Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

A set of genotoxicity tests has been conducted on 1,2-Benzenedicarboxylic acid, di-C6 -10 -alkyl esters, 1,2 -Benzenedicarboxylic acid, di-C8 -10 -

alkyl esters and structurally related phthalic acid esters. Bacterial reverse mutation assays (Ames test) have been undertaken using methods similar to or equivalent to OECD test methods. The substances do not induce reverse mutation in Salmonella typhimurium.

No effects were observed in a mammalian cell gene mutation test (HPRT) for structurally related phthalates.

 

The ability to cause chromosomal damage in cultured human lymphocytes, following in vitro treatment in the absence and presence of S9 metabolic activation has been investigated with structurally related phthalates according to OECD/EU test methods. No statistically significant increase in the incidence of cells bearing aberrations, including or excluding gaps, was observed at any dose level or any sampling time.

 

Mutagenic activity has been examined with structurally related phthalates by assaying for the induction mutants in mouse lymphoma L5178Y cells after in vitro treatment, in the absence and presence of S9 metabolic activation, using a fluctuation method according to OECD/EU test methods. No relevant increases in mutant frequencies were observed following treatment.

 

Mutagenic activity has also been examined with structurally related phthalates by the mouse Balb/3T3 cell transformation assay. No activity was apparent even at concentrations higher than the aqueous solubility of the phthalates.


Short description of key information:
The Ames-Test for the 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters was negative. Negative findings were also observed in the bacterial reverse mutation test, chromosome aberration test, HPRT test, gene mutation test using mouse lymphoma L5178Y cells and mouse Balb/3T3 cell transformation assay for the structurally related substance 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters, Diundecylphthalate and other phthalates.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Negative findings in various separate and key in-vitro tests for gene mutation / mutagenicity. Supporting information from an additional in-vitro cell transformation assay.