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EC number: 201-545-9
CAS number: 84-61-7
The potential of the test item,
DICYCLOHEXYLPHTHALATE, to cause skin sensitisation reactions following
topical application to the skin of CBA/JN(CBA/J) mice, was assessed
using the LLNA:BrdU-ELISA method, according to the OECD Guideline for
testing of chemicals no. 442b.
Five concentrations (25, 10, 5, 2.5,
1% w/w in acetone:olive oil 4:1 (v/v), the highest being selected on the
basis of a preliminary solubility test) were selected to be used in the
preliminary phase, to identify a non toxic and minimally irritant
concentration in order to avoid false positive results.
No toxicity signs (clinical signs or
toxicologically relevant body weight losses) were observed at any
concentration tested. According to the results of the irritation
screening, the concentration judged as minimally irritant was 10% w/w.
In the main assay, the test item was
topically administrered at the concentrations of 10, 5 and 2.5% w/w, in
acetone:olive oil 4:1 (v/v).No mortality or toxicologically relevant
clinical signs were recorded in animals treated at all dose levels.
Changes in body weight observed during the study were within the
expected range for this strain and age of animals.
Increases in cell proliferation of
draining lymph nodes were observed in the three test item treated
groups. The calculated stimulation indices were equal to 2.22, 2.82 and
1.94 respectively at low, mid- and high dose level.
The variations were statistically
significant at the low and mid- dose levels but not at the high dose
No dose response relationship was
stimulation index (SI) values at the three concentrations were slightly
over the threshold of 1.9 for a positive result as established in the
relevant guideline. Therefore, the results obtained in this study
indicate that the test item
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