Registration Dossier
Registration Dossier
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EC number: 931-251-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
A set of genotoxicity tests has been conducted on 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).
The ability to cause chromosomal damage in cultured human lymphocytes, followingin vitrotreatment in the absence and presence of S9 metabolic activation has been investigated 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 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 by the mouse Balb/3T3 cell transformation assay. No activity was apparent even at concentrations higher than the aqueous solubility of the substance.
Short description of key information:
Negative findings 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.
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.
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