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EC number: 203-052-4
CAS number: 102-77-2
The sensitisation potential of the test substance MBS was evaluated in a
guinea pig assay, a modification of the Buhler's method (Wang 1988). The
test substance was applied at a concentration of 5 % in petrolatum to
the shaved skin of guinea pigs (10 animals per dose group) for
induction. The test material was removed 24 h after application and
readings were performed 1h after removal of the test material. This
procedure was repeated 3 times a week for 2 weeks. Two weeks after the
final induction application, the challenge test was performed. The left
flank of the test animal was shaved, and 0.1 %, 0.5 % and 2 % dose
preparations of the test material were used for challenge. The test
material was removed 24 h after application and readings were performed
1 h, 24 h, 48 h and 7 d after removal of the test material. The test
substance induced a dose dependent sensitizing reactions at
concentrations of 0.5 % (5/10) and 2 % (10/10). No effects were noted at
the lowest concentration (0.1 %, 0/10).
Thus, the findings of the guinea pig assay indicated a sensitizing
potential of the test substance in animals.
The test substance MBS was evaluated in a human Repeated Insult Patch
test (modified Shelanski method) with 49 volunteers (Monsanto 1982). The
chemical was tested as a 75 % preparation in petrolatum. 200 mg of the
test substance was placed in contact with a selected site on the back of
each subject for 24 hours. Following this exposure, the test material
was removed and the reaction of the site of application was evaluated
and graded (score 0 through 4) by the clinical investigator. The test
material was applied in this manner for four consecutive 24 hour periods
each weak (monday through friday) for three consecutive weeks (induction
phase). Subjects were then allowed a two week rest period, during which
no exposures to the test material occurred. The sixth week was scheduled
for the challenge applications. Because of the large number of
panellists who had responded intensely to contact with the test
material, the investigator decided to terminate the test sample
applications. For the challenge applications, therefore, petrolatum
alone was applied in lieu of the test sample.
The test material elicited irritation in thirty-one individuals. This
was well over 50 percent of the panellists participating in this study.
Although minimal or moderate erythema was the extent of irritation in
seven of these individuals, the picture in the remaining twenty-four
individuals was quite different. In all of these individuals, intense or
very intense irritation, consisting of erythema, induration, weeping and
extension beyond the margin of the contact site, was observed. The
characteristics of these responses were consistent with that of a
Thus, after repeated treatment with the 75 % test substance preparation
24/49 volunteers showed an allergic reaction. Moreover, the allergic
potential of MBS preparations was confirmed in additional Repeated
Insult Patch Test with human volunteers (Monsanto 1986abc).
No data available.
The test substance MBS is classified as skin sensitizer according to the
classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).
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