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EC number: 237-529-3
CAS number: 13826-66-9
In a guinea pig maximisation test according to OECD guideline 406,
zirconium dinitrate oxide was observed to be not sensitising to the skin
(Totok-Batho, 2015). This study was scored Klimisch 1 and was considered
as the key study for endpoint coverage.
Guinea Pig Maximisation Test (OECD guideline 406) was selected based on
previous experience with several comparable compounds, which learned
that the irritating potential of the test substance may confound the
results obtained with LLNA tests. Additionally, insoluble inorganic
forms are often not able to penetrate the skin. Although zirconium
dinitrate oxide is soluble in pure water (accompanied by a pH decrease),
it is converted to insoluble forms in physiologically relevant test
media such as the sweat on the skin.
Mortality/clinical observations/body weight:
No treatment related mortality was observed during the study.
There were no overt signs of an adverse clinical response to treatment
with the test item during the course of the study.
Body weight was recorded at randomisation, then at least weekly,
including day 25 prior to euthanasia. There were no notable differences
between the test animals group and the control group.
A skin sensitisation study was performed in the guinea pig according to
the Magnusson-Kligman method, using a maximisation method with Freund's
Complete Adjuvant to evaluate the sensitisation potential of the test
item zirconium dinitrate oxide.
This study was performed according to the OECD guideline 406 and in
accordance with GLP and was thus scored as Klimisch 1. The Guinea Pig
Maximisation Test was selected, based on previous experience with
several comparable compounds, which learned that the irritating
potential of the test substance may confound the results obtained with
LLNA tests. Additionally, insoluble inorganic forms are often not able
to penetrate the skin. Although zirconium dinitrate oxide is soluble in
pure water (accompanied by a pH decrease), it was converted to insoluble
forms in physiologically relevant test media such as the sweat on the
Based on the results of a preliminary test, ten test animals were
subjected to sensitisation procedures in a two-stage process, named
induction phase i.e. an intra-dermal treatment and a 48 h topical
application (dermal treatment under an occlusive dressing). The test
item was used at a concentration of 0.25% (w/v) for intra-dermal
injections and at a concentration of 25% (w/v) for topical application,
in 1% methylcellulose in PBS. Five control guinea pigs were
simultaneously exposed to 1% methylcellulose in PBS during the
Two weeks after the last induction exposure, a challenge dose (at a
concentration of 25% (w/v)) was administered on the left flank of all
animals for 24h. The right flank area of the animals was treated with
vehicle (1% methylcellulose in PBS). Challenge was performed by dermal
application of the test item. Skin reactions were measured 24 and 48
hours after patch removal.
No signs of systemic toxicity were observed in any animal.
During the induction period no local skin effects were observed in
either the test group or in the control group.
Following challenge with 25% (w/v) zirconium dinitrate oxide in 1%
methylcellulose in PBS, there were no skin reactions in the test or
Intensity of sensitisation response:
The net response value represented an incidence rate of 0% after a
challenge exposure at 25% (w/v) zirconium dinitrate oxide.
In conclusion, under the conditions of the present assay the test item
zirconium dinitrate oxide was shown to have no sensitisation potential
and therefore it is classified as a non-sensitiser, according to current
According to the criteria of the CLP Regulation and based on the
available data, zirconium dinitrate oxide should not be classified as
sensitising to skin.
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