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EC number: 220-985-2 | CAS number: 2958-36-3
- 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:
- 01 Sep - 20 Dec 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-amino-2',5-dichlorobenzophenone
- EC Number:
- 220-985-2
- EC Name:
- 2-amino-2',5-dichlorobenzophenone
- Cas Number:
- 2958-36-3
- Molecular formula:
- C13H9Cl2NO
- IUPAC Name:
- 4-chloro-2-(2-chlorobenzoyl)aniline
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (rat)
- Test concentrations with justification for top dose:
- Plate incorporation method without metabolic activation [µg/plate]:
0.5, 1, 5, 10, 50, 100, 500, 1000, 5000 S. typhimurium TA 1535 and TA 1537
1, 5, 10, 50, 100, 500, 1000, 5000 S. typhimurium TA 98 and E. coli WP2uvrA
0.1, 0.5, 1, 5, 10, 50, 100, 500, 1000, 5000 S. typhimurium TA 100
Plate incorporation method with metabolic activation [µg/plate]:
0.5, 1, 5, 10, 50, 100, 500 S. typhimurium TA 1535 and TA 1537
0.5, 1, 5, 10, 50, 100, 500, 1000 S. typhimurium TA 98
0.1, 0.5, 1, 5, 10, 50, 100 S. typhimurium TA 100
1, 5, 10, 50, 100, 500, 1000 S. typhimurium E. coli WP2uvrA
Pre-incubation method without metabolic activation [µg/plate]:
0.5, 1, 5, 10, 50, 100, 500 S. typhimurium TA 1535
0.05, 0.1, 0.5, 1, 5, 10, 50 S. typhimurium TA 1537
0.1, 0.5, 1, 5, 10, 50, 100 S. typhimurium TA 98
0.1, 0.5, 1, 5, 10 S. typhimurium TA 100
1, 5, 10, 50, 100 E. coli WP2uvrA
Pre-incubation method with metabolic activation [µg/plate]:
0.5, 1, 5, 10, 50, 100 S. typhimurium TA 1535
0.05, 0.1, 0.5, 1, 5, 10 S. typhimurium TA 1537
0.1, 0.5, 1, 5, 10, 50 S. typhimurium TA 98
0.1, 0.5, 1, 5, 10, 50 S. typhimurium TA 100
1, 5, 10, 50, 100, 500, 1000 E. coli WP2uvrA - Vehicle / solvent:
- Concurrent untreated and vehicle ( dimethyl sulfoxide) controls were performed.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile deionised water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5.0 µg/plate
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535 and TA 100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulfoxide
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 100 µg/plate
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulfoxide
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 5.0 µg/plate
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile deionised water
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 1.3 µg/plate
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: 1st main experiment: in agar (plate incorporation); 2nd main experiment: preincubation
DURATION
- 1st main experiment: 48 hours incubation (37°C)
- 2nd main experiment: 20 min preincubation (37°C), 48 hours incubation (37°C)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: determination of background lawn - Evaluation criteria:
- VALIDITY CRITERIA:
- negative controls in the laboratory historical control range (range of spontaneous reversion frequencies)
- positive controls show a distinct enhancement in all tester strains within laboratory historical range
- corresponding background growth on both negative control and test plates should be observed
- selected dose range should include a clearly toxic concentration or should exhibit limited solubility
CRITERIA FOR POSITIVE RESPONSE:
A test is considered to be positive if the test item induces dose related increases in numbers of revertants scored in two separate experiments and these
increases are deemed to be of biological relevance. Reproducible increases at one experimental point may also be indicative of a positive response. For a
biologically relevant response the number of revertants 1s expected to be at least the double of the spontaneaus reversion.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at higher concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Bacteria tester strain |
MA | Exp. | Mean numbers of revertants per plate | Evaluation | |||||||||||||
Controls | µg test item per plate | ||||||||||||||||
UTC | VC | PC | 5000 | 1000 | 500 | 100 | 50 | 10 | 5 | 1 | 0.5 | 0.1 | 0.05 | ||||
Salmonella typhimurium | |||||||||||||||||
TA 1535 | no | 1st | 30.7 | 28.3 | 1864.0 | 14.3 | 15.3 | 19.3 | 117.3 | 25.3 | 21.3 | n.e. | n.e. | n.e. | n.e. | n.e. | - |
no | 1st_a | 17.3 | 21.3 | 2621.3 | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | 16.3 | 16.0 | 14.7 | n.e. | n.e. | - | |
