Zirconium oxide sulphate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Does not meet important criteria of today standard methods.

Data source

Reference

Reference Type:

publication

Title:

The acute, chronic and topical toxicity of zirconium carbonate.

Author:

Harrisson, J.W.E., Trabin, B., Martin, E.W.

Year:

1951

Bibliographic source:

Journal of Pharmacology and Experimental Therapeutics 102, 179-184

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Guinea pigs were exposed to an ointment containing the test substance or controls under a rubber sleeve for 9 days and 60 days.

GLP compliance:

not specified

Type of study:

Draize test

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

IUPAC Name:

57219-64-4

Constituent 2

Reference substance name:

zirconium basic carbonate

IUPAC Name:

zirconium basic carbonate

Details on test material:

- Name of test material (as cited in study report): HZC or hydrated zirconium carbonate
- Molecular formula: approximately 3ZrO2.CO2.H2O
- Physical state: water-insoluble powder
- Analytical purity: No data

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: white

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 250-300 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum; containing a minimum level of vitamin C to increase the sensitivity of dermal response
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
no data

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

other: a mixture of stearic acid, glycerin, water and emulsifier

Induction 2

Concentration / amount:

The ointment containing 21% of HZC (4.3% of ZrO2) was prepared from stearic acid, glycerin, water and emulsifier. The control ointment contained the same ingredients except the HZC. Dosage levels were 4 and 8 g of ointment per kg of animal and 0.5 g portions.

Challenge

Challenge 1

Route:

other: no challenge exposure

Vehicle:

other: a mixture of stearic acid, glycerin, water and emulsifier

Challenge 2

Concentration / amount:

The ointment containing 21% of HZC (4.3% of ZrO2) was prepared from stearic acid, glycerin, water and emulsifier. The control ointment contained the same ingredients except the HZC. Dosage levels were 4 and 8 g of ointment per kg of animal and 0.5 g portions.

No. of animals per dose:

10 males

Details on study design:

The HZC ointment was gently massaged into the closely shaved skins of 2 groups of guinea pigs on dosage levels of 4 and 8 g ointment/kg bw. Pieces of gauze were folded to form small pads about 25 mm square and four layers in thickness, and on these pads were spread 0.5 g portions of moist paste of HZC, or HZC ointment (21 per cent HZC), or the ointment base used as a control. A rubber sleeve was then placed in position to prevent contact of the skin with the cage. After 9 days, the ointment was again applied. The animals were observed for a total period of 60 days and autopsies were performed on all animals.
In a more prolonged test, 0.5 g portions of HZC ointment were weekly applied to a 25 mm area on one side of the closely clipped skins. Twelve applications were made, and the opposite site served as control (treatement with control ointment). Observations were made 4, 24 and 48 h after each inunction and at the end of the test.

Challenge controls:

no challenge exposure

Positive control substance(s):

no

Results and discussion

Positive control results:

no positive control used

Any other information on results incl. tables

When the animals were examined at autopsy there was no evidence of vascularization under any treated area, but most animals exhibited symptoms of vitamin C deficiency. No topical toxicity was evident at dose levels of 4 and 8 g ointment/kg bw.

During the prolonged test, three guinea pigs died because of vitamin C deficiency, but no significant vascularization was evident on any of the animals. Findings at autopsy of the three animals which died were negative, except for symptoms of low vitamin C intake.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the conditions of the current test, the ointment containing 21% of hydrated zirconium carbonate did not induce any topical or sensitising effects in guinea pigs.