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EC number: 604-045-2
CAS number: 137862-53-4
Owing to a sensitization rate below 30%, classification of PBS 856 DS
according to Council Directive 67/548/EEC, Commission Directive
93/21/EEC for Classification, Labelling and Packaging of Dangerous
Substances, is not required.
After removal of the occlusive dressing on Day 10 after epidermal
induction, irritation at the application site was seen in all 20 guinea
pigs of the test group.
Epidermal challenge of 10 male and 10 female guinea pigs (test group)
resulted in positive responses in 1 female after 24 h and in 2 females
after 48 h, corresponding to a sensitisation rate of 10%. No skin
reactions were recorded for control animals.
Body weights were not affected by treatment with the test substance.
A guinea pig maximisation test was initiated to determine sensitising
properties of PBS 856 DS after challenge exposure by skin contact. The
procedure of Magnusson and Kligman for adjuvant tests was followed.
Epidermal challenge of 10 male and 10 female guinea pigs (test groups)
resulted in positive responses in 1 female after 24 hours and in 2
females after 48 hours, corresponding to a sensitisation rate of 10%. No
irritant skin reactions were recorded for control animals.
Body weights were unaffected by the treatment.
PBS 856 DS was graded as a mild sensitiser according to the Magnusson
and Kligman maximisation scale.
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