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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: 7 day range-finding study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 9 October 2012 to 01 November 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the relevant results.
Data source
Reference
- Reference Type:
- other: Study notes from range-finding test
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of 3 rats per sex per dose were exposed to the test material in a 7 day palatability test, designed to yield information to determine the dose range for an upcoming 14 day dietary dose range finding study. Animals received treated diet over a 7 day period at the following nominal dose levels; 0 (control), 140, 400, 1200 and 4000 ppm. Mortality, clinical signs, body weight, food consumption and water consumption were monitored during the study. Following the last day of treatment the animals were sacrificed and subjected to gross pathology.
- GLP compliance:
- no
- 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: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): dipotassium heptafluorotantalate
- Appearance: white crystalline powder
- Storage condition of test material: controlled room temperature (15 - 25 °C, below 70 RH%)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Crl:WI
- Age at study initiation: at least 8 weeks.
- Weight at study initiation: 233 - 281 g (males); 191 - 215 g (females). Weights did not exceed ± 20 % of the mean weight for each sex at onset of treatment.
- Housing: animals were housed in groups of up to 3 animals per sex per goroup, in grid floor cages.
- Diet: Complete breeding and maintenance diet for rats and mice was provided, ad libitum.
- Water: tap water, ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 - 20 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: sunflower oil
- Details on oral exposure:
- DIET PREPARATION
4 g of test material was mixed with 50 g (approximately 60 mL) of sunflower oil. This formulation was then mixed into a diet premix with powdered diet before being mixed into a total weight of 1 kg of powder diet mix. This procedure was used to prepare the 4000 ppm diet, the maximum concentration used in the study.
Animals dosed at 0 ppm (control group) received powder diet mixed with 5 % w/w sunflower oil. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- At least three samples of test material treated diets were collected into plastic tubes (from the top, middle and bottom of the container) on day 0, (for homogeneity) and day 7. At least one sample will be similarly taken from the control diet on each occasion.
The level of test material in the diet was determined by ICP. - Duration of treatment / exposure:
- 7 days
- Frequency of treatment:
- Continuously (in diet)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 140, 400, 1200, 4000 ppm
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0, 13, 39, 117, 350 mg/kg bw/day
Basis:
other: target dose levels, achieved dose levels dependent on food consumption.
- No. of animals per sex per dose:
- 3 males and 3 females per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: doses were selected, based on the results of previous investigations on the test material in attempt to obtain palatability information and identify toxicity associated with the test material under the conditions of this study and to permit the selection of the intended high dose level for use in a long term repeated dose toxicity study.
- Rationale for animal assignment: Animals were sorted according to body weight by computer and divided to weight ranges. There were an equal number of animals from each weight group randomly assigned to each dose group to ensure that animals of all test groups were of a uniform weight. The grouping was controlled by SPSS/PC software, according to the actual body weight verifying the homogeneity/variability between/within the groups and cages. Males and females will be randomised separately.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Animals were inspected for signs of morbidity and mortality twice daily (at the beginning and end of each working day.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: At least twice daily, animals may be observed more frequently in cases that show signs of toxicity. The onset, degree and duration of all signs were recorded as applicable.
- Signs evaluated included: changes in skin, fur, eyes, mucous membranes, occurrence of secretions and excretions, and autonomic activity (e.g. lachrymation, piloerection, pupil size, unusual respiratory pattern). Changes in gait, posture and response to handling as well as the presence of clonic or tonic movements, stereotypies (e.g. excessive grooming, repetitive circling), and bizarre behaviour (e.g. self-mutilation, walking backwards). Special attention was directed towards the observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
BODY WEIGHT: Yes
- Time schedule for examinations: The body weight of each animal was recorded on Day 0, 2, 4 and 6 (prior to necropsy).
FOOD CONSUMPTION: Yes
- Time schedule: Daily
WATER CONSUMPTION: Yes
- Time schedule for examinations: Daily, estimated by weighing the daily consumption by cage. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Gross necropsy was performed on each animal irrespective of the date of death, including the animals found dead or euthanised pre-terminally in extremis. Surviving animals were euthanised under pentobarbital anaesthesia by exsanguination.
After exsanguination the external appearance was examined, cranium, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed macroscopically. Any abnormality was recorded with details of the location, colour, shape and size, as appropriate. Special attention was paid to the gastrointestinal tract (stomach mucosa and full length of intestine).
On completion of the macroscopic examination, stomach, intestine, kidneys and any tissues showing macroscopic abnormality were preserved in 10 % buffered formaldehyde solution or in Bouin’s fixative solution (testes and epididymides) or Davidson’s fixative solution (eyes). - Statistics:
- Statistical evaluation of data was performed with the program package SPSS PC+4.0 (SPSS Hungary Kft, Budapest). The homogeneity of variance between groups was checked by Bartlett`s homogeneity of variance test. Where no significant heterogeneity was detected a one-way analysis of variance (ANOVA) was made. If the obtained result was significant Duncan’s Multiple Range test was used to assess the significance of inter-group differences. Significant results with inter-group comparisons were further compared using Kruskal-Wallis and Mann-Whitney U-tests.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- See "Details on results" for information.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- See "Details on results" for information.
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- MORTALITY
None of the animals died during the study.
BODY WEIGHT AND WEIGHT GAIN
Decrease in body weight gain was observed in males and females, but this was not unequivocally dose-related.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
There was no negative effect recorded in food consumption, however, spillage of the diet was observed in all groups (including the control group). Calculation of food consumption (and test material intake) was therefore not possible.
