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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.
A bacterial reverse mutation assays (Ames test) have been reported for
the substance itself, a phthalate ester with a chain length of C9-C11
and similar phthalate esters with chain lengths of C11, C6-C10, C8-C10
and C-10-C12-C14.All do not induce reverse mutation in Salmonella
The ability of phthalate esters with chain lengths of C11 and C8-C10 to
cause chromosomal damage in cultured human lymphocytes, followingin-vitrotreatment
in the absence and presence of S9 metabolic activation has been
investigated. No statistically significant increase in the incidence of
cells bearing aberrations occurred.
Mutagenic activity has been examined by assaying for the induction
mutants in mouse lymphoma L5178Y cells (phthalate ester C11) or Chinese
hamster ovary cells with no relevant increases in mutant frequencies
Non classification is justified based on negative findings in 3 separate
and key in-vitro tests for gene mutation / mutagenicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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