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EC number: -
CAS number: -
No abnormal clinical signs or lymph node weight or body weight were
observed in any of the animals throughout the study period.
The sensitisation potential of E-C104 was assessed in 30 female mice
using the LLNA study performed according to OECD 429. E-C104 was
suspended in a mixture of acetone/olive oil (4:1) to make three
concentrations of test substance: 5, 15 and 50 w/v%. HCA 25 v/v% was
used as positive control and the vehicle was used as negative control.
The SI values were 0.77, 0.44 and 0.53 in the 5, 15 and 50 w/v% test
substance groups, respectively. The SI value of HCA was 2.85, was
slightly less than the criterion (SI value>3). However, the negative
control showed very high dpm values compared to the historical control
data, resulting in a lower SI value for the positive control. In
addition, the test groups would still have an SI<3 and no dose related
increase is observed. Therefore, the study is considered valid. No
abnormalities in body weight, lymph node weight or clinical signs were
observed in any of the animals. From the results, it is concluded that
E-C104 has no sensitisation potential under the conditions of this study.
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