Registration Dossier

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: see 'Remark'
Remarks:
Well documented, scientifically sound GLP study that was based on the OECD Guideline 404 "Acute Dermal Irritation/Corrosion". The substance was used as a reference substance and was also tested on the same animals a week following testing of other substances in the study.

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:
Substance was tested on the same animals a week following testing of the other substances in the study.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium
EC Number:
260-633-5
EC Name:
[μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium
Cas Number:
57219-64-4
Molecular formula:
CH2O7Zr2
IUPAC Name:
[μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium
Details on test material:
- Name of test material (as cited in study report): Zirconium basic carbonate (ZBC)
- Physical state: white powdery paste

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 (%): 43-73

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): 0.5 g
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 were 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
Irritant / corrosive response data:
No reaction to the test substances was reported in any of the test animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test the test substance was determined not to be irritating to the skin of rabbits.