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EC number: 203-812-5
CAS number: 110-88-3
Negative in vitro and in vivo genotoxicity assays (for details see chapter 7.6.). Negative 2-year carcinogenicity experiment in rats. Negative cell transformation assay
No indications of a mutagenic, clastogenic or aneugenic potential
were identified in a variety of in vitro and in vivo genotoxicity assays
(for details see chapter 7.6.).
In a 2-year carcinogenicity experiment in rats 30 animals per sex
were fed with dose levels of 1 or 5% for 104 weeks. No treatment related
increase in neoplastic (and non-neoplastic) lesions were reported (Hoechst
Furthermore, in a 2-year chronic study in cats no apparent increase in
mortality due to a significant tumor formation was observed (Hoechst
The quality of study reporting and study performance of both
sudies is not to current standards. Here both studies are reported for
completness but their value for an assessment is limited.
In a cell transformation assay using C3H 10T-1/2 cells, concentrations
up to 20000 µg/ml were tested in 11- and 38-day incubations following a
24 h exposure to trioxane (Celanese, 1981). No increase in the number of
transformed colonies or transformed foci was noted at any dose level.
By means of a weight of evidence the clearly negative results in the
available genetox assays, together with the cell transformation assay
and the available information of a 2-year carcinogenicity
experiment in rats provide an acceptable database for the evaluation of
the carcinogenic potential of trioxane. No indications of a carcinogenic
potential were described and therefore further chronic testing
regarding carcinogenicity is not indicated from a scientific point of
view and by means of animal welfare.
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