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EC number: 229-856-5 | CAS number: 6789-88-4
- 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:
- 12 February 2014 - 02 May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hexyl benzoate
- EC Number:
- 229-856-5
- EC Name:
- Hexyl benzoate
- Cas Number:
- 6789-88-4
- Molecular formula:
- C13H18O2
- IUPAC Name:
- hexyl benzoate
- Test material form:
- liquid
1
Method
- Target gene:
- Salmonella typhimurium: histidine gene
Escherichia coli: tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: Additional mutations: mutation of the uvrB gene to enhance their sensitivity to some mutagenic compounds and rfa wall mutation to increase permeability to certain classes of chemicals. Tester strains TA98 and TA100 also contain pKM101 plasmid.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: Additional mutation of the UvrA gene to enhance the sensitivity to some mutagenic compounds.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver homogenate (S9) from male Sprague-Dawley rats injected with Aroclor 1254 (200 mg/mL in corn oil)
- Test concentrations with justification for top dose:
- Initial assay: 5.00, 16.0, 50.0, 160, 500, 1600 and 5000 µg/plate (all strains)
Confirmatory assay: 16.0, 50.0, 160, 500, 1600 and 5000 µg/plate (with S9) and 1.60, 5.00, 16.0, 50.0, 160, 500, 1600 and 5000 µg/plate (without S9) (all strains)
Top dose was chosen according to OECD guideline. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: according to OECD 471
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- See section ''any other information on materials and methods incl. tables''
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 52 +/- 4 hours
NUMBER OF REPLICATIONS: three replicates per dose level
METHODS OF SLIDE PREPARATION: 100 µL of tester strain and 100 µL of test or vehicle control article were added to 2.5 mL of diluted molten selective top agar (maintained at 45 +/- 2°C). After the required components had been added, the mixture was vortexed and overlaid onto the surface of 25 mL minimal bottom agar in a 15 x 100 mm petri dish. - Evaluation criteria:
- - A test article is considered to have produced a positive response if it induces a dose-dependent increase in revertant frequency that is ≥2.0-fold vehicle control values for tester strains TA98, TA100, and WP2uvrA, or ≥3.0-fold vehicle control values for tester strains TA1535 and TA1537. In addition, any response should be reproducible.
- A test article is considered to have produced a negative response if no dose-dependent, ≥2.0-fold or ≥3.0-fold increases are observed in tester strains TA98, TA100, and WP2uvrA, or TA1535 and TA1537, respectively.
ACCEPTABILITY CRITERIA:
The vehicle control and positive control plates from each tester strain (with or without S9-mix) must exhibit a characteristic number f revertant colonies when compared against relevant historical control data generated at Charles River Den Bosch.
b) The selected dose-range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the reliminary toxicity range-finding test or should extend to 5 mg/plate.
c) No more than 5% of the plates are lost through contamination or some other unforeseen event. If the results are considered invalid due to contamination, the experiment will be repeated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 160 µg/plate; without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 50 µg/plate; without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 50 µg/plate; without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 50 µg/plate; without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation was observed in any of the strains up to and including the concentration of 5000 µg/plate, with and without S9.
RANGE-FINDING/SCREENING STUDIES: no
HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- The substance caused a reduction in the growth of the bacterial background lawn to all Salmonella strains when tested without S9
Initial test: TA1535, TA98 and TA100 ≥160 µg/plate; TA1537 ≥50 µg/plate
Confirmatory test: TA98 and TA100 ≥50 µg/plate; TA1535 and TA1537 ≥160 µg/plate
- No toxicity was observed in Salmonella strains when tested with S9.
- No toxicity was observed in the E. coli strain WP2uvrA with and without S9.
