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EC number: 203-623-8 | CAS number: 108-86-1
- 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
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- Solubility in organic solvents / fat solubility
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- Flash point
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- Oxidation reduction potential
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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- 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
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test (OECD 471): negative in S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvrA with and without metabolic activation
Link to relevant study records
- 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:
- 22 Nov - 05 Dec 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline-conform study under GLP without deviations
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his and trp operon
- Species / strain / cell type:
- other: TA 1535, TA 1537, TA 98, TA 100, and WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/Beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II:
Strain TA 100: 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
All remaining strains: 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- Solvent used: DMSO
Justification for choice of solvent: best suitable solvent, because of its solubility properties and its relative nontoxicity to the bacteria - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate incorporation; pre-incubation
DURATION:
Preincubation period: 30 Minutes
exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates for each concentration including the controls
DETERMINATION OF CYTOTOXICITY: Evident as a reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, and WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in all strains, except of strain TA 1537
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST SPECIFIC CONFOUNDING FACTORS
Effects of pH: none
Water solubility: not soluble
Precipitation: The test item precipitated in the overlay agar in the test tubes at 5000 µg/plate in the presence of S9 mix. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 2500 to 5000 µg/plate in experiment I in the presence of S9 mix.
Other confounding effects: none
COMPARISON WIT HISTORICAL CONTROL DATA: performed, no deviations
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Experiment I: TA 100 with and without S9 mix: 2500 to 5000 µg/plate
WP2 uvrA with S9 mix: 5000 µg/plate
Experiment II:
without S9 mix: TA 1535, TA 98, TA 100; WP2 uvrA w: 5000 µg/plate
with S9 mix: TA 1535: 1000 - 5000 µg/plate
TA 98: 5000 µg/plate
TA 100: 333 - 5000 µg/plate - Remarks on result:
- other:
- Remarks:
- the test item did not induce gene mutations.
- Conclusions:
- It can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, Art. 801786 (Brombenzene) is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay. - Executive summary:
The test item Art. 801786 (Brombenzene) was assessed for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II:
