Registration Dossier

Administrative data

Description of key information

Minimally Toxic. Based on test data for the material.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 160 mg/kg bw

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.  

Like other high molecular weight phthalate esters, DTDP was observed to have a low order of toxicity by the dermal and oral routes of exposure in acute toxicity animal studies (ExxonMobil., 1981a,b; Sasol Germany GmbH, 1984). For example, in oral studies, no significant signs of toxicity are reported, even in studies using doses well above the limit dose recommended by current regulatory guidelines (2000 mg/kg). In dermal studies, limited reversible irritation is the only effect associated with treatment. 

 

Due to their low vapor pressures and the technical difficulties of generating a vapor at ambient temperatures, few studies by the inhalation route of exposure for any high molecular weight phthalate are available, most of which are relatively old and conducted before the development of testing guidelines or the implementation of good laboratory practice procedures. Although poorly documented, there were no reports of body weight changes, gross lesions or microscopic alterations of lungs; only slight tearing of the eye and slight clear nasal discharge when animals were exposed to DINP at the saturated vapor concentration. As reported in the European Union Risk Assessment for DINP, the LC50 for an aerosol is greater than 4.4 mg/l (European Commission). It is expected that DTDP would exhibit similar properties.  

 

These data taken together with data from structurally similar compounds suggest that DTDP has a low potential for acute toxicity. 

Justification for classification or non-classification

No classification for acute toxicity 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.