Any other information on results incl. tables
Table 1 Initial Mutagenicity Assay Results with S9
|
|
Dose |
Mean |
|
Ratio |
|
|
|
level |
revertants |
|
treated/ |
Individual revertant |
Strain |
Compound |
( g/plate) |
per plate |
SD |
vehicle |
colony counts |
TA98 |
Test substance |
5000 |
22.0 |
1.0 |
0.8 |
22 N, 21 N, 23 N |
|
|
1600 |
20.0 |
5.3 |
0.7 |
16 N, 26 N, 18 N |
|
|
500 |
23.0 |
6.2 |
0.9 |
28 N, 16 N, 25 N |
|
|
160 |
23.7 |
5.1 |
0.9 |
18 N, 28 N, 25 N |
|
|
50.0 |
21.7 |
3.5 |
0.8 |
18 N, 25 N, 22 N |
|
|
16.0 |
23.0 |
5.2 |
0.9 |
26 N, 26 N, 17 N |
|
Dimethyl |
5.00 |
21.3 |
3.5 |
0.8 |
25 N, 21 N, 18 N |
|
|
27.0 |
4.6 |
|
28 N, 31 N, 22 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA100 |
Test substance |
5000 |
101.7 |
11.4 |
0.7 |
105 N, 111 N, 89 N |
|
|
1600 |
125.7 |
14.3 |
0.9 |
129 N, 138 N, 110 N |
|
|
500 |
125.3 |
2.5 |
0.9 |
123 N, 128 N, 125 N |
|
|
160 |
134.7 |
17.8 |
1.0 |
155 N, 127 N, 122 N |
|
|
50.0 |
152.7 |
13.3 |
1.1 |
138 N, 156 N, 164 N |
|
|
16.0 |
130.7 |
18.6 |
0.9 |
110 N, 146 N, 136 N |
|
Dimethyl |
5.00 |
138.7 |
15.6 |
1.0 |
153 N, 141 N, 122 N |
|
|
140.7 |
15.0 |
|
153 N, 145 N, 124 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA1535 |
Test substance |
5000 |
10.3 |
2.3 |
1.0 |
13 N, 9 N, 9 N |
|
|
1600 |
13.3 |
0.6 |
1.3 |
13 N, 14 N, 13 N |
|
|
500 |
14.3 |
4.6 |
1.4 |
17 N, 17 N, 9 N |
|
|
160 |
13.3 |
4.0 |
1.3 |
9 N, 14 N, 17 N |
|
|
50.0 |
12.0 |
3.5 |
1.2 |
10 N, 10 N, 16 N |
|
|
16.0 |
14.0 |
8.5 |
1.4 |
23 M N, 13 N, 6 N |
|
Dimethyl |
5.00 |
13.3 |
3.5 |
1.3 |
17 N, 10 N, 13 N |
|
|
10.3 |
3.2 |
|
14 N, 8 N, 9 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA1537 |
Test substance |
5000 |
12.7 |
1.2 |
1.8 |
12 M N, 12 N, 14 N |
|
|
1600 |
8.0 |
2.6 |
1.1 |
5 N, 9 N, 10 N |
|
|
500 |
7.0 |
1.7 |
1.0 |
8 N, 8 N, 5 N |
|
|
160 |
9.7 |
2.1 |
1.4 |
8 N, 12 N, 9 N |
|
|
50.0 |
9.0 |
3.6 |
1.3 |
13 N, 8 N, 6 N |
|
|
16.0 |
8.3 |
2.1 |
1.2 |
10 N, 9 N, 6 N |
|
Dimethyl |
5.00 |
7.7 |
2.3 |
1.1 |
5 N, 9 N, 9 M N |
|
|
7.0 |
2.6 |
|
10 N, 5 N, 6 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
Table 1 (continued) Initial Mutagenicity Assay Results with S9
|
|
Dose |
Mean |
|
Ratio |
|
|
|
level |
revertants |
|
treated/ |
Individual revertant |
Strain |
