Tin sulphide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-04-07 to 2010-04-22

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 402 (Acute Dermal Toxicity)

Version / remarks:

, adopted February 24, 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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

Sex:

male/female

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 one week, five healthy male and five healthy, non-pregnant and nulliparous
female New Zealand White rabbits were randomly assigned to the treatment group using standard
methods of randomization.
The animals were born on 12/12/09. The pretest body weight range was 2.4-2.8 kg for males and
2.4 - 2.6 kg for females. The weight variation of the animals used did not exceed.:_ 20% of the mean
weight.
The animals were identified by cage notation and a uniquely numbered metal eartag and housed 1/cage in
suspended wire 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.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free
of hair. The prepared site was approximately 1 0% of the body surface and remained intact.A single dose of the test article was moistened with 1.4 ml of destilled water to form a paste and applied to the prepared site under a four layered surgical gauze patch measuring 10x15 cm at a dose level of 200 mg/kg bw. The dose was based on the dry weight of the test article. Gentle pressure was applied to the
gauze to aid in the distribution of the test substance over the prepared site. The torso was wrapped with
plastic in a semi-occlusive manner and was secured with non-irritating tape. The test article remained in
contact with the skin for 24 hours at which time the wrappings were removed. Residual test article was
removed by gently washing with distilled water.

Duration of exposure:

24 h

Doses:

2000 mg/ kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

In vivo - The test sites were scored for dermal irritation at 24 hours postdose and on days 7 and 14 using
the numerical Draize scoring code below. The skin was also evaluated for ulceration and necrosis or any
evidence of tissue destruction. Additional signs were described.
Erythema & Eschar
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)

The animals were observed 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and
pharmacological effects. The animals were observed twice daily for 14 days for mortality.
Body weights were recorded pretest, weekly and at termination.
All animals were humanely sacrificed using C02 following study termination and examined for gross
pathology.

Statistics:

not apllicable

Results and discussion

Preliminary study:

All animals survived the 2000 mg/kg dermal application.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality: All animals survived the 2000 mg/kg dermal application. Skin reactions were normal in all animals at all observations periods. Test article staining was noted on all dose sites at all observation periods. Body weight changes were normal. There were no abnormal physical and clinical signs noted during the observation period. Necropsy results were without any findings.

Clinical signs:

other: All animals survived the 2000 mg/kg dermal application. Skin reactions were normal in all animals at all observations periods. Test article staining was noted on all dose sites at all observation periods. Body weight changes were normal. There were no abn

Gross pathology:

All animals survived the 2000 mg/kg dermal application. Skin reactions were normal in all animals at all observations periods. Test article staining was noted on all dose sites at all observation periods. Body weight changes were normal. There were no abnormal physical and clinical signs noted during the observation period. Necropsy results were without any findings.

Other findings:

No other findings

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

CLP: Not classified

Conclusions:

In an acute toxicity study according to OECD guideline 402 the dermal LD50 of tin sulfide was higher than 2000 mg/kg bw.

Executive summary:

The study according to OECD guideline 402 was used to determine the potential for toxicity of tin sulfide when applied dermally. All animals survived the 2000 mg/kg dermal application. Skin reactions were normal in all animals at all observations periods. Test item staining was noted on all dose sites at all observation periods. Body weight changes were normal. There were no abnormal physical and clinical signs noted during the observation period. Necropsy results were without any findings.