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EC number: 939-559-9 | CAS number: -
- 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:
- 20 Feb 2014 - 19 Mar 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dehydrate
- IUPAC Name:
- Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dehydrate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, Inc.
- Age at study initiation: 8 weeks
- Weight at study initiation: males 242-267 g; females 170-199 g
- Housing: singly housing in suspended stainless steel perforated bottom caging; enrichment (e.g., toy) was placed in each cage; litter paper was placed beneath the cage and was changed at least three times per week
- Diet: Harlan Teklad Global 16% Protein Rodent Diet® #2016, ad libitum, except during the exposure
- Water: Filtered tap water was supplied ad libitum, except during exposure
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 45-55
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Nose Only Inhalation Chamber, ADG Developments LTD
- Exposure chamber volume: 28 L
- Method of holding animals in test chamber: Animals were individually housed in polycarbonate holding tubes which seal to the chamber with an “O” ring during exposure.
- Source and rate of air: Approx. 60.0 liters per minute (Lpm) of filtered generator air was supplied by an air compressor (Powerex Model: SES050822).
- Method of conditioning air: Mass Flow Controller (Omega, Model # FMA-5527)
- System of generating particulates/aerosols: The test substance was aerosolized using a Jet-Mill (Fluid Energy Jet-Mill Serial #J2724E). Prior to aerosolization, the test substance was ground in a coffee mill (Cuisinart, Model #DCG-20N).
- Method of particle size determination: An eight-stage 1 ACFM Andersen Ambient Particle Sizing Sampler was used to assess the particle size distribution of the test atmosphere.
- Temperature, humidity, pressure in air chamber: The exposure chamber temperature and relative humidity range during exposure were 20ºC and 22-24%, respectively.
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric samples were withdrawn at 6 intervals from the breathing zone of the animals. Samples were collected using 37 mm glass fiber filters (WhatmanTM GF/B) in a filter holder attached by ¼ inch Tygon® tubing to a vacuum pump (GAST, Model #1531-107B-G557X). Filter papers were weighed before and after collection to determine the mass collected. This value was divided by the total volume of air sampled to determine the chamber concentration. The collections were carried out for 1 minute at airflows of 4.0 Lpm. Sample airflows were measured using a Mass Flow Controller (Aalborg, Model #GFC-17).
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: An eight-stage 1 ACFM Andersen Ambient Particle Sizing Sampler was used to assess the particle size distribution of the test atmosphere. Samples were withdrawn from the breathing zone of the animals at two intervals. The filter paper collection stages were weighed before and after sampling to determine the mass collected upon each stage.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The mass median aerodynamic diameter (MMAD) and geometric standard deviation (GSD) were determined graphically using two-cycle logarithmic probit axes. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.1 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality during the exposure period. The animals were examined for signs of gross toxicity, and behavioral changes upon removal from the exposure tube and at least once daily thereafter for 14 days or until death occurred. Individual body weights of the animals were recorded prior to test substance exposure (initial) and again on Days 1, 3, 7, and 14 (terminal) or after death.
- Necropsy of survivors performed: yes. Surviving rats were euthanized via CO2 inhalation on Day 14. Gross necropsies were performed on all decedents and euthanized animals. Tissues and organs of the thoracic and abdominal cavities were examined.
- Other examinations performed: Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma. - Statistics:
- Statistical analysis was limited to the calculation of the mean and standard deviation.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- < 5.1 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 5.1 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.1 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- One male and three females died within seven days of exposure to the test atmosphere. Prior to death, the animals were hypoactive and exhibited abnormal respiration and/or ano-genital staining.
- Clinical signs:
- other:
- Body weight:
- Although all animals lost weight through Day 3, the animals gained body weight during Days 7 to 14. However, two of the survivors did not surpass their initial body weights by the end of the 14-day observation period.
- Gross pathology:
- Gross necropsy of the decedents revealed discoloration of the lungs, distention of the stomach, discoloration of the liver and/or distention of the intestines. No gross abnormalities were noted for any of the surviving animals when necropsied at the conclusion of the 14-day observation period.