Compound |
( g/plate) |
per plate |
SD |
vehicle |
colony counts |
WP2uvrA |
Test substance |
5000 |
12.0 |
2.6 |
0.9 |
14 N, 9 N, 13 N |
|
|
1600 |
11.3 |
3.1 |
0.9 |
12 N, 8 N, 14 N |
|
|
500 |
13.3 |
4.2 |
1.0 |
18 N, 12 N, 10 N |
|
|
160 |
15.0 |
1.7 |
1.1 |
14 N, 17 N, 14 N |
|
|
50.0 |
17.7 |
1.5 |
1.3 |
16 M N, 18 N, 19 N |
|
|
16.0 |
14.7 |
5.1 |
1.1 |
16 N, 19 N, 9 N |
|
Dimethyl |
5.00 |
15.0 |
1.7 |
1.1 |
16 N, 16 N, 13 N |
|
|
13.3 |
3.5 |
|
17 N, 10 N, 13 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA98 |
BP |
2.5 |
563.0 |
33.2 |
20.9 |
586 N, 578 N, 525 N |
TA100 |
2AA |
2.5 |
1753.3 |
97.0 |
12.5 |
1849 N, 1756 N, 1655 N |
TA1535 |
2AA |
2.5 |
242.3 |
23.8 |
23.5 |
268 N, 221 N, 238 N |
TA1537 |
2AA |
2.5 |
139.7 |
6.7 |
20.0 |
138 N, 134 N, 147 N |
WP2uvrA |
2AA |
25.0 |
291.0 |
58.1 |
21.8 |
231 N, 295 N, 347 N |
Table 2 Initial Mutagenicity Assay Results without S9
|
|
Dose |
Mean |
|
Ratio |
|
|
|
level |
revertants |
|
treated/ |
Individual revertant |
Strain |
Compound |
( g/plate) |
per plate |
SD |
vehicle |
colony counts |
TA98 |
Test substance |
5000 |
9.0 |
0.0 |
0.5 |
9 R, 9 R, 9 R |
|
|
1600 |
13.3 |
2.3 |
0.7 |
12 R, 12 R, 16 R |
|
|
500 |
11.7 |
3.2 |
0.6 |
8 R, 13 R, 14 R |
|
|
160 |
15.7 |
5.5 |
0.8 |
13 R, 22 R, 12 R |
|
|
50.0 |
16.3 |
2.5 |
0.8 |
19 N, 14 N, 16 N |
|
|
16.0 |
14.0 |
2.6 |
0.7 |
17 N, 13 N, 12 N |
|
Dimethyl |
5.00 |
14.3 |
5.7 |
0.7 |
19 N, 8 N, 16 N |
|
|
19.7 |
1.2 |
|
19 N, 19 N, 21 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA100 |
Test substance |
5000 |
85.3 |
3.8 |
0.7 |
81 R, 88 R, 87 R |
|
|
1600 |
71.7 |
0.6 |
0.6 |
72 R, 72 R, 71 R |
|
|
500 |
90.0 |
7.5 |
0.7 |
89 R, 83 R, 98 R |
|
|
160 |
97.0 |
10.8 |
0.8 |
88 R, 109 R, 94 R |
|
|
50.0 |
108.7 |
11.5 |
0.9 |
102 N, 122 N, 102 N |
|
|
16.0 |
112.7 |
13.2 |
0.9 |
110 N, 127 N, 101 N |
|
Dimethyl |
5.00 |
117.0 |
13.0 |
0.9 |
109 N, 132 N, 110 N |
|
|
127.3 |
15.0 |
|
136 N, 110 N, 136 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA1535 |
Test substance |
5000 |
11.0 |
6.6 |
0.7 |
5 R, 18 R, 10 R |
|
|
1600 |
12.0 |
3.5 |
0.7 |
14 R, 14 R, 8 R |
|
|
500 |
10.0 |
2.0 |
0.6 |
8 R, 12 R, 10 R |
|
|
160 |
14.0 |
2.0 |
0.8 |
16 R, 12 R, 14 R |
|
|
50.0 |
10.3 |
6.1 |
0.6 |
9 N, 17 N, 5 N |
|
