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EC number: 290-754-9
CAS number: 90218-76-1
1,2,4-Benzenetricarboxylic acid, mixed decyl
and octyl triesters was tested for mutation in three histidine requiring
strains (TA97, TA98 and TA100) of Salmonella typhimurium both in the
absence and presence of metabolic activation by an Aroclor 1254 induced
rat liver post-mitochondrial fraction (S9) according to OECD guideline
471. The substance failed to induce a two-fold increase in revertant
numbers with any tester strain either in the absence or presence of S9,
so was considered non-mutagenic in this assy.
The substance was assayed for the ability to
cause chromosomal damage in cultured human lymphocytes, following in
vitro treatment in the absence and presence of S9 metabolic activation
according to Test method B.10 described in Council Regulation (EC) No.
440/2008 and OECD Guideline No. 473 (adopted July 1997).
Two independent experiments for chromosomal
damage were performed. Following treatment with the test item, no
statistically significant increase in the incidence of cells bearing
aberrations, including or excluding gaps, was observed at any dose level
of any sampling time. Statistically significant increases in the
incidence of cells bearing aberrations (both including and excluding
gaps) were seen following positive control treatments with Mitomycin-C
and Cyclophosphamide, indicating the correct functioning of the assay
system. It was concluded that 1,2,4 -Benzenetricarboxylic acid, decyl
octyl ester did not induce chromosomal aberrations in human lymphocytes
after in vitro treatment, under the reported experimental conditions.
Also in a second chromosome aberration test the test item did not induce
a statistically significant increase in the frequency of cells with
chromosome aberrations, in either the absence or presence of a liver
enzyme metabolizing system, in either of two separate experiments. Therefore
also in the second test according to OECD 473 the test item can be
considered to be non-clastogenic to human lymphocytes in vitro.
The test item 1,2,4 -Benzenetricarboxylic
acid, decyl octyl ester was examined for mutagenic activity by assaying
for the induction of 5 -trifluorothymidine resistant mutants in mouse
lymphoma L5178Y cells after in vitro treatment, in the absence and
presence of S9 metabolic activation, using a fluctuation method.
The study was designed to comply with the
experimental methods indicated in: Test method B.17 "in vitro mammalian
cell gene mutation test" described in Council Regulation (EC) No.
440/2008 and OECD Guideline for the testing of chemicals No. 476
(adopted July 1997). Both in the absence and presence of S9 metabolic
activation, the test item was assayed at a maximum dose level of 2500
µg/mL and at a wide range of lower dose levels: 1250, 625, 313, 78.1,
39.1, 19.5 and 9.77 µg/mL. No relevant toxicity was observed at any dose
level at any sampling time, in the absence and presence of S9
Based on the toxicity results obtained in
the preliminary assay, two independent assays for mutation to 5
-trifluorothymidine resistance were performed using the following dose
levels and treatment times:
Assay No. 1: 156, 313, 626, 1250 and 2500
µg/mL, 3 hours treatment with and without metabolic activation
Assay No. 2: 156, 313, 625, 1250 and 2500
µg/mL, 24 hours treatment without meatbolic activation; resp. 875, 1138,
1479, 1923 and 2500 µg/mL, 3 hours treatment with metabolic activation.
No relevant increases in mutant frequencies were observed following
treatment with the test item, in the absence or presence of S9
metabolism. Marked increases were obtained with the positive control
treatments indicating the correct functioning of the assay system.
It was concluded that 1,2,4
-Benzenetricarboxylic acid, decyl octyl ester does not induce mutation
at the TK locus of L5178Y mouse lymphoma cells in vitro in the absence
or presence of S9 metabolic activation, under the reported experimental
All available data clearly demonstrate the
lack of genotoxic effects.
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