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
62 080 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
130 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
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. 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.   

 

In a series of LD50 studies reported by Smyth et al. (1962), the LD50 of DIDP in rats is above 62,080 mg/kg. In a 24-hour exposure dermal study (ExxonMobil, 1978) in rabbits (4 animals, sex not specified), a dose of 3,160 mg/kg was applied on abraded skin and remained in contact with the skin by means of a non-absorbent binding. There was no mortality during the 14-day test period. The dermal LD50 was therefore estimated to be greater than 3,160 mg/kg. (ExxonMobil, 1975) was conducted in rats, mice and Guinea pigs (5 males and 5 females) at 0.13 mg/l (nominal concentration). DIDP was reported to have been administered as a vapor, but regarding the test conditions the substance was probably administered as an aerosol. No deaths occurred, no adverse reactions were noticed following the 14-day observation period, and there were no gross tissue changes attributable to effects of the test The LC50 is >0.13 mg/l.

 

The weight of evidence for data from DIUP and data from the structurally similar compound (DIDP) suggest that DIUP 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.