|
16.0 |
17.0 |
1.0 |
1.0 |
17 N, 16 N, 18 N |
|
Dimethyl |
5.00 |
13.7 |
3.5 |
0.8 |
10 N, 17 N, 14 N |
|
|
16.7 |
2.3 |
|
14 N, 18 N, 18 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA1537 |
Test substance |
5000 |
2.0 |
1.0 |
0.2 |
1 R, 3 M R, 2 M R |
|
|
1600 |
7.0 |
2.6 |
0.8 |
4 R, 9 R, 8 R |
|
|
500 |
3.0 |
2.0 |
0.4 |
1 R, 3 M R, 5 R |
|
|
160 |
5.7 |
3.1 |
0.7 |
5 R, 9 R, 3 R |
|
|
50.0 |
7.0 |
2.6 |
0.8 |
6 R, 10 R, 5 R |
|
|
16.0 |
8.3 |
0.6 |
1.0 |
8 N, 8 N, 9 M N |
|
Dimethyl |
5.00 |
6.7 |
1.2 |
0.8 |
6 N, 8 N, 6 N |
|
|
8.3 |
4.0 |
|
9 N, 4 N, 12 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
Table 2 (continued) Initial Mutagenicity Assay Results without S9
|
|
Dose |
Mean |
|
Ratio |
|
|
|
level |
revertants |
|
treated/ |
Individual revertant |
Strain |
Compound |
( g/plate) |
per plate |
SD |
vehicle |
colony counts |
WP2uvrA |
Test substance |
5000 |
18.7 |
2.1 |
1.4 |
18 M N, 17 N, 21 N |
|
|
1600 |
19.3 |
1.5 |
1.5 |
18 N, 19 N, 21 N |
|
|
500 |
16.7 |
2.5 |
1.3 |
14 N, 19 N, 17 N |
|
|
160 |
14.7 |
2.3 |
1.1 |
16 N, 12 N, 16 N |
|
|
50.0 |
13.7 |
3.5 |
1.0 |
14 N, 17 N, 10 N |
|
|
16.0 |
12.7 |
3.1 |
1.0 |
12 N, 10 N, 16 N |
|
Dimethyl |
5.00 |
20.3 |
2.1 |
1.5 |
21 N, 22 N, 18 N |
|
|
13.3 |
5.1 |
|
12 N, 9 M N, 19 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA98 |
2NF |
1.0 |
480.0 |
43.0 |
24.4 |
524 N, 478 N, 438 N |
TA100 |
SA |
2.0 |
1513.7 |
32.5 |
11.9 |
1547 N, 1512 N, 1482 N |
TA1535 |
SA |
2.0 |
1081.7 |
65.5 |
64.9 |
1146 N, 1084 N, 1015 N |
TA1537 |
ICR |
2.0 |
130.7 |
14.5 |
15.7 |
140 N, 114 N, 138 N |
WP2uvrA |
4NQO |
1.0 |
114.3 |
8.4 |
8.6 |
109 N, 124 N, 110 N |
Table 3 Confirmatory Mutagenicity Assay Results with S9
|
|
Dose |
Mean |
|
Ratio |
|
|
|
level |
revertants |
|
treated/ |
Individual revertant |
Strain |
Compound |
( g/plate) |
per plate |
SD |
vehicle |
colony counts |
TA98 |
Test substance |
5000 |
19.3 |
6.1 |
0.8 |
18 N, 14 N, 26 N |
|
|
1600 |
20.0 |
9.6 |
0.8 |
31 N, 16 N, 13 N |
|
|
500 |
22.3 |
0.6 |
0.9 |
22 N, 22 N, 23 N |
|
|
160 |
22.0 |
9.0 |
0.9 |
31 M N, 22 N, 13 N |
|
|
50.0 |
19.0 |
7.0 |
0.7 |
27 N, 14 N, 16 N |
|
Dimethyl |
16.0 |
19.0 |
2.6 |
0.7 |
17 N, 22 N, 18 N |
|
|
25.7 |
3.2 |
|
28 N, 27 N, 22 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA100 |
