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EC number: 888-364-4 | CAS number: 146569-48-4
- 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:
- 29 October 2020 to 18 November 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals No. 403 – Traditional Protocol “Acute Inhalation Toxicity” adopted on 07 September 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- yes
Test material
- Reference substance name:
- niobium trivanadium decamolybdenum tellurium dotetracontaoxide
- EC Number:
- 888-364-4
- Cas Number:
- 146569-48-4
- Molecular formula:
- Mo10V3Nb1Te1O42
- IUPAC Name:
- niobium trivanadium decamolybdenum tellurium dotetracontaoxide
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Clariant Produkte (Deutschland) GmbH
83052 Bruckmühl/Heufeld
Germany
and EX.14402.600
- Expiration date of the batch: No change of properties known over time (endless)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient (21 to 29°C)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Aerosol
- Preliminary purification step (if any): No
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 weeks
- Weight at study initiation: Males : 183.27 g to 191.12 g
Females : 167.28 g to 175.15 g
- Fasting period before study: No
- Housing: standard polypropylene cage (size: L 430 × B 285 × H 150 mm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 29 October 2020 to 03 November 2020
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0°C to 22.9°C
- Humidity (%): 49% to 64%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle
IN-LIFE DATES: From: 29 October 2020 To: 18 November 2020
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- > 2.86 - <= 3.18 µm
- Geometric standard deviation (GSD):
- > 2.55 - <= 2.58
- Remark on MMAD/GSD:
- All the values were within the acceptable range
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: flow-past, nose-only dynamic inhalation exposure system supplied by CH Technologies, USA
- Exposure chamber volume: 0.76 L
- Method of holding animals in test chamber: restrainer
- Source and rate of air: compressor air and 20 L/min
- Method of conditioning air: purified air
- System of generating particulates/aerosols: Palas RBG 1000
- Method of particle size determination: 7 stage cascade mercer impactor
- Treatment of exhaust air: NaOH
- Temperature, humidity, pressure in air chamber: 22.4 to 22.6°C, 55.3 to 55.9%, 60psi
TEST ATMOSPHERE
- Brief description of analytical method used: gravimetrically
- Samples taken from breathing zone: yes
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Based on technical pre-test and achieved limit concentration i.e., 5 mg/L. - Analytical verification of test atmosphere concentrations:
- no
- Remarks on duration:
- 4 hours exposure
- Concentrations:
- Limit concentration 5 mg/L
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily thereafter for clinical signs and twice daily for mortality and weighing on day 1, 2, 4, 8 and 15
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.04 mg/L air
- Based on:
- test mat.
- Body weight:
- No substance related changes were observed in body weight and percent change in body weight with respect to day 1 at the mean maximum achievable concentration of 5.04 mg/L of air. However, all animals showed slight decrease in body weight on day 2 due to restraining of animals during exposure. This slight change was transient and no clinical signs were observed during the experimental period. All animals increased in body weight from day 4 onwards
- Gross pathology:
- No treatment related gross pathological findings were observed at the maximum achievable concentration of 5.04 mg/L of air
Any other information on results incl. tables
TABLE 1. CLINICAL SIGNS AND MORTALITY RECORD
Group & Concentration (mg/L of air) | Animal No. | Sex | Day 1 | Days | |||||||||||||||||||||||||||||||||||||||||