TA 100: 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
all remaining strains: 33; 100; 333; 1000; 2500; and 5000 µg/plateThe test item precipitated in the overlay agar in the test tubes at 5000 µg/plate in the presence of S9 mix. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 2500 to 5000 µg/plate in experiment I in the presence of S9 mix.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain
Experiment I
Experiment II
without S9 mix
with S9 mix
without S9 mix
with S9 mix
TA 1535
/
/
5000
1000 – 5000
TA 1537
/
/
/
/
TA 98
/
/
5000
5000
TA 100
2500 – 5000
2500 – 5000
5000
333 – 5000
WP2 uvrA
/
5000
5000
/
/ = no toxic effect (induction factor>0.5)
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Art. 801786 (Brombenzene) at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
Reference
Summary of Experiment I
Metabolic Activation |
Test Group |
Dose Level (per plate) |
TA 1535 Revertant Colony Counts (Mean ±SD) |
TA 1537 Revertant Colony Counts (Mean ±SD) |
TA 98 Revertant Colony Counts (Mean ±SD) |
TA 100 Revertant Colony Counts (Mean ±SD) |
WP2 uvrA Revertant Colony Counts (Mean ±SD) |
|
|
|
|
|
|
|
|
Without |
DMSO |
|
12 ± 4 |
11 ± 1 |
28 ± 6 |
182 ± 0 |
29 ± 2 |
Activation |
Untreated |
|
11 ± 3 |
16 ± 2 |
27 ± 7 |
201 ± 7 |
43 ± 2 |
|
Art. 801786 |
3 µg |
12 ± 4 |
12 ± 5 |
35 ± 5 |
205 ± 18 |
27 ± 6 |
|
(Brombenzene) |
10 µg |
13 ± 1 |
12 ± 3 |
32 ± 5 |
186 ± 13 |
39 ± 5 |
|
|
33 µg |
10 ± 4 |
12 ± 6 |
23 ± 3 |
191 ± 16 |
31 ± 5 |
|
|
100 µg |
14 ± 3 |
13 ± 6 |
30 ± 11 |
205 ± 12 |
40 ± 5 |
|
|
333 µg |
10 ± 4 |
12 ± 4 |
37 ± 8 |
153 ± 17 |
36 ± 4 |
|
|
1000 µg |
13 ± 3 |
10 ± 1 |
25 ± 4 |
120 ± 14 |
41 ± 9 |
|
|
2500 µg |
13 ± 1 |
8 ± 2 |
16 ± 0 |
82 ± 3 |
25 ± 5 |
|
|
5000 µg |
12 ± 2 |
7 ± 4 |
16 ± 6 |
67 ± 18 |
20 ± 5 |
|
NaN3 |
10 µg |
1437 ± 130 |
|
|
2691 ± 32 |
|
|
4-NOPD |
10 µg |
|
|
357 ± 61 |
|
|
|
4-NOPD |
50 µg |
|
77 ± 9 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
1115 ± 55 |
|
|
|
|
|
|
|
|
With |
DMSO |
|
14 ± 7 |
10 ± 1 |
36 ± 6 |
155 ± 30 |
46 ± 0 |
Activation |
Untreated |
|
13 ± 6 |
14 ± 6 |
43 ± 6 |
171 ± 56 |
51 ± 3 |
|
Art. 801786 |
3 µg |
11 ± 4 |
12 ± 4 |
28 ± 3 |
156 ± 32 |
37 ± 7 |
|
(Brombenzene) |
10 µg |
12 ± 3 |
14 ± 2 |
34 ± 3 |
141 ± 21 |
40 ± 6 |
|
|
33 µg |
13 ± 3 |
13 ± 3 |
27 ± 9 |
177 ± 14 |
50 ± 8 |
|
|
100 µg |
10 ± 6 |
10 ± 2 |
39 ± 7 |
171 ± 21 |
46 ± 7 |
|
|
333 µg |
10 ± 2 |
13 ± 1 |
38 ± 7 |
145 ± 9 |
49 ± 4 |
|
|
1000 µg |
10 ± 1 |
11 ± 3 |
41 ± 4 |
124 ± 16 |
47 ± 5 |
|
|
2500 µg |
11 ± 2P M |
10 ± 2P M |
32 ± 1P |
46 ± 9P |
40 ± 7P |
|
|
5000 µg |
11 ± 4P M |
14 ± 2P M |
34 ± 7P M |
24 ± 5P M |
15 ± 2P M |
|
2-AA |
2.5 µg |
505 ± 18 |
154 ± 12 |
3562 ± 677 |
4545 ± 663 |
|
|
2-AA |
10.0 µg |
|
|
|
|
403 ± 40 |
Summary of Experiment II
Metabolic Activation |
Test Group |
Dose Level (per plate) |
TA 1535 Revertant Colony Counts (Mean ±SD) |
TA 1537 Revertant Colony Counts (Mean ±SD) |
TA 98 Revertant Colony Counts (Mean ±SD) |
TA 100 Revertant Colony Counts (Mean ±SD) |
WP2 uvrA Revertant Colony Counts (Mean ±SD) |
|
|
|
|
|
|
|
|