Test substance |
5000 |
109.3 |
16.5 |
0.9 |
114 N, 91 N, 123 N |
|
|
1600 |
116.7 |
7.1 |
0.9 |
118 N, 109 N, 123 N |
|
|
500 |
122.0 |
11.5 |
1.0 |
133 N, 123 N, 110 N |
|
|
160 |
135.7 |
8.5 |
1.1 |
127 N, 144 N, 136 N |
|
|
50.0 |
136.0 |
3.5 |
1.1 |
134 N, 140 N, 134 N |
|
Dimethyl |
16.0 |
140.0 |
6.0 |
1.1 |
146 N, 134 N, 140 N |
|
|
126.7 |
13.7 |
|
111 N, 136 N, 133 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA1535 |
Test substance |
5000 |
13.7 |
3.5 |
1.1 |
14 M N, 10 N, 17 N |
|
|
1600 |
12.7 |
3.1 |
1.0 |
12 N, 16 N, 10 N |
|
|
500 |
18.3 |
4.0 |
1.4 |
22 N, 19 N, 14 N |
|
|
160 |
15.3 |
1.2 |
1.2 |
16 N, 14 N, 16 N |
|
|
50.0 |
13.0 |
3.6 |
1.0 |
12 N, 17 N, 10 N |
|
Dimethyl |
16.0 |
19.0 |
0.0 |
1.5 |
19 N, 19 N, 19 N |
|
|
13.0 |
3.6 |
|
17 N, 10 N, 12 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA1537 |
Test substance |
5000 |
7.0 |
2.6 |
0.7 |
10 N, 6 N, 5 N |
|
|
1600 |
5.3 |
1.2 |
0.5 |
6 N, 6 N, 4 N |
|
|
500 |
8.0 |
3.5 |
0.8 |
10 N, 4 N, 10 N |
|
|
160 |
8.3 |
4.0 |
0.8 |
12 N, 4 N, 9 N |
|
|
50.0 |
7.0 |
1.7 |
0.7 |
8 N, 8 N, 5 N |
|
Dimethyl |
16.0 |
8.0 |
2.6 |
0.8 |
9 N, 10 N, 5 N |
|
|
10.7 |
4.2 |
|
14 N, 6 N, 12 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
WP2uvrA |
Test substance |
5000 |
10.3 |
4.7 |
0.6 |
14 N, 5 N, 12 N |
|
|
1600 |
11.7 |
1.5 |
0.7 |
13 N, 10 N, 12 N |
|
|
500 |
16.3 |
0.6 |
0.9 |
16 N, 17 N, 16 N |
|
|
160 |
10.0 |
2.6 |
0.6 |
8 N, 13 N, 9 N |
|
|
50.0 |
15.7 |
6.5 |
0.9 |
9 N, 22 N, 16 N |
|
Dimethyl |
16.0 |
17.0 |
3.6 |
1.0 |
14 N, 21 N, 16 N |
|
|
17.3 |
1.5 |
|
17 N, 19 N, 16 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
Table 3 (continued) Confirmatory Mutagenicity Assay Results with S9
|
|
Dose |
Mean |
|
Ratio |
|
|
|
level |
revertants |
|
treated/ |
Individual revertant |
Strain |
Compound |
( g/plate) |
per plate |
SD |
vehicle |
colony counts |
TA98 |
BP |
2.5 |
615.7 |
28.3 |
24.0 |
632 N, 632 N, 583 N |
TA100 |
2AA |
2.5 |
2083.3 |
161.6 |
16.4 |
2205 N, 2145 N, 1900 N |
TA1535 |
2AA |
2.5 |
243.0 |
28.6 |
18.7 |
275 N, 220 N, 234 N |
TA1537 |
2AA |
2.5 |
192.7 |
5.9 |
18.1 |
186 N, 195 N, 197 N |
WP2uvrA |
2AA |
25.0 |
423.0 |
66.2 |
24.4 |
468 N, 347 N, 454 N |
Table 4 Confirmatory Mutagenicity Assay Results without S9
