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EC number: 231-141-8 | CAS number: 7440-31-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 September 2008 to 8 October 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The information obtained is relevant to to hazard assessment of metallic tin and all efforts were made to determine as accurately as feasiblly possible, the likely inhalation or respiratory effects of exposure to tin metal.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tin
- EC Number:
- 231-141-8
- EC Name:
- Tin
- Cas Number:
- 7440-31-5
- Molecular formula:
- Sn
- IUPAC Name:
- tin
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Tin Metal Powder
- Physical state: grey metallic powder
- Analytical purity: 99.99 %
- Lot/batch No.: 814461
- Expiration date of the lot/batch: Not stated
- Stability under test conditions:
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Limited, Margate, Kent UK
- Age at study initiation: 57 days (males) and 78 days (females)
- Weight at study initiation: 230-251g (males) and 199-221g (females)
- Fasting period before study: no
- Housing: in groups of five in standard laboratory caging
- Diet: ad libitum, SQC Rat and Mouse Maintenance Diet No 1, Expanded, (Special Diets Services Ltd, Witham, UK)
- Water: ad libitum, mains water via water bottles
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 40-70% RH
- Air changes: 15 per hr
- Photoperiod:12/12 (hrs dark / hrs light)
IN-LIFE DATES: From: 17 September 2008 To: 1 October 2008
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- not specified
- Mass median aerodynamic diameter (MMAD):
- 3.34 µm
- Geometric standard deviation (GSD):
- 2.38
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Rotating brush generator and flow through chamber
- Exposure chamber volume: 40 L
- Method of holding animals in test chamber: Standard holding tubes (polycarbonate type restraining tubes) attached to chamber walls to give nose-only exposure
- Source and rate of air: Generator, 20.1 L/min flow rate to achieve 12 air changes per hour
- System of generating particulates/aerosols: Rotating brush generator
- Method of particle size determination: Supplied test material was ground to produce a powder with particle size of 1-5 µm. Samples were returned for analysis and confirmation of particle size range. Particle sizes in the test aerosol were measured gravimetrically using a Marple 298 cascade impactor, from which the MMAD and GSD were determined. During the aerosol characterisation phase of the study, samples of the generated tin metal powder were sent to the Sponsor for examination under a microscope to check that agglomeration of the particles had not occurred during generation. The tin metal particles were collected from a port representative of the animals breathing zone. The duration of collection was 5 minutes. The tin particles were collected on Vaseline smeared glass slides. The slides were not directly analysed by scanning electron microscope (SEM) as it was expected that the Vaseline would degas in the SEM machine. Carbon tape was pressed onto the glass slide and then lifted off to collect a sample of tin powder and was then gold coated before being viewed by SEM.
- Treatment of exhaust air: The chamber was exhausted from the bottom of the chamber to ensure a dynamic flow of fresh aerosol through the chamber during exposure. Treatment of exhaust air was not reported.
- Temperature, humidity, pressure in air chamber: Measured continuously within the chamber along with oxygen content with targets of 20-24 °C; 30-70 % RH and 19 % v/v oxygen.
TEST ATMOSPHERE
- Brief description of analytical method used: Nominal test atmosphere concentration determined and achieved concentration determined by gravimetric analysis at half hourly intervals throughout the exposure period
- Samples taken from breathing zone: yes
VEHICLE
No vehicle employed
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 3.34 µm and 2.38 respectively - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- >= 4 h
- Concentrations:
- 4.75 mg/L measured (5 mg/L target)
- No. of animals per sex per dose:
- Five males and five females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Hourly observations during exposure and at daily intervals from day 2 to 15. Bodyweights recorded on daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology.
At necropsy the respiratory tract tissues were preserved for histopathology. The tissues included trachea, lung including main stem bronchi and bronchioles, tracheal bifurcation (bronchial), larynx, and nasopharynx.