Without |
DMSO |
|
14 ± 4 |
10 ± 5 |
26 ± 3 |
131 ± 5 |
43 ± 10 |
Activation |
Untreated |
|
9 ± 2 |
18 ± 2 |
23 ± 4 |
194 ± 1 |
43 ± 8 |
|
Art. 801786 |
10 µg |
|
|
|
119 ± 16 |
|
|
(Brombenzene) |
33 µg |
13 ± 2 |
11 ± 3 |
24 ± 4 |
122 ± 16 |
38 ± 5 |
|
|
100 µg |
14 ± 2 |
14 ± 3 |
32 ± 4 |
114 ± 6 |
36 ± 1 |
|
|
333 µg |
11 ± 1 |
11 ± 2 |
25 ± 2 |
84 ± 1 |
43 ± 9 |
|
|
1000 µg |
11 ± 5 |
12 ± 4 |
18 ± 4 |
62 ± 12 |
33 ± 9 |
|
|
2500 µg |
10 ± 6 |
8 ± 2 |
19 ± 3 |
73 ± 11 |
29 ± 6 |
|
|
5000 µg |
1 ± 1 |
7 ± 1 |
6 ± 1 |
51 ± 7 |
10 ± 1 |
|
NaN3 |
10 µg |
1610 ± 69 |
|
|
2364 ± 240 |
|
|
4-NOPD |
10 µg |
|
|
450 ± 28 |
|
|
|
4-NOPD |
50 µg |
|
89 ± 8 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
696 ± 48 |
|
|
|
|
|
|
|
|
With |
DMSO |
|
10 ± 1 |
11 ± 5 |
31 ± 4 |
123 ± 5 |
65 ± 4 |
Activation |
Untreated |
|
15 ± 5 |
15 ± 6 |
39 ± 4 |
184 ± 28 |
56 ± 11 |
Art. 801786 |
10 µg |
|
|
|
112 ± 9 |
|
|
|
(Brombenzene) |
33 µg |
13 ± 3 |
9 ± 3 |
39 ± 7 |
117 ± 10 |
54 ± 13 |
|
|
100 µg |
11 ± 5 |
9 ± 3 |
34 ± 7 |
98 ± 13 |
51 ± 7 |
|
|
333 µg |
9 ± 2 |
9 ± 4 |
26 ± 2 |
53 ± 6 |
45 ± 11 |
|
|
1000 µg |
4 ± 1 |
10 ± 2 |
33 ± 9 |
51 ± 7 |
42 ± 10 |
|
|
2500 µg |
3 ± 2 |
11 ± 2 |
18 ± 6 |
45 ± 6 |
30 ± 8 |
|
|
5000 µg |
1 ± 1 |
11 ± 1 |
11 ± 3 |
14 ± 5 |
30 ± 8 |
|
2-AA |
2.5 µg |
392 ± 7 |
92 ± 19 |
5138 ± 73 |
4310 ± 254 |
|
|
2-AA |
10.0 µg |
|
|
|
|
363 ± 54 |
|
|
|
|
|
|
|
|
Key to Plate Postfix Codes:
P: Precipitate
M: Manuel Count
Key to positive controls:
NaN3: sodium azide
4 -NOPD: 4 -nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
2-AA: 2 -aminoanthracene
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Gene mutation in bacteria
Mutagenicity of bromobenzene was tested in a GLP-compliant bacterial reverse mutation assay according to OECD TG 471 performed with a standard battery of Salmonella typhimurium tester strains including TA 1535, TA 1537, TA 98 and TA 100 and WP2uvrA bacterial cells (reference 7.6.1-1). Based on the results of a preliminary cytotoxicity test, the highest concentration of 5000 µg/plate was tested in all strains. Bromobenzene did not exhibit mutagenic properties in the absence or presence of metabolic activation. Toxicity indicated by reduced number of revertants was observed in all strains at least at the highest applied dose except for TA 1537 in at least one experiment. Positive control substances induced a distinct increase in the number of revertants in all strains with and without metabolic activation thereby proving validity of the assay. Based on the results of the conducted study, bromobenzene is not considered to exhibit mutagenic properties in bacterial cells.
Justification for classification or non-classification
Based on the available data on genetic toxicity, there is no indication that bromobenzene induces genetic toxicity in bacteria. However, no final decision on classification for genetic toxicity according to Regulation (EC) 1272/2008 can be made, as no information on chromosomal aberration and mutagenicity in mammalian cells/in vivo is available.
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