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EC number: 943-030-8
CAS number: -
OECD 406, GPMT; Not Skin Sensitiser
Skin sensitisation potential was evaluated
in an experimental study according to the Guinea Pig Maximisation Test
(GPMT), comparable to the OECD Guideline 406 (1981). A separate,
preliminary study found that the test item was non-irritant to skin, so
the following test concentrations were determined as appropriate: 5.0 %
(w/v) in distilled water and in adjuvant for induction by intradermal
injection; and 25 % (w/v) in distilled water for induction by topical
induction and for the challenge applications.
Induction: 10 male and 10 female
guinea pigs were administered 3 pairs of 0.1 ml intradermal injections
along the side of a 4 x 6 cm area on the clipped shoulder region. The
three pairs of injections contained the following: 1. 0.1 ml 5.0 % (w/v)
test item in distilled water; 2. 0.1 ml Complete adjuvant (50 % v/v in
water); 3. 0.1 ml 5.0 % (w/v) test item emulsified in 50 % (v/v)
Complete adjuvant. An additional 5 male and 5 female control guinea pigs
were administered three pairs of injections containing: 1. 0.1 ml
distilled water; 2. 0.1 ml Complete Adjuvant (50 % (v/v) in water); 3.
0.1 ml Complete Adjuvant (50 % (v/v) in water. One week later, the same
region was re-clipped and a 2 x 4 cm patch of Whatman No. 3 filter
paper, saturated in 25 % (w/v) test item (test group) or vehicle
(control group), was secured using overlapping occlusive tape for 48
Challenge: Two weeks later, the
flanks of test and control animals were clipped (5 x 5 cm area). 2 x 2
cm patch of filter paper saturated with 25 % test item was applied to
the left flank, and another saturated with distilled water to the right
flank, with overlapping occlusive tape for 24 hours, at which time the
dressing was removed. Skin reactions were recorded 24 and 48 hours after
the dressing was removed.
Skin sensitiser means a substance that
will lead to an allergic response following skin contact. Sensitisation
includes two phases: the first phase is induction of specialised
immunological memory in an individual by exposure to an allergen. The
second phase is elicitation, i.e. production of a cell-mediated or
antibody-mediated allergic response by exposure of a sensitised
individual to an allergen. For respiratory sensitisation, the pattern of
induction followed by elicitation phases is shared in common with skin
sensitisation. For skin sensitisation, an induction phase is required in
which the immune system learns to react; clinical symptoms can then
arise when subsequent exposure is sufficient to elicit a visible skin
reaction (elicitation phase). As a consequence, predictive tests usually
follow this pattern in which there is an induction phase, the response
to which is measured by a standardised elicitation phase, typically
involving a patch test. Usually, lower levels are necessary for
elicitation than are required for induction.
The Guinea Pig Maximisation Test (GPMT) is
a two-phase, in vivo sensitisation test involving initial
intradermal injection of the substance and an adjuvant and subsequent
epidermal exposure to evaluate sensitisation potential in guinea pigs
which may be applicable to humans. A significant skin sensitising effect
following the GPMT is defined as "redness (score ≥ 1) in ≥ 30% of the
test animals", according to the CLP Classification Criteria (EC
According to the CLP Regulation (EC
1272/2008), substances showing (a) a high frequency of occurrence in
humans and/or (b) a high potency in animals can be presumed to have the
potential to produce significant sensitisation in humans. Specifically,
a substance shall be classified as a Category 1A: Skin Sensitiser
if 30 % or more of test animals respond to an intradermal induction
concentration of ≤ 0.1 %, or if 60 % or more of test animals respond to
a concentration > 0.1 % to ≤ 1 %, in a GPMT.
Substances showing (a) a low to moderate
frequency of occurrence in humans and/or (b) a low to moderate potency
in animals can be presumed to have the potential to produce
sensitisation in humans. Specifically, a substance shall be classified
as a Category 1B: Skin Sensitiser if at least 30 % but < 60 % of
test animals respond to an intradermal induction concentration of > 0.1
% to ≤ 1 %, or if 30 % or more test animals respond to a concentration
of > 1 %, in a GPMT.
Substances shall be classified as Category
1: Skin Sensitisers where data are not sufficient for
sub-categorisation in accordance with the following criteria: (a) if
there is evidence in humans that the substance can lead to sensitisation
by skin contact in a substantial numer of persons; or (b) if there are
positive results from an appropriate animal test. This may include
positive data from patch testing, normally obtained in more than one
dermatology clinic, epidemiological studies showing allergic contact
dermatitis caused by the substance (situations in which a high
proportion of those exposed exhibit characteristic symptoms are to be
looked at with special concern, even if the number of cases is small),
positive data from appropriate animal studies, positive data from
experimental studies in man, and/or well documented episodes of allergic
contact dermatitis (normally obtained in more than one dermatology
clinic). The severity of the reaction may also be considered.
No test or control animals responded to an
intradermal induction concentration of 5.0 % test item followed by a
subsequent dermal application challenge of 25 % test item in the Guinea
Pig Maximisation Test (GPMT); therefore, the substance cannot be
considered a Skin Sensitiser, and therefore no classification is
warranted according to the CLP Regulation (EC 1272/2008).
Based on the read across considerations
same results apply to the target substance
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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