Registration Dossier

Administrative data

Description of key information

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 inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
4 400 mg/m³

Acute toxicity: via dermal route

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

Additional information

Like other high molecular weight phthalate esters, DINP was observed to have a low order of toxicity by the inhalation, dermal, oral routes of exposure in acute toxicity animal studies with LD50/LC50 values exceeding the maximum amounts that can be administered to test animals (ExxonMobil., 1968a,b; BASF, 1981a,b). 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. 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 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).

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.