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EC number: 203-140-2 | CAS number: 103-74-2
- 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
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 05, 1985 - May 06, 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- performed with the Salmonella typhimurium strains TA98, TA 100, TA 1535, TA 1537 and TA 1538
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Principles of method if other than guideline:
- Investigation of the potential gene mutagenic activity of Pyridin-2-ethanol according to the plate incorporation test of Ames et al.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(2-pyridyl)ethanol
- EC Number:
- 203-140-2
- EC Name:
- 2-(2-pyridyl)ethanol
- Cas Number:
- 103-74-2
- Molecular formula:
- C7H9NO
- IUPAC Name:
- 2-(pyridin-2-yl)ethan-1-ol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): PYRIDIN-2-ETHANOL
- Substance type: organic
- Physical state: liquid
- Analytical purity: at least 98%
- Lot/batch No.: CH. 5/1
- Expiration date of the lot/batch: no expiration date proposed by the sponsor
- Stability under test conditions: pure: stable from 0 to 20 °C
- Storage condition of test material: the test article was stored dry, in the refrigerator, in the dark
- Other: To avoid any light effects on the test article, all experiments were performed under yellow light.
Constituent 1
Method
- Target gene:
- his-, obtained from B.N. Ames, University of California, Berkeley CA, 94720, USA, May 1981.
Characterization of strains:
The strains used are mutants derived from Salmonella typhimurium LT2 and have the following genotypes:
S. typhimurium TA 1535 his G46 rfa- uvrB-
S. typhimurium TA 1537 his C3076 rfa- uvrB-
S. typhimuriumTA 1538 his D3052 rfa- uvrB-
S. typhimurium TA 98 his D3052 rfa- uvrB- R +
S. typhimurium TA 100 his G46 rfa- uvrB- R +
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor-supplemented post-mitochondrial fraction prepared from the livers of rats treated with the enzyme-inducing agent Aroclor 1254.
- Test concentrations with justification for top dose:
- 1.58, 5, 15.8, 50, 158, 500, 1580 and 5000 micrograms per plate (mcg/pl.). Each concentration, including the controls, was tested in triplicate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water (bidistilled water)
- Justification for choice of solvent/vehicle: On the day of the experiment, the test article was dissolved in bidistilled water at the highest investigated dose. The other doses were dilutions from this stock solution with the solvent in half-log intervals. All control data were established on the same day as the experiment.
Controls
- Untreated negative controls:
- yes
- Remarks:
- Bidistilled water, solvent of the test article
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Bidistilled water
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- methylmethanesulfonate
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: none
- Exposure duration: the plates were incubated at 37 degrees centigrade in the dark for 3 days.
OTHER: To avoid any light effects on the test article, all experiments were performed under yellow light.
Storage:
The strain cultures are stored in sterile 0.5 ml ampoules (0.45 mL bacterial culture and 0.05 mL dimethylsuIfoxide) at -70°C.
Pre-culture of strains:
The bacteria were grown in a shaking water bath for 16 hours overnight at 37 °C in 2 .5% Nutrient Broth No. 2. After centrifugation, the bacteria were resuspended to a concentration of approximately 1 x 10 exp. 8 to 2 x 10 exp.9 cells per milliliter in 0 .16 % Nutrient Broth and 0.5% sodium chloride. The concentration of germs was controlled photometrically and determined in an experimental test with histidine-rich potassium chloride solution on selective agar plates. - Evaluation criteria:
- A material is identified as a mutagen in this test system if there was a reproducible demonstration of a dose effect relation with a 2-fold increase in the number of revertants over the controls in a minimum of one strain. With the strain TA 100, a 1.5-fold increase was the criterion for a positive result. These criteria are generally in accordance with the international used standards for the evaluation of Ames Test results.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- In the toxicity experiment with Pyridin-2-ethanol, neither quantitative nor qualitative evidence of a cytotoxic effect was observed
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA:
Control plates with the solvent (negative control) showed numbers of spontaneous revertant colonies per plate which were within the normal range of those cited in the literature. In the second experiment, the rate of spontaneous revertants in the strain TA 100 were at the lower limit of the normal range cited in the literature and compared to historical controls, gathered in the testing laboratory.