Histopathological examinations included trachea, mainstem bronchi, bronchioles and lung for two animals per group
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.75 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortalities during the study
- Clinical signs:
- other: Treatment-related clinical signs observed on Day 1, during exposure to 4.75 mg/L tin metal powder were limited to tachypnoea (abnormally fast breathing). This observation was seen in all animals (both sexes) from 3 hours onwards during exposure. Wet fur w
- Body weight:
- All animals lost weight during exposure. The mean post exposure body weight loss (14 g) was considered to be due to removal of food and water during the exposure period and not due to the effects of the test article. This weight loss is considered to be a common phenomenon observed in acute inhalation studies. All animals gained weight on Day 2, however, females took longer on average to recover their pre-exposure body weight.
- Gross pathology:
- Dark lung was noted in all animals at necropsy. This observation is consistent with inhalation exposure to respirable particulate material. There were no other macroscopic findings due to effects of the test article. Most tissues were macroscopically unremarkable and the findings seen were generally consistent with the usual pattern of findings in animals of this strain and age.
- Other findings:
- - Histopathology:Microscopic evaluation of the trachea, mainstem bronchi, bronchioles and lung was performed on two animals of each sex. In addition, representative photomicrographs of intra-alveolar particles in the lung, and intra epithelial particles in the trachea were taken using a digital camera attached to a microscope.
Test article was noted in the lung in all treated animals examined which generally correlated with findings seen macroscopically of heavy staining in the lungs. In one male, sub-epithelial particles were noted in the trachea.
Test article in the lung was characterised by multiple dark particles in the alveolar spaces, generally associated with pale eosinophilic homogenous material, and occasionally within alveolar macrophages. Particles were located in all lung sections and distributed from alveoli in the deep lung parenchyma to sub-pleural alveoli, with no clear anatomic localisation. In addition, there were occasional very minor foci of mucus-associated particles adherent to the bronchial and/or bronchiolar epithelium.
Sub-epithelial particles in the trachea were characterised by a few dark particles associated with minor lymphoid foci localised beneath the epithelium of the carina of the tracheal bifurcation.
There were no other microscopic findings due to effects of the test article.
Any other information on results incl. tables
Table1
Group summary clinical signs
Group/Sex |
Clinical sign |
Number of animals in group showing signs during exposure on Day 1 (hours): |
Number of animals in group showing signs post-exposure on Day 1 (hours): |
|
||||||
3 |
4 |
Imm |
1 |
2 |
3 |
4 |
|
|||
1M |
Number examined: |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
|
Tachypnoea |
5 |
5 |
|
|
|
|
|
||
|
Wet fur |
5 |
5 |
5 |
|
|
|
|
||
|
Unkempt |
|
|
|
5 |
5 |
5 |
5 |
||
|
Staining - head |
|
|
5 |
|
|
|
|
||
|
Staining* |
|
|
|
3 |
2 |
1 |
2 |
||
|
Vocalisation |
|
|
1 |
|
|
|
|
||
1F |
Number examined: |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
||
|
Tachypnoea |
5 |
5 |
|
|
|
|
|
||
|
Wet fur |
5 |
5 |
5 |
|
|
|
|
||
|
Unkempt |
|
|
|
5 |
5 |
5 |
5 |
||
|
Staining - head |
|
|
5 |
|
|
|
|
||
|
Staining* |
|
|
|
5 |
3 |
