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EC number: 231-599-9 | CAS number: 7647-15-6
- 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
Endpoint summary
Administrative data
Description of key information
Oral: The LD50 was determined to be > 2000 mg/kg bw
Dermal: The acute dermal LD50 was determined to be > 2000 mg/kg bw.
Inhalation: The substance is not volatile and is not inhalable.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA FIFRA 81-1
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CD [Crl: CD(SD)BR]
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U. K. Limited, Margate, Kent, England
- Age at study initiation: six weeks
- Weight at study initiation: 112 to 150 g
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 % aqueous methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Sodium bromide was prepared at various concentrations in 1% aqueous methylcellulose and administered at a volume of 20 ml/kg.
- Amount of vehicle (if gavage): 20 ml/kg bodyweight
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bodyweight
- Doses:
- Preliminary study: 2 g/kg bw and 5 g/kg bw
Main Study: 3.2 g/kg bw, 4 g/kg bw and 5 g/kg bw - No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs and mortality soon after dosing and at frequent intervals for the remainder of day 1. On subsequent days the animals were observed twice daily for 5 (preliminary study) and 14 days (main study) respectively.
Individual bodyweights of rats were taken on Days 1 (day of dosing), 8 and 15 and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight; A pre-test was carried out to establish a dosing regimen using groups of two male and two female rats at two dose levels of 2 and 5 g/kg bodyweight. Animals were observed for mortality and clinical signs for 5 days. - Preliminary study:
- The results indicated that the acute median lethal oral dose of sodium bromide, technical grade, was greater than 5 g/kg bodyweight for male rats and between 2 and 5 g/kg bodyweight for female rats.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4.2 other: g/kg bw
- Mortality:
- Two female rats dosed at 5 g/kg bodyweight died on Day 4 of preliminary study. All other animals survived during the study period of five days.
During the main study there were deaths amongst rats of both sexes dosed at 4 and 5 g/kg. Deaths occurred from Day 3 to Day 7. One male was sacrificed after being found moribund on Day 5. - Clinical signs:
- other: Signs of reaction to treatment observed were recorded for animals in the main study only. All treated animals showed piloerection within 5 minutes of dosing and abnormal body carriage (hunched posture), abnormal gate (waddling), lethargy, decreased respir
- Gross pathology:
- Autopsy of rats that died commonly revealed slight congestion of the glandular region of the stomach; red coloured fluid was observed in the urinary bladder of a single male (4 g/kg); isolated cases of congestion or vascular congestion of other zones of the gastrointestinal tract.
Terminal autopsy findings of rats killed at the end of the study, were normal. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 was determined to be 4.5 g/kg bw (males), 3.9 g/kg bw (females) and 4.2 g/kg bw (both sexes combined). In accordance with CLP Regulation (EC) No 1272/2008, sodium bromide does not have to be classified and labelled with respect to acute oral toxicity.
- Executive summary:
Materials and methods
The study was designed to assess the toxicity following a single oral dose of sodium bromide. Groups of 5 fasted CD rats received a single oral dose of the test substance formulated in 1 % aqueous methylcellulose and administered at a volume of 20 ml/kg and dose levels of 3.2; 4 and 5 g/kg bw. Animals were observed for mortality and clinical signs soon after dosing, at frequent intervals for the remainder of day 1 and twice daily on the subsequent days. Body weights were taken on Day 1, 8 and 15 and at death. All animals were subject to necropsy and LD50 was determined.
Results and discussion
Signs of reaction observed were piloerection, abnormal body carriage, abnormal gait, lethargy, decreased respiratory rate, ptosis, pallor of the extremities, ataxia and prostration. There were death amongst rats of both sexes dosed at 4 and 5 g/kg. Autopsy of these rats revealed slight congestion of the glandular region of the stomach; red coloured fluid was observed in the urinary bladder of a single male (4 g/kg) and isolated cases of congestion or vascular congestion of other zones of the gastrointestinal tract were observed. Low bodyweight gains were recorded for surviving rats at all dose levels. Body weight losses were recorded for all rats that died.
Reference
Table A6.1.1/02-1 Summary of Acute Oral Toxicity |
|||||
Dose g/kg |
Number of dead / |
Time of death (range) |
Observations |
||
male |
female |
||||
3.2 |
0/5 |
0/5 |
- |
Piloerection, hunched posture, waddling, lethargy, decreased respiratory rate, ptosis, pallor of extremities, prostrate |
|
4 |
1/5 |
3/5 |
Day 5-7 |
Piloerection, hunched posture, waddling, lethargy, decreased respiratory rate, ptosis, pallor of extremities, ataxia, prostrate |
|
5 |
4/5 |
5/5 |
Day 3-6 |
Piloerection, hunched posture, waddling, lethargy, decreased respiratory rate, ptosis, pallor of extremities, ataxia, prostrate, moribund (apathy, prostrate, cyanosis, decreased respiration) |
|
LD50 value |
4.5 g/kg bw (males), 3.9 g/kg bw (females), 4.2 g/kg bw (combined) |
|
|||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA FIFRA 81-6
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshire, England
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2090-2900 g - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- % coverage: 10 % of body surface
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm water (30-40°C)
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg bw
- Concentration (if solution): the test substance was moistened at 1 mL/kg with distilled water
- Constant volume or concentration used: yes
- For solids, paste formed: yes; the test substance was moistened at 1 mL/kg with distilled water
VEHICLE
- Amount(s) applied (volume or weight with unit): 1 mL - Duration of exposure:
- 24 hours
- Doses:
- 2 g/kg bw
- No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation for clinical signs and dermal irritation soon after dosing, then at frequent intervals for the remainder of Day 1. On subsequent days the animals were examined at least twice for 14 days. Body weights were taken on Day 1, 8 and 15 and at death.
