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EC number: 201-622-7
CAS number: 85-68-7
Santicizer 160 (butyl benzyl phthalate) was assessed for its skin sensitizing potential in humans using a repeated insult patch test method.
During the induction phase 200 healthy volunteers were exposed to 0.2 ml of the undiluted test substance applied to an occusive patch for 24 hours on fifteen separate occasions; after a 2 week period the same dose was applied as a challenge (24 -hour covered) to a new area of the skin. The skin was assessed for irritation after each induction exposure and for sensitization 0, 24, 48 and 72 hours after the challenge.
No evidence of sensitization (or irritation) was reported for any of the volunteers during the study.
Santicizer 160 (butyl benzyl phthalate) showed no skin sensitization (or irritation) potential in healthy human subjects in a repeated insult patch test.
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).
Migrated from Short description of key information:
Benzyl butyl phthalate (BBP) has shown no evidence of skin sensitisation potential in a human repeated insult patch test or in laboratory animal studies (a guinea-pig footpad test and two mouse ear swelling tests). Although none of these are guideline studies, all appear to be reliable with restrictions (reliability code 2).
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).
Data on butyl benzyl phthalate and other phthalate esters do not indicate a potential for respiratory tract sensitisation (Butala et al., 2004; Dearman et al. 2009). In addition, as the high-molecular-weight phthalates have provided no indication of skin sensitisation, a respiratory sensitising effect is considered unlikely. The low vapour pressures of these substances provide additional reassurance, as exposure by inhalation is likely to be minimal.
Based on the available data, BBP does not need to be classified as a
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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