Zirconium iron pink zircon

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981-05-12

Deviations:

yes

Remarks:

fur clipped at least 15 h before test begin; examination for erythema & oedema at 30 - 60 min. after test patch removal & 24 h, 48 h, 72 h after the beginning of application; modified Draize scoring system; reading skin reaction at 30 - 60 min. missing.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Zirconium zircon with encapsulated hematite

Cas Number:

68412-79-3

Molecular formula:

ZrSiO4*xFe2O3 0,1≤x≤0,5

IUPAC Name:

Zirconium zircon with encapsulated hematite

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material: Sicocer F Eisenrosa 2320
- OLD EC name: zirconium iron pink zircon
- NEW EC name: zirconium zircon with encapsulated hematite
- Physical state: solid, pink powder

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.62 - 2.87 kg
- Housing: cage made of stainless steel with wire mesh walk floors; floor area: 40 cm x 51 cm; no bedding in the cages; sawdust in the waste trays; rabbits were housed singly
- Diet (about 130 g per animal per day): Kliba 341, 4 mm; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (about 250 mL per animal per day): tap water
- Acclimation period: at least 8 days before beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS - animals were housed in fully air-conditioned rooms.
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the unchanged test substance

Duration of treatment / exposure:

4 hours

Observation period:

30 - 60 minutes after removal of the test patches and 24, 48 and 72 hours after the beginning of the application

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: at least 15 hours before the beginning of the study the upper third of the back or flanks were clipped. The application area was 2.5 cm x 2.5 cm. The test patch (2.5 cm x 2.5 cm) was covered with a dose of the unchanged test substance and has been moistened with aqua bidest.. Because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible.
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze + porous bandage).

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: at the end of the exposure period
- Washing: with lutrol and lutrol/water (1:1)

SCORING SYSTEM: according to a modified Draize scale.
Evaluation of erythema and oedema:
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4 = severe to very severe

OBSERVATIONS:
Shortly before application of the test substance the weight of the rabbits was determined. Symptoms were recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

anmimal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight erythema was observed in all animals at a 4 hour observation.
Very slight erythema was observed in one animal at the 24 hour observation.
No erythema or oedema was observed in two animals at the 24, 48 and 72 hour observations.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Sicocer F Eisenrosa 2320 is not irritating to the skin.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.