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EC number: 235-183-8 | CAS number: 12124-97-9
- 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:
- 1997-07-08 to 1997-08-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-3 (Acute inhalation toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ammonium bromide
- EC Number:
- 235-183-8
- EC Name:
- Ammonium bromide
- Cas Number:
- 12124-97-9
- Molecular formula:
- BrH4N
- IUPAC Name:
- Bromide activated chloramine (BAC) generated from ammonium bromide and sodium hypochlorite
- Details on test material:
- - Name of test material (as cited in study report): Ammonium bromide (powder aerosol)
- Physical state: White crystalline solid
- Analytical purity: 98.5%
- Lot/batch No.: 970027/1
- Stability under test conditions: The stability of the test material was not determined but it is stated in the study that the test material arrived undamaged and in good condition and was used as supplied
- Storage condition of test material: Ambient temperature in the dark
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 Limited, Margate, Kent, England
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 161-191 g
- Fasting period before study: None ( fasting during exposure period)
- Housing: 5 x sex per cage - suspended polypropylene cages (58 x 40 x 18 cm) with detachable stainless steel tops and bottoms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C
- Humidity (%): 48 - 68%
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 1997-07-08 To: 1997-08-21
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:
- Exposure chamber volume:
- Method of holding animals in test chamber:
- Source and rate of air:
- Method of conditioning air:
- System of generating particulates/aerosols: RBG-1000 dust generator. Wright Dust Feed Mechanism was used to achieve a stable aerosol
- Method of particle size determination: Marple Cascade Impactor. This device consisted of an in-line sampler and a series of impaction stages (including a back-up filter). The device was capable of fractionating the aerosol into the size range 0.25>7.8 µm
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber:
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric method used pressed glass fibre filters (Whatman GF/A, 37 mm). The filter was placed in a conical holder and was positioned and temporarily sealed in a port in the exposure chamber at the animals breathing zone. Chamber air was drawn through the filter at a measured rate of approximately 1 l/min via a gas meter and vacuum pump.
The nominal chamber concentration was estimated from the amount of material and the total air used by the generation system with the following equation:
Measured concentration [mg/l] = weight of material used [mg] / total air flow through system [l]
- Samples taken from breathing zone: yes
TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD (mass median aerodynamic diameter): 2.61 µm
+ GSD (geometric standard deviation): 3.204
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Maximum attainable concentration - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetric measure
- Duration of exposure:
- 4 h
- Concentrations:
- Nominal concentration: 37.96 mg/L
Measured concentration: 0.1 mg/L (maximum attainable concentration) - No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats were observed continously throughout each exposure period, and any clinical signs noted were recorded at 30 min intervals. Animals were also observed immediately after exposure and for the first 1-2 h post dosing and thereafter at least once daily during the 14 day study period. Body weight was taken immediately before dosing and on Days 2, 3, 4, 7,10 and 14 post exposure
- Necropsy of survivors performed: yes
- Other examinations performed: organ weights - The lungs of each animal were removed and weighed to allow calculation of lung to body weight ratio.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.1 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: at the maximum attainable concentration of 0.1 mg/L, no mortalities were observed.
- Mortality:
- No mortalities
- Clinical signs:
- other: During exposure: slight reductions on respiratory rates were noted in response to the test material. During observation period: rats were observed to be wet and unkempt and have staining on head. These signs were considered related to restraint and not o
- Body weight:
- There were no effects on body weights considered to be related to treatment with the test material.
- Gross pathology:
- There were no findings at necropsy considered to be related to treatment with the test material.
Any other information on results incl. tables
Table 1: Summary of results
Dose [mg/L] |
Number of dead / |
Time of death (range) |
Observations |
|
0.1 mg/L |
0/10 |
- |
All animals were wet/unkempt and four rats (two male and two female) showed staining on head immediately post exposure. These signs were gone 1-2 hours post exposure and no further signs were noted. |
|
LD50value > 0.10 mg/L |
|
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this acute inhalation toxicity study performed with a dust aerosol of ammonium bromide and taking into account that no mortalities were observed at the maximum attainable concentration of 0.1 mg/L, ammonium bromide does not have to be classified and labelled with respect to acute inhalation toxicity.
- Executive summary:
Materials and Methods
The study was undertaken to investigate the acute inhalation toxicity of aerosolized ammonium bromide in rats. Five male and five female rats were exposed to a single 4 h snout only exposure of 0.1 mg/L (maximum attainable concentration) of test substance and were observed for clinical signs for a period of 14 days post-exposure. Individual bodyweights were taken on the day before dosing and on Day 2, 3, 4, 7,10 and 14 post treatment. All animals were subjected to necropsy at termination of the study. Lungs were removed and weight taken to allow calculation of lung to body weight ratio.
Results and discussion
Rats exposed to a test atmosphere containing aerosolized ammonium bromide at a concentration of 0.1 mg/L by snout inhalation for a period of 4 hours showed minimal evidence of toxicity and no mortalities were observed. During exposure rats were observed to have slight reductions in respiratory rates. This is consistent with exposure to any irritant dust atmosphere and restraint in a tube. During the observation period rats were observed to be wet and unkempt and have staining on head for a short period after exposure. This was considered consistent with restraint in tubes and not specifically related to exposure to the test material.
There were no effects on body weights considered to be due to treatment with the test material.
There were no necropsy findings considered to be related to treatment with the test material.
There were no effects on lung to body weight ratios considered to be related to treatment with the test material.
The maximum attainable concentration of 0.1 mg/L was considered to be relatively low. The poor stability of the aerosol at this concentration and the 64.4% aerosol mass < 4 µm resulted in an extremely low respirable fraction. These characteristics were expected from the difficulties observed during optimisation and supported by the high nominal concentration obtained in attempting to aerosolise the test material.
The unusually high value of nominal concentration (37.96 mg/L) relative to the measured aerosol concentration (0.1 mg/L) indicates that a substantial fraction of the test material would not readily aerosolise. The losses are typically due to sedimentation within the exposure chamber. Non-volatile test materials such as this which do not readily aerosolise tend to present low inhalation hazards. Under the conditions of this acute inhalation toxicity study performed with a dust aerosol of ammonium bromide and taking into account that no mortalities were observed at the maximum attainable concentration of 0.1 mg/L, ammonium bromide does not have to be classified and labelled with respect to acute inhalation toxicity.
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