|
|
Dose |
Mean |
|
Ratio |
|
|
|
level |
revertants |
|
treated/ |
Individual revertant |
Strain |
Compound |
( g/plate) |
per plate |
SD |
vehicle |
colony counts |
TA98 |
Test substance |
5000 |
11.7 |
5.1 |
0.8 |
13 R, 16 R, 6 R |
|
|
1600 |
9.0 |
4.6 |
0.6 |
14 R, 5 R, 8 R |
|
|
500 |
10.0 |
4.4 |
0.7 |
13 R, 5 R, 12 R |
|
|
160 |
12.7 |
3.5 |
0.8 |
13 R, 9 R, 16 R |
|
|
50.0 |
14.3 |
3.8 |
1.0 |
16 R, 17 R, 10 R |
|
|
16.0 |
12.7 |
3.1 |
0.8 |
12 N, 10 N, 16 N |
|
|
5.00 |
14.0 |
6.6 |
0.9 |
21 N, 8 N, 13 N |
|
Dimethyl |
1.60 |
15.3 |
6.0 |
1.0 |
16 N, 21 N, 9 N |
|
|
15.0 |
6.2 |
|
13 N, 10 N, 22 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA100 |
Test substance |
5000 |
70.3 |
8.1 |
0.6 |
79 R, 69 R, 63 R |
|
|
1600 |
63.3 |
7.5 |
0.6 |
71 R, 63 R, 56 R |
|
|
500 |
74.3 |
5.0 |
0.7 |
69 R, 75 R, 79 R |
|
|
160 |
77.3 |
3.2 |
0.7 |
81 R, 75 R, 76 R |
|
|
50.0 |
89.0 |
14.9 |
0.8 |
106 R, 78 R, 83 R |
|
|
16.0 |
111.3 |
15.8 |
1.0 |
125 N, 94 N, 115 N |
|
|
5.00 |
120.7 |
17.5 |
1.1 |
106 N, 140 N, 116 N |
|
Dimethyl |
1.60 |
115.0 |
6.2 |
1.0 |
113 N, 122 N, 110 N |
|
|
111.7 |
7.6 |
|
110 N, 120 N, 105 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA1535 |
Test substance |
5000 |
11.7 |
5.1 |
0.5 |
13 R, 16 R, 6 R |
|
|
1600 |
13.3 |
4.2 |
0.6 |
18 R, 10 R, 12 R |
|
|
500 |
16.0 |
9.5 |
0.7 |
25 R, 6 R, 17 R |
|
|
160 |
17.3 |
1.5 |
0.8 |
17 R, 16 R, 19 R |
|
|
50.0 |
17.7 |
3.5 |
0.8 |
21 N, 14 N, 18 N |
|
|
16.0 |
18.0 |
4.0 |
0.8 |
14 N, 18 N, 22 N |
|
|
5.00 |
17.0 |
2.6 |
0.8 |
18 N, 19 N, 14 N |
|
Dimethyl |
1.60 |
11.0 |
4.4 |
0.5 |
13 N, 14 N, 6 N |
|
|
21.7 |
5.5 |
|
28 N, 19 N, 18 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
|
TA1537 |
Test substance |
5000 |
4.0 |
0.0 |
0.6 |
4 R, 4 R, 4 R |
|
|
1600 |
5.7 |
2.9 |
0.8 |
4 R, 4 R, 9 R |
|
|
500 |
6.3 |
1.5 |
0.9 |
5 R, 6 R, 8 R |
|
|
160 |
7.0 |
4.6 |
1.0 |
3 R, 6 R, 12 R |
|
|
50.0 |
8.0 |
5.2 |
1.1 |
5 N, 5 N, 14 N |
|
|
16.0 |
8.7 |
3.1 |
1.2 |
12 N, 6 N, 8 N |
|
|
5.00 |
5.0 |
1.7 |
0.7 |
3 N, 6 N, 6 N |
|
Dimethyl |
1.60 |
9.0 |
3.0 |
1.3 |
12 N, 6 N, 9 M N |
|
|
7.0 |
5.3 |
|
13 N, 5 N, 3 N |
|
|
Sulfoxide |
|
|
|||
|
|
|
|
|
|
Table 4 (continued) Confirmatory Mutagenicity Assay Results without S9
|
|
Dose |
Mean |
