Zirconium, tetrakis(isobutyrato)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5-16th December, 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD guideline with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

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

Test material

Test material information

Constituent 1

Reference substance name:

Tetrakis(isobutyrato)zirconium

EC Number:

619-635-5

Cas Number:

12567-73-6

Molecular formula:

Hill formula: C16H28O8Zr CAS formula: C16H28O8Zr

IUPAC Name:

Tetrakis(isobutyrato)zirconium

Constituent 2

Reference substance name:

Zirconium, tetrakis(isobutyrato)- (8CI)

IUPAC Name:

Zirconium, tetrakis(isobutyrato)- (8CI)

Details on test material:

- Name of test material (as cited in study report): Zirkonium-tetrakis(isobutyrato)
- Physical state: solid
- Analytical purity: 97.4 % (complexometric titration)
- Impurities (identity and concentrations): By-products:
toluene: ca. 2.1 %.
iso-butyric acid: ca. 0.5 %.
- Lot/batch No.: 02/05 (HK1005)
- Expiration date of the lot/batch: September 2006
- Storage condition of test material: Ambient temperature. Tightly closed. Storage under a nitrogen atmosphere, as the substance reacts with water.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Age at study initiation:
- Weight at study initiation: 2.2-2.5 kg
- Housing: Individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height.
- Diet (e.g. ad libitum): Altromin 2123, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days (one animal) and 12 days (2 animals)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19.0 °C
- Humidity (%): Average of 50.8 %
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: corn oil

Controls:

other: The surrounding of the administration area, i.e. the untreated skin, served as a negative control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 0.5 g of the test substance in 1.0 mL corn oil

Duration of treatment / exposure:

4 hours

Observation period:

The skins of the animals were examined for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas of the animals were examined for erythema/eschar and oedema as well as for other local alterations (such as hyperplasia, scaling, discolouration, fissures, scabs and alopecia) approximately 1, 24, 48 and 72 hours after patch removal.

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: about 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patches, held in place by fixing them marginally with non irritating tapes. The application sites were covered semi-occlusively by a dressing.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema / Eschar formation:
0 No erythema.
1 Very slight erythema (barely perceptible).
2 Well-defined erythema.
3 Moderate to severe erythema.
4 Severe erythema (beet redness) or eschar formation (injuries in depth).
Oedema formation:
0 No oedema.
1 Very slight oedema (barely perceptible).
2 Slight oedema (edges of area well defined by definite raising).
3 Moderate oedema (raised approximately 1 mm).
4 Severe oedema (raised more than 1 mm and extending beyond area of exposure).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

erythema/eschar

Basis:

other: all animals

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Remarks on result:

other: No erythema

Results 2

Irritation parameter:

edema score

Basis:

other: all animals

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Remarks on result:

other: No oedema

Irritant / corrosive response data:

All areas to be treated with the test substance and all control areas were normal before the application and at each observation time.

Any other information on results incl. tables

General signs of toxicity: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Skin examinations: All areas to be treated with the test substance and all control areas were normal before the application and at each observation time.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

All areas to be treated with the test substance and all control areas were normal before the application and at each observation time.

Executive summary:

In vivo skin irritation/corrosion: key study in rabbits, according to OECD Guideline 404 and the Directive 2004/73/EC, method B.4.

The aim of this study was to investigate possible irritation or corrosion by the test substance following a single application to the intact skin of rabbits.

0.5 g of Zirkonium-tetrakis(isobutyrato) was applied by a semi-occlusive dressing. The duration of the exposure was 4 hours.

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Skin examinations were carried out at 1, 24, 48 and 72 h after patch removal (p.a.). The mean scores calculated for all animals were

Erythema / Eschar: 0 and Oedema: 0. All areas to be treated with the test substance and all control areas were normal before the application and at each observation time. The substance is classified as not irritating.