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EC number: 271-089-3
CAS number: 68515-47-9
The High Molecular Weight Phthalate Ester (HMWPE) Category consists of
phthalate esters with an alkyl carbon backbone with 7 carbon (C7) atoms
or greater. The category is formed on the principle that substances of
similar structure have similar toxicological properties. The data
available on high molecular weight phthalates demonstrate that members
of this category have similar biological activities and toxicological
properties; verifying the use of read-across data as an appropriate
approach to characterize endpoints. DTDP (C13) is a
high molecular weight phthalate ester. Where data
maybe lacking for DTDP, DINP (C9) and DIDP (C10), which are also high
molecular weight phthalate esters, are used as read-across substances to
provide toxicological information.
No studies investigating the respiratory sensitization potential of DTDP
have been conducted. However, the respiratory sensitizing potential of
several other phthalates were evaluated by dermal application of test
substances (50 ul/flank) to female B6C3F1 mice 5 times/week for 2
weeks. Trimellitic anhydride (TMA) was given once as a positive control
at the last day of the 2-week induction phase. On study day 21,
challenge doses (25 ul/ear) of test or control substances were applied
to both ears of the mice. A week later, blood samples were collected
for measurement of total serum IgE and auricular lymph nodes for IL-4
and IL-13 proteins and their corresponding mRNAs. Treatment with
phthalates did not result in significant changes in IgE, IL-4, and IL-13
proteins, and IL-4 and IL-13 mRNAs while the positive control, TMA,
produced statistically significant increases in all parameters.
Therefore, this study indicates that phthalates in general have little
if any potential to produce antibody-mediated respiratory allergy
(Butala et al., 2004). Due to the similarity in structure, it
can be similarly concluded that DTDP is unlikely to produce
antibody-mediated respiratory allergy.
No classification for sensitization is indicated according to the
general classification and labeling requirements for dangerous
substances and preparations (Directive 67-548-EEC) or the
classification, labeling and packaging (CLP) regulation (EC) No
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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