Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-03-04 to 1986-07-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented, scientifically sound GLP study that was based on the OECD Guideline 404 "Acute Dermal Irritation/Corrosion". The test substance was tested simultaneously on the same animals.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Substances were tested simultaneously on the same animals
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Zirconium dioxide
EC Number:
215-227-2
EC Name:
Zirconium dioxide
Cas Number:
1314-23-4
Molecular formula:
O2Zr
IUPAC Name:
zirconium dioxide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Superfine zirconium oxide
- Physical state: a fine white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Regal Rabbits, Great Bookham, Surrey
- Housing: individually in metal grid-floored cages
- Diet: ad libitum, Grain Harvester's special rabbit diet 679
- Water: ad libitum tap water
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 43-74

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): spread on a patch previously moistened with 0.5 mL of water to ensure good contact with the skin
Duration of treatment / exposure:
4 hours
Observation period:
24, 48 and 72 hours
Number of animals:
4 male animals
Details on study design:
TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: 2.5 cm square patches were applied to the skin on 6 cm square patches of polythene held in place by adhesive tape and elastic net bandages.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize (1959), Indices of irritation were calculated for each animal by totalling the scores for oedema and erythema for each animal and dividing by two.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 0
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0
Max. score:
8
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: average of 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: average of 24, 48, and 72 hous
Score:
0
Max. score:
4
Irritant / corrosive response data:
No reaction to the test substances was reported in any of the test animals.

Applicant's summary and conclusion

Conclusions:
The test substance was determined to be not irritating to the skin of rabbits.