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Toxicological information

Acute Toxicity: inhalation

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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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

Test guidelineopen allclose all
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

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:
stannanethione
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
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.

Applicant's summary and conclusion

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.