Registration Dossier

Administrative data

Key value for chemical safety assessment

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.  

DIDP is not mutagenic in vitro in bacterial mutation assays (with and without metabolic activation) and is negative in a mouse lymphoma assay (Zeiger et al., 1982; 1985; Hazleton Biotechnologies Company, 1986; Barber et al., 2000). DIDP is not clastogenic in a mouse micronucleus assay in vivo (Hazleton Washington, 1994; McKee et al., 2000).


Short description of key information:
Not mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification for mutagenicity 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.