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EC number: 238-694-4
CAS number: 14644-61-2
Genetic toxicity in vitro:
- Bacterial reverse mutation assay:
Dillon (1994) performed a bacterial reverse mutation assay using a
method similar to OECD 471 with Salmonella typhimurium strains TA
1535, TA 1537, TA 98, TA 1538 and TA 100 with and without metabolic
activation to test the mutagenic potential of a solution of zirconium
orthosulfate. Zirconium orthosulfate solution was diluted in sterile
ultra-pure water to achieve concentrations of 0.15, 0.5, 1.5, 5, 15 and
50% (here % is equal to µL/plate). Concentrations were tested in
triplicate in 2 independent tests. Negative controls and positive
controls were run in triplicate and the values were withing the normal
ranges experienced in the laboratory and reported in the literature with
these strains. Both tests were performed using a plate-incorporation
method. According to the results of the study, the test substance was
not mutagenic to Salmonella typhimurium with and without metabolic
activation when tested at concentrations exceeding the toxic range.
- In vitro chromosome aberration in mammalian cells:
Ciliutti (2013) performed an in vitro Chromosome Aberration test in
Chinese hamster ovary cells (OECD 473). Two experiments were performed
using different test concentrations with and without S9 activation (3 h
exposure and harvested at 20 h in experiment I; continuous exposure
until harvest at 20 h for experiment II).
For the experiment I, dose levels of 2.00, 1.00, 0.500, 0.250, 0.125,
0.0625, 0.0313, 0.0156 and 0.00781 mM (corresponding to 567, 284, 142,
70.9, 35.4, 17.7,8.86 , 4.43 and 2.21 µg of zirconium sulfate/mL), were
employed in the presence and absence of S9 metabolism. The dose levels
of 1.00, 0.500, 0.250, 0.125, 0.0625, 0.0313, 0.0156 and 0.00781 mM
(corresponding to 284, 142, 71.0, 35.5, 17.7, 8.86, 4.43 and 2.21 µg
zirconium sulfate/mL) were used for the experiment II.
Both negative and positive controls were considered to be valid. On the
basis of the results obtained, it was concluded that zirconium sulfate
did not induce structural chromosome aberrations after in vitro
treatment and under the reported conditions, and this both in the
absence and presence of metabolic activation.
- In vitro mammalian cell gene mutation:
Bisini (2013) performed an in vitro mammalian gene mutation assay in
L5178Y TK+/- lymphoma cells using the fluctuation method with the read
across substance zirconium acetate. The test was performed according to
OECD Guideline 476. Two experiments were performed using different
concentrations with and without metabolic S9 activation (experiment I)
and without metabolic S9 activation (experiment II). Plates were tested
in duplicate. Plates were exposed for 3 h (experiment I) and 24 h
(experiment II). The positive and negative (vehicle) controls were
considered to be valid. It was concluded that the test substance did 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
Genetic toxicity in vivo:
According to REACH Annex IX section 8.4, column 2, no further in vivo
testing is required as no positive results were obtained in any of the
three in vitro studies performed according to REACH Annexes VII and VIII
Based on the available data and according to the criteria of the DSD and
CLP Regulation, zirconium sulfate should not be classified for
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