2 |
1 |
||
|
Vocalisation |
|
|
3 |
|
|
|
|
||
Imm = Immediately on return to cage
* where no area has been specified, this indicates that staining was
seen across the whole of the animal's body
Table2
Group mean body weights
Group/ |
Animal |
Group mean body weights (g) for Day: |
|||||
|
|
1 |
1 |
2 |
3 |
4 |
5 |
1M |
Mean |
239 |
225 |
239 |
245 |
246 |
249 |
SD |
8.5 |
7.3 |
9.7 |
9.4 |
8.8 |
11.5 |
|
1F |
Mean |
211 9.8 |
197 |
210 |
210 |
209 |
211 |
SD |
8.2 |
9.5 |
11.5 |
9.6 |
10.4 |
Group/ |
Animal |
Group mean body weights (g) for Day: |
|||||
|
|
6 |
7 |
8 |
9 |
10 |
11 |
1M |
Mean |
256 |
258 |
260 |
263 |
266 |
268 |
SD |
8.5 |
9.5 |
8.9 |
9.6 |
10.8 |
11.5 |
|
1F |
Mean |
213 |
213 |
214 |
214 |
216 |
216 |
SD |
9.8 |
10.4 |
9.0 |
9.1 |
10.2 |
13.3 |
Group/ |
Animal |
Group mean body weights (g) for Day: |
|||
12 |
13 |
14 |
15 |
||
1M |
Mean |
271 |
274 |
279 |
279 |
SD |
12.6 |
11.8 |
12.8 |
12.6 |
|
1F |
Mean |
213 |
215 |
217 |
220 |
SD |
10.7 |
11.5 |
12.4 |
12.7 |
Table3
Group mean body weightgains
Group/ Sex |
Animal
number
|
Pre-exposure body weight (g) |
Body weight gain relative to pre-exposure(g) |
||||||
Day 1 |
Day 2 |
Day 8 |
Day 15 |
||||||
1M |
Mean |
239 |
-14 |
0 |
21 |
40 |
|||
SD
|
8.5 |
3.6 |
1.7 |
5.4 |
8.4 |
||||
1F |
Mean |
211 |
-14 |
-1 |
3 |
9 |
|||
SD |
9.8 |
3.9 |
3.4 |
7.4 |
5.5 |
||||
Table 4
Particle Size
|
% Mass of total |
|||||||||||
Cut point (µm) |
100 |
21.3 |
14.8 |
9.8 |
6.0 |
3.5 |
1.55 |
0.93 |
0.52 |
MMAD (µm) |
GSD |
|
Stage |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
Filter |
|||
Gravimetric |
||||||||||||
PSD 1 |
100 |
100 |
100 |
98.43 |
35.08 |
19.37 |
14.14 |
11.52 |
5.76 |
3.82 |
2.76 |
|
PSD 2 |
100 |
99.32 |
99.32 |
99.32 |
40.54 |
20.27 |
12.16 |
9.46 |
6.08 |
3.06 |
2.21 |
|
PSD 3 |
100 |
100 |
99.29 |
99.29 |
43.26 |
19.86 |
12.77 |
7.80 |
4.26 |
3.15 |
2.17 |
|
Mean |
3.34 |
2.38 |
||||||||||
MMAD = Mass median aerodynamic diameter
GSD = Geometric standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- All animals survived a single 4-hour (nose only) inhalation exposure to tin metal powder. The mean achieved aerosol concentration during the 4 hour exposure was slightly below the OECD target dose level however, this concentration is considered to be the maximum practical achievable in order to maintain a respirable aerosol.
The mass median aerodynamic diameter (MMAD) was below 4 microns and therefore the particle size distribution was within the respirable range for rats.
No treatment related adverse effects were noted during the study. Macroscopic findings were consistent with exposure to dark material within the respirable range. Microscopic evaluation demonstrated that the test article had penetrated the deep lung.
The maximum practically achievable, respirable concentration of tin metal powder was 4.75 mg/L. In the absence of adverse clinical signs or pathology findings it is considered that the LC50 is in excess of 5 mg/L. The European Union (EU) classification of inhalation risk for test articles with an LC50 of greater than 5 mg/L is ‘unclassified’. - Executive summary:
A group of male and female rats was dosed with the maximum practical dose concentration of particulate tin metal, prepared as a dust in size range of 1 -5 µm. Nose only exposure for 4 hours was followed by 14 days observation, macroscopic and microscopic investigations were completed after necropsy. The LC50 for metallic tin dust was greater than 4.75 mg/L. No signs of a toxic response were evident following inhalation exposure.
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