Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

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:

Poorly documented studies of acute oral toxicity with the substance (chain length C9-C11) give no indication that the substance is acutely toxic, LD50 values being in excess of 6170 mg/kg body weight. The same findings occurred in better documented animal studies on phthalate esters with chain lengths of C11, C6-C10, C8-C10 and C10 -C12 -C14.

Information on acute dermal toxicity is available from studies on phthalate esters with chain lengths of C-11 and C6-C10. No mortality occurred, demonstrating the LD50 to be greater than 2000 mg/kg.

Six hours exposure to a saturated vapour concentration of 1.8 mg/L phthalate ester with a chain length C-11 resulted in no mortality. The vapour concentration tested was considered to represent the highest achievable.

Justification for classification or non-classification

Non classification justified by lack of observed toxicity in acute single exposure studies by oral, dermal and inhalation routes.