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EC number: 271-085-1
CAS number: 68515-43-5
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
Non classification justified by lack of observed toxicity in acute
single exposure studies by oral, dermal and inhalation routes.
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