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EC number: 272-657-3 | CAS number: 68901-15-5
- 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
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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
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 24 Aug - 24 Sep 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Allyl (cyclohexyloxy)acetate
- EC Number:
- 272-657-3
- EC Name:
- Allyl (cyclohexyloxy)acetate
- Cas Number:
- 68901-15-5
- Molecular formula:
- C11H18O3
- IUPAC Name:
- allyl (cyclohexyloxy)acetate
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbitone/ß-naphthoflavone (80/100 mg/kg bw/d, oral)
- Test concentrations with justification for top dose:
- Preliminary toxicity study:
0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation for TA100
First experiment:
15, 50, 150, 500, 1500 and 5000 µg/plate without metabolic activation for TA98
50, 150, 500, 1500 and 5000 µg/plate without metabolic activation for TA100, TA1535, TA102 and TA1537
5, 15, 50, 150, 500, 1500 and 5000 µg/plate with metabolic activation for TA1535
5, 15, 50, 150, 500 and 1500 µg/plate with metabolic activation for TA100, TA102, TA98 and TA1537
Second experiment:
15, 50, 150, 500, 1500 and 5000 µg/plate without metabolic activation for all strains
5, 15, 50, 150, 500 and 1500 µg/plate with metabolic activation for all strains - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- mitomycin C
- other: 2-Aminoanthracene (2AA); 1,8- dihydroxyanthraquinon (DANTHRON)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) in experiment 1 and 2
DURATION
- Exposure duration: approx. 48 h
NUMBER OF REPLICATIONS: triplicates each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the bacterial background lawn and/or a reduction in the frequency of revertant colonies - Evaluation criteria:
- The test material may be considered to be positive in this test system if the following criteria are met:
The test material should have induced a reproducible, dose-related and statistically (Dunnett's method of linear regression) significant increase in the revertant count in at least one strain of bacteria.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 500 µg/plate with and without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- 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:
- starting at 500 µg/plate with and without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- 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:
- starting at 500 µg/plate with and without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- 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:
- starting at 500 µg/plate with and without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- starting at 500 µg/plate with and without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
RANGE-FINDING/SCREENING STUDIES:
In order to select appropriate dose levels for use in the main study, a preliminary test was carried out to determine the toxicity of the test material. The test material was toxic at 5000 µg/plate to the strain of Salmonella used (TA100). The test material formulation and the S9-mix used in this experiment were both shown to be sterile.
