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EC number: 235-118-3 | CAS number: 12070-06-3
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2000-09-25 to 2001-03-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. Tantalum used as read-across partner to Tantalum carbide.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- ; see text box below
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- yes
- Remarks:
- ; see text box below
- Principles of method if other than guideline:
- The mass median aerodynamic diameter (MMAD) of the test aerosol was 4.6 µm. This MMAD is slightly in excess of the guideline maximum of 4.0 µm. However it is considered that the value obtained was the minimum practical at the concentration achieved given the nature of the test material.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tantalum
- EC Number:
- 231-135-5
- EC Name:
- Tantalum
- Cas Number:
- 7440-25-7
- IUPAC Name:
- tantalum(2+)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Ta MP STA-40 KD
- Physical state: grey powder
- Analytical purity: 99.9%
- Lot/batch No.: 20000804
- Storage condition of test material: in the dark at room temperature
- Expiry date: not advised but assumed to be stable for six months from date of receipt
- Sample received: 2000-08-25
- Purity test date: 2000-08-23
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Margate, England
- Age at study initiation: 7 and 8 weeks (males and females respectively)
- Housing: by sex, in groups of 5 in holding cages made of stainless steel sheet and wire mesh suspended on a movable rack
- Diet: ad libitum
- Water: tap water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 20.5
- Humidity (%): 39 - 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: a Wright Dust Feed mechanism was used to produce and maintain atmospheres containing a particulate aerosol by suspending material scraped from the surface of a compressed powder in a stream of dry air. The concentration of particulate aerosol was altered by changing the rate at which the scraper blade is advanced into the compressed powder held in the test material canister. The Wright Dust Feed was mounted on a glass cylinder attached to the top of the exposure chamber. The conditioned test atmosphere entered through a port at the top centre of the chamber and passed out through a port at the base section below the level of the rats.
- Exposure chamber volume: 30 L
- Method of holding animals in test chamber: snout-only exposure chambers (animals held in moulded polycarbonate restraining tubes and held in a forward position by an adjustable foamed plastic stopper, which also provided a seal for the tube)
- Source and rate of air: clean, dry air was passed through an electronic neutraliser, connected to a generator and the supply pressure adjusted to give a flow rate of 16 litre/minute. An in-line flow meter was used to monitor the generator air supply throughout the exposure. The exhaust airflow was calibrated and adjusted to produce a slightly negative pressure.
- Method of particle size determination: particle size measured with a Marple cascade impactor. The volume of air sampled was measured using a wet-type gas meter. The amount of material collected on the stages of the sampler was determined gravimetrically. The particle size distribution of the test atmosphere was then assessed using linear regression analysis.
- Treatment of exhausted air: the exposure system was positioned inside a large cabinet equipped with an extract fan exhausting to atmosphere through an absolute filter.
- Temperature and humidity in air chamber: 20.0 - 20.1 °C, 42 - 58 % (mean values)
TEST ATMOSPHERE
- Brief description of analytical method used: five samples of air were removed from the test chamber following equilibration and hourly thereafter. Each air sample was withdrawn at a rate of 2 L/min through a pre-weighed glass fibre filter. The volume of air sampled was measured using a wet-type gas meter. The filters were reweighed following sampling for gravimetric analysis of the test aerosol.
TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter): 4.6 µm (approximately 67 % of the aerosol generated consisted of particulate of size < 7 µm) - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- The nominal concentration was 92.2 mg/L. The mean chamber concentration was 5.6 % of the nominal concentration that reflects losses of the test material due to impaction, deposition and cohesion due to static within the exposure system. The mean chamber concentration of total particulate was 5.18 mg/L and was in good agreement with target (5 mg/L).
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Environmental conditions in the exposure chamber: air temperature was measured using an alcohol-in-glass thermometer and relative humidity was measured using a Casella type T6900 relative humidity meter. The temperature and relative humidity were recorded at the start of exposure and then at 30 minute intervals during the 4 hour exposure.
- Frequency of observations and weighing: throughout the study, all cages were checked at least twice daily for dead or moribund animals. Rats were observed intermittently for signs of reaction to the test material during exposure and at least twice daily throughout the observation period. Clinical signs were recorded at the end of the chamber equilibration period, at 0.25, 0.5 and 1.0 hours then hourly during the exposure. Clinical signs were recorded immediately following exposure and then at 1.0 and 2.0 hours post-exposure. During the observation period, clinical signs were recorded twice daily. Bodyweights were recorded twice during the week prior to exposure (day 0) and then weekly during the observation period and on the day of death.
- Necropsy of survivors performed: yes.
- Other examinations performed: at the end of the 14-day observation period, the rats were killed by intraperitoneal injection of pentobarbitone sodium followed by exsanguinations from the brachial blood vessels and subjected to a detailed macroscopic examination. The lungs (including the larynx and trachea) were removed, dissected clear of surrounding tissue, weighed and the weights recorded.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.18 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- There were no unscheduled deaths.
- Clinical signs:
- other: DURING EXPOSURE: - Exaggerated breathing was observed in a proportion of test rats from 15 minutes and in all test rats from 30 minutes into exposure. Grey staining of the fur was noted for all test rats from 3 hours into exposure. Soiling of the fur wit
- Body weight:
- There were no treatment-related effects.
- Gross pathology:
- There were no treatment-related effects at necropsy.
Incidental effects noted included: small dark foci noted on the lungs of two male test rats and a male control rat. Hair loss from head was noted for a male test rat. - Other findings:
- Lung weight: there were no treatment-related effects.
