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EC number: 629-732-4
CAS number: 1224966-13-5
The potential of the test substance BASE 136
(batch No. AB77l) 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/S4/EEC, B.6, 30 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:
complete adjuvant (FCA) diluted at 50% with 0.9% NaCl (both groups),
substance at the chosen concentration in the chosen vehicle (treated
group) or vehicle alone (control group),
substance at the chosen concentration in a mixture FCA/0.9% NaCl 50/50
(treated group) or vehicle at the concentration of SO% in a mixture
FCAl/0.9% NaCl 50/50 (control group).
On day 8, the test substance (treated group)
or the vehicle (control group) was applied topically to the same test
site, which was then covered by an occlusive dressing for 48 hours.
On day 22, all animals of the treated and
control groups were challenged by a cutaneous application of the test
substance to the right flank. The left flank served as control and
received the vehicle only. Test substance and vehicle were maintained
under an occlusive dressing for 24 hours.
Skin reactions were evaluated approximately
24 and 48 hours after removal of the dressing.
Test substance concentrations were as
Induction (treated group)
injections (day 1): BASE 136 at the concentration of 0.1% (w/w) in
sterile isotonic saline solution (0.9% NaCl),
application (day 8): BASE 136 at the concentration of S% (w/w) in
sterile isotonic saline solution (0.9% NaCl).
Challenge (all groups)
application (day 22): BASE 136 at the concentration of 1% (w/w) in
sterile isotonic saline solution (0.9% NaCl).
At the end of the study, animals were killed
without examination of internal organs.
Skin samples were taken from the challenge
application sites of all the animals.
No histological examination was performed.
No clinical signs and no deaths related to
treatment were noted during the study.
These results on Fatty acids C16-18, C18
unsat reaction products with tetraethylenepentamine are fully valid for
Tall oil, reaction products with tetraethylene-pentamine
(Amidoamine/Imidazoline) as both substances have the same fatty acid
distribution and both used TEPA as starting material.
After the challenge application, no relevant
cutaneous reactions were observed in the animals of the control group.
In the treated group, a discrete or moderate
erythema was noted in all animals. An oedema was recorded in 11/19
animals. Dryness of the skin and/or crusts were observed all animals.
The observed cutaneous were attributed to delayed contact
Under our experimental conditions and
according to the maximization method of Magnusson and Kligman, the test
substance BASE 136 (batch No. AB771) induces delayed contact
hypersensitivity in 19/19 (100%) guinea pigs.
results lead to classification according to CLP (ATP 2): Skin sensitiser
Cat.1A (GPMT ≥ 30% positive at ≤ 0.1% i.d. induction)
This study on Fatty acids C16-18, C18 unsat
reaction products with tetraethylenepentamine is valid for the
evaluation of Tall oil fatty acids, reaction products with
polyethylenepolyamines (Amidoamine/Imidazoline). All
substances within the AAI group show the same reactive groups, show
similar composition of amide, imidazoline, and some dimer structures of
both, with the length of original EA amines used for production as
biggest difference. Inherent reactivity and toxicity is not expected to
differ much between these substances, aspects which determine
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