Abstract for TR-148

Bioassay of 1-Phenyl-2-thiourea for Possible Carcinogenicity

CASRN: 103-85-5
Chemical Formula: C7H8N2S
Molecular Weight: 152.22
Synonyms/Common Names: Phenylthiourea; Phenylthiocarbamide; 1-Phenylthiourea; N-Phenylthiourea; PTU
Report Date: 1978

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1-Phenyl-2-thiourea was selected for bioassay by the National Cancer Institute because of the structural similarity of this compound to ethylene thiourea, a tumorigen in hybrid mice (C57BL/6 x C3H/Anf and C57BL/6 x AKR), and the widespread oral exposure to this compound when used in classroom demonstrations of genetic polymorphism in taste.

A bioassay of 1-phenyl-2-thiourea for possible carcinogenicity was conducted using Fischer 344 rats and B6C3F1 mice. 1-Phenyl-2-thiourea was administered in the feed, at either of two concentrations, to groups of 50 male and 50 female animals of each species. The high and low concentrations of 1-phenyl-2-thiourea utilized in the chronic bioassay were, respectively, 120 and 60 ppm for rats and 300 and 150 ppm for mice. Twenty animals of each species and sex were placed on test as controls. A 78-week period of chemical administration was followed by an additional observation period of 26 weeks for rats and 13 weeks for mice.

Adequate numbers of animals in all groups survived sufficiently long to be at risk from late-developing tumors. Distinct dose-related depression of mean body weight gain was observed in male and female mice when compared with their controls, but growth retardation was not observed inany dosed rat group. In addition, since no significant accelerated mortality or other toxic effects were associated with the dietary administration of 1- phenyl-2-thiourea to rats, it is possible that the compound was not administered to these animals at the maximum tolerated concentrations.

There were no tumors in either sex of rats or mice for which a significant positive association could be established between chemical administration and tumor incidence.

Under the conditions of this bioassay, 1-phenyl-2-thiourea was not carcinogenic to Fischer 344 rats or B6C3F1 mice.