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EC number: 200-143-0 | CAS number: 52-51-7
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 April - 7 Dec 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bronopol
- EC Number:
- 200-143-0
- EC Name:
- Bronopol
- Cas Number:
- 52-51-7
- Molecular formula:
- C3H6BrNO4
- IUPAC Name:
- 2-bromo-2-nitropropane-1,3-diol
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: histidine deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- Prepared from livers of male Sprague-Dawley rats induced with a single i.p. injection of 500 mg/kg bw Arochlor 1254 in corn oil five days prior t sacrifice; co-factors were added.
- Test concentrations with justification for top dose:
- Cytotoxicity tests: 50, 158, 500, 1581, 5000 µg/plate in absence and presence of S9
Mutagenicity tests: 1-64 µg/plate in absence and presence of S9 - Vehicle / solvent:
- deionized water
Controls
- Untreated negative controls:
- other: not applicable
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- other: not applicable
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-nitro-1,2,-phenylene diamine, nitrofurantoin, cumene hydroperoxide, 2-aminoantracene
- Details on test system and experimental conditions:
- Plate incorporation test: The bacterial suspensions (0.1 mL) were mixed with soft agar (2.0 mL), 0.1 mL of Bronopol stock solutions or vehicle control, 0.5 mL S9 mix (in presence of metabolic activation) or buffer (in absence of S9) before being poured onto minimal agar plates.
Preincubation test: The bacterial suspensions (0.1 mL) were mixed with 0.1 mL of Bronopol stock solutions or vehicle control, 0.5 mL S9 mix (in presence of metabolic activation) or buffer (in absence of S9) and incubated for 20 min at 37°C. Soft agar (2.0 mL) was then added to the mixture before being poured onto minimal agar plates
The plates (three per concentration, negative and positive controls in each test) were then incubated for 48 hours at 37°C.
Total bacterial counts were also determined (soft agar with 5x higher histidine concentration) using two plates each in absence and presence of S9.
Examination for toxicity was (reduction of) background growth and number of mutant colonies and examination for mutagenicity was frequency of revertant colonies - Evaluation criteria:
- The test was considered to be positive if a reproducible and dose-related increase in mutant counts of at least one strain was seen. The increase should be at least:
• twice that of negative controls for strains TA 1535, TA 100, TA 98
• threefold that of negative controls for strain TA 1537
• about 100 mutant colonies higher than negative controls for strain TA 102
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- In the cytotoxicity test marked toxicity was seen at >/=50 µg/plate for TA 98, TA 1537, TA 100 in presence or absence of S9 and for TA 1535 ( S9), at >/=158 µg/plate for TA 1535 (+S9) and TA 102 (+/- S9).
In the plate incorporation assay, cytotoxicity was seen in absence of S9 at 64 µg/plate for TA 1535 and TA 100. The same applied to TA 100, TA 1537, TA 98 and TA 102 in absence of S9 in the preincubation test. Also in the preincubation assay cytotoxicity was seen at >/=32 µg/plate in absence of S9 for TA 1535.
In the plate incorporation test mutant counts about twice the concurrent control level were seen in several concentrations in strain TA 1535 without metabolic activation. This was not considered to be relevant as this was in absence of a dose relationship, as there were no increases in the plate incorporation test and as the mutant counts observed with Bronopol were within the range of the normal fluctuation of negative controls.
In comparison to historical controls (ranging from median 8, semi-Q range 2 to median 10 semi-Q range 2), the concurrent control of TA 1535 in the plate incorporation test was relatively low (6).
Positive control compounds gave a clear positive result.
Any other information on results incl. tables
Strain/concen-tration [µg/plate] |
Number of mutant cells |
|||
Plate incorporation test |
Preincubation test |
|||
— S9 |
+ S9 |
— S9 |
+ S9 |
|
TA 1535: 0 Positive control |
6 580 |
10 183 |
11 542 |
12 123 |
TA 100: 0 Positive control |
127 277 |
151 1719 |
114 272 |
108 1311 |
TA 1537: 0 Positive control |
10 114 |
8 298 |
12 115 |
13 248 |
TA 98: 0 Positive control |
36 221 |
37 1767 |
32 192 |
31 1458 |
TA 102: 0 Positive control |
251 413 |
240 704 |
213 401 |
199 456 |
Applicant's summary and conclusion
- Conclusions:
- No mutagenic potential of Bronopol was detected in S. typhimurium strains in presence and absence of metabolic activation.
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