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EC number: 210-112-3 | CAS number: 606-28-0
- 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:
- 2007 -11-29 till 2007-12-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methyl 2-benzoylbenzoate
- EC Number:
- 210-112-3
- EC Name:
- Methyl 2-benzoylbenzoate
- Cas Number:
- 606-28-0
- Molecular formula:
- C15H12O3
- IUPAC Name:
- methyl 2-benzoylbenzoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identity: GENOCURE* MBB
Chemical Name: Methyl 2-benzoylbenzoate
CAS No.: 606-28-0
Batch No.: G07001
Aggregate state at room temperature: solid
Colour: Off white, light yellow
Molecular weight:240.26 g/mol
Purity: > 99 %
Solubility: Soluble in water <1 g/L
Stability in solvent:Stable for at least 30 days at THF and acetone
Storage: At room temperature
Expiration Date: June 30, 2008
Constituent 1
- Specific details on test material used for the study:
- Identity: GENOCURE* MBB
Chemical Name: Methyl 2-benzoylbenzoate
CAS No.: 606-28-0
Batch No.: G07001
Aggregate state: Solid
Colour: off-white, light yellow
Molecular weight: 240.26 g/mol
Purity: > 99 %
Solubility: soluble in water <1 g/L
Stability in solvent: stable for at least 30 days at THF and acetone
Storage: at room temperature
Expiration Date: June 30, 2008
Method
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / pre-experiment/experiment I
33; 100; 333; 1000; 2500; and 5000 µg/plate / experiment II - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dry THF
- Justification for choice of solvent/vehicle: chosen because of its solubility properties
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide; 4-nitro-o-phenylene-diamine; methyl methane sulfonate, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation and preincubation method
DURATION
- Preincubation period: 1 hour
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
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.
Results and discussion
Test results
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation:
The test item precipitated in the overlay agar in the test tubes from 2500 µg/plate up to 5000 µg/plate in experiment I and at 5000 µg/plate in experiment II. The undissolved particles had no influence on the data recording.
COMPARISON WITH HISTORICAL CONTROL DATA: performed
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The plates incubated with the test item showed reduced background growth 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 / / / 2500 - 5000
TA 1537 / / / 1000 - 5000
TA 98 / / / /
TA 100 / / 1000 - 5000 333 - 5000
WP2 uvrA / / / /
/ = no reduced background growth
No toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), occurred in the test groups with and without metabol¬ic activation. Only in strain TA 1537 with metabolic activation a reduction in the number of revertants (below the induction factor of 0.5) was observed from 2500 µg/plate up to 5000 µg/plate in experiment I and at 1000 µg/plate in experiment II. - Remarks on result:
- other: other: reverse mutation assay
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
1.1 Summary of Results Pre-Experiment/Experiment I
Study Name: 1142601 |
Study Code: RCC-CCR 1142601 |
Experiment: 1142601 VV Plate |
Date Plated: 29/11/2007 |
Assay Conditions: |
Date Counted: 05/12/2007 |
Metabolic Activation |
Test Group |
Dose Level (µg/plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
Without Activation |
THF |
|
|
11 ± 1B M |
14 ± 4 |
33 ± 12 |
128 ± 5 |
37 ± 5 |
Untreated |
|
|
14 ± 1B M |
12 ± 5 |
23 ± 3 |
135 ± 13 |
36 ± 5 |
|
GENOCURE* |
3 µg |
|
13 ± 3B M |
12 ± 6 |
37 ± 4 |
133 ± 8 |
42 ± 5 |
|
MBB |
10 µg |
|
11 ± 1B M |
15 ± 6 |
30 ± 10 |
133 ± 17 |
39 ± 4 |
|
|
33 µg |
|
13 ± 3B M |
17 ± 5 |
28 ± 4 |
126 ± 3 |
41 ± 5 |
|
|
100 µg |
|
10 ± 2B M |
13 ± 6 |
39 ± 4 |
129 ± 6 |
41 ± 6 |
|
|
333 µg |
|
11 ± 1B M |
15 ± 2 |
25 ± 10 |
120 ± 18 |
40 ± 6 |
|
|
1000 µg |
|
11 ± 2B M |
15 ± 2 |
25 ± 4 |
115 ± 18 |
38 ± 5 |
|
|
2500 µg |
|
9 ± 1B M |
11 ± 4 |
30 ± 4 |
115 ± 9 |
40 ± 3 |
|
|
5000 µg |
|
11 ± 2B M |
11 ± 4 |
29 ± 9 |
128 ± 14 |
40 ± 4 |
|
NaN3 |
10 µg |
|
1880 ± 85 |
|
|
1868 ± 118 |
|
|
4-NOPD |
10 µg |
|
|
|
