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EC number: 696-364-9
CAS number: 133779-11-0
Buehler test was conducted to assess the contact hypersensitivity or
sensitizing potential of N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine
in guinea-pigs according to the EU Method B.6 and in compliance with
test and ten control animals were used. First the animals were exposed
to three topical induction doses (on Days 1, 8, and 15) of 0.5 mL of the
1% v/v test substance (0.3% a.i.) saturated in 20 x 20 mm patch of
surgical gauze (3 layers thick). The patch was sealed to the skin under
a 5 cm strip of “Blenderm” covered by elastic adhesive bandage
(“Elastoplast”) wound around the trunk and sealed with “Sleek”. Contact
was maintained for approximately 6 h for each induction exposure and the
reactions were noted 24 h after dressing removal. Control animals were
treated similarly to test animals with the exception of test substance
omission from the induction applications. Two
weeks after the final induction the control and test animals were
exposed to challenge doses of 0.5 mL of the 0.5% v/v test substance
(0.15% a.i.) test substance for 6 h under similar occlusive conditions
followed by evaluation after 24 and 48 h. Dermal reactions were scored
on a numerical system for oedema and erythema. Evaluations were
performed blind (i.e. the scorer had no knowledge of previous scores).
The animals were observed daily for clinical signs of toxicity and the
bodyweights were recorded on Day 1 (first day of topical application)
and on the last day of observations for the challenge.
dermal reactions were observed in 3/10 control animals at the 24-h
observation and 1/10 control animals at the 48-h observation, consisting
of varying dermal responses of erythema, oedema and dryness and
sloughing of the epidermis. 5/20 test animals at the 24-h observation
and 4/20 test animals at the 48-h observation exhibited very slight
erythema with or without very slight oedema and dryness and sloughing of
the epidermis. Two other test animals exhibited dryness and sloughing of
the epidermis only, at the 48-h observation. Hence, it was concluded
that none of the test animals showed a positive response.
the conditions of the Buehler study, the test substance was not
considered to be sensitising to the skin of guinea-pigs. Therefore, the
test substance is not classified as sensitising to skin according to the
criteria of EU CLP Regulation (1272/2008/EEC).
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