Tin titanium zinc oxide

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:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nousan No. 8147

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Experimental Toxicology and Ecology, BASF AG

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

485-430-0

EC Name:

-

Cas Number:

923954-49-8

Molecular formula:

SnxZnyTi2Oz with x = 0,5 – 1,7 y = 0,5 – 1,7 z = 5,5 – 7,5

IUPAC Name:

oxygen titanium zinc λ²-stannane

Details on test material:

- Test-substance No.: 07/0285-1
- Analytical purity: 99.61 g/100 g (analytical report No. 07L00144)
- Lot/batch No.: GV 33900-66

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: ca. 7 months
- Weight at study initiation: 3.86 kg – 3.96 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm²
- Diet (e.g. ad libitum): Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period:at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: intact untreated

Vehicle:

water

Controls:

other: Untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test patch (2.5 cm x 2.5 cm) was covered with an amount of minimally moistened solid preparation (see section 3.5 Test-substance preparation) corresponding to a dose of 0.5 g of undiluted test substance.

Duration of treatment / exposure:

4 h

Observation period:

Immediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals maximally up to day 14.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Flank
- Type of wrap if used: test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol / water (1 : 1)
- Time after start of exposure: 4 h


SCORING SYSTEM:
The evaluation of skin reactions was performed according to the quoted guidelines.
- 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) to eschar formation preventing grading of erythema

- Edema formation
0 = No edema
1 = Very slight edema (barely perceptible)
2 = Slight edema (edges of area well defined by definite raising)
3 = Moderate edema (raised approx. 1 mm)
4 = Severe edema (raised more than 1 mm and extending beyond area of exposure)

Descriptions of any dermal findings not covered by this scale were recorded

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

Well defined erythema (grade 2) was observed in all animals immediately after removal of the patch and persisted in one animal up to 1 hour. Very slight erythema (grade 1) was noted in two animals after 1 hour and in one animal at the 24-hour reading. The cutaneous reactions were reversible in two animals within 24 hours and in one animal within 48 hours after removal of the patch.

Any other information on results incl. tables

Results:

Readings	Animal	Erythema	Edema	Additional findings
0 h	1	2	0
	2	2	0
	3	2	0
1 h	1	1	0
	2	1	0
	3	2	0
24 h	1	0	0
	2	0	0
	3	1	0
48 h	1	0	0
	2	0	0
	3	0	0
72 h	1	0	0
	2	0	0
	3	0	0
mean 24 - 72 h	1	0.0	0.0
	2	0.0	0.0
	3	0.3	0.0
mean 24 - 72 h		0.1	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU