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EC number: 232-092-5
CAS number: 7786-17-6
Table 1 Skin
Reactions in Sensitisation Test
Guinea pig Number
Challenge Dose Site
Diameter of wheal (mm)
Height of wheal (mm)
Degree of Erythema†
*Scored according to
of 0 to 4 for increasing intensity
The intracutaneous injections of the test material produced moderate
degrees of irritation. The first sign of irritation developed at the
third or fourth injection in most cases and was then apparent in all
However, the challenge injections produced less severe reactions than
the induction doses with none of the challenge sites flaring up as a
result of the challenge injections.
A skin sensitisation study was carried out to assess the potential of
the test material to induce a sensitising reaction in the albino guinea
pig. The study was carried out according to the method of Draize, as
published in the Food-Drug-Cosmetic Law Journal, 10, 679, (1955).
The test material was administered as a 0.1 % dilution and injected
intracutaneously. An initial dose of 0.05 mL was followed by nine
successive injections of 0.1 mL on alternate weekdays.
Following a rest interval of two weeks, a single challenge dose of 0.05
mL was administered.
The skin reactions were scored on the height and depth of any wheals
formed and the intensity of any erythema seen (on a scale of 0 to 4 for
It was seen that the induction intracutaneous injections produced
moderate degrees of irritation. However the challenge injections
produced less severe reactions. Therefore this test showed the test
material to be slightly irritating under the conditions of the study but
did not induce sensitisation.
In the key study, the potential of the test material to induce a
sensitising reaction in the albino guinea pig was assessed in accordance
with the method of Draize, as published in the Food-Drug-Cosmetic Law
Journal,10, 679, (1955). The study was performed to a good
standard with a sufficient level of reporting to assess the quality of
the submitted data, accordingly the study was assigned a reliability
score of 2 in line with Klimisch (1997).
The irritation observed in this study is in agreement with the findings
presented for dermal irritation, where slight reactions were observed
below the limits of classification.
According to the criteria outlined in Regulation (EC) No. 1272/2008 and
Directive 67/548/EEC, this substance does not meet the criteria for
classification as a skin sensitizer.
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