Magnesium potassium titanium oxide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 October 2000 - 03 November 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1992)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1992)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

436-900-9

EC Name:

-

Cas Number:

39290-90-9

Molecular formula:

Hill Empirical formula: K(0.2-0.7) Mg(0.4) Ti(1.6) O(3.7-3.95) CAS Empirical formula: K(0.2-0.7) Mg(0.4) Ti(1.6) O(3.7-3.95)

IUPAC Name:

Magnesium Potassium Titanium Oxide

Details on test material:

Batch: 0G99
White powder
Expiry date: 21 August 2001
Test substance storage: At room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Animal: Albino rabbit, New Zealand white (SPF quality). Earmark.
- Source: Charles River Deutschland, Kissleg, Germany
- Age at study initiation: at least 8 weeks old
- Body weight at study initiation: between 1.0 and 3.5 kg
- Housing: individually housed in labelled cages with perforated floors (Scanbur, Denmark, 53.3x63x38.5 cm) and equipped with an automatic drinking system.
- Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approximately 100 grams per day. In addition hay (BMI, Helmond, The Netherlands) was provided twice a week.
- Water: Free access to tap water.
- The acclimation period was at least 5 days before the start of treatment under laboratory conditions.

A health inspection was performed prior to treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.

All certificates of analysis (diet and water) are retained in the NOTOX archives.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3CºC
- Humidity (%): 30 - 70%
- Air changes (per hr): approximately 15 air changes per hour- Photoperiod (hrs dark / hrs light): 12 hours artificial
fluorescent light and 12 hours darkness per day.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped with electric clippers

Vehicle:

water

Remarks:

Milli-U water

Controls:

other: Adjacent areas of the untreated skin of each animal

Amount / concentration applied:

500 mg. The powdery test substance was moistened with Milli-U water, immediately before application, to ensure close contact with the animal's skin.

Duration of treatment / exposure:

4 h of exposure-single application

Observation period:

The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.

Number of animals:

3 males

Details on study design:

TEST SITE/OBSERVATIONS:
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm²). Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring.

Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was applied to the skin of one flank, using a metalline patch# of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage. Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water.

The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.
The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls.

Observations for mortality/viability: twice daily. Obervations for toxicity: at least once daily. Body weight: measured prior to application.

SCORING SYSTEM:
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:

Erythema and 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) *
*. Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the maximum grade for erythema (= 4) was given.

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 millimeter)
4: Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2 and #3

Time point:

other: average score over 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: Highest score (1) after 1 h

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

other: average score over 24, 48 and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: All individual scores: 0

Irritant / corrosive response data:

Very slight erythema in the treated skin-areas of all three rabbits. The skin irritation had resolved within 24 hours after exposure.

Other effects:

No staining of the treated skin by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Terracess P is not irritating to skin (4 h exposure to rabbit skin under semi-occlusive conditions).
Terracess P does not have to be classified and has no obligatory labelling requirement for skin irritation.