Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

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.  

Acute skin irritation studies with DIDP, a substance with structural similarity to DIUP, have been conducted in both humans and rabbits.  In laboratory animals, DIDP is at most slightly irritating to the skin and eye and the effects are fully reversible in a relatively short period of time. In human studies, there are no indications DIDP produces skin irritation. These results are similar to the results observed with other high molecular weight phthalate esters. Respiratory tract irritation has not been reported in humans. Based on these observations, DIUP is not considered irritating or corrosive.

Justification for classification or non-classification

No classification for skin/eye irritation or corrosion 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.