502 ± 33 |
|
|
|
4-NOPD |
50 µg |
|
|
103 ± 10 |
|
|
|
|
MMS |
3.0 µL |
|
|
|
|
|
1163 ± 27 |
|
|
|
|
|
|
|
|
|
|
With Activation |
THF |
|
|
15 ± 1B M |
24 ± 7 |
39 ± 4 |
128 ± 12 |
55 ± 15 |
Untreated |
|
|
12 ± 1B M |
18 ± 4 |
33 ± 9 |
126 ± 13 |
54 ± 12 |
|
GENOCURE* |
3 µg |
|
12 ± 1B M |
21 ± 7 |
36 ± 7 |
117 ± 7 |
52 ± 13 |
|
MBB |
10 µg |
|
12 ± 2B M |
24 ± 8 |
36 ± 6 |
122 ± 12 |
64 ± 14 |
|
|
33 µg |
|
15 ± 1B M |
25 ± 3 |
33 ± 3 |
131 ± 16 |
64 ± 7 |
|
|
100 µg |
|
12 ± 2B M |
17 ± 7 |
39 ± 5 |
143 ± 7 |
57 ± 2 |
|
|
333 µg |
|
11 ± 3B M |
26 ± 7 |
39 ± 8 |
122 ± 17 |
59 ± 10 |
|
|
1000 µg |
|
8 ± 2B M |
17 ± 3 |
36 ± 5 |
99 ± 9 |
50 ± 10 |
|
|
2500 µg |
|
8 ± 2B M |
11 ± 4 |
35 ± 7 |
107 ± 2 |
52 ± 7 |
|
|
5000 µg |
|
8 ± 3B M |
9 ± 2 |
38 ± 3 |
95 ± 11 |
48 ± 8 |
|
2-AA |
2.5 µg |
|
366 ± 30 |
134 ± 5 |
905 ± 67 |
1350 ± 32 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
315 ± 33 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
B M |
Extensive bacterial growth Manual count |
1.2 Summary of Results Experiment II
Study Name: 1142601 |
Study Code: RCC-CCR 1142601 |
Experiment: 1142601 HV2 Pre |
Date Plated: 06/12/2007 |
Assay Conditions: |
Date Counted: 11/12/2007 |
Metabolic Activation |
Test Group |
Dose Level (µg/plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
Without Activation |
THF |
|
|
14 ± 3B M |
11 ± 4 |
30 ± 11 |
119 ± 5 |
45 ± 2 |
Untreated |
|
|
20 ± 1B M |
11 ± 6 |
26 ± 8 |
131 ± 10 |
50 ± 13 |
|
GENOCURE* |
33 µg |
|
12 ± 4B M |
11 ± 6 |
22 ± 7 |
109 ± 19 |
46 ± 11 |
|
MBB |
100 µg |
|
12 ± 3B M |
9 ± 3 |
22 ± 11 |
122 ± 16 |
30 ± 9 |
|
|
333 µg |
|
11 ± 1B M |
12 ± 3 |
29 ± 11 |
115 ± 7 |
41 ± 13 |
|
|
1000 µg |
|
11 ± 2B M |
8 ± 1 |
20 ± 7 |
69 ± 3R |
45 ± 10 |
|
|
2500 µg |
|
11 ± 4B M |
12 ± 5 |
21 ± 12 |
67 ± 4R |
36 ± 9 |
|
|
5000 µg |
|
14 ± 3B M |
12 ± 3 |
23 ± 5 |
65 ± 20R M |
41 ± 8 |
|
NaN3 |
10 µg |
|
2042 ± 97 |
|
|
2060 ± 25 |
|
|
4-NOPD |
10 µg |
|
|
|
607 ± 9 |
|
|
|
4-NOPD |
50 µg |
|
|
127 ± 21 |
|
|
|
|
MMS |
3.0 µL |
|
|
|
|
|
281 ± 21 |
|
|
|
|
|
|
|
|
|
|
With Activation |
THF |
|
|
16 ± 4B M |
23 ± 4 |
36 ± 5 |
135 ± 15 |
64 ± 8 |
Untreated |
|
|
16 ± 3B M |
19 ± 3 |
38 ± 2 |
150 ± 12 |
57 ± 7 |
|
GENOCURE* |
33 µg |
|
18 ± 4B M |
18 ± 5 |
40 ± 5 |
144 ± 9 |
58 ± 13 |
|
MBB |
100 µg |
|
13 ± 4B M |
18 ± 5 |
35 ± 6 |
135 ± 13 |
60 ± 12 |
|
|
333 µg |
|
12 ± 2B M |
16 ± 4 |
34 ± 1 |
99 ± 14R |
56 ± 1 |
|
|
1000 µg |
|
12 ± 3B M |
9 ± 3R |
32 ± 5 |
78 ± 1R |
56 ± 4 |
|
|
2500 µg |
|
8 ± 3B M R |
12 ± 3R |
27 ± 7 |
104 ± 10R |
47 ± 3 |
|
|
5000 µg |
|
8 ± 2B M R |
12 ± 3R |
23 ± 5 |
88 ± 18R |
56 ± 4 |
|
2-AA |
2.5 µg |
|
129 ± 20 |
120 ± 6 |
797 ± 72 |
1052 ± 28 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
334 ± 17 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
R M B |
Reduced background growth Manual count Extensive bacterial growth |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without S9 MIx
In conclusion, it can be stated that during the described mutage¬nicity 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. - Executive summary:
This study was performed to investigate the potential of GENOCURE* MBB to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and 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, including the controls, was 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: 33; 100; 333; 1000; 2500; and 5000 µg/plate
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without metabolic activation in experiment I. Reduced background growth was observed in experiment II in few strains.
No toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), occurred in the test groups with and without metabolic activation. Only in strain TA 1537 with metabolic activation a reduction in the number of revertants (below the induction factor of 0.5) was observed from 2500 µg/plate up to 5000 µg/plate in experiment I and at 1000 µg/plate in experiment II.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with GENOCURE* MBB at any dose 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 and showed a distinct increase of induced revertant colonies.
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