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EC number: 420-380-5
CAS number: 136465-81-1
Ro 31 -9373/000 was tested in four strains of S. typhimurium
(TA97, TA98, TA100 and TA102) in a standard plate incorporation and
pre-inubation modification of the Ames test for mutagenic activity. The
test material was disolved in DMSO and administered at concentrations
ranging from 50 to 5000 ug/plate, in the presence or absence of
metabolic activation in the form of rat liver induced S-9. Ro 31
-9373/000 was not toxic up to the maximal concentration tested in the
standard plate incorporation assay but signs of toxicity were evident in
the pre-incubation assay at 1666 ug/ml.
No increase in the his+ revertants was evident, PTH-decahydroamide was
not found to be mutagenic under the conditions of this assay.
In a replicated assay to determine the effects of PTH-decahydroamide on
the induction of chromosomal aberrations in cultured peripheral human
lymphocytes, cultures were prepared with or without metabolic activation
(rat liver S-9 mix) and tested using concentrations of up to 1000 ug/ml
for 24 or 48 hour fixation periods. None of the concentrations evaluated
gave a postive response under the test conditions. Vehicle and positive
control cultures gave responses consistent with historical ranges and
met the acceptance criteria for the assay. PTH-decahydroamide was not
clastogenic under the conditions of this assay.
Both in vitro studies - a clastogenicity investigation with human
cultured peripheral lymphocytes and an Ames test using four strains of S.typhimurium
- gave negative responses for mutagenicity. No classification is
warranted for PTH-decahydroamide based on the available data.
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