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EC number: 700-957-0
CAS number: -
The skin sensitising potential of Y-15866 was investigated in a
Local Lymph Node Assay (LLNA) in mice according to OECD guideline 429
and in compliance with GLP (Vogel, 2010). Based on a preliminary test in
two female CBA/CaOlaHsd mice, the undiluted test substance (100%) and
dilutions of 25 and 50% (w/v) of the test substance in dimethylformamide
(DMF) were selected as treatment concentrations for the main study. In
this experiment, 5 female CBA/CaOlaHsd mice per test group were treated
with the undiluted or diluted test substance or vehicle alone,
respectively. The test substance formulations or the vehicle were
applied on the external surface of each ear (25 µL/ear) for three
consecutive days. Five days after the first topical application, the
cell proliferation of pooled lymph nodes from individual animals was
measured by incorporation of ³H-methyl thymidine and expressed as the
amount of radioactive disintegration per minute (DPM). The mean
DPM/lymph node for each test group was 520.8, 784.6 and 1450.2 at
concentrations of 25, 50 and 100% of the test substance, respectively.
Treatment with the undiluted test substance (100% concentration)
resulted in a statistically significant increase in DPM/lymph node
(1450.2) compared to control values (DPM/node = 305.3) and showed a
clear dose-response relationship. Based on these results, stimulation
indices of 4.75, 2.57 and 1.71 were calculated for the treatment
concentrations of 100%, 50% and 25%, respectively. The estimated
concentration for a stimulation index of 3 (EC3) was 59.9%. No local or
systemic toxicity and no effects on body weights were observed. The
historical positive control hexyl cinnamic aldehyde confirmed the
sensitivity and reliability of the experimental technique (SI ≥ 3).
Under the above mentioned conditions, the test substance was found to be
a sensitiser in the LLNA.
The available data on the skin sensitising potential of Y-15866
meet the criteria for classification as Skin Sens. 1B (H317) according
to Regulation (EC) 1272/2008 and as Xi (R43) according to Directive
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