GROSS PATHOLOGY
Gross pathology revealed significant effects on the stomach mucosa, as follows:
- Concentration 4000 ppm: ulcers, glandular mucosa, dark red focuses on mucosa
- Concentration 1200 ppm: ulcers, glandular mucosa, dark red focuses on mucosa
- Concentration 400 ppm: ulcers, glandular mucosa
- Concentration 140 ppm: no effect, NOAEL under the conditions of this study.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 140 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Based on significant effects observed in the stomach and mucosa.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Body Weight and Weight Gain
Concentration (mg/kg diet) |
Sex |
Individual body weights |
Individual body weight gain from Day 0 to Day 7 |
Mean body weight gain Day 0 to Day 7 |
||||
Day 0 |
Day 2 |
Day 4 |
Day 6 |
Day 7 |
||||
0 |
Male |
251 |
264 |
265 |
282 |
286 |
35 |
50.33 |
246 |
263 |
273 |
294 |
304 |
58 |
|||
250 |
276 |
281 |
303 |
308 |
58 |
|||
Female |
200 |
198 |
206 |
216 |
223 |
23 |
27.00 |
|
194 |
211 |
210 |
226 |
223 |
29 |
|||
201 |
215 |
217 |
231 |
230 |
29 |
|||
140 |
Male |
257 |
268 |
274 |
291 |
291 |
34 |
49.00 |
259 |
278 |
288 |
308 |
318 |
59 |
|||
233 |
248 |
256 |
278 |
287 |
54 |
|||
Female |
205 |
218 |
218 |
224 |
219 |
14 |
17.67 |
|
203 |
209 |
217 |
219 |
222 |
19 |
|||
203 |
203 |
213 |
214 |
223 |
20 |
|||
400 |
Male |
254 |
268 |
281 |
301 |
315 |
61 |
57.67 |
239 |
257 |
261 |
283 |
291 |
52 |
|||
264 |
278 |
290 |
311 |
324 |
60 |
|||
Female |
202 |
218 |
224 |
235 |
236 |
34 |
23.67 |
|
192 |
200 |
206 |
210 |
214 |
22 |
|||
200 |
197 |
211 |
208 |
215 |
15 |
|||
1200 |
Male |
253 |
262 |
271 |
290 |
298 |
45 |
54.00 |
245 |
260 |
269 |
292 |
306 |
61 |
|||
273 |
287 |
297 |
317 |
329 |
56 |
|||
Female |
193 |
208 |
209 |
218 |
211 |
18 |
22.00 |
|
208 |
222 |
225 |
236 |
230 |
22 |
|||
191 |
206 |
202 |
212 |
217 |
26 |
|||
4000 |
Male |
281 |
268 |
281 |
185 |
298 |
17 |
0.67 |
248 |
255 |
261 |
280 |
197 |
-51 |
|||
251 |
246 |
257 |
268 |
287 |
36 |
|||
Female |
200 |
199 |
197 |
211 |
216 |
16 |
12.00 |
|
215 |
212 |
211 |
223 |
230 |
15 |
|||
195 |
188 |
194 |
186 |
200 |
5 |
Table 2: Food Consumption
Concentration (mg/kg diet) |
Sex |
Food consumption (g/animal/day)* |
Mean food consumption g/ animal/Day |
||||||
Day 0 |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
|||
0 |
Male |
28 |
29 |
27 |
30 |
27 |
26 |
28 |
27.86 |
Female |
23 |
22 |
12 |
24 |
23 |
21 |
23 |
21.14 |
|
140 |
Male |
27 |
28 |
27 |
32 |
27 |
24 |
28 |
27.57 |
Female |
21 |
21 |
26 |
26 |
22 |
17 |
28 |
23.00 |
|
400 |
Male |
30 |
29 |
26 |
31 |
30 |
27 |
31 |
29.14 |
Female |
26 |
26 |
20 |
29 |
21 |
21 |
25 |
24.00 |
|
1200 |
Male |
27 |
28 |
28 |
31 |
38 |
28 |
31 |
30.14 |
Female |
26 |
33 |
22 |
35 |
24 |
28 |
21 |
27.00 |
|
4000 |
Male |
19 |
22 |
25 |
39 |
25 |
32 |
41 |
29.00 |
Female |
23 |
27 |
27 |
39 |
23 |
25 |
42 |
29.43 |
* calculated data = cage level measured food consumption/number of animals in the cage (3)
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study none of the animals died. Decrease in body weight gain was observed in males and females, but this was not unequivocally dose-related. There was no negative effect recorded in food consumption, however, spillage of the diet was observed in all groups (including the control group). Calculation of food consumption (and test material intake) was therefore impaired. Gross pathology revealed significant effects on the stomach mucosa, most probably due to degradation of the test material in the stomach to Ta2O5, KF and HF. KF and HF are considered responsible for acute corrosive effects seen in the gastrointestinal tract.
- Executive summary:
The repeated dose toxicity, and palatability, of the test material was investigated in a preliminary study in which groups of 3 rats per sex per dose were exposed to the test material over 7 consecutive days. Animals received treated diet at the following nominal dose levels; 0 (control), 140, 400, 1200 and 4000 ppm formulated in sunflower oil. Mortality, clinical signs, body weight, food consumption and water consumption were monitored during the study. Following the last day of treatment the animals were sacrificed and subjected to gross pathology.
None of the animals died. Decrease in body weight gain was observed in males and females, but this was not unequivocally dose-related. There was no negative effect recorded in food consumption, however, spillage of the diet was observed in all groups (including the control group). Calculation of food consumption (and test material intake) was therefore impaired. Gross pathology revealed significant effects on the stomach mucosa, most probably due to degradation of the test material in the stomach to Ta2O5, KF and HF. KF and HF are considered responsible for acute corrosive effects seen in the gastrointestinal tract.
Under the conditions of the study the No Observed Adverse Effect Level (NOAEL) was considered to be 140 ppm in diet.
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