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EC number: 201-622-7
CAS number: 85-68-7
Santicizer 160 (BBP) showed no skin sensitisation potential in a human
repeated insult patch test. During the induction phase, 200 healthy
volunteers were exposed to 0.2 ml of the undiluted test material applied
to an occlusive patch for 24 hours on fifteen separate occasions; after
a 2 -week period, the same dose was applied as a challenge (24 -hour
covered contact) to a new area of the skin. The skin was assessed for
irritation after each induction exposure and for sensitisation 0, 24, 48
and 72 hours after the challenge. No evidence of sensitisation was
observed by the investigators or reported by any of the volunteers
during the study (Shelanski, 1980).
In a reliable study, no skin sensitisation was seen in guinea pigs after
intradermal induction and epicutaneous challenge with BBP.
Two other reliable studies, both ear swelling tests involving
epicutaneous administration of BBP to the skin of AKR and BALB/c mice
and subsequent challenge application to the ears, showed no evidence of
skin sensitisation (Little, 1983b,c).
The potential for respiratory tract sensitisation by butyl benzyl
phthalate (BBP) and certain other phthalate esters (DEHP, DINP and
di-isohexyl phthalate) was investigated in B6C3F1 mice using an
experimental procedure developed by Dearman et al., 1992 (J. Appl.
Toxicol. 12(5), 317 -323). Repeated dermal applications of these four
phthalates did not increase serum levels of IgE or of the interleukins
IL-4 or IL-13, in contrast to the effects observed with the known
respiratory sensitiser, trimellitic anhydride. Based on these results,
it was concluded that these phthalates "have little, if any, potential
to produce antibody-mediated respiratory allergy" (Butala et al., 2004).
Based on the available data, BBP does not need to be classified as a
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