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- One male rabbit was found dead on Day 2. There were no clinical signs recorded prior to death. A slight loss in bodyweight was recorded. Autopsy revealed congestion of the lungs. No other macroscopic abnormalities were observed. The death of this animal was not considered to be treatment related.
- Clinical signs:
- other: There were no clinical signs of toxicity seen in any of the treated animals including those found dead. No dermal irritation was observed at the treated skin sites of any of the animals throughout the fourteen day study.
- Gross pathology:
- One rabbit showed small pale areas on the liver. Some of these contained a purulent material. One male rabbit that died during the study showed congestion of the lungs. Terminal autopsy findings of all other rabbits were normal.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 in male and female rabbits was determined to be greater than 2000 mg/kg. In accordance with CLP Regulation (EC) No 1272/2008, sodium bromide does not have to be classified and labelled with respect to acute dermal toxicity.
- Executive summary:
Materials and Methods
The study was designed to assess the dermal toxicity of sodium bromide. Five male and five female rabbits were exposed to a single dermal dose of 2 g/kg bodyweight sodium bromide moistened at 1 mL/kg with distilled water. The treated skin area was clipped the day before. Animals were observed daily for mortality and clinical signs for dermal irritation and toxicity. Body weights were recorded once per week. Autopsy was performed for all rabbits at termination of the study.
Results and Discussion
No clinical signs or dermal irritation was observed at the treated skin sites of both surviving and decedent animals. A slightly low body weight gain was recorded for one of the female rabbits in the first week of the study. All other animals achieved anticipated bodyweight gains. One male rabbit was found dead on Day 2. Autopsy revealed congestion of the lungs. No other abnormalities were observed and there were no clinical signs recorded prior to death. The death of this animal was not considered to be treatment related.
The LD50 >2000 mg/kg bw (both sexes) (equivalent to: >1552 mg (Br-)/kg bw (both sexes)).
Reference
Table A6.1.2/02-1 Summary of Acute Dermal Toxicity |
||||
Dose [g/kg] / sex |
Number of dead / |
Time of death (range) |
Observations |
|
2 / male |
1/5 |
Day 2 |
No treatment related observations |
|
2 / female |
0/5 |
|
No treatment related observations |
|
LD50value |
> 2 g/kg body weight |
|
||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Oral
In a key study performed to OECD 401 5 rats/sex/dose group were each given a single dose of sodium bromide by gavage in 20 mL of 1 % aqueous methylcellulose. Clinical observations were made over the following 14 days including weekly bodyweight measurements. At death during the study period, or sacrifice at study termination, the animals were subjected to a macroscopic post mortem examination. An LD50 was determined from the observation data. Females: 3900 mg/kg bw, males: 4500 mg/kg bw (equivalent to females: 3028 mg (Br-)/kg bw, males: 3492 mg (Br-)/kg bw) Males + females combined: 4200 mg/kg bw (equivalent to: 3260 mg (Br-)/kg bw)
Inhalation
The bromide ion is not a volatile species [vapour pressure value of 1.8 x 10-6 Pa] with a high water solubility (946000 mg/L at 25 °C) so it remain in the water phase when solubilised during use. The particle size distribution indicates that it will not be available for inhalation with particle size > 100 µm.
Dermal
In a key study 5 Rabbits/sex were each given a single application of 2000 mg/kg bw the test substance moistened with 1 mL/kg water. Clinical observations were made over the following 14 days including weekly bodyweight measurements. At death during the study period, or sacrifice at study termination, the animals were subjected to a macroscopic post mortem examination. An LD50 was determined from the observation data.
No clinical signs or dermal irritation was observed at the treated skin sites of both surviving and decedent animals. A slightly low body weight gain was recorded for one of the female rabbits in the first week of the study. All other animals achieved anticipated bodyweight gains. One male rabbit was found dead on Day 2. Autopsy revealed congestion of the lungs. No other abnormalities were observed and there were no clinical signs recorded prior to death. The death of this animal was not considered to be treatment related.
The LD50 >2000 mg/kg bw (both sexes) (equivalent to: >1552 mg (Br-)/kg bw (both sexes)).Justification for classification or non-classification
Sodium bromide is not acutely toxic by the oral or dermal routes (Oral LD50 = 4200 mg/kg, dermal LD50 >2000 mg/kg).
The inhalation study of sodium bromide is scientifically unjustified, since the bromide ion has a very low volatility based on the vapour pressure of 1.8 x 10-6Pa (Cowlyn T.C., 1991) and has a particle size which excludes inhalation (> 100 µm). Therefore exposure to significant quantities of bromide ions by direct inhalation is not likely to occur.
Based on the experimental results, sodium bromide is not classified for acute toxicity by the oral or dermal routes.
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