During Exposure | Post exposure | ||||||||||||||||||||||||||||||||||||||||||||
1 hr* | 2 hrs* | 3 hrs* | 4 hrs* | 30-40 min | 1 hr* | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | ||||||||||||||||||||||||||
Limit Test & 5.04 | Re9026 | M | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |||||||||||||||||||||||
Re9027 | M | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | ||||||||||||||||||||||||
Re9028 | M | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | ||||||||||||||||||||||||
Re9029 | F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | ||||||||||||||||||||||||
Re9030 | F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | ||||||||||||||||||||||||
Re9031 | F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
*: ± 10 minutes; N: Normal; M: Male; F: Female; min: minute; hr(s): hour(s)
TABLE 2. BODY WEIGHT (g) AND PERCENT CHANGE IN BODY WEIGHT (%) WITH RESPECT TO DAY 1
Group & Concentration (mg/L of air) | Animal No. | Sex | Body Weight (g) on Days |
| Percent Change in Body Weight with Respect to Day 1 | ||||||||||||||||||||
1# | 2 | 4 | 8 | 15 |
| 1-2 | 1-4 | 1-8 | 1-15 | ||||||||||||||||
Limit Test & 5.04 | Re9026 | M | 202.42 | 200.20 | 203.27 | 216.43 | 238.59 |
| -1.10 | 0.42 | 6.92 | 17.87 | |||||||||||||
Re9027 | M | 211.59 | 209.87 | 213.11 | 227.74 | 249.45 |
| -0.81 | 0.72 | 7.63 | 17.89 | ||||||||||||||
Re9028 | M | 206.11 | 205.46 | 207.65 | 221.55 | 247.01 |
| -0.32 | 0.75 | 7.49 | 19.84 | ||||||||||||||
Mean |
| 206.71 | 205.18 | 208.01 | 221.91 | 245.02 |
| -0.74 | 0.63 | 7.35 | 18.54 | ||||||||||||||
(±) SD |
| 4.61 | 4.84 | 4.93 | 5.66 | 5.70 |
| 0.40 | 0.18 | 0.38 | 1.13 | ||||||||||||||
n |
| 3 | 3 | 3 | 3 | 3 |
| 3 | 3 | 3 | 3 | ||||||||||||||
Re9029 | F | 182.63 | 180.22 | 184.83 | 193.16 | 210.09 |
| -1.32 | 1.20 | 5.77 | 15.04 | ||||||||||||||
Re9030 | F | 191.80 | 189.30 | 193.42 | 203.88 | 214.76 |
| -1.30 | 0.84 | 6.30 | 11.97 | ||||||||||||||
Re9031 | F | 186.47 | 185.06 | 188.09 | 199.60 | 212.69 |
| -0.76 | 0.87 | 7.04 | 14.06 | ||||||||||||||
Mean |
| 186.97 | 184.86 | 188.78 | 198.88 | 212.51 |
| -1.13 | 0.97 | 6.37 | 13.69 | ||||||||||||||
(±) SD |
| 4.61 | 4.54 | 4.34 | 5.40 | 2.34 |
| 0.32 | 0.20 | 0.64 | 1.57 | ||||||||||||||
n |
| 3 | 3 | 3 | 3 | 3 |
| 3 | 3 | 3 | 3 |
#: Prior to exposure;M: Male; F: Female;SD: Standard Deviation, n: Number of animals
TABLE 3. BREATHING ZONE CONCENTRATION (ACTUAL TEST ITEM CONCENTRATION)
Technical Pre-test:
Sl. No. | Feed rate (mm/hour) | Rotation (rpm) | Initial weight (mg) (a) | Final weight (mg) (b) | Difference (mg) (c) = (b) – (a) | Air Flow Rate (L/min) (d) | Time (min) (e) | BZC (mg/L of air)
|
Mean BZC (mg/L of Air) | ||||||||||
1 | 012 | 600 | 345.61 | 349.85 | 4.24 | 0.84 | 1 | 5.05 | 5.05 | ||||||||||
2 | 012 | 600 | 346.60 | 350.85 | 4.25 | 0.84 | 1 | 5.06 |
Limit Test:
Sl. No. | Feed rate (mm/hour) | Rotation (rpm) | Initial weight (mg) (a) | Final weight (mg) (b) | Difference (mg) (c) = (b) – (a) | Air Flow Rate (L/min) (d) | Time (min) (e) | BZC (mg/L of air)
| Mean BZC (mg/L of Air) | ||||||||||
1 | 012 | 600 | 346.63 | 350.85 | 4.22 | 0.84 | 1 | 5.02 | 5.04 | ||||||||||
2 | 012 | 600 | 343.84 | 348.09 | 4.25 | 0.84 | 1 | 5.06 | |||||||||||
3 | 012 | 600 | 349.44 | 353.67 | 4.23 | 0.84 | 1 | 5.04 |
BZC: Breathing Zone Concentration; Sampled volume: 0.84 L/min; Sampling time: 1 minute
BZC (f) = | Mass of test item collected on the filter paper (c) | ||
Volume of air passed through the filter paper (d) X time (e) |
TABLE 4. CHAMBER (EXPOSURE) CONDITIONS
Technical Pre-test:
Concentration (mg/L of air) | SL. No. | Feed rate (mm/hour) | Rotation (rpm) | Temperature (°C) | Relative Humidity (%) | Oxygen Concentration (%) | Carbon dioxide Concentration (ppm) | Air Flow (L/min) |
5.05 | 1 | 012 | 600 | 22.7 | 55.6 | 20.2 | 615 | 20 |
2 | 012 | 600 | 22.4 | 56.2 | 20.5 | 612 | 20 |
