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EC number: 216-706-9 | CAS number: 1646-26-0
- 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:
- 3 Feb - 14 Mar 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Commission Regulation (EC) No. 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Benzofuran-2-yl methyl ketone
- EC Number:
- 216-706-9
- EC Name:
- Benzofuran-2-yl methyl ketone
- Cas Number:
- 1646-26-0
- Molecular formula:
- C10H8O2
- IUPAC Name:
- benzofuran-2-yl methyl ketone
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains)
trp operon (for E. coli strain)
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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital/β-naphthoflavone
- Test concentrations with justification for top dose:
- Pre-experiment: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate with and without metabolic activation
The pre-experiment is reported as Experiment 1.
Experiment 2:
33, 100, 333, 1000, 2500 and 5000 µg/plate with and without metabolic activation for TA 100 and TA 1535
10, 33, 100, 333, 1000, 2500 and 5000 µg/plate with and without metabolic activation for remaining strains - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine (4-NOPD), 2-aminoanthracene (2-AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) (Experiment 1); pre-incubation (Experiment 2)
DURATION
- Preincubation period: 1 h
- Exposure duration: at least 48 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn - Evaluation criteria:
- A test substance is considered as a mutagenic 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:
- Mean values and standard deviations were calculated.
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
- Remarks:
- Exp 2: -S9: at 5000 µg/plate; +S9: at and above 2500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp 1: -S9: at 5000 µg/plate; Exp 2: +/-S9: at and above 2500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp 1: +S9: at 5000 µg/plate; Exp 2: +S9: at and above 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp 1: +S9: at 5000 µg/plate; Exp 2: -S9: at 5000 µg/plate; +S9: at and above 1000 µg/plate
- Vehicle controls validity:
- valid
- 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:
- cytotoxicity
- Remarks:
- Exp 1 and 2: +/- S9: at and above 1000 µg/plate
- 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 at 5000 μg/plate with and without S9 mix in both experiments. Precipitation of the test item in the overlay agar on the incubated agar plates was observed in Experiment 1 at 5000 μg/plate with S9 mix. In Experiment 2 no precipitation of the test susbtance was observed on the incubated agar plates. The undissolved particles had no influence on the data recording.
RANGE-FINDING/SCREENING STUDIES: The pre-experiment is reported as Experiment I (all strains were tested in the pre-experiment).
ADDITIONAL INFORMATION ON CYTOTOXICITY:The plates incubated with the test substance showed reduced background growth in Experiment 2 in all strains used, except of strain WP2 uvrA. Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), were observed in all strains used.
Any other information on results incl. tables
Table 1: Results of Experiment 1 (plate incorporation).
|
Number of revertant colonies (mean of 3 plates ± SD) |
|||||||
Without S9 |
||||||||
Test substance (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
|||
DMSO |
13 ± 2 |
8 ± 2 |
27 ± 2 |
194 ± 10 |
33 ± 6 |
|||
Untreated |
12 ± 2 |
7 ± 3 |
29 ± 6 |
208 ± 16 |
38 ± 5 |
|||
3 |
14 ± 2 |
9 ± 4 |
26 ± 4 |
184 ± 22 |
30 ± 6 |
|||
10 |
10 ± 2 |
8 ± 1 |
27 ± 5 |
200 ± 13 |
33 ± 3 |
|||
33 |
9 ± 3 |
6 ± 1 |
23 ± 4 |
181 ± 19 |
28 ± 4 |
|||
100 |
11 ± 4 |
8 ± 3 |
28 ± 4 |
181 ± 18 |
33 ± 7 |
|||
333 |
12 ± 4 |
10 ± 1 |
28 ± 7 |
193 ± 14 |
30 ± 3 |
|||
1000 |
13 ± 3 |
4 ± 1 |
26 ± 4 |
179 ± 8 |
15 ± 5 |
|||
2500 |
12 ± 0 |
4 ± 2 |
25 ± 5 |
166 ± 21 |
13 ± 3 |
|||
5000 |
11 ± 4 |
3 ± 1 |
23 ± 4 |
169 ± 21 |
14 ± 2 |
|||
Positive Control |
NaN3 |
4-NOPD |
4-NOPD |
NaN3 |
MMS |
|||
Dose (µg/plate) |
10 |
50 |
10 |
10 |
2 |
|||
Number of revertant colonies/plate |
930 ± 93 |
100 ± 18 |
478 ± 53 |
2300 ± 55 |
923 ± 20 |
|||
With S9 |
||||||||
Test substance (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
|||
DMSO |
13 ± 3 |
9 ± 4 |
37 ± 4 |
177 ± 8 |
43 ± 6 |
|||
Untreated |
19 ± 3 |
9 ± 3 |
42 ± 8 |
186 ± 17 |
46 ± 7 |
|||
3 |
9 ± 2 |
8 ± 4 |
38 ± 3 |
183 ± 13 |
44 ± 11 |
|||
10 |
11 ± 2 |
8 ± 3 |
40 ± 2 |
179 ± 6 |
42 ± 7 |
|||
33 |
10 ± 3 |
7 ± 2 |
31 ± 2 |
180 ± 22 |
44 ± 11 |
|||
100 |
12 ± 4 |
11 ± 3 |
31 ± 4 |
188 ± 21 |
48 ± 7 |
|||
333 |
15 ± 1 |
11 ± 6 |
41 ± 5 |
157 ± 5 |
34 ± 7 |
|||
1000 |
9 ± 2 |
11 ± 2 |
27 ± 5 |
164 ± 14 |
18 ± 4 |
|||
2500 |
12 ± 5 |
12 ± 5 |
18 ± 1 |
99 ± 7 |
8 ± 2 |
|||
5000 |
8 ± 1 p |
5 ± 1 p |
11 ± 2 p |
36 ± 10 p |
2 ± 1 p |
|||
Positive Control |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
|||
Dose (µg/plate) |
2.5 |
2.5 |
2.5 |
2.5 |
10 |
|||
Number of revertant colonies/plate |
219 ± 34 |
173 ± 24 |
4806 ± 849 |
4719 ± 196 |
346 ± 48 |
|||
NaN3: sodium azide 2AA: 2-Aminoanthracene 4-NOPD: 4-nitro-o-phenylene-diamine MMS: methyl methane silfonate |
p: Precipitate |
Table 2: Results of Experiment 2 (pre-incubation).
