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EC number: 202-617-2
CAS number: 97-90-5
a 78 weeks dermal carcinogenicity study, TREGDMA (91% a.i.) was applied
to the clipped interscapular region of the back of 70 maleC3H/HeNHsd
mice/dose at dose levels of 5, 25 and 50% TREGDMA in acetone,
corresponding to approx. 100, 500 and 1000 mg/kg bw/d. Untreated
and acetone-treated control groups were used as controls.The
doses were applied in 50 µL/animal/day 5 days per week.
treatment of male mice with TREGDMA did not result in any
treatment-related changes in hematology, clinical chemistry, body
weights or weight gain. There was a significant increase in mortality in
the 50% TREGDMA dose group compared to the control groups.However,
there were no clinical or histological effects to which the increased
mortality could be attributed, and it was uncertain whether test
substance related toxicity was directly responsible.
dose-related increase in kidney weight was observed in the 25 and 50%
dose groups at the terminal sacrifice. However, there were no
correlating microscopic findings in the kidneys and the biological
significance of the increase in weight was uncertain.
signs of irritation, consisting primarily of exfoliation were observed
in all dose groups. The time of onset, incidence, and severity of
exfoliation were related to dose.
mean measured rate of epidermal basal cell proliferation of the mid and
high dose groups was consistently increased compared to both control
groups at each measurement. There was no relationship between chronic
inflammation of the skin and cell proliferation and the induction of
skin tumors in normal mouse skin after 78 weeks of treatment although
there was evidence of irritation and cell proliferation throughout the
was no indication of carcinogenicity at any dose level.
NOAEL for local effects was 5% (approx. 100 mg/kg bw/d). Taking into
account the increased mortality and effects in the kidneys in the high
dose group the systemic NOAEL is 25% (approx. 500 mg/kg bw/d).
For EGDMA and its first metabolite HEMA there are two important
pieces of information in this study: The progression of lesions over
time does not exceed the additional safety factors applied for shorter,
in this case subacute, studies. Secondly, dimethacrylate functionality
does not indtroduce other toxicological alerts which are not covered by
the existing studies.
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