Limit Test:
Concentration (mg/L of air) | SL. No. | Feed rate (mm/hour) | Rotation (rpm) | Temperature (°C) | Relative Humidity (%) | Oxygen Concentration (%) | Carbon dioxide Concentration (ppm) | Air Flow (L/min) |
5.04 | 1 | 012 | 600 | 22.6 | 55.9 | 20.4 | 618 | 20 |
2 | 012 | 600 | 22.4 | 55.7 | 20.3 | 619 | 20 | |
3 | 012 | 600 | 22.5 | 55.3 | 20.2 | 620 | 20 |
Note: 1% Carbon dioxide = 10000 ppm
TABLE 5. GROSS PATHOLOGICAL FINDINGS
Group &Concentration (mg/L of air) | Animal No. | Sex | Fate | Gross Pathology Findings | |
External | Internal | ||||
Limit Test & 5.04 | Re9026 | M | TS | NAD | NAD |
Re9027 | M | TS | NAD | NAD | |
Re9028 | M | TS | NAD | NAD | |
Re9029 | F | TS | NAD | NAD | |
Re9030 | F | TS | NAD | NAD | |
Re9031 | F | TS | NAD | NAD |
NAD: No Abnormality Detected; M: Male; F: Female; TS: Terminal Sacrifice
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions employed and based on the above results of experiment, there were no clinical signs and mortality observed at mean maximum achievable concentration of 5.04 mg/L of air. Hence, the LC50 of the test item is > 5.04 mg/L of air. This result, taking into account that there is no identification of a harm of acute nature towards vulnerable populations, does not justify a classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
- Executive summary:
The test item was evaluated for acute inhalation toxicity in Sprague Dawley rats.
The objective of the study was to assess the toxic potential and to determine the LC50 of test item when administered by inhalation route through flow-past nose-only dynamic inhalation equipment for a single 4 hours exposure to rats. Three male and three female rats were used for conducting the acute inhalation toxicity study.
As such test item was used during technical pre-test and limit test to generate the dust aerosols through rotating brush generator. The technical pre-test was carried out without animals. During the technical pre-test, the target concentration i.e. 5.04 mg/L of air was achieved.
During the exposure period, the temperature, relative humidity, oxygen and carbon dioxide concentration of the chamber were 22.4°C to 22.6°C, 55.3% to 55.9%, 20.2% to 20.4% and 618 ppm to 620 ppm (0.06%) respectively for limit test. The particle size MMAD and GSD were 2.86 µm to 3.18 µm and 2.55 to 2.58 respectively. All the values were within theacceptablerange. The mean maximum achievable breathing zone concentration (actual concentration) was 5.04 mg/Lof airand it was considered as the limit concentration.
All the animals were observed for clinical signs and pre-terminal deaths at 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) during exposure and 30 to 40 minutes and 1 hour (±10 mins) post-exposure on day 1 and once daily thereafter for clinical signs and twice daily for mortality till 14 days post exposure period.Individual animal body weight was recorded on day 1 (on the day of exposure) prior to the exposure and on day 2, 4, 8 and 15. During exposure period, the chamber (exposure) conditions were recorded. All rats were euthanized after 14 days post exposure period by intraperitoneal administration of sodium thiopentone and the gross pathological findings were recorded.
No treatment related clinical signs of toxicity and mortalities were observed. Slight decrease in body weight was noted on Day 2 due to exposure. All animals showed increase in body weight on day 4, 8 and 15.
No treatment related gross pathological findings were observed atthe mean maximum achievable concentration of 5.04mg/L of air.
This result, taking into account that there is no identification of a harm of acute nature towards vulnerable populations, does not justify a classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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