Any other information on results incl. tables
TABLE 1: GRAVIMETRIC CHAMBER CONCENTRATIONS
Sample Number |
Time of Sample (hour) |
Mass Collected (mg) |
Airflow Sampled (Lpm) |
Collection Time (min) |
Chamber Concentration (mg/L) |
1 |
0.5 |
22.2 |
4 |
1 |
5.55 |
2 |
1 |
17.4 |
4 |
1 |
4.35 |
3 |
2 |
20.6 |
4 |
1 |
5.15 |
4 |
2.5 |
21.1 |
4 |
1 |
5.28 |
5 |
3.5 |
20.6 |
4 |
1 |
5.15 |
6 |
3.75 |
20.5 |
4 |
1 |
5.13 |
Average ± Standard Deviation |
5.10±0.40 |
TABLE 2: SUMMARY OF PARTICLE SIZE DISTRIBUTION
Sample No. |
Time of Sample (hours) |
Collection Time (minutes) |
Mass Median Aerodynamic Diameter1 (µm) |
Geometric Standard Deviation |
1 |
1.5 |
1 |
2.80 |
2.32 |
2 |
3 |
1 |
3.06 |
2.51 |
Average |
2.93 |
2.42 |
1This figure is an estimation based on graphic analysis of the particle size distribution as measured with a 1 ACFM Andersen Ambient Sizing Sampler.
TABLE 3: INDIVIDUAL BODY WEIGHTS AND MORTALITY (5.10 mg/L)
Animal No. |
Sex |
Body Weight (g) |
Mortality |
|||||
Initial |
Day 1 |
Day 3 |
Day 7 |
Day 14 |
Day |
Weight (g) |
||
3301 |
M |
253 |
215 |
215 |
237 |
279 |
E |
- |
3302 |
M |
267 |
229 |
201 |
216 |
236 |
E |
- |
3303 |
M |
242 |
211 |
201 |
223 |
238 |
E |
- |
3304 |
M |
248 |
211 |
192 |
- |
- |
7 |
178 |
3305 |
M |
265 |
230 |
240 |
269 |
298 |
E |
- |
3306 |
F |
193 |
169 |
155 |
168 |
197 |
E |
- |
3307 |
F |
199 |
172 |
158 |
- |
- |
5 |
139 |
3308 |
F |
179 |
157 |
- |
- |
- |
2 |
149 |
3309 |
F |
196 |
171 |
171 |
- |
- |
6 |
169 |
3310 |
F |
170 |
163 |
167 |
173 |
183 |
E |
- |
E - Euthanized via CO2inhalation after weighing on Day 14
TABLE 4: INDIVIDUAL CAGE-SIDE OBSERVATIONS (5.10 mg/L)
Animal Day of
Number Findings Occurrence
MALES
3301 Rales (moist) CR1-1
Hypoactivity CR-2
Irregular respiration CR-3, 5-11
Gasping 0 (2 hrs)-1
Ano-genital staining 2
Ocular discharge (black, left eye) 3-8
Active and healthy 12-14
3302 Rales (moist) CR-3
Hypoactivity CR-4
Irregular respiration CR-13
Gasping 0 (2 hrs)-1, 8-11
Nasal discharge (red) 1-2
Facial staining (black) 3-5
Active and healthy 14
3303 Rales (moist) CR-1
Irregular respiration CR-4
Hypoactivity 0 (1 hr)-1
Active and healthy 5-14
3304 Rales (moist), irregular respiration CR-6
Hypoactivity 0 (1 hr)-6
Ano-genital staining 1-3
Dead 7
3305 Hypoactivity CR-0 (2 hrs)
Irregular respiration CR-2
Active and healthy 3-14
FEMALES
3306 Irregular respiration CR-6
Hypoactivity 0 (1 hr)-3
Rales (moist) 1-4
Ano-genital staining 2-8
Active and healthy 9-14
3307 Irregular respiration CR-4
Hypoactivity 0 (1 hr)-2
Rales (moist) 1-4
Ano-genital staining 2
Dead 5
3308 Irregular respiration, hypoactivity CR-1
Rales (moist) 1
Dead 2
3309 Hypoactivity CR-1, 6 (am)
Irregular respiration CR-3, 5-6 (am)
Rales (moist) 1
Ano-genital staining 1-2
Active and healthy 4
Dead 6 (pm)
3310 Hypoactivity CR-0 (2 hrs)
Irregular respiration CR-2
Active and healthy 3-14
1CR - removal from the exposure tube
TABLE 5: INDIVIDUAL NECROPSY OBSERVATIONS (5.10 mg/L)
Animal
Number Tissue Findings
MALES
3301-3303, 3305 All tissues and organs No gross abnormalities
3304 Lungs Extremely red
Intestines Slightly distended
FEMALES
3306, 3310 All tissues and organs No gross abnormalities
3307 Lungs Slightly red
Stomach, intestines Slightly distended
3308 Lungs Extremely red
Liver Mottled
Stomach, intestines Slightly distended
3309 Lungs Slightly red
Liver Mottled
Applicant's summary and conclusion
- Interpretation of results:
- other: Irritating to the respiratory tract according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: STOT Single Exp. 3, H335
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