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EC number: 701-315-2
CAS number: -
Table 1: Stimulation indices (SI)
BrdU labelling index (SI)
Ear punch weight (SI)
Ear thickness increase (%, TD3)
Ear thickness increase (%, TD6)
*Significantly increased compared to
negative control at p ≤ 0.01
TM - Test material (Karstedt concentrate)
TD - Test Day
Treatment with the test item at
concentrations of 10%, 25% or 50% revealed a dose-related increase in
the BrdU labelling index, but not exceeding the SI threshold value of
1.6. Hence, the test item is not considered a skin sensitiser.
No signs of erythema were observed at any
concentration. According to the study investigators, the "dose-related
increase of the ear weight and the increase of ear thickness at the
concentration of 50% may be caused by irritating properties of the test
item at higher concentrations".
No mortality, clinical signs or effects on
body weight were observed during the study.
The skin sensitising potential of 'Karstedt
concentrate' has been assessed in a GLP mouse local lymph node assay
(LLNA): BrdU-ELISA, conducted according to OECD Test Guideline 442B.
Following a preliminary range-finding study to assess irritancy, female
mice CBA/JN mice (5/group) were treated topically with 0, 10, 25 or 50%
Karstedt concentrate (in acetone/olive oil 4:1) on three consecutive
days (1, 2 and 3). On day 6, cell proliferation in the local lymph nodes
was measured by incorporation of injected 5-bromo-2-deoxyuridine (BrdU)
No mortality or clinical signs of toxicity
were observed. No signs of erythema were observed at any test
concentration (10-50%). At the highest tested concentration (50%),
increases in ear weight and ear thickness were observed, which the study
investigators suggest may be caused by local irritation (at higher
concentrations). The BrdU labelling index resulted in stimulation index
(SI) values of 1.236, 1.503 and 1.588 at test material concentrations of
10, 25 and 50% w/w, respectively. As such, a dose-related increase in
the BrdU labelling index (SI) was observed. However, none of the
corresponding SI values exceeded the threshold of 1.6. Positive and
vehicle controls performed as expected.
Therefore, under the conditions of this
study, Karstedt concentrate does not require classification for skin
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