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EC number: 944-855-6
CAS number: 199445-85-7
Table 2 Main Test Skin Reaction Scores
Test item Concentration - hours after challenge
12.5 % v/v - 24 h
12.5 % v/v- 48 h
6.25 % v/v- 24 h
6.25 % v/v- 48 h
1.0 % v/v- 24 h
1.0 % v/v- 48 h
0.2 % v/v- 24 h
0.2 % v/v- 48 h
Table 3 Bodyweights of Test Animals
Table 3 Bodyweights of Control Animals
The skin sensitisation potential of the test substance
was assessed in guinea pig using the Beuhler method similar to EU Method
B.6 and GLP.
In a preliminary test, 4 guinea pigs were exposed to 100,
50, 25 and 12.5 % v/v concentrations of the test substance (prepared in
ethanol). An aliquot (0.5 mL) of the test solution was applied by way
of a 2 cm patch secured to the animal at one of four sites on the back
of the animal. Patches were removed after 6 h contact. Animals were
examined after 24 and 48 h under a standard light to comply with the
requirements of BS 950 Part 1. Presence of erythema and/or oedema was
recorded using a point scoring system. A test concentration of 25 % v/v
was selected for application in the main test as it was the lowest
concentration tested that elicited a response.
Twenty individuals within the weight range 400 - 478 g
were selcted for the main test, 10 of which were allocated as control
animals and the remaining 10 as test animals. On the first day of the
test a 0.5 mL aliquot of the test solution (25 % v.v, prepared in
ethanol) was applied to the shoulder region of each of the test animals
by way of a 2 x 2 cm patch. The patch was occluded using surgical tape
and covered using and elastic bandage. The dressings were removed after
6 h contact time. The dosing process was repeated weekly for a total of
3 weeks (Day 1, 8 and 15) during which time the control animals were
left untreated. The challenge test was conducted on Day 29, after a two
week rest period. Test solutions prepared at 12.5 % v/v and 6.25 % v/v
(prepared in ethanol) were applied, as previously described, to the left
and right flanks of each test animal. The control animals were left
untreated. The contact patches were removed after 6 h contact time.
Animals were examined visually 24 h and 48 h after test item application
for erthema or oedema. A second challenge test was conducted 5 days
after completion of the first challenge test by applying test solutions
of concentration 1.0 % v/v and 0.2 % v/v to virgin sites on the flanks
of each of the test animals. The procedures applied were the same as
those employed for the first challenge test. During visual assessment
animals were scored on two indices, incidence and severity.
During the observation period nine test animals exhibited
responses following the challenge application of 12.5 and 6.25 % v/v
solution that equated to a reaction score of 1 or greater. No response
was observed in the control animals or test animals when treated at 1.0
and 0.2 % v/v.
It was concluded that the test substance produced a
delayed dermal hypersensitivity in the guinea pig at concentrations ≥
6.25 % v/v.
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