Control plates with reference mutagens (positive controls) showed a distinct increase of the revertant colonies with the tester strains. This confirms the reversion properties of each strain. The positive results of the mutagens 2-Amino-anthracene and Benzo(a)pyrene indicate that the metabolizing system was functioning.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No cytotoxic effect of the test article was observed. - Remarks on result:
- other: strain/cell type: all strains/cell types tested (in addition S. typhimurium TA1538)
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Individual results:
Table 1: | Salmonella test without S-9 mix (first experiment) | |||||||||
Number of revertant colonies per plate with group means | ||||||||||
Dose/plate | TA 98 | TA 100 | TA 1535 | TA 1537 | TA 1538 | |||||
0 mcg control | 25 | 30 | 122 | 108 | 42 | 26 | 7 | 10 | 14 | 14 |
29 | 111 | 17 | 8 | 12 | ||||||
35 | 91 | 20 | 15 | 15 | ||||||
1,58 mcg | 25 | 27 | 135 | 114 | 29 | 27 | 4 | 8 | 18 | 17 |
29 | 95 | 28 | 7 | 19 | ||||||
28 | 111 | 25 | 14 | 14 | ||||||
5 mcg | 31 | 27 | 99 | 108 | 22 | 24 | 12 | 10 | 14 | 12 |
23 | 118 | 26 | 11 | 12 | ||||||
26 | 108 | 25 | 8 | 17 | ||||||
15.8 mcg | 27 | 30 | 114 | 112 | 21 | 24 | 9 | 8 | 10 | 12 |
37 | 116 | 35 | 10 | 12 | ||||||
26 | 107 | 16 | 6 | 13 | ||||||
50 mcg | 31 | 25 | 119 | 103 | 26 | 22 | 6 | 7 | 12 | 13 |
23 | 97 | 24 | 4 | 14 | ||||||
21 | 92 | 15 | 10 | 13 | ||||||
158 mcg | 19 | 23 | 120 | 114 | 16 | 18 | 9 | 9 | 12 | 13 |
27 | 109 | 22 | 5 | 14 | ||||||
24 | 112 | 15 | 13 | 12 | ||||||
500 mcg | 25 | 27 | 122 | 119 | 16 | 20 | 5 | 9 | 15 | 13 |
31 | 118 | 26 | 6 | 12 | ||||||
26 | 116 | 18 | 16 | 11 | ||||||
1580 mcg | 20 | 23 | 119 | 114 | 14 | 17 | 13 | 11 | 14 | 13 |
30 | 95 | 13 | 7 | 12 | ||||||
18 | 129 | 23 | 14 | 14 | ||||||
5000 mcg | 19 | 22 | 124 | 109 | 15 | 16 | 8 | 6 | 15 | 13 |
24 | 95 | 18 | 8 | 13 | ||||||
23 | 108 | 14 | 3 | 12 | ||||||
MMS 500 mcg | --- | --- | 324 | 421 | --- | --- | --- | --- | --- | --- |
--- | 450 | --- | --- | --- | ||||||
--- | 489 | --- | --- | --- | ||||||
9-AMA 40 mcg | --- | --- | --- | --- | --- | --- | 53 | 59 | --- | --- |
--- | --- | --- | 56 | --- | ||||||
--- | --- | --- | 69 | --- | ||||||
2-NF 5 mcg | 718 | 698 | 397 | 372 | ___ | --- | 38 | 29 | 1054 | 1086 |
766 | 347 | --- | 24 | 1115 | ||||||
610 | 371 | --- | 24 | 1088 | ||||||
ENNG 10 mcg | 124 | 121 | 1027 | 1057 | 623 | 742 | --- | --- | --- | --- |
119 | 1102 | 661 | --- | --- | ||||||
121 | 1042 | 943 | --- | --- | ||||||
