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EC number: 237-529-3
CAS number: 13826-66-9
Repeated dose toxicity: oralRossiello (2013) performed a combined repeated dose toxicity study (scored Klimisch 1) with reproduction/developmental toxicity screening test via oral route in rats according to OECD guideline 422. This study was performed in compliance with GLP guidelines. A NOAEL of >=1000 mg/kg bw/day was derived (expressed as zirconium acetate anhydrous). No adverse effects were reported in this study. Zirconium acetate is a water-soluble zirconium compound with similar behaviour as zirconium dinitrate oxide. Therefore the results of this study are considered relevant for zirconium dinitrate oxide too.
The overall results of the test formulation
analyses were within the limits of acceptance for concentration (15% of
the theoretical concentration).
Repeated dose toxicity: oral
No reliable data are available on oral repeated dose toxicity of
zirconium dinitrate oxide. Therefore, the endpoint was covered using a
read across study performed with zirconium acetate, a water-soluble
substance with similar behaviour as zirconium dinitrate oxide.
The systemic toxic effects of zirconium acetate solution (containing
40.7% of the active ingredient zirconium acetate) after repeated dose
exposure, as well as any toxic effects on reproduction and development
were investigated in Sprague Dawley rats up to early lactation (day 4
post partum). The study (Rossiello, 2013) was performed according to
OECD guideline 422 (GLP).
In this study, three groups of 10 males and 10 females each received the
test item, by oral gavage, at 100, 300 and 1000 mg/kg bw/day, expressed
as zirconium acetate (anhydrous form). A similar constituted control
group received the vehicle alone during the treatment period. The test
item was diluted in purified water (vehicle) at concentrations of 10, 30
and 100 mg of zirconium acetate/mL. Chemical analyses of the formulated
test item were performed during the study and the overall results were
within the limits of acceptance. The overall dosing period was 32 days
for males, which included 2 weeks before pairing and continuously
thereafter up to the day before necropsy and up to 50 days for females
including 2 weeks before pairing thereafter during pairing, gestation
and lactation periods until day 3 post partum.
The animals were followed for daily clinical signs, weekly body weight,
food consumption, neurotoxicity assessment, oestrous cycle, mating
performance, clinical pathology evaluation including haematology and
clinical chemistry and offspring delivery. A detailed macroscopic
examination, organ weights and histopathology including the
spermatogenic cycle were performed.
No treatment-related findings were observed either during the in vivo
phase or at post mortem examination. Microscopically, a
treatment-related finding was seen in males receiving 300 and 1000 mg/kg
bw/day consisting of minimal focal vacuolation of squamous epithelium
(limiting ridge) of non-glandular region of the stomach. This change may
be attributed to a local irritant effect of the compound administered by
oral gavage and since humans do not have forestomach or structure
analogous to forestomach, it is not considered of toxicological
No systemic adverse effects were therefore reported. On the basis of
these results, the NOAEL (No Observed Adverse Effect Level) for systemic
toxicity after repeated oral exposure was considered to be >= 1000 mg of
zirconium acetate/kg bw/day for both males and females. This result was
considered relevant for zirconium dinitrate too. Taking into account the
fact that zirconium dinitrate oxide contains a lower % w/w zirconium
compared to zirconium acetate, the NOAEL for zirconium dinitrate oxide
can be expected to be >= 1000 mg/kg bw/day for zirconium dinitrate oxide
too if a similar study would be performed. The read across justification
is attached to IUCLID Section 13.
Based on the available read across data with the related substance
zirconium acetate and according to the criteria of the CLP Regulation,
zirconium dinitrate oxide should not be classified for specific target
organ toxicity after repeated exposure.
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