reaction mass of cerium(IV)oxide, praseodymium(III,IV)oxide and zirconium (IV)oxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

from 16-OCT-1995 to 08-MAR-1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of cerium dioxide and zirconium dioxide

IUPAC Name:

Reaction mass of cerium dioxide and zirconium dioxide

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Poudre catalytique à base d'oxyde de cérium et d'oxyde de zirconium (OBD 30)
- Substance type: multi-constituent substance
- Physical state: yellow powder
- Further information on test material confidential

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.4 +/- 0.2 kg
- Housing: individually in polystyrene cages (35x55x32 cm or 48.2x58x36.5 cm)
- Diet (e.g. ad libitum): free access to 112 pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): drinking water filtered by a Millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30 to 70% relative humidity
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h / 12h

IN-LIFE DATES: From: 15 nov 1995 To: 18 nov 1995

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: control on the other untreated flank

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 500 mg of the substance was applied to a 6 cm2 moistened gauze pad which was thus applied to the right flank of the animals.
- Type of wrap if used: The test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test item was wiped off by means of a moistened gauze pad.

SCORING SYSTEM: according to EEC Criteria

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Not irritating to skin.

The reaction mass of cerium dioxide and zirconium dioxide is not classified according to the criteria of the EU-CLP Regulation 1272/2008.

Executive summary:

In a primary dermal irritation study (CIT, 1996), New Zealand White rabbits (3 males) were dermally exposed to 500 mg of the reaction mass of cerium dioxide and zirconium dioxide onto one flank.

Test sites were covered with semi-occlusive dressing for 4 hours. The cutaneous examinations were performed 1, 24, 48 and 72 hours after removal of the dressing. The mean score values for erythema and oedema were calculated for 24, 48 and 72 hours.

No cutaneous reactions were observed during the study.

In this study, the reaction mass of cerium dioxide and zirconium dioxide is not classified according to the EU classification criteria.