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EC number: 701-008-3
CAS number: -
No skin sensitisation data are available on
S278. The structurally related compound, Santicizer 160 (butyl benzyl
phthalate, 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 (Product Investigations Inc, 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 (Washington University School
of Medicine, 1983b,c).
No respiratory sensitisation data are
available on S278. However, 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). 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). It
is expected that a similar conclusion can be drawn for phthalates with a
higher molecular weight (such as S278).
A more recent study by Dearman et al. (2009)
assessed the strength of immune responses induced in BALB/c mice
immunised subcutaneously with the reference allergen ovalbumin, when
they received a concurrent topical application of BBP. When the BBP was
applied either near to or distant from the site of ovalbumin
immunisation, it had no impact on anti-ovalbumin IgE antibody responses.
However, when applied at the same site as the immunisation, the high
dose of BBP (100 mg) did produce a modest increase in anti-ovalbumin
IgG1 antibody production, in the absence of any effect on IgE antibody
production. The investigators concluded that "the doses of phthalate
[BBP] encountered in the home environment are unlikely to be a major
factor contributing to the increased incidence of asthma and allergy in
the developed world".
Based on the available data on other
phthalates, S278 does not need to be classified as a sensitiser.
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