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EC number: -
CAS number: -
Clinical Observations and Mortality Data
There were no deaths. No signs of systemic
toxicity were noted in the test or control animals during the test. Red
coloured staining of the ears and fur was noted post dose on Days 1 to 3
in all test animals.
Bodyweight changes of the test animals
between Day 1 and Day 6 were comparable to those observed in the
corresponding control group animals over the same period.
Introduction. A study was performed
to assess the skin sensitisation potential of the test material in the
CBAlCa strain mouse following topical application to the dorsal surface
of the ear. The method was designed to meet the requirements of the
• OECD Guideline for the Testing of
Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted
24 April 2002)
• Method B42 Skin Sensitisation (Local Lymph
Node Assay) of Commission Regulation (EC) No. 440/2008
• United States Environmental Protection
Agency Health Effects Test Guidelines OPPTS 870.2600 Skin Sensitisation
Methods. Following a preliminary
screening test in which no clinical signs of toxicity were noted at a
concentration of 25% w/w, this concentration was selected as the highest
dose investigated in the main test of the Local Lymph Node Assay. Three
groups, each of five animals, were treated with 50 µl (25 µl per ear) of
the test material as a solution in ethanol/distilled water 7:3 at
concentrations of 25%, 10% or 5% w/w. A further group of five animals
was treated with ethanol/distilled water 7:3 alone.
Results. The Stimulation Index
expressed as the mean radioactive incorporation for each treatment group
divided by the mean radioactive incorporation of the vehicle control
group are as follows:
Concentration (% w/w) in
ethanol/distilled water 7:3
Conclusion. The test material was
considered to be a non-sensitiser under the conditions of the test.
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