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EC number: 603-837-5
CAS number: 134605-64-4
The study was performed to assess the skin sensitisation
potential of the test material in Crl :(HA)BR male guinea pigs following
the guinea pig maximisation method. The study was performed to GLP and
the method was designed to meet the requirements of EPA OPP 81-6 and
equivalent methodology to OECD Guideline 406 and EU Method B.6. In a
preliminary skin irritation screening test in 4 test animals were
treated with the test material at concentrations of 1%, 10%, 15%, and
25% w/w in petrolatum and were applied to the shaved backs for a period
of 24 hours. The test material caused no dermal reaction in any animal
at any concentration and was therefore administered as a 25% w/w mixture
in petrolatum for the topical induction application and for the
challenge phase in the definitive study. In the main study, a group of
45 test animals (20 test animals treated with test material, 10 animals
serving as an irritation control, 10 animals serving as a positive
control and 5 animals serving as a positive control-irritation control)
received induction doses by intradermal injection and topical
application. The intradermal injections were made within the boundaries
of a 2 -cm x 4 -cm area, one row of three injections on each side of the
midline. Each animal received the following: anterior sites: 0.1 ml of a
1:1 dilution of Freund's Complete Adjuvant in sterile water; medial
site: 0.1ml test material in Freund's Complete Adjuvant in sterile water
/ positive control in sterile water in Freund's Complete Adjuvant /
vehicle in Freund's Complete Adjuvant. On Day 7 test animals backs were
shaved and pretreated with a 10% w;w sodium lauryl sulfate (SLS)
suspension in petrolatum before the topical induction application. A 25%
w/w mixture of test material in petrolatum, a 25% w;w mixture of
sulfathiazole (positive control substance) in petrolatum, or petrolatum
was applied over the injection sites of the animals in the respective
groups. The patches were covered with overlapping strips of BlendermN
tape and secured by an overwrap of Elastoplast® tape wound around the
trunk and remained in place for 48 hours. 2 weeks after the topical
induction, a topical challenge dose was applied. A 25% w/w mixture of
test material in petrolatum and petrolatum alone or a 10% w/w mixture of
sulfathiazole in petrolatum and petrolatum alone were applied to the
backs of the test animals. The filter paper containing the test or
positive control material mixture was placed on the right side and the
filter paper containing petrolatum alone was placed on the left side of
each animal. The patches were sealed for 24 hours under occlussive
dressing. Twenty-four hours after application, the wrappings were
removed and the test sites wiped clean with wet disposable paper towels.
The test sites were closely shaved approximately 3 hours before the
24-hour challenge observation.
None of the test animals exhibited a dermal reaction to
the challenge application of the test or control materials. All animals
of the positive control group exhibited slight to moderate sensitization
reactions on the test sites treated with sulfathiazole and no dermal
reactions on the test sites treated with petrolatum alone. None of the
animals in the positive control-irritation control exhibited a dermal
reaction to the challenge application of sulfathiazole or petrolatum.
Based on these results, the test material is not considered to be a skin
sensitizer in guinea pigs.
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