Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Two Buehler tests have been carried out in Guinea pigs with DTDP (ExxonMobil, 1994; Sasol Germany GmbH, 1993. The substance was applied neat (0.5 ml) for induction at day 1, 8 and 15 for 6 hours under occlusive bandaging and for challenge at day 29. No evidence of skin sensitization was observed in any of the treated animals in both studies. No positive reactions were reported in patch test studies conducted in humans (ExxonMobil, 1995).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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.

Justification for classification or non-classification

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 1272/2008.