Tin sulfide (Sn2S3)

Acute Toxicity: inhalation

Administrative data

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 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:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Test guideline 3

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

Test material

Test material information

Constituent 1

Reference substance name:

Tin sulfide

IUPAC Name:

Tin sulfide

Constituent 2

Reference substance name:

Tin(II)-Sulfide

IUPAC Name:

Tin(II)-Sulfide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

Conclusions:

The acute inhalation median lethal concentration (4hr LC50) for 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 regularly during exposure period. Clinical observations 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 5.03 mg/L, because no death occurred.