--- Not determined | ||||||||||
Table 2: | Salmonella test with S-9 mix (first experiment) | |||||||||
Number of revertant colonies per plate with group means | ||||||||||
Dose/plate | TA 98 | TA 100 | TA 1535 | TA 1537 | TA 1533 | |||||
0 mcg control | 21 | 27 | 114 | 131 | 12 | 14 | 30 | 26 | 27 | 28 |
38 | 144 | 15 | 30 | 30 | ||||||
23 | 135 | 14 | 19 | 28 | ||||||
1,58 mcg | 19 | 25 | 103 | 102 | 14 | 18 | 30 | 27 | 28 | 23 |
26 | 95 | 20 | 28 | 22 | ||||||
31 | 108 | 21 | 24 | 18 | ||||||
5 mcg | 20 | 24 | 101 | 111 | 16 | 14 | 36 | 31 | 19 | 25 |
25 | 122 | 14 | 30 | 27 | ||||||
28 | 110 | 11 | 28 | 28 | ||||||
15.8 mcg | 24 | 24 | 138 | 138 | 21 | 21 | 27 | 33 | 25 | 27 |
22 | 127 | 16 | 39 | 29 | ||||||
27 | 148 | 26 | 33 | 26 | ||||||
50 mcg | 30 | 29 | 107 | 119 | 16 | 15 | 27 | 28 | 27 | 26 |
30 | 113 | 12 | 29 | 21 | ||||||
28 | 138 | 16 | 28 | 30 | ||||||
158 mcg | 23 | 29 | 128 | 120 | 26 | 21 | 33 | 31 | 31 | 32 |
32 | 106 | 20 | 30 | 36 | ||||||
32 | 127 | 16 | 31 | 28 | ||||||
500 mcg | 34 | 29 | 115 | 112 | 14 | 15 | 26 | 29 | 19 | 22 |
29 | 98 | 17 | 30 | 24 | ||||||
24 | 123 | 15 | 30 | 22 | ||||||
1580 mcg | 31 | 28 | 115 | 119 | 17 | 15 | 29 | 30 | 25 | 26 |
27 | 106 | 13 | 29 | 25 | ||||||
25 | 137 | 16 | 32 | 28 | ||||||
5000 mcg | 29 | 27 | 126 | 116 | 11 | 14 | 33 | 29 | 19 | 24 |
24 | 95 | 19 | 28 | 28 | ||||||
27 | 128 | 12 | 26 | 25 | ||||||
2-AA 0.5 mcg | 91 | 86 | 185 | 217 | --- | --- | --- | --- | 115 | 107 |
91 | 233 | --- | --- | 97 | ||||||
77 | 232 | --- | --- | 109 | ||||||
2-AA 1 mcg | --- | --- | --- | --- | 150 | 133 | --- | --- | --- | --- |
--- | --- | 126 | --- | --- | ||||||
--- | --- | 122 | --- | --- | ||||||
2-AA 10 mcg | --- | --- | --- | --- | --- | --- | 168 | 165 | --- | --- |
--- | --- | --- | 182 | --- | ||||||
--- | --- | --- | 145 | --- | ||||||
BaP 5 mcg | 295 | 288 | 480 | 462 | --- | --- | 142 | 143 | 129 | 144 |
285 | 460 | --- | 162 | 143 | ||||||
284 | 446 | --- | 124 | 160 | ||||||
--- Not determined | ||||||||||
TABLE 3 : Toxicity test without S-9 mix (first experiment) | |||||
DOSE | MEAN NUMBERS OF REVERTANT COLONIES | RELATIVE SURVIVAL RATE | |||
TA 1537 | TA 1537 + RTA | ||||
0 mcg control | 10 | 369 | 1,00 | ||
1.58 mcg | 8 | 353 | 0,96 | ||
5 mcg | 10 | 355 | 0,96 | ||
15.8 mcg | 8 | 376 | 1,03 | ||
50 mcg | 7 | 388 | 1,06 | ||
158 mcg | 9 | 375 | 1,02 | ||
500 mcg | 9 | 349 | 0,95 | ||
1580 mcg | 11 | 353 | 0,95 | ||
5000 mcg | 6 | 393 | 1,08 |
TABLE 4 : Toxicity test with S-9 mix (first experiment) | |||||