Any other information on results incl. tables
Table 1: Chamber Concentration of Test Material
Sample | Time taken (h:min) | Gravimetric conc. (mg/L) | Nominal conc. (mg/L) |
1 | 0:10 | 4.95 | |
2 | 1:00 | 5.00 | |
3 | 2:00 | 5.48 | |
4 | 2:58 | 5.04 | |
5 | 3:54 | 5.41 | |
Mean | 5.18 | 92.2 | |
SD | 0.249 |
Table 2: Particle Size Distribution of Test Material
Sample | Time taken (h:min) | Stage | Cut-off size (µm) | Amount collected (mg) |
PSD 1 | 1:31 | 1 | 21.30 | 0.06 |
2 | 14.80 | 0.07 | ||
3 | 9.80 | 0.35 | ||
4 | 6.00 | 0.63 | ||
5 | 3.50 | 0.34 | ||
6 | 1.55 | 0.26 | ||
7 | 0.93 | 0.01 | ||
8 | 0.52 | 0.00 | ||
Filter | 0.00 | 0.08 | ||
Total | 1.80 | |||
PSD 2 | 3:31 | 1 | 21.30 | 0.00 |
2 | 14.80 | 0.09 | ||
3 | 9.80 | 0.39 | ||
4 | 6.00 | 0.77 | ||
5 | 3.50 | 0.40 | ||
6 | 1.55 | 0.29 | ||
7 | 0.93 | 0.06 | ||
8 | 0.52 | 0.03 | ||
Filter | 0.00 | 0.08 | ||
Total | 2.11 |
Table 3: Calculations | |||
Cut-off size (µm) | % less than size (cumulative) | ||
PSD 1 | PSD 2 | Combined | |
21.30 | 96.60 | 100.00 | 98.50 |
14.80 | 92.70 | 95.70 | 94.40 |
9.80 | 73.30 | 77.20 | 75.50 |
6.00 | 38.30 | 40.70 | 39.70 |
3.50 | 19.40 | 21.70 | 20.80 |
1.55 | 5.00 | 8.00 | 6.70 |
0.93 | 4.40 | 5.20 | 4.90 |
0.52 | 4.40 | 3.80 | 4.10 |
MMAD (µm) | 5.10 | 4.00 | 4.60 |
geometric SD | 2.66 | 2.28 | 2.53 |
% respirable (< 7 µm) | 62.00 | 75.00 | 67.00 |
SD= standard deviation
Table 4: Individual and Group Mean Bodyweights
Group | Rat | Day of observation | ||||||
-7 | -4 | -2 | -1 | 0 | 7 | 14 | ||
1 M (Control) | 101 | 215 | 246 | 268 | 278 | 331 | 377 | |
102 | 221 | 253 | 277 | 284 | 331 | 368 | ||
103 | 223 | 245 | 274 | 280 | 332 | 349 | ||
104 | 235 | 265 | 288 | 298 | 350 | 386 | ||
105 | 228 | 265 | 292 | 295 | 359 | 404 | ||
Mean | 224 | 255 | 280 | 287 | 341 | 377 | ||
2 M (Test) | 81 | 219 | 239 | 258 | 306 | 352 | ||
82 | 220 | 239 | 257 | 297 | 332 | |||
83 | 228 | 243 | 261 | 299 | 335 | |||
84 | 228 | 249 | 263 | 300 | 343 | |||
85 | 218 | 235 | 253 | 300 | 343 | |||
Mean | 223 | 241 | 258 | 300 | 341 | |||
1 F (Control) | 106 | 204 | 223 | 234 | 237 | 256 | 265 | |
107 | 189 | 199 | 199 | 204 | 209 | 205 | ||
108 | 208 | 220 | 228 | 229 | 243 | 252 | ||
109 | 204 | 222 | 225 | 233 | 255 | 255 | ||
110 | 209 | 222 | 231 | 236 | 245 | 247 | ||
Mean | 203 | 217 | 223 | 228 | 242 | 245 | ||
2 F (Test) | 86 | 199 | 215 | 222 | 238 | 242 | ||
87 | 205 | 211 | 212 | 227 | 235 | |||
88 | 203 | 207 | 216 | 233 | 237 | |||
89 | 208 | 212 | 219 | 222 | 211 | |||
90 | 196 | 205 | 209 | 218 | 229 | |||
Mean | 202 | 210 | 216 | 228 | 231 |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusions, in acute inhalation study in rats the LC50 after nose-only exposure to Tantalum was estimated to be greater than 5.18 mg/L.
- Executive summary:
In an acute inhalation toxicity study (OECD 403), groups of young adult Sprague Dawley rats (5/sex) were exposed nose-only to Tantalum (99.9%) for 4 hours at a concentration of 5.18 mg/L. Animals then were observed for 14 days. A further group, acting as a concurrent common control was exposed to clean air only. No unscheduled deaths occurred. Clinical signs during the exposure period were limited to exaggerated breathing in test rats 15 to 30 minutes into exposure and grey staining on the fur 3 hours into exposure. During the observation period, clinical signs were limited to exaggerated breathing in all test rats immediately post exposure, persisting to day 4 of the observation period. A black/grey substance on the fur of the snout and jaws was evident on all test animals, persisting to day 2 of the observation period and hair loss from head of a single male test rat on day 14 of the observation period. All animals gained weight during the study. There were no macroscopic abnormalities at examination post mortem. Based on the results, LC50 was estimated to be greater than 5.18 mg/L for both male and female rats.
This information is used in a read-across approach for the assessment of tantalum carbide.
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