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EC number: 262-309-9
CAS number: 60580-61-2
Zinc 5-nitroisophthalate has been tested in a bacterial reverse mutation
assay, in a gene mutation test, and in a cytogenicity test. All tests
showed a negative response, thus, Zinc 5-nitroisophthalate does not
require classification for mutagenic properties.
Endpoint Conclusion: No adverse effect observed (negative).
Genetic toxicity – in vitro results
Gene mutation in bacterial test systems
Engelhardt and Hoffmann (1999, GLP) evaluated the mutagenic potential of
Zinc 5-nitroisophthalate in a bacterial reverse mutation assay. In two
different experiments, four Salmonella strains(TA98, TA100,
TA1535, and TA1537) and one E.coli strain (WP2uvrA) were tested
either in a plate incorporation experiment (29-7250 µg/plate) or in a
preincubation experiment (20-5000 µg/plate). Both experiments were
performed either with or without metabolic activation. After exposure to
the test item for 48‑72 hours, the plates were scored for revertant
colony number. None of the doses applied resulted in an increase in
revertant colony number under any condition tested. According to
Regulation (EC) No 1272/2008 and subsequent adaptations, the substance
should not be considered to have a mutagenic potential.
Cytogenicity in mammalian cells
In a GLP study (Donath, 2018), cytogenic activity of Zinc
5-nitroisophthalate was assessed via a micronucleus test. Human
peripheral blood lymphocytes were exposed to the test item without a
metabolic activation system for either 4 or 44 hours at concentrations
of 2.5-500 µg/mL. Additionally, the cells were also tested in presence
of a metabolic activation system (S-9 from activated rat liver).
Whenever possible, 2000 cells were scored for micronuclei occurrence.
During the study described and under the experimental conditions
reported, the test item Zinc 5-nitroisophthalate did not induce
structural and/or numerical chromosomal damage in human lymphocytes.
Therefore, Zinc 5-nitroisophthalate is considered to be non-mutagenic
with respect to clastogenicity and/or aneugenicity in the in vitro
Mammalian Cell Micronucleus Test.
Gene mutation in mammalian cells
A GLP study (Hargreaves, 2018) evaluated Zinc 5-nitroisophthalate for
the potential to induce mutations at the hprt locus in mouse lymphoma
L5178Y cells. To this end, cells were exposed to the test item either
without metabolic activation or in combination with a metabolic
activation system (S-9 from activated rat liver). In both cases the top
dose was 50 µg/mL based on solubility limits. The cells were treated for
three hours. After a total of 13-14 days the mutant cell number was
counted, and the mutant frequency was determined subsequently. It is
concluded that Zinc 5-nitroisophthalate did not induce biologically
relevant increases in mutant frequency at the hprt locus in mouse
lymphoma L5178Y cells when tested up to the limit of solubility in
culture medium, for 3 hours in the absence and presence of a rat liver
metabolic activation system (S 9).
Genetic toxicity, in vitro
All studies present are GLP compliant and showed not any effect in a
bacterial reverse mutation assay, in a mammalian cell gene mutation test
(hprt) or in a mammalian cell micronucleus test. The classification
criteria according to regulation (EC) 1272/2008 as germ cell mutagen are
not met, thus no classification applicable.
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