Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-07-29 to 1997-09-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP 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 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
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
- Physical state: White powder
- Analytical purity: 98.5%
- Storage condition of test material: in the dark at ambient temperature
Constituent 1
Method
- Target gene:
- S. typhimurium:
TA 1535, TA 1537, TA 98, TA 100
(TA 1535 and TA 100 : base-pair substitutions, TA 1537 and TA 98 : frameshift-mutations)
E. coli:
WP2 uvr A (base-pair substitutions, base-pair reversions)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: All Salmonella typhimurium strains tested: - are histidine-auxotroph - contain deep rough (rfa) mutation and uvrB mutation
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- 17, 50, 167, 500, 1667 and 5000 µg per plate for the toxicity test (pre-test) and for mutation tests
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: Solubility
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9: 2-Aminoanthracene (2-AAN) for all strains -S9: Sodium Azide (NaN3) for TA 1535 and TA 100 9-Aminoacridine (9-AA) for TA 1537 2-Nitrofluorene (2-NF) for TA98 N-Ethyl-N-nitro-N-nitrosoguanidin (ENNG) for WP2 uvr A
- Details on test system and experimental conditions:
- Two independent mutation tests were conducted using 5 bacterial strains. Triplicate plates were prepared for each bacterial stain and dose level in both the presence and absence of S9 mix. Ammonium bromide was dissolved and diluted in ultra-pure water
The first test performed used the direct plate method for which 2 ml of soft agar were dispensed into small sterile tubes. To this 0,5 ml of S9 mix or 0,05 M phosphate buffer, pH 7,4 were added followed by 0,1 ml of bacteria and 0,1 ml of solvent or test solution. The tube contains, which were continually cooling, were mixed and poured onto minimal medium. These plates contained 25 ml of 1,5 % purified agar in Vogel-Bonner Medium E with 2 % glucose. When the soft agar had set, the plates were inverted and incubated at 37°C for 2 days.
The second test used the pre-incubation method. 0,5 ml of S9 mix or 0,05 M phosphate buffer, pH 7,4 were dispensed into small sterile tubes. This was followed by 0,1 ml bacteria and, finally the solvent or test solution (0,1 ml). The tube top was then screwed tightly and the tube placed in a shaking incubator at 37°C for 20 minutes. At the end of this time, the tube top was removed and 2 ml of soft agar added to the tube. The tube contains, which were continually cooling, were mixed and poured onto minimal medium. These plates contained 25 ml of 1,5 % purified agar in Vogel-Bonner Medium E with 2 % glucose. When the soft agar had set, the plates were inverted and incubated at 37°C for 2 days.
At the end of the incubation period the colonies were counted using a Biotran III automated counter at maximum sensitivity ie colonies of 0,1 mm or more diameter were counted. The plates were also examined for precipitates and, microscopically, for microcolony growth.
Each concentration was tested in triplicate
A toxicity test using strain TA 100 only was performed in the presence and absence of S9 mix to establish suitable dose levels for the mutation tests. No toxicity was detected in any of the concentrations used. - Evaluation criteria:
- A test was considered acceptable if: the bacteria demonstrated their typical response to crystal violet, ampicillin and u.v. light; at least two of the vehicle control plates were within lab-internal defined ranges; on at least two of the positive control plates there were twice (or in the case of TA 100 1,5-times) the mean vehicle control mutant numbers per plate; no toxicity or contamination was observed in at least 4 dose levels; in cases where a mutagenic response was observed, that no more than one dose level was discarded before the dose which gave the highest significant mean colony number.
- Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The number of revertants per plate was comparable to that observed for untreated or solvent controls; the positive controls induced the expected increased in the number of revertants per plate thereby confirming the sensitivity and reliability of the test system used
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Up to and including the maximum concentration of 5 mg/plate, there was no cytotoxic effect (i.e. clearing of background lawn or reduction in the number of spontaneous revertants) observable. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Results of thein vitroGene Mutation Assay (Plate Incorporation Test) with Ammonium Bromide
Concentration |
Number of mutant cells* |
||||
without metabolic activation |
|||||
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
Solvent |
8 |
6 |
24 |
105 |
2 |
17 |
8 |
12 |
12 |
124 |
3 |
50 |
7 |
10 |
12 |
118 |
6 |
167 |
5 |
10 |
11 |
98 |
6 |
500 |
11 |
7 |
14 |
72 |
5 |
1667 |
8 |
15 |
11 |
72 |
3 |
5000 |
5 |
13 |
25 |
77 |
4 |
NaN3 |
179 |
- |
- |
275 |
- |
9-AC |
- |
427 |
- |
- |
- |
2NF |
- |
- |
122 |
- |
- |
ENNG |
- |
- |
- |
- |
225 |
with metabolic activation |
|||||
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
Solvent |
8 |
9 |
12 |
99 |
2 |
17 |
10 |
15 |
15 |
130 |
5 |
50 |
8 |
10 |
18 |
129 |
6 |
167 |
9 |
12 |
12 |
120 |
6 |
500 |
8 |
15 |
14 |
125 |
4 |
1667 |
11 |
15 |
15 |
128 |
2 |
5000 |
7 |
11 |
16 |
125 |
4 |
2-AAN |
194 |
68 |
24 |
22 |
106 |
* mean of three individual plates ENNG N-ethyl-N-nitro-N-nitrosoguanidin: 2 µg/plate withE. coli 9-AC 9-aminoacridine: 80 µg/plate with TA 1537 2AAN 2-aminoanthracene: 20 µg/plate with E. coli; 2 µg/plate with TA 1535 and Ta 1537; 0,5 µg/plate with TA 98 and TA 100 2NF 2-nitrofuorene: 1 µg/plate with TA 98 NaN3 Sodium azide: 1 µg/plate with TA 1535 and TA 100 |
Table 2: Results of thein vitroGene Mutation Assay (Pre-Incubation Test) with Ammonium Bromide
Concentration |
Number of mutant cells* |
||||
without metabolic activation |
|||||
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
Solvent |
6 |
5 |
16 |
63 |
5 |
17 |
10 |
8 |
19 |
62 |
5 |
50 |
9 |
7 |
18 |
65 |
5 |
167 |
8 |
5 |
17 |
62 |
4 |
500 |
13 |
7 |
17 |
58 |
5 |
1667 |
8 |
9 |
16 |
52 |
5 |
5000 |
10 |
5 |
19 |
54 |
7 |
NaN3 |
113 |
- |
- |
383 |
- |
9-AC |
- |
441 |
- |
- |
- |
2NF |
- |
- |
211 |
- |
- |
ENNG |
- |
- |
- |
- |
142 |
with metabolic activation |
|||||
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
Solvent |
9 |
5 |
18 |
74 |
3 |
17 |
9 |
5 |
19 |
71 |
4 |
50 |
9 |
6 |
20 |
74 |
4 |
167 |
6 |
7 |
20 |
66 |
4 |
500 |
7 |
8 |
23 |
84 |
4 |
1667 |
9 |
10 |
21 |
83 |
5 |
5000 |
7 |
9 |
20 |
81 |
3 |
2-AAN |
134 |
100 |
105 |
281 |
374 |
* mean of three individual plates ENNG N-ethyl-N-nitro-N-nitrosoguanidin: 2 µg/plate withE. coli 9-AC 9-aminoacridine: 80 µg/plate with TA 1537 2AAN 2-aminoanthracene: 20 µg/plate with E. coli; 2 µg/plate with TA 1535 and Ta 1537; 0,5 µg/plate with TA 98 and TA 100 2NF 2-nitrofuorene: 1 µg/plate with TA 98 NaN3 Sodium azide: 1 µg/plate with TA 1535 and TA 100 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Ammonium bromide was not mutagenic to Salmonella typhimurium or Escherichia coli, when tested in ultra-pure water up to a predetermined maximum limit of 5 mg/plate with and without a metabolic activation system. - Executive summary:
Purpose of the study was to test ammonium bromide for mutagenic activity in Salmonella typhimurium strains TA 1535, TA 1537, TA98 and TA 100 and Escherichia coli WP2uvrA.
Bacteria were tested at concentrations ranging from 17 to 5000 µg ammonium bromide per plate in presence and absence of S9 mix in triplicate plates each. No cytotoxicity (clearing of background lawn) or precipitation was observed up to and including the maximum concentration of 5 mg/plate.
The reliability and sensitivity of the test system was confirmed by parallel testing of positive and negative controls.
A test substance was considered mutagenic if:
- a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 1535, TA 1537 and WP2 uvrA) or 1.5-times (strains TA 100) the colony count of the corresponding vehicle control was observed
- a related dose response where mutagens require metabolic activation was seen
- a reproducible effect in independent tests was observed
No mutagenic activity was observed in any of the 5 bacterial strains tested both in the absence and presence of S9 mix. Positive controls were shown to have significantly increased the number of revertants per plate and results obtained were within the ranges expected for each bacterial strain and activation condition.
Ammonium bromide was not mutagenic to Salmonella typhimurium or Escherichia coli, when tested in ultra-pure water up to a predetermined maximum limit of 5 mg/plate with and without a metabolic activation system.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.