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EC number: 439-210-6
CAS number: 554-62-1
PRELIMINARY IRRITATION STUDY
Based on preliminary results, a 0.2% test substance concentration was
selected for the intradermal induction in the Main Study, as it produced
moderate irritation (erythema score 3). A 50% concentration was selected
for the epidermal induction exposure.
No signs of irritation were observed to the highest test substance
concentration tested in the preliminary irritation study. Therefore, the
test site of all animals was treated with 10% SDS approximately 24 hours
before the epidermal induction in the main study, to provoke a mild
inflammatory reaction. A 50% test substance concentration was selected
for the challenge phase.
A. Induction phase
The skin effects caused by the intradermal injection and epidermal
exposure during the induction phase are given in Table 1.
The reactions noted in the experimental and control animals after the
epidermal induction exposure were considered to be enhanced by the SDS
B. Challenge phase
No skin reactions were evident after the challenge exposure in the
experimental and control animals (Table 2).
Toxicity / Mortality
No mortality occurred and no symptoms of systemic toxicity were observed
in the animals of the main study.
Body weights and body weight gain of experimental animals remained in
the same range as controls over the study period.
Table 1. Induction Readings.
A. 1:1 mixture of FCA(Freunds' Complete Adjuvant) and water for
B. A 0.2% test substance concentration (Experimental); vehicle (Control).
C. 1:1 mixture of FCA and a 0.4% concentration (Experimental) or vehicle
#. Test substance concent ti (Experimental); vehicle (Control).
Skin effects intradermal injections:
NA No abnormalities
E(.) Erythema (grade)
N( .) Signs of necrosis (mm in diameter)
Table2. Challenge readings
Assessment for contact hypersensitivity to phytosphingosine in the
albino guinea pig (maximisation test) was carried out according to OECD
406 'Skin Sensitisation' and in compliance with GLP.
Test substance concentrations selected for the main study were based on
the results of a preliminary study. In the main study, ten experimental
animals were intradermally injected with a 0.2% concentration and
epidermally exposed to a 50% concentration. In addition, five control
animals were similarly treated with the vehicle (corn oil) only
(negative control). Approximately 24 hours before the epidermal
induction exposure all animals were treated with 10% SDS. Two weeks
after the epidermal application all animals were challenged with a 50%
test substance concentrationl and the vehicle. No skin reactions were
evident after the challenge exposure in the experimental and control
No evidence was obtained that phytosphingosine had caused skin
hypersensitivity in the guinea pig, since no respones were observed in
the experimental animal in the challenge phase. This result indicates a
sensitisation rate of 0 percent. In conclusion, phytosphingosine was
considered not sensitsing to skin.
The study was considered reliable and adequate for hazard assessment of
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