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EC number: 240-986-1 | CAS number: 16924-00-8
- 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:
- 14th March 2006 to 1st August 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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))
- Version / remarks:
- 92/69/EEC and 93/21/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Dipotassium heptafluorotantalate
- EC Number:
- 240-986-1
- EC Name:
- Dipotassium heptafluorotantalate
- Cas Number:
- 16924-00-8
- Molecular formula:
- F7Ta.2K
- IUPAC Name:
- Tantalate(2-), heptafluoro-, potassium (1:2)
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Dikaliumheptafluorotantalat (Kaliumtantalfluorid)
- Substance type: White crystals
- Storage condition of test material: Room temperature, tightly closed, dry.
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 Deutschland GmbH, D-97633
- Age at study initiation: Approximately 9 weeks at time of administration.
- Weight at study initiation: 288g - 321g males, 214 - 235g females.
- Housing: Individually caged in Makrolon cages type lll (39 cm x 23 cm x 18 cm). Wire mesh lids. Cages sanitised weekly.
- Diet: Altromin diet No. 1324forte ad libitum. None during exposure.
- Water: Acidified water to pH 3 with HCl, taken from a watering system. Ad libitum excluding exposure period.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21.1 to 23.5 ºC
- Humidity: range 39.8 to 79.4%
- Air changes: 12 per hour
- Photoperiod: 12 hours of artificial light/12 hours darkness
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Nose only apparatus
- Exposure chamber volume: 19 litres
- Source and rate of air: Air obtained from a central pressure pump at 700 L/h
- System of generating particulates/aerosols: The test material was stirred in the dust generator and trickled onto an adjustable metering system. It then fell into the aerosol flask, where it was picked up by an air flow and transported to the lower centre of the inhalation chamber. The metering system was adjusted to get the desired dust concentration.
- Method of particle size determination: anaylsed by cascade impactor (Berner-Impaktor Type LP14/0,06/2 from Hauke KG, Gumunden, Austria). Approximately 8 to 14 litres of the test material-air mixture was passed through the impactor within 1.5 to 2.5 minutes and the amount which sedimented was determined gravimetrically. The mean particle size was calculated.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Preliminary experiments provided information for the starting concentration. As less than half of the animals of groups 1 and 2 died, the concentration of the dust was increased for the following group. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Analysed: Low dose 0.77 mg/L, mid dose 1.84mg/L and high 4.38mg/L
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: Test animals were observed 1, 2, 3, 4, 5, and 6 hours after the start of exposure then at least once a day for a total of 14 days.
- Frequency of observations and weighing: body weights were observed before administration then at 7 and 14 days post exposure.
- Necropsy of survivors performed: yes, 14 days post exposure.
- Other examinations performed: Deceased animals were examined macroscopically, to identify target organs. Surviving animals were sacrificed and subject to a necropsy and pathological examination. The microscopic anatomy of two test animals' lungs were examined under a light microscope, after fixing in Bouin's solution. - Statistics:
- None reported
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 6.8 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: confidence limits not reported
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 2.1 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: confidence limits not reported
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 3.3 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: confidemce limits not reported
- Mortality:
- Within the high dose group 2 males and 4 females died 1 to 7 days post exposure.
In the mid dose group 1 male died 3 days post exposure. One female died 2 days post exposure with another female being sacrificed moribund 3 days post exposure.
In the low dose group 1 female was sacrificed moribund 3 days after exposure.
A synopsis of these results can be seen in the field " Any other information on results incl. tables". - Clinical signs:
- other: Dyspoea and respiratory murmur were the most prominent findings in a dose dependent severity. They indicate an adverse action of the test material to the lungs. Piloerection, sedation or apathy, chromodacryorrhoea, hunched posture and closed eyes are sig
- Body weight:
- All surviving rats in the low and mid dose groups continued to gain weight after exposure. High dose males and females lost weight in the first week, then gained weight in the second week.
Week 1 values:
Low dose males gained 18 g
Mid dose males gained 8g
High dose males lost 37g
Low dose females gained 3g
Mid dose females gained 10 g
The sole remaining high dose female lost 71 g.
Figures are based on mean averages. - Gross pathology:
- Prominent findings were damage to the lungs, only those which died were affected.
All other findings were attributed to the poor condition of the test animals:
- Emaciation, exsiccosis due to weight loss.
- Meteorism and empty intestine consequential of the animals’ refusal to feed.
The following were seen in high dose animals:
- Sanguineous secretion at the nose was observed in 6 animals.
- A fibrin plug was found in the larynx of 2 males.
Histopathology observations:
-Local destruction of lung tissue in the lower airways and the alveoli with some reactive inflammation.
-Bacteria were seen to have started to grow within the necrotic material.
Any other information on results incl. tables
Table 1. Synopsis of Mortality Results
Sex | Concentration mg/L | Number of Animals | ||
dead (time of death) | affected | exposed | ||
male | 4.38 | 2 (1d - 3d) | 5 | 5 |
female | 4.38 | 4 (3d - 7d) | 5 | 5 |
male | 1.84 | 1 (3d) | 3 | 5 |
female | 1.84 | 2 (2d - 3d)* | 3 | 5 |
male | 0.77 | 0 | 0 | 5 |
female | 0.77 | 1 (3d)* | 1 | 5 |
*indicates one animal of this group was moribund and therefore killed
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 4 (Harmful)
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test material caused local tissue destruction in the lungs when administered by inhalation to rats. This was followed by a decrease in oxygen exchange to an extent that became lethal in some cases. The LC50 values were determined to be 6.8 mg/l (males), 2.1 mg/l (females) and 3.3 mg/l (males and females). Therefore the test material is classified as harmful by inhalation.
- Executive summary:
In a GLP compliant acute inhalation study conducted in accordance with OCED Guideline 403 and EU method B.2, the acute inhalation toxicity of the substance was determined. Rats were exposed to three concentrations of the test material for a period of four hours. Under the conditions of the test, the test material caused local tissue destruction in the lungs when administered by inhalation to rats. This was followed by a decrease in oxygen exchange to an extent that became lethal in some cases. The LC50 values were determined to be 6.8 mg/l (males), 2.1 mg/l (females) and 3.3 mg/l (males and females).
Under the conditions of the study, the test material was considered to be harmful by inhalation. The test material requires classification as Harmful (Xn) with the associated risk phrase R20 “Harmful by inhalation" under Directive 67/548/EC. Under Regulation 1272/2008 the test material requires classification as "Acute Tox. 4" with the associated hazard statement "H332: Harmful if inhaled".
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