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EC number: -
CAS number: -
A GLP-compliant local lymph node assay in mice was performed according
to OECD 429 to evaluate the sensitising potential of the test substance
(Lütkenhaus, 2012). Based on a preliminary test in two female
CBA/CaOlaHsd mice, the test substance at the maximum technical
achievable concentration of 25% (w/v) in 4:1 (v/v) acetone/olive oil
(AOO) and further dilutions of 12.5 and 6.25% (w/v) in AOO were selected
as treatment concentrations for the main study. During the study period,
no clinical signs of toxicity were observed and all animals showed the
expected weight development compared to control animals. The mean
DPM/lymph node for each test group was 598.3, 3960.9, 3446.0 and 3200.7
at concentrations of 0, 6.25, 12.5 and 25% (w/v) of the test substance,
respectively. Based on these data, the mean stimulation indices (SI)
relative to the negative control were calculated to be 6.6, 5.8 and 5.2
after treatment with 6.25, 12.5 and 25% (w/v) of the test substance,
respectively. Since no conventional dose-response-relationship was
followed, the EC3 value for the test substance could not be derived by
linear extrapolation. The historical positive control p-phenylendiamine
(1% in AOO) confirmed the sensitivity and reliability of the
experimental technique (SI ≥ 3). Based on the results of this study, the
substance is considered to be a skin sensitiser.
Based on the available data on skin sensitisation, the test substance
meets the criteria for classification as skin sensitiser category 1
(H317) according to Regulation (EC) No 1272/2008 and Xi (R43) according
to Directive 67/548/EEC.
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