DOSE | MEAN NUMBERS OF REVERTANT COLONIES | RELATIVE SURVIVAL RATE | |||
TA 1537 | TA 1537 + RTA | ||||
0 mcg control | 26 | 339 | 1,00 | ||
1.58 mcg | 27 | 315 | 0,92 | ||
5 mcg | 31 | 326 | 0,94 | ||
15.8 mcg | 33 | 336 | 0,97 | ||
50 mcg | 28 | 370 | 1,09 | ||
158 mcg | 31 | 334 | 0,97 | ||
500 mcg | 29 | 321 | 0,93 | ||
1580 mcg | 30 | 315 | 0,91 | ||
5000 mcg | 29 | 335 | 0,98 |
Table 5: | Salmonella test without S-9 mix (second experiment) | |||||||||
Number of revertant colonies per plate with group means | ||||||||||
Dose/plate | TA 98 | TA 100 | TA 1535 | TA 1537 | TA 1533 | |||||
0 mcg control | 32 | 30 | 93 | 81 | 38 | 31 | 9 | 10 | 24 | 19 |
30 | 63 | 29 | 8 | 18 | ||||||
29 | 86 | 26 | 12 | 15 | ||||||
1,58 mcg | 29 | 31 | 116 | 101 | 36 | 31 | 11 | 11 | 16 | 15 |
30 | 89 | 30 | 10 | 13 | ||||||
34 | 99 | 26 | 12 | 15 | ||||||
5 mcg | 24 | 25 | 76 | 87 | 38 | 32 | 13 | 9 | 21 | 19 |
30 | 98 | 25 | 9 | 14 | ||||||
22 | 87 | 32 | 6 | 22 | ||||||
15.8 mcg | 27 | 22 | 91 | 105 | 29 | 27 | 14 | 14 | 18 | 18 |
21 | 109 | 24 | 10 | 16 | ||||||
17 | 115 | 28 | 18 | 19 | ||||||
50 mcg | 27 | 26 | 115 | 120 | 28 | 34 | 6 | 7 | 20 | 21 |
26 | 134 | 29 | 7 | 21 | ||||||
25 | 112 | 46 | 8 | 22 | ||||||
158 mcg | 18 | 25 | 121 | 116 | 30 | 30 | 12 | 10 | 19 | 21 |
31 | 117 | 25 | 10 | 18 | ||||||
25 | 110 | 34 | 8 | 25 | ||||||
500 mcg | 26 | 25 | 87 | 96 | 24 | 30 | 9 | 11 | 16 | 19 |
23 | 108 | 38 | 8 | 20 | ||||||
26 | 94 | 27 | 16 | 22 | ||||||
1580 mcg | 36 | 25 | 84 | 81 | 26 | 27 | 7 | 9 | 15 | 19 |
18 | 74 | 32 | 9 | 23 | ||||||
20 | 86 | 22 | 11 | 19 | ||||||
5000 mcg | 33 | 27 | 130 | 107 | 32 | 37 | 13 | 9 | 17 | 16 |
21 | 99 | 42 | 8 | 11 | ||||||
26 | 93 | 36 | 5 | 19 | ||||||
MMS 500 mcg | --- | --- | 482 | 515 | --- | --- | --- | --- | --- | --- |
--- | 494 | --- | --- | --- | ||||||
--- | 569 | --- | --- | --- | ||||||
9-AMA 40 mcg | --- | --- | --- | --- | --- | --- | 98 | 99 | --- | --- |
--- | --- | --- | 73 | --- | ||||||
--- | --- | --- | 126 | --- | ||||||
2-NF 5 mcg | 891 | 899 | 613 | 612 | ___ | --- | 45 | 39 | 1144 | 1178 |
870 | 550 | --- | 35 | 1142 | ||||||
935 | 674 | --- | 36 | 1247 | ||||||
ENNG 10 mcg | 214 | 231 | 1737 | 1699 | 1576 | 794 | --- | --- | --- | --- |
241 | 1845 | 1327 | --- | --- | ||||||
238 | 1516 | 1889 | --- | --- | ||||||
--- Not determined | ||||||||||
Table 6: | Salmonella test with S-9 mix (second experiment) | |||||||||
Number of revertant colonies per plate with group means | ||||||||||
Dose/plate | TA 98 | TA 100 | TA 1535 | TA 1537 | TA 1533 | |||||
