Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study on a structural analogous read-across substance (Please refer to the Read-Across Justification in Section 13)

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

Constituent 1
Chemical structure
Reference substance name:
Tin sulphide
EC Number:
215-248-7
EC Name:
Tin sulphide
Cas Number:
1314-95-0
Molecular formula:
SSn
IUPAC Name:
Tin(II) sulfide
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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
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:
not irritating
Remarks:
Criteria used for interpretation of results: EU
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.