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EC number: 307-301-9
CAS number: 97593-01-6
a guinea pig maximization skin test, concentrations for the main study
were determined by “sighting tests” in which groups of guinea pigs were
treated with various concentrations of test material.
on the outcome of the “sighting tests”, a group of 15 female guinea pigs
were used in the main study with 10 serving as test animals and 5 as
the induction phase, immediately before treatment, on day 0, the animals
were clipped free of hair on the shoulder region and a row of three
injections comprised of 0.1 mL Freund's Complete Adjuvant plus isotonic
sodium chloride in the ratio 1:1, 100% of the test material, and a 50%
formulation of the test material 1:1 preparation of Freund's Complete
Adjuvant plus olive oil, on each side of the spine.A
week later (day 7), the scapular region of all test and control animals
was shaved and was brushed with a solution of sodium lauryl sulfate at
10% in thick vaseline, in order to create a local irritation. On
Day 8 the same area on the shoulder region was previously for
intradermal injetions was clipped again and treated with a topical
application of the test material formulation. The topical application of
the test material was 100% under occlusive dressing, which was kept in
place for 48 hours. The degree of erythema and oedema was determined 24
hours later after the patches were removed using the Draize scale (1977).The
induction of the control animals was performed identical to that used
for the test animals except that the test material was omitted from the
challenge phase applied the test material formulation at 12.5% in liquid
paraffin to the flanks of the each animal. The flanks were clipped free
of hair. The test material was applied to one side of the shorn flank of
each animal under occlusive dressing. To ensure that maximum
non-irritant concentration was used in the challenge phase, the test
material at a concentration of 6.25% (v/v) in liquid paraffin was also
similarly applied to a separate skin site on the opposite shorn flank of
the animals. These patches were also occluded to keep the test material
in contact with the skin. After a 24 hour contact period, the dressing
was carefully removed and the challenge sites were cleaned if required.
Approximately 24, and 48 hours after removal of the challenge dressing,
the degree of erythema and oedema was quantified using the Draize scale
(1977). Any other toxicologically relevant reactions were also noted.
the preliminary sighting tests no skin reactions were noted at the
intradermal induction sites following treatment with the test material
at concentrations of 100%, 50%, 25%, 12.5%, 6.25% and 3.125%. The
concentration chosen for use in the Intradermal Induction phase of the
main test was 100%. Well defined erythema was noted at the topical
induction sites of the preliminary sighting test after treatment with
100% test material concentration. Slight erythema was noted at the test
site for the 50% test material concentration as well as at 25% test
material concentration. No skin reactions were noted at the topical
induction sites for the 12.5% test concentration sites. No skin
reactions were noted at the topical challenge sites of the preliminary
sighting test animals following treatment with the test material at
concentrations of 12.5%, 6.25%, 3.125% and 1.56%.
No skin reactions were noted at the topical
challenge site of the 6.25% or 12.5% in liquid paraffin test or control
group animals at the 24 and 48 -hour observations.
topical challenge, no skin reactions were noted at the challenge sites
of the test or control animals at the 24 and 48 hour observation period.
Animal body weight increases were
comparable to those noted in the control group over the course of the
study. Based on these results, the
study authors concluded that test material produced a 0% (0/10)
sensitization rate in the female albino guinea pigs.
a Klimisch score of 1 and was classified as reliable
without restriction because the study was conducted similar
to OECD 406 testing guidelines and is GLP compliant.
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