ADDITIONAL INFORMATION ON CYTOTOXICITY: The test material caused a visible reduction in the bacterial background lawn and/or a reduction in the frequency of revertant colonies in all of the tester strains both with and without metabolic activation. The first evidence of a weakened bacterial background lawn was observed at 500 µg/plate. Generally, the test material induced a greater toxic response after the addition of S9-mix. The sensitivity of the bacterial strains to the toxicity of the test material varied between strains and between exposures with or without S9-mix. The test material was, therefore, tested up to its toxic limit.
Any other information on results incl. tables
Table 1. Test results of experiment 1
With or without S9-mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
TA102 |
TA98 |
TA1537 |
||
– |
0 |
128 |
20 |
247 |
24 |
7 |
– |
0 (DMSO) |
114 ± 13.7 |
30 ± 3.5 |
317 ± 36.4 |
28 ± 3.5 |
13 ± 2.3 |
– |
15 |
NT |
NT |
NT |
25 ± 4.0 |
NT |
– |
50 |
109 ± 4.4 |
19 ± 5.5 |
278 ± 3.6 |
22 ± 3.2 |
11 ± 2.9 |
– |
150 |
112 ± 12.0 |
20 ± 2.6 |
281 ± 31.8 |
31 ± 6.5 |
12 ± 4.5 |
– |
500 |
105 ± 2.1 |
15 ± 5.5 |
279 ± 22.2 |
28 ± 2.0 |
11 ± 1.0 |
– |
1500 |
67 ± 6.1 |
5 ± 1.7 |
107 ± 12.1 |
10 ± 2.9 |
5 ± 4.7 |
– |
5000 |
0 |
0 |
0T |
0 |
0 |
Positive controls, –S9 |
Name |
ENNG |
ENNG |
MMC |
4-NQO |
9-AA |
Concentrations (μg/plate) |
3 |
5 |
0.5 |
0.2 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
539 ± 64.2 |
222 ± 39.2 |
751 ± 184.5 |
171 ± 19.0 |
784 ± 250.9 |
|
+ |
0 |
143 |
22 |
310 |
- |
10 |
+ |
0 (DMSO) |
145 ± 3.0 |
12 ± 3.5 |
310 ± 28.7 |
39 ± 1.7 |
16 ± 2.6 |
+ |
5 |
119 ± 9.8 |
12 ± 0.6 |
284 ± 63.4 |
40 ± 3.1 |
17 ± 7.8 |
+ |
15 |
118 ± 6.4 |
17 ± 4.5 |
318 ± 51.8 |
27 ± 8.1 |
15 ± 6.7 |
+ |
50 |
120 ± 14.7 |
10 ± 1.7 |
333 ± 21.7 |
29 ± 2.5 |
9 ± 2.1 |
+ |
150 |
98 ± 4.7 |
13 ± 2.6 |
296 ± 5.8 |
31 ± 4.0 |
10 ± 2.0 |
+ |
500 |
85 ± 6.1 |
6 ± 2.6 |
0V |
12 ± 3.8 |
0V |
+ |
1500 |
0V |
0V |
0V |
0V |
0T |
+ |
5000 |
NT |
0T |
NT |
NT |
NT |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
DAN |
B[a]P |
2-AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1770 ± 182.4 |
192 ± 16.2 |
707 ± 65.6 |
255 ± 6.7 |
685 ± 40.8 |
DMSO: Dimethylsulphoxide
NT: Not tested at this dose level
2-AA: 2-aminoanthracene
9-AA: 9-aminoacridine
ENNG: N-ethyl-N-nitro-N-nitrosoguanidine
4-NQO: 4-nitroquinoline-N-oxide
MMC: Mitomycin C
B[a]P: Benzo(a)pyrene
DAN: 1,8-dihydroxyanthraquinone
T: Toxic
V: Very weak lawn
Table 2. Test results of experiment 2.
With or without S9-mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA100 |
TA1535 |
TA102 |
TA98 |
TA1537 |
||
– |
0 |
145 |
20 |
306 |
32 |
12 |
– |
0 (DMSO) |
147 ± 5.7 |
20 ± 1.5 |
339 ± 3.2 |
33 ± 4.0 |
12 ± 5.9 |
– |
15 |
127 ± 17.7 |
18 ± 0.6 |
295 ± 23.0 |
38 ± 6.5 |
12 ± 4.9 |
– |
50 |
146 ± 7.6 |
18 ± 2.6 |
300 ± 16.1 |
28 ± 5.3 |
5 ± 1.7 |
– |
150 |
124 ± 4.5 |
15 ± 0.6 |
297 ± 29.4 |
22 ± 5.0 |
9 ± 4.6 |
– |
500 |
110 ± 26.5 |
10 ± 0.6 |
310 ± 14.9 |
22 ± 5.5 |
6 ± 3.1 |
– |
1500 |
63 ± 5.6 |
4 ± 2.1 |
158 ± 18.7 |
9 ± 3.5 |
6 ± 3.6 |
– |
5000 |
0 |
2 ± 1.5 |
0 |
1 ± 1.2 |
4 ± 3.2S |
Positive controls, –S9 |
Name |
ENNG |
ENNG |
MMC |
4-NQO |
9-AA |
Concentrations (μg/plate) |
3 |
5 |
0.5 |
0.2 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
471 ± 47.3 |
144 ± 20.9 |
1054 ± 39.6 |
139 ± 52.3 |
1032 ± 104.8 |
|
+ |
0 |
90 |
- |
- |
- |
- |
+ |
0 (DMSO) |
107 ± 9.5 |
17 ± 5.0 |
302 ± 17.1 |
32 ± 3.5 |
10 ± 2.3 |
+ |
5 |
103 ± 3.8 |
15 ± 0.6 |
302 ± 34.8 |
28 ± 2.6 |
10 ± 4.4 |
+ |
15 |
100 ± 4.6 |
11 ± 2.9 |
310 ± 9.2 |
28 ± 4.6 |
8 ± 0.6 |
+ |
50 |
88 ± 20.3 |
16 ± 5.7 |
289 ± 12.9 |
38 ± 7.1 |
8 ± 0.6 |
+ |
150 |
85 ± 7.6 |
15 ± 4.2 |
265 ± 11.1 |
29 ± 1.5 |
3 ± 1.0 |