|
Ratio |
|
|
|
|
level |
revertants |
|
treated/ |
Individual revertant |
|
Strain |
Compound |
( g/plate) |
per plate |
SD |
vehicle |
colony counts |
|
WP2uvrA |
Test substance |
5000 |
12.3 |
2.9 |
0.8 |
14 N, 9 N, 14 N |
|
|
|
1600 |
11.3 |
6.4 |
0.8 |
14 N, 4 N, 16 N |
|
|
|
500 |
13.0 |
3.6 |
0.9 |
14 N, 16 N, 9 N |
|
|
|
160 |
14.0 |
4.0 |
0.9 |
10 N, 18 N, 14 N |
|
|
|
50.0 |
10.3 |
3.8 |
0.7 |
12 |
N, 6 N, 13 N |
|
|
16.0 |
13.3 |
3.1 |
0.9 |
14 |
N, 16 N, 10 N |
|
|
5.00 |
13.0 |
3.0 |
0.9 |
10 |
N, 13 N, 16 N |
|
Dimethyl |
1.60 |
13.0 |
3.0 |
0.9 |
10 |
N, 16 N, 13 N |
|
|
15.0 |
5.3 |
|
17 N, 9 N, 19 N |
||
|
Sulfoxide |
|
|
||||
|
|
|
|
|
|
|
|
TA98 |
2NF |
1.0 |
307.3 |
53.4 |
20.5 |
291 N, 264 N, 367 N |
|
TA100 |
SA |
2.0 |
1431.7 |
107.4 |
12.8 |
1477 N, 1509 N, 1309 N |
|
TA1535 |
SA |
2.0 |
1165.7 |
55.1 |
53.8 |
1183 N, 1210 N, 1104 N |
|
TA1537 |
ICR |
2.0 |
364.3 |
23.2 |
52.0 |
349 N, 391 N, 353 N |
|
WP2uvrA |
4NQO |
1.0 |
300.7 |
33.5 |
20.0 |
299 N, 335 N, 268 N |
Key to Positive Controls |
Key to Plate Postfix Codes |
||
2NF |
2-nitrofluorene |
R |
Reduced background bacterial lawn |
SA |
sodium azide |
N |
Normal background bacterial lawn |
ICR |
ICR-191 |
M |
Plate counted manually |
4NQO |
4-nitroquinoline-N-oxide |
|
|
BP |
Benzo{a}pyrene |
|
|
2AA |
2-aminoanthracene |
|
|
Applicant's summary and conclusion
- Conclusions:
- The substance is negative in the Bacterial Reverse Mutation Assay, performed according to OECD 471 guideline and GLP principles, when tested up to 5000 µg/plate in the presence and absence of S9.
- Executive summary:
A Bacterial Reverse Mutation Assay test was conducted to assess the mutagenic activity of the substance. The study was conducted according to OECD 471 guideline and GLP principles. One initial and one confirmatory test was performed with doses up to and including 5000 µg/plate, in the absence and presence of S9-mix. Adequate solvent and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Tryp+) colonies in E.coli WP2uvrA, both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment. Based on the results of this study it is concluded that the substance is not mutagenic in the Bacterial Reverse Mutation Assay.
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