no | 2nd | 17.7 | 21.7 | 1842.0 | n.e. | n.e. | ** | ** | 19.7 | 18.7 | 22.0 | 20.0 | 20.7 | n.e. | n.e. | - | |
yes | 1st | 25.7 | 28.3 | 514.0 | n.e. | n.e. | 26.7 | 28.7 | 24.3 | 23.3 | 27.3 | 32.0 | 33.3 | n.e. | n.e. | - | |
yes | 2nd | 23.0 | 18.0 | 339.3 | n.e. | n.e. | n.e. | 24.0 | 23.0 | 26.7 | 24.3 | 29.3 | 23.7 | n.e. | n.e. | - | |
TA 1537 | no | 1st | 16.7 | 13.0 | 2630.0 | no bg. | no bg. | no bg. | ** | 10.7 | 19.3 | n.e. | n.e. | n.e. | n.e. | n.e. | - |
no | 1st_a | 9.3 | 11.3 | 772.0 | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | 9.0 | 9.0 | 13.0 | n.e. | n.e. | - | |
no | 2nd | 16.3 | 15.7 | 1250.0 | n.e. | n.e. | n.e. | n.e. | no bg. | no bg. | 14.7 | 11.0 | 13.3 | n.e. | n.e. | - | |
no | 2nd_a | 13.3 | 11.3 | 656.7 | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | 14.0 | 13.7 | - | |
yes | 1st | 14.0 | 16.7 | 217.0 | n.e. | n.e. | no bg. | ** | 16.7 | 15.0 | 23.7 | 13.3 | 14.3 | n.e. | n.e. | - | |
yes | 2nd | 23.7 | 19.7 | 301.3 | n.e. | n.e. | n.e. | n.e. | n.e. | 29.0 | 21.0 | 22.0 | 22.0 | 26.0 | 21.0 | - | |
TA 98 | no | 1st | 32.0 | 26.7 | 511.3 | no bg. | no bg. | no bg. | 24.3 | 27.3 | 24.3 | n.e. | n.e. | n.e. | n.e. | n.e. | - |
no | 1st_a | 29.3 | 25.3 | 354.7 | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | 22.0 | 22.7 | n.e. | n.e. | n.e. | - | |
no | 2nd | 67.0 | 50.0 | 642.7 | n.e. | n.e. | n.e. | 19.0 | 23.3 | 46.7 | 53.3 | 51.7 | n.e. | n.e. | n.e. | - | |
no | 2nd_a | 30.7 | 26.0 | 409.3 | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | 18.7 | 24.3 | n.e. | - | |
yes | 1st | 40.3 | 30.7 | 4498.0 | n.e. | ** | ** | ** | 36.3 | 37.3 | 43.7 | 39.3 | n.e. | n.e. | n.e. | - | |
yes | 1st_a | 27.7 | 24.0 | 4386.7 | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | 26.3 | n.e. | n.e. | - | |
yes | 2nd | 37.7 | 33.7 | 3528.0 | n.e. | n.e. | n.e. | n.e. | 41.0 | 40.3 | 44.3 | 46.0 | 38.7 | 45.0 | n.e. | - | |
TA 100 | no | 1st | 1177.3 | 160.0 | 2016.0 | no bg. | 36.7 | 94.0 | 118.7 | 109.3 | 166.3 | n.e. | n.e. | n.e. | n.e. | n.e. | - |
no | 1st_a | 162.0 | 162.0 | 2917.3 | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | 168.7 | 187.3 | 185.3 | 170.3 | n.e. | - | |
no | 2nd | 211.7 | 184.3 | 1992.0 | n.e. | n.e. | n.e. | n.e. | n.e. | 156.3 | 177.0 | 175.0 | 150.0 | 156.0 | n.e. | - | |
yes | 1st | 187.0 | 176.3 | 4154.0 | n.e. | n.e. | n.e. | 112.7 | 196.0 | 195.7 | 189.3 | 195.7 | 188.3 | 175.7 | n.e. | - | |
yes | 2nd | 169.0 | 160.0 | 2624.0 | n.e. | n.e. | n.e. | n.e. | 142.7 | 173.0 | 175.3 | 182.3 | 172.3 | 165.3 | n.e. | - | |
Escherichia coli | |||||||||||||||||
WP2uvrA | no | 1st | 30.3 | 33.7 | 272.7 | no bg. | 13.7 | 16.0 | 26.3 | 28.3 | 29.7 | n.e. | n.e. | n.e. | n.e. | n.e. | - |
no | 1st_a | 34.3 | 35.7 | 332.0 | n.e. | n.e. | n.e. | n.e. | n.e. | n.e. | 36.0 | 33.3 | n.e. | n.e. | n.e. | - | |
no | 2nd | 25.3 | 24.3 | 475.3 | n.e. | n.e. | n.e. | 20.0 | 23.7 | 27.7 | 24.3 | 26.0 | n.e. | n.e. | n.e. | - | |
yes | 1st | 32.3 | 36.0 | 1242.7 | n.e. | 16.7 | 27.3 | 48.3 | 39.7 | 36.7 | 41.0 | 33.0 | n.e. | n.e. | n.e. | - | |
yes | 2nd | 30.0 | 26.3 | 855.3 | n.e. | 17.7 | 20.3 | 39.0 | 43.7 | 43.0 | 31.3 | 32.3 | n.e. | n.e. | n.e. | - |
** instead of the normal background a lot of small bacteria colonies were observed as a sign of an incipient cytotoxicity, scored colonies can not be evaluated
Bacteria | Without metabolic activation | With metabolic activation | ||||||||||
Negative control | Positive control | Negative control | Positive control | |||||||||
X | ± sd | n | X | ± sd | n | X | ± sd | n | X | ± sd | n | |
TA 98 | 24.3 | 7.2 | 235 | 770 | 323 | 110 | 30.4 | 7.7 | 246 | 2815 | 1318 | 116 |
TA 100 | 184.8 | 43.0 | 237 | 1621 | 507 | 114 | 198.1 | 46.5 | 232 | 3183 | 1083 | 108 |
TA 1535 | 15.7 | 5.3 | 231 | 1438 | 479 | 111 | 18.3 | 17.3 | 224 | 240 | 84 | 103 |
TA 1537 | 13.2 | 4.5 | 228 | 2990 | 1386 | 107 | 14.2 | 4.4 | 222 | 372 | 182 | 102 |
WP2uvrA | 24.2 | 5.8 | 140 | 307 | 106 | 69 | 28.5 | 6.7 | 134 | 218 | 158 | 66 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results of the reported study it is concluded that ADB does not induce gene mutation in Salmonella typhimurium and Escherichia coli under the
experimental conditions described. Therefore, ADB is considered to be non-motagenie in the bacterial reverse mutation test.
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