Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
25/11/2014-28/11/2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Relative humidity of min. 26% with no impact on outcome of the study and interpretation of the results
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Zirconium dinitrate oxide
EC Number:
237-529-3
EC Name:
Zirconium dinitrate oxide
Cas Number:
13826-66-9
Molecular formula:
N2O7Zr
IUPAC Name:
zirconium dinitrate oxide
Test material form:
solid
Details on test material:
Name of test material (as cited in study report): zirconium dinitrate oxide

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:
S&K-LAP Kft.
2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: 11 weeks old
- Weight at study initiation: 2832 – 2944 g
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): municipal tap water, as for human consumption, ad libitum, from an automatic system
- Acclimation period: 6/8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2 – 21.5 °C
- Humidity (%): 26 – 68 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: the untreated skin of each animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
The test item was moistened with water to ensure good skin contact. The untreated skin of each animal served as a control.
Duration of treatment / exposure:
4 hours
Observation period:
To assess skin irritation, the animals were examined 1, 24, 48 and 72 hours after patch removal.
Number of animals:
For ethical reasons, an initial test was performed using a single animal. One hour after application of the test item to the skin of the sentinel animal, the application site was examined and evaluated. After one hour in one rabbit no corrosive effect, no significant systemic toxicity and no other severe local effects were observed in the initial test, therefore the bandage was replaced and the exposure continued for a further 3 hours (a total 4 hours of exposure).
At 24 hour observation time the substance was found not to be corrosive. There was no significant systemic toxicity and no other severe local effects have been observed in the initial tested animal. Therefore the 2 other rabbits were exposed.
Details on study design:
TEST SITE
- Area of exposure:
The test item was applied to an approximately 6 cm² area of intact skin.
A single layer of a fine medical gauze (open-weave with large holes) of approximately 5x5 cm was placed over the application area.
The appropriate amount of test item was carefully spread over the application area (the gauze helped maintain the test item in place).
Three more layers of gauze were placed over the test item.
- Type of wrap if used:
These gauze patches were kept in contact with the skin by a patch of clear plastic with a surrounding adhesive hypoallergenic plaster to ensure continued good contact between the moistened test item and the shaved skin.
The entire trunks of the animals were wrapped with plastic wrap for 4 hours.
Medical elastic tubing was placed over the plastic to keep it in place.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the treatment period, the test item was removed with water at body temperature.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, score 0 from first reading
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, score 0 from first reading
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, score 0 from first reading
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, score 0 from first reading
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, score 0 from first reading
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, score 0 from first reading
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other: sum of all edema scores and erythema scores for each animal at each time point (18 values) divided by 9 (3 test animals and 3 time intervals)
Time point:
24/48/72 h
Score:
0
Max. score:
8
Reversibility:
other: not applicable, score 0 from first reading
Irritant / corrosive response data:
At observation time 1, 24, 48 and 72 hours after patch removal, there were no observed local and clinical signs noted on the skin of the treated animals. As no clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation period.
Other effects:
No mortality observed during the study
No test item related clinical signs noted
No test item related effect on body weight

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals and the CLP regulation 1272/2008, zirconium dinitrate oxide does not require classification as a skin irritant.
According to the classification system based on the scheme devised by Draize (1959), zirconium dinitrate oxide is a "non-irritant".