Tin sulphide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-04-11 to 2010-04-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

, adopted 24 April 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tin sulphide

EC Number:

215-248-7

EC Name:

Tin sulphide

Cas Number:

1314-95-0

Molecular formula:

SSn

IUPAC Name:

stannanethione

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals were received from Covance Research Products Inc., Denver, PA on 03/31/10. Following an
acclimation period of at least five days, three healthy New Zealand White rabbits (females) were selected
from a larger group without conscious bias.
The animals were born on 12/12/09. The pretest body weight range was 2.8-2.9 kg.
The animals were identified by cage notation and a uniquely numbered metal eartag and individually
housed in suspended cages. Paper bedding was placed beneath the cages and changed at least three
times/week. Fresh PMI Rabbit Chow (Diet #5321) was provided daily. Water was available ad libitum.
The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12-
hour light/dark cycle, and was kept clean and vermin free.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5g substance/ site, moistened with 0.2 mL distilled water as a pasty.

Duration of treatment / exposure:

4h

Observation period:

After 60 minutes and 24, 48 and 72 hours

Number of animals:

3

Details on study design:

The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free
of hair. Each dose site was approximately 3 x 3 cm.
The test article was individually weighed, 0.5 g/site and moistened with 0.2 mL of distilled water to form a
pasty consistency. The test article was applied under a 2.5 x 2.5 cm gauze patch. Gentle pressure was
applied to aid in the distribution of the test article over the prepared site. The patch was secured with nonirritating
tape. The torso was covered with a piece of porous dressing (semi-occlusive) large enough to
cover all dose sites with at least 5 cm square to spare on all sides of the gauze patch. Porous, nonirritating
tape was used to encircle the trunk of the animal. The test article was kept in contact with the skin
for 4 hours at which time the wrappings and patches were removed . Distilled water was used to aid in the
attempted removal of residual test article at the end of the exposure period, prior to scoring for dermal
reactions. However, test material stained all of the dose sites. The test sites were scored for dermal irritation at
60 minutes and at 24, 48 and 72 hours following patch removal. Erythema and edema were scored according to the
numerical Draize technique below. The skin was also evaluated for ulceration and necrosis or any evidence of tissue
destruction. Additional signs were described.

Erythema
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Edema
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well-defined by definite raising)
3: Moderate edema (raised approximately 1.0 mm)
4: Severe edema (raised more than 1.0 mm, extending beyond the area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24, 48, 72

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48, 72

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

There was no erythema or edema noted for any animal at any observation period.
There were no abnormal physical signs noted during the observation period and
all body weights were normal. Therefore the test item tin sulfide is not a dermal irritant.

Other effects:

No abnormal physical signs were noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Tin sulfide had no skin irritating/corrosive effects in an in vivo study according to OECD guideline 404.

Executive summary:

A skin irritation/corrosion study with rabbits according to OECD guideline 404 was performed to determine the irritant or corrosive effects, if any, of tin sulfide when applied to the skin. There was no erythema or edema noted for any animal at any observation period. Test item stained the dose sites at all observation periods. There were no abnormal physical signs noted during the observation period. All body weights were normal.