Tin sulphide

Endpoint summary

Description of key information

No toxicity has been seen in acute oral and dermal toxicity studies with tin sulfide. No death occurred in an anute inhalation toxicity study with tin sulfide but test item-related brown discoloration of the lungs
and enlarged lung-associated lymph nodes and in some animals slight body weight loss during the first three days of the observation period was noted.
Supporting studies on the read-across substance tin disulfide confirm the lack of toxicity after acute exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-04-12 to 2010-04-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline compliant study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

, adopted 17 December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals were received from Ace Animals, Boyertown, PA on 04/06/10. Following an acclimation period of
at least five days, three healthy male and three healthy, non-pregnant and nulliparous female Sprague
Dawley rats were assigned to treatment groups without conscious bias.
The animals were born the weeks of 02/07/10 & 02/15/10. The pretest body weight range was
201 - 225 grams for males and 169- 189 grams for females. The weight variation of the animals used did
not exceed ± 20% of the mean weight of the previously dosed animals within a sex.
The animals were identified by cage notation and indelible body marks, and housed in suspended wire
cages, 5/sex/cage prior to dosing and 3/sex/cage following dosing. Paper bedding was placed beneath
the cages and changed at least three times/week. Fresh PMI Rat Chow (Diet #5012) was freely available
except for 16-20 hours prior to dosing. Water was available ad libitum. The animal room, reserved
exclusively for rats on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was
kept clean and vermin free.

Route of administration:

oral: feed

Vehicle:

CMC (carboxymethyl cellulose)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Dosing
The test article was mixed with 2% methyl cellulose to make dosing by gavage possible. The dose was
based on the dry weight of the test article. A single dose was administered orally by syringe and dosing
needle at a dose level of 2000 mg/kg to three male and three female rats.
Type and Frequency of Observations
In Vivo- Animals were observed 0.5, 1, 2, 3 and 4 hours postdose and once daily for 14 days for mortality,
toxicity and pharmacological effects. Body weights were recorded immediately pretest, weekly, and at
termination.
Post Mortem- All animals were humanely sacrificed using C02 and were examined for gross pathology
following study termination.
Analysis of Data
The Acute Toxic Category is assigned as follows:
Category 1 = LD50 (>0 mg/kg <5 mg/kg) Category 4 = LD50 (>300 mg/kg <2000 mg/kg)
Category 2 = LD50 (>5 mg/kg <50 mg/kg) Category 5 = LD50 (>2000 mg/kg <5000 mg/kg)
Category 3= LD50 (>50 mg/kg <300 mg/kg) Category 5 or Unclassified = LD50
(>2000 mg/kg <5000 mg/kg with 0 Mortality)

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the 2000 mg/kg oral dose.

Clinical signs:

other: All animals survived the 2000 mg/kg oral dose, all body weights were normal for both sexes. There were no abnormal physical signs noted during the observation period. Necropsy results were normal.

Gross pathology:

All animals survived the 2000 mg/kg oral dose, all body weights were normal for both sexes. There were no abnormal physical signs noted during the observation period. Necropsy results were normal.

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

CLP: Not classified

Conclusions:

The Acute Toxic Class Determination according to OECD guideline 423 revealed an LD50 is > 2000 mg/kg bw for tin sulfide in rats.

Executive summary:

The Acute Toxic Class Determination according to OECD guideline 423 was used to determine the oral toxicity of tin sulfide in rats.

All animals survived the 2000 mg/kg oral dose, all body weights were normal for both sexes. There were no abnormal physical signs noted during the observation period. Necropsy results were normal.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline compliant study on tin sulfide

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13-12-017 to 14-01-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP and Guideline compliant study

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld
- Age at study initiation: young adult rats, 8-12 weeks old
- Weight at study initiation: 226 to 465 g (males: 363-465g, females: 226-261 g)
- Housing: standard hygienic level, Group of 5 (by sex) in Type III solid floor cages with stainless steel mesh lids, Enrichment: deep wood sawdust to allow normal rodent activities
- Diet (e.g. ad libitum): ssniff SM R/M
- Water (e.g. ad libitum): ad libitum tap water for human consumption (qualitiy control analysis once every 3 month)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.3 - 24.4 °C
- Humidity (%): 30-58%
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours light daily from 6.00 a.m to 6.00 p.m.

I

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

Preperation of test item:
Test item was grounded in a grinding jar. Prior exposure of animals material atmospheres were generated using two Wright´s Dust Feed Systems. Animals were exposed, nose-only, to an atmosphere of test item using a TSE Rodent Exposure System.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

Mean Achieved 5.03 mg/L

No. of animals per sex per dose:

5 male and 5 female were exposed.

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.03 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality was observed.

Clinical signs:

other: Slight laboured respiration for some exposed animals on day 1 of exposure. No abnormaliies were detected during later observation period.

Body weight:

Normal body weight for all animals during the observation period was messured, with exeption of some animals during the first three days, who lost slightly body weight.

Gross pathology:

The exposure was associated with test item-related brown discolarion of lungs and enlarged lung-associated lymph nodes.

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

CLP: Not classified

Conclusions:

The acute inhalation median lethal concentration (4hr LC50) fo Tin sulfide was considered to be greater than 5.03 mg/L.

Executive summary:

The study was performed in accordance to test guidelines OPPTS 870.1300 and OECD guideline 403. The acute toxicity of Tin sulfide after a 4 hour exposure at target concentration of 5 mg/L to 5 male and 5 female rats (CRL: (WI) Wistar strain) was determined. Rats were exposed using a nose-only exposure system followed by a 14 day observation period. Aerosol concentrations were measured gravimetrically. Particle size distribution was determined regulary during exposure period. Clinical obserbations and body weights were recorded and animals were subjected to a gross examination post mortem. All clinical observations (e.g. wet fur, fur staining) were considered to be related to exposure procedures and not as biologically significant. Normal body weights were noted during observation period with exception of slight body weight loss of some animals during the first three days of observation. In addition the exposure was associated with test item-related brown discoloration of lungs and enlarged lung-associated lymph nodes. But the mean lethal concentration after 4 hours is greater than 5 mg/L, because no death occurred.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

5 030 mg/m³ air

Quality of whole database:

GLP and guideline compliant study on tin sulfide

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

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

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.

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

Preliminary study:

All animals survived the 2000 mg/kg dermal application.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline compliant study on tin sulfide

Additional information

Oral exposure: The Acute Toxic Class Determination according to OECD guideline 423 revealed an LD50 is > 2000 mg/kg bw for tin sulfide in rats. Inhalation exposure: In an acute inhalation study according to OECD guideline 403 no death occurred up to the limit concentration of 5.03 mg/L for four hours. Dermal exposure: In an acute toxicity study according to OECD guideline 402 the dermal LD50 of tin sulfide was higher than 2000 mg/kg bw.

Justification for classification or non-classification

According to the results from the acute oral, dermal and inhalation toxicity studies, no classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.