[μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium

Skin irritation / corrosion

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

Test material information

Constituent 1

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:

[({[Hydroxy(Oxo)Zirconio]Oxy}Carbonyl)Oxy]Zirconiumoylol

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

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hours

Score:

ca. 0

Max. score:

8

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 hours

Score:

ca. 0

Max. score:

8

Results 3

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.