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EC number: 610-522-6
CAS number: 503155-49-5
Based on the result obtained from the
studies available for the structurally similar read across chemicals, it
can be concluded that the test chemical cannot cause skin sensitization
and thus cannot be considered as skin sensitizing.
Table 1: Patch test results
No of patients tested
4548 -53 -2(2% petrolatum)
In different studies, the given test
chemical has been investigated for the skin sensitization potential to a
greater or lesser extent. The studies are based on in-vivo experiments
conducted in humans which have been summarized as below -
Draize-Shelanski repeated insult patch
test was conducted on 200 human subjects to assess the skin
sensitization potential of the test chemical .In this study, the
chemical applied to the subject’s volvar forearms (200 subjects) as an
aqueous solution for 10 alternate days, for 24-hour periods, followed by
a 14-day rest period. Challenge batches were then applied under
occlusion to fresh skin sites on the subjects scapular backs for 24
hours. The color did not produce either irritation or allergic responses
during the induction phase nor contact dermatitis in the challenge
period. Therefore the test chemical was considered to be not sensitizing
in a Draize-Shelanski repeated insult patch test conducted on 200 human
The above study is supported with
another sensitization study conducted for the test chemical to
determined sensitization potential by performing patch tests on humans.
2% test chemical in petrolatum was applied in Finn Chambers to the skin
of 52 patients. The reactions were first read at 2 or (more commonly) 3
days and again at 4–7 days. The reactions of the patients were graded as
‘? + ‘, ‘+’ and ‘++’ categories 16 patients were tested with the dye.
1/52 showed questionable reactions, 2 patients showed + reactions and no
reactions were observed in the remaining patients. Hence, the test
chemical can be considered to be not sensitizing to skin.
on the result obtained from the studies available for the structurally
similar read across chemicals, it can be concluded that the test
chemical cannot cause skin sensitization and thus cannot be considered
as skin sensitizing.
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