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:

DIUP did not produce a sensitizing response in a guinea pig study conducted by the method of Buehler (ExxonMobil, 1994). DIUP gave negative results for sensitization with no evidence of irritating effect. Positive controls functioned appropriately.

 

No positive reactions were reported in patch test studies conducted in humans (Medeiros et al., 1999). Consequently the evidence suggests that DIUP does not cause sensitization in humans.

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. DIUP (C11) is a high molecular weight phthalate ester. Where data maybe lacking for DIUP, 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 DIUP have been conducted. However, the respiratory sensitizing potential of di-ethylhexyl phthalate (DEHP), di-isononyl phthalate (DINP), di-isoheptyl phthalate (DIHP), and butylbenzyl phthalate (BBP) 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 fro 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 DEHP, DINP, DIHP, and BBP 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 DIUP is unlikely to produce antibody-mediated respiratory allergy.

Justification for classification or non-classification

No classification for skin/respiratory 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.