Diiron titanium pentaoxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-02-19 until 1990-03-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diiron titanium pentaoxide

EC Number:

234-679-1

EC Name:

Diiron titanium pentaoxide

Cas Number:

12023-27-7

Molecular formula:

Fe2O5Ti

IUPAC Name:

titanium(4+) diiron(3+) pentaoxidandiide

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Sex: 1 male and 2 females
- Age at study initiation: 16 - 17 weeks
- Mean weight at study initiation: 2.84 kg
- Housing: single in cages type KK 017
- Diet: ad libitum, Altromin Standard Diet TPF 2113
- Water: ad libitum, acidified, fully demineralized water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 42 - 55 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

3 hours after removal of the patches, and then daily for a period of 8 days.

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 24 hours before treatment the backs and flanks of the animals were cautiously shaved with an electric clipper, so that the skin stayed intact.
- Type of wrap: The application sites were wrapped with polyethylene foil which was kept on place by a leather sleeve.

REMOVAL OF TEST SUBSTANCE
- Washing: After 4 hours of occlusive exposure the patches were removed and any test material left was wiped off.

OBSERVATION TIME POINTS
The rabbits were investigated for skin alterations, behaviour, and general conditions 3 hours after removal of the patches, and then daily for a period of 8 days.

SCORING SYSTEM:
- Method of calculation: Skin changes at the application site were evaluated according to Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No indication for skin irritation was observed at any time point.

Other effects:

- Other adverse local effects: Only brown discoloration of the skin was observed on day 1 and 2 of the study due to the coloration of the test item.
- Other adverse systemic effects: All animals survived the observation period. No signs of systemic toxicity were detected. The body weight development of the treated rabbits was inconspicuous.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No skin irritating potential could be detected.

Executive summary:

The acute skin irritation potential was investigated in three White New Zealand rabbits (1 male and 2 females) following application on the intact skin according OECD TG 404. Aliquots of neat test material (0.5 g) were moistened with water and applied to the intact skin of each rabbit for a 4-hour period under occlusive conditions. The rabbits were examined for skin reactions three hours after removal of the patches and then daily up to eight days. Skin reactions were evaluated and graded according to Draize. No signs of skin irritation were observed at any time point. Based on this study the test item is considered not to be irritating to the skin.