+ |
500 |
59 ± 2.5 |
11 ± 0.6 |
0S |
10 ± 7.4S |
0V |
+ |
1500 |
21 ± 4.0V |
2 ± 2.1S |
0V |
9 ± 3.1S |
0T |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
DAN |
B[a]P |
2-AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1277 ± 77.7 |
124 ± 7.4 |
727 ± 165.4 |
188 ± 13.2 |
169 ± 12.0 |
DMSO: Dimethylsulphoxide
NT: Not tested at this dose level
2-AA: 2-aminoanthracene
9-AA: 9-aminoacridine
ENNG: N-ethyl-N-nitro-N-nitrosoguanidine
4-NQO: 4-nitroquinoline-N-oxide
MMC: Mitomycin C
B[a]P: Benzo(a)pyrene
DAN: 1,8-dihydroxyanthraquinone
S: Sparse lawn
T: Toxic
V: Very weak lawn
Table 3. Historical control data
positive control values up to and including 1997 | ||||||||||||||
Strain | TA100 | TA98 | TA1535 | TA1538 | TA1537 | WP2uvrA | TA102 | |||||||
S9-Mix | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 |
Mean | 117 | 120 | 28 | 33 | 24 | 18 | 21 | 25 | 10 | 11 | 20 | 21 | 264 | 283 |
SD | 25 | 22 | 7 | 7 | 5 | 4 | 7 | 6 | 2 | 2 | 5 | s | 30 | 33 |
Min | 61 | 63 | 13 | 14 | 10 | 11 | 6 | 11 | 4 | 5 | 12 | 11 | 216 | 205 |
Max | 196 | 177 | 56 | 52 | 39 | 39 | 41 | 50 | 17. | 20 | .39 | 40 | 339 | 343 |
Values | 1603 | 863 | 1047 | 837 | 948 | 718 | 309 | 190 | 938 | 703 | 634 | 436 | 197 | 100 |
vehicle control values up to and including 1997 | ||||||||||||||
Strain | TA100 | TA98 | TA1535 | TA1538 | TA1537 | WP2uvrA | TA102 | |||||||
S9-Mix | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 |
Mean | 613 | 949 | 203 | 420 | 466 | 291 | 484 | 454 | 812 | 266 | 834 | 734 | 785 | 705 |
SD | 176 | 190 | 57 | 113 | 208 | 64 | 146 | 131 | 201 | 90 | 197 | 211 | 172 | 127 |
Min | 277 | 412 | 127 | 198 | 163 | 139 | 190 | 212 | 161 | 123 | 342 | 225 | 540 | 511 |
M ax | 1126 | 1315 | 698 | 757 | 1005 | 516 | 799 | 915 | 1149 | 718 | 1209 | 1089 | 1188 | 1090 |
Values | 195 | 195 | 194 | 195 | 180 | 181 | 93 | 92 | 182 | 183 | 162 | 157 | 76 | 72 |
positive control values up to and including 1998 | ||||||||||||||
Strain | TA100 | TA98 | TA1535 | TA1538 | TA1537 | WP2uvrA | TA102 | |||||||
S9-Mix | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 |
Mean | 124 | 125 | 31 | 36 | 26 | 18 | 26 | 28 | 11 | 14 | 23 | 25 | 262 | 285 |
SD | 16 | 16 | 6 | 6 | 5 | 4 | 6 | 5 | 3 | 3 | 4 | 4 | 31 | 32 |
Min | 73 | 81 | 15 | 22 | 12 | 10 | 15 | 18 | 5 | 6 | 13 | 13 | 191 | 231 |
Max | 173 | 170 | 45 | 54 | 38 | 37 | 36 | 36 | 20 | 23 | 34 | 41 | 304 | 363 |
Values | 342 | 339 | 337 | 340 | 341 | 331 | 16 | 16 | 323 | 325 | 287 | 285 | 20 | 22 |
vehicle control values up to and including 1998 | ||||||||||||||
Strain | TA100 | TA98 | TA1535 | TA1538 | TA1537 | WP2uvrA | TA102 | |||||||
S9-Mix | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 |
Mean | 556 | 1209 | 143 | 472 | 375 | 260 | 403 | 556 | 1052 | 298 | 851 | 837 | 863 | 747 |
SD | 114 | 318 | 24 | 119 | 173 | 64 | 93 | 197 | 259 | 106 | 202 | 223 | 127 | 116 |
Min | 349 | 681 | 101 | 198 | 112 | 105 | 305 | 344 | 173 | 123 | 415 | 260 | 646 | 591 |
Max | 1147 | 2740 | 225 | 733 | 1143 | 601 | 604 | 1073 | 1912 | 652 | 1486 | 1380 | 1096 | 1096 |
Values | 141 | 141 | 140 | 143 | 142 | 141 | 12 | 12 | 142 | 141 | 138 | 138 | 24 | 25 |
SD = standard deviation
Min = minimal value
Max = maximal value
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the Ames Assay the substance was not mutagenic in any of the five strains (TA1535, TA1537, TA98, TA100 and TA102) with and without metabolic activation tested.
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