg/kg) 28 56
Sex Male Female Male Female
Tumor type
Breast 1/26 7/26 1/26 13/26
Glioma 12/26 15/26 16/26 13/26
Ear duct 1/26 0/26 3/26 3/26
Leukemia 0/26 2/26 4/26 3/26
Intestinal adenocarcinoma 4/26 1/26 3/26 1/26
Miscellaneous 5/26 7/26 4/26 6/26
One female control died of a cerebral glioma after 33 weeks, and a pituitary chromophobe adenoma
was discovered in a female control. No other control animal tumor incidences were reported.
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