Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The phthalate esters are1,2-benzenedicarboxylic acids with side chain esters ranging in carbon chain length from C1 to C13.The US EPA High Production Volume (HPV) chemical challenge program has proposed grouping phthalate esters into a single category, divided into 3 sub-categories, this based on the structural similarities of the substances and their physicochemical and toxicological properties. These sub-categories are: low molecular weight phthalates, transitional phthalates, and high molecular weight phthalates. The high molecular weight phthalates are defined as being produced from alcohols with straight-chain carbon backbones of >C7 or a ring structure. These include varying mixed isomers of linear and branched diheptyl, dioctyl, dinonyl, didecyl, diundecyl and ditridecyl phthalate. All exhibit low solublity in water and are regarded as being too insoluble to exhibit acute or chronic toxicity. Read-across from closely related phthalates thus appears reasonable and this is supported by the data, below:

Studies of sensitisation with the substance (chain length C9-C11) give no indication that the substance is a sensitiser.

The same findings occurred in better documented studies on phthalate esters with chain lengths of C11, C8-C10 and C10-C12-C14.


Migrated from Short description of key information:
Skin sensitisation: Not sensitising

Justification for classification or non-classification

Non classification is justified as there is no evidence of sensitisation occurring in animal models.