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EC number: 220-020-5
CAS number: 2605-79-0
Gonadal tissues were not examined for gross pathology or histopathology
for this study.
This preliminary study was conducted to obtain toxicity and mortality
data on two test substances (UDL-1379 and UDL-1380, dodecyl dimethyl
amine oxide) for use in setting dose levels in a subsequent chronic
study. In the first study the test substances were administered dermally
to four groups of Charles River ICR Swiss mice at dosage levels of 5%,
10%, 15%, and 20% dodecyl dimethyl amine oxide for three weeks. Based on
the severity and high incidence observations from the first study a
second study was conducted with three groups of Charles River ICR Swiss
mice at dosage levels of 0.5%, 1.0%, and 2.0% for four weeks.
The parameters monitored were body weight, mortaility, and clinical
observations. In the first study, after the first week the negative
control group gained weight and all of the test groups lost weight. Over
the next two weeks there was a slight weight gain in the negative
control and all of the test groups. After five dermal applications all
of the animals at the 5% and 10% dose levels of both test substances
UDL-1379 and UDL-1380 showed slight to moderate irritation. The skin
irritation was so severe at dosage levels of 15% and 20% for both test
substances that the dermal applications were discontinued. After two
additional dermal applications (total of 7 applications) all of the
animals at the 5% and 10% dose levels of both test substances showed
severe irritation and other signs of compound toxicity including arched
spine and unkempt fur. Due to the severity and high incidence of the
observations, dermal applications were discontinuted in these groups.
Scar tissue was observed at dosage levels 10%, 15%, and 20% for test
substance UDL-1379 and all dosage levels for test substance UDL-1380.
None of the control group died during the study. Several mice died at
all dosage levels for both test substances.
In the second study, after the first week the negative control group and
test groups gained weight except for the male in group 6 (1.0%
UDL-1380). Over the next three weeks all groups had a slight weight
gain. After four weeks of the dermal applications the control group,
three out of thirty animals were observed with unkempt fur. For the 0.5%
UDL-1379 test group two out of thirty animals were observed with unkempt
fur. Scabs on the dorsal skin and unkempt fur were observed in the
remaining test groups (1.0% & 2.0% UDL-1379 and 0.5%, 1.0% & 2.0%
UDL-1380). None of the control group or 0.5% and 1.0% dose UDL-1379 and
UDL 1380 test groups died during the study. One animal died at 2.0% for
test substance UDL-1379 and 4 at 2.0% for test substance UDL-1380. The
second study indicated that UDL-1379 at concentrations of 2.0% induced
minimal effects in treatment area of dorsal skin. The death of one
animal in this group may have been caused by the compound. UDL-1380 at
concentrations of 2.0% caused mortality in 4 mice and some dermal and
systemic effects in 10 of 30 mice.
A LOEL of 2% and a NOAEL of 1% dodecyl dimethyl amine oxide was
determined for the study.
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