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Key value for chemical safety assessment

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.

 

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 typhimurium.

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 observed


Short description of key information:
Negative findings in bacterial reverse mutation tests, chromosome aberration tests and gene mutation tests.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Non classification is justified based on negative findings in 3 separate and key in-vitro tests for gene mutation / mutagenicity.