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EC number: 246-807-3
CAS number: 25307-17-9
substance was not soluble in 0.9% NaCl: two phases were observed.
vehicle chosen for intradermal injections was corn oil: a solution was
obtained at the concentration of 25%; the dosage form preparation at the
concentration of 25% (w/w) passed freely through a needle and into the
topical applications, the vehicles used were a mixture ethanol/water
(80/20) for the induction phase and acetone for the challenge
application: solutions obtained whatever the proportion.
local reactions at the intradermal injection sites were noted in a few
animals of the treated group, between days 21 to 25.
systemic clinical signs and no mortality were observed during the study.
weight change of treated animals was similar to that of controls.
The potential of the
test item (Z)
-2,2’-(Octadec-9-enylimino) bisethanol CAS 13127-82-7
to induce delayed contact hypersensitivity was evaluated in guinea pigs
according to the maximization method of Magnusson and Kligman and to
OECD (No. 406, 17th July 1992) and EC (96/54/EEC, B.6, 30th July 1996)
guidelines. The study was conducted in compliance with the principles of
Good Laboratory Practice Regulations.
Thirty guinea pigs
were allocated to two groups: a control group of five males and five
females and a treated group of ten males and ten females. On day 1,
three pairs of intradermal injections were performed in the
interscapular region of all animals:
• Freund's complete
adjuvant (FCA) diluted to 50% (v/v) with 0.9% NaCl (both groups),
• test item at the
concentration of 0.1% in corn oil (treated group) or vehicle alone
• test item at the
concentration of 0.1% in a mixture FCA/0.9% NaCl (50/50, w/w) (treated
group) or vehicle at the concentration of 50% (w/v) in a mixture
FCA/0.9% NaCl (50/50, v/v) (control group).
On day 8, the animals
of the treated group received a topical application of the test item at
the concentration of 10% (w/w) in ethanol/water (80/20) to the same test
site, which was then covered by an occlusive dressing for 48 hours. The
animals of the control group received an application of the vehicle
under the same experimental conditions.
On day 22, all animals
of both groups were challenged by a cutaneous application of the test
item at the concentration of 1% (w/w) in acetone to the right flank. The
test item was maintained under an occlusive dressing for 24 hours. The
vehicle was applied to the left flank under the same experimental
conditions. Skin reactions were evaluated approximately 24 and 48 hours
after removal of the dressing.
At the end of the
study, the animals were killed without examination of internal organs.
No skin samples were taken from the challenge application sites. No
histological examination was performed.
No systemic clinical
signs and no deaths were noted during the study. No relevant cutaneous
reactions were observed after the challenge application.
Under the experimental
conditions and according to the maximization method of Magnusson and
Kligman, the test substance (Z)
-2,2’-(Octadec-9-enylimino) bisethanol CAS 13127-82-7d
oes not induce delayed contact hypersensitivity in guinea pigs.
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