|
Number of revertant colonies (mean of 3 plates ± SD) |
|||||||
Without S9 |
||||||||
Test substance (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
|||
DMSO |
9 ± 2 |
8 ± 3 |
26 ± 8 |
149 ± 9 |
44 ± 8 |
|||
Untreated |
10 ± 3 |
13 ± 3 |
22 ± 9 |
189 ± 5 |
42 ± 10 |
|||
10 |
|
9 ± 3 |
29 ± 8 |
|
44 ± 8 |
|||
33 |
11 ± 2 |
9 ± 4 |
25 ± 3 |
143 ± 12 |
40 ± 3 |
|||
100 |
9 ± 3 |
10 ± 2 |
25 ± 4 |
151 ± 6 |
42 ± 1 |
|||
333 |
8 ± 2 |
9 ± 3 |
26 ± 5 |
126 ± 17 |
25 ± 4 |
|||
1000 |
13 ± 3 |
8 ± 3 |
21 ± 6 |
114 ± 26 |
14 ± 5 |
|||
2500 |
10 ± 2 |
11 ± 3 r |
20 ± 3 |
75 ± 17 |
16 ± 1 |
|||
5000 |
10 ± 1 r |
9 ± 6 r |
18 ± 3 |
48 ± 23 r |
17 ± 8 |
|||
Positive Control |
NaN3 |
4-NOPD |
4-NOPD |
NaN3 |
MMS |
|||
Dose (µg/plate) |
10 |
50 |
10 |
10 |
2 |
|||
Number of revertant colonies/plate |
1225 ± 59 |
89 ± 10 |
462 ± 22 |
1884 ± 169 |
732 ± 13 |
|||
With S9 |
||||||||
Test substance (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
|||
DMSO |
13 ± 2 |
11 ± 5 |
32 ± 4 |
136 ± 7 |
43 ± 10 |
|||
Untreated |
10 ± 6 |
8 ± 3 |
44 ± 9 |
206 ± 10 |
59 ± 5 |
|||
10 |
|
13 ± 2 |
39 ± 7 |
|
52 ± 7 |
|||
33 |
9 ± 2 |
11 ± 5 |
35 ± 7 |
130 ± 6 |
49 ± 8 |
|||
100 |
13 ± 3 |
8 ± 2 |
30 ± 6 |
153 ± 21 |
42 ± 12 |
|||
333 |
10 ± 3 |
11 ± 3 |
33 ± 6 |
145 ± 14 |
36 ± 4 |
|||
1000 |
10 ± 4 |
10 ± 4 |
39 ± 10 r |
85 ± 1 r |
18 ± 4 |
|||
2500 |
5 ± 2 r, m |
5 ± 2 r, m |
9 ± 1 r, m |
5 ± 1 r, m |
18 ± 4 |
|||
5000 |
2 ± 1 r, m |
7 ± 4 r, m |
6 ± 2 r, m |
5 ± 1 r, m |
8 ± 2 |
|||
Positive Control |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
|||
Dose (µg/plate) |
2.5 |
2.5 |
2.5 |
2.5 |
10 |
|||
Number of revertant colonies/plate |
369 ± 24 |
160 ± 7 |
4201 ± 214 |
2905 ± 543 |
377 ± 14 |
|||
NaN3: sodium azide 2AA: 2-Aminoanthracene 4-NOPD: 4-nitro-o-phenylene-diamine MMS: methyl methane silfonate |
r: reduced background growth m: manual count |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted test the substance was not mutagenic in any of the five strains (TA 1535, TA 1537, TA 98, TA 100 and WP2 uvrA) tested with and without metabolic activation up to 5000 µg/plate.
- Executive summary:
Ames test according to OECD 471 and GLP was performed. 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: Strains TA 1535 and TA 100: 33; 100; 333; 1000; 2500; and 5000 µg/plate; the remaining strains: 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate.
No substantial increase in revertant colony numbers of any of the five tester strains was observed any dose level, neither in the presence nor absence of metabolic activation (S9 mix). In conclusion, the test item did not induce gene mutations by base pair
changes or frameshifts in the genome of the strains used.
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