Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

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:

No toxicity occurred following acute (96 hours) exposure of fish to the substance itself (chain length C9-C11) or structural analogues with chain lengths of C11and C8 -C10. Long-term toxicity with a phthalate ester with C11 chain length found no effects at 0.30 mg/L, the highest concentration investigated and regarded as the maximum water solubility under the test conditions.

Exposure of Daphnia over a 48 hour period to the substance, a phthalate ester with C9 –C11 chain length, resulted in no effects being observed at 500 mg/L, a concentration greatly in excess of the water solubility of the substance. Similarly, no effects were observed with other phthalate esters, with chain lengths of C-11, C8 -C10 and C6-C10. Long-term exposure of Daphnia to the substance, a phthalate ester with C9 -C11 chain length caused no effects, as did a phthalate ester with C11 chain length.

Toxicity to aquatic algae over a 72 hour exposure period has been investigated with C9-C11, C6 -C10 and C8 -C10 chain length phthalate esters. No effects were apparent at the tested concentrations, regarded as being the maximum achievable.