0 mcg control | 48 | 49 | 97 | 68 | 19 | 21 | 23 | 34 | 30 | 31 |
48 | 59 | 21 | 36 | 31 | ||||||
50 | 48 | 23 | 44 | 33 | ||||||
1,58 mcg | 62 | 55 | 69 | 73 | 16 | 17 | 33 | 27 | 33 | 33 |
49 | 73 | 17 | 27 | 32 | ||||||
54 | 77 | 17 | 20 | 33 | ||||||
5 mcg | 46 | 56 | 94 | 90 | 7 | 10 | 34 | 35 | 25 | 27 |
66 | 83 | 13 | 41 | 27 | ||||||
57 | 92 | 11 | 31 | 30 | ||||||
15.8 mcg | 57 | 53 | 67 | 78 | 14 | 10 | 29 | 27 | 34 | 32 |
57 | 88 | 7 | 26 | 31 | ||||||
46 | 80 | 10 | 26 | 30 | ||||||
50 mcg | 57 | 51 | 95 | 109 | 16 | 14 | 19 | 22 | 38 | 27 |
52 | 110 | 21 | 32 | 27 | ||||||
43 | 121 | 6 | 15 | 16 | ||||||
158 mcg | 54 | 52 | 108 | 104 | 16 | 15 | 37 | 31 | 33 | 29 |
55 | 115 | 14 | 32 | 34 | ||||||
48 | 88 | 15 | 25 | 20 | ||||||
500 mcg | 48 | 53 | 97 | 106 | 6 | 12 | 31 | 31 | 34 | 29 |
58 | 112 | 14 | 26 | 30 | ||||||
53 | 110 | 15 | 37 | 23 | ||||||
1580 mcg | 49 | 46 | 99 | 115 | 19 | 14 | 16 | 21 | 29 | 30 |
45 | 133 | 13 | 28 | 29 | ||||||
44 | 113 | 11 | 19 | 33 | ||||||
5000 mcg | 38 | 46 | 91 | 114 | 22 | 18 | 31 | 31 | 29 | 30 |
50 | 120 | 16 | 28 | 34 | ||||||
51 | 132 | 16 | 33 | 26 | ||||||
2-AA 0.5 mcg | 90 | 104 | 147 | 152 | --- | --- | --- | --- | 69 | 72 |
110 | 147 | --- | --- | 68 | ||||||
113 | 161 | --- | --- | 78 | ||||||
2-AA 1 mcg | --- | --- | --- | --- | 70 | 70 | --- | --- | --- | --- |
--- | --- | 67 | --- | --- | ||||||
--- | --- | 73 | --- | --- | ||||||
2-AA 10 mcg | --- | --- | --- | --- | --- | --- | 188 | 207 | --- | --- |
--- | --- | --- | 215 | --- | ||||||
--- | --- | --- | 217 | --- | ||||||
BaP 5 mcg | 270 | 251 | 298 | 325 | --- | --- | 115 | 112 | 99 | 102 |
266 | 341 | --- | 113 | 98 | ||||||
217 | 335 | --- | 109 | 109 | ||||||
--- Not determined |
TABLE 7 : Toxicity test without S-9 mix (second experiment) | |||||
DOSE | MEAN NUMBERS OF REVERTANT COLONIES | RELATIVE SURVIVAL RATE | |||
TA 1537 | TA 1537 + RTA | ||||
0 mcg control | 10 | 346 | 1,00 | ||
1.58 mcg | 11 | 333 | 0,96 | ||
5 mcg | 9 | 346 | 1,00 | ||
15.8 mcg | 14 | 339 | 0,97 | ||
50 mcg | 7 | 339 | 0,99 | ||
158 mcg | 10 | 329 | 0,95 | ||
500 mcg | 11 | 350 | 1,01 | ||
1580 mcg | 9 | 349 | 1,01 | ||
5000 mcg | 9 | 362 | 1,05 |
TABLE 8 : Toxicity test with S-9 mix (second experiment) | |||||
DOSE | MEAN NUMBERS OF REVERTANT COLONIES | RELATIVE SURVIVAL RATE | |||
TA 1537 | TA 1537 + RTA | ||||
0 mcg control | 34 | 349 | 1,00 | ||
1.58 mcg | 27 | 333 | 0,97 | ||
5 mcg | 35 | 335 | 0,95 | ||
15.8 mcg | 27 | 332 | 0,97 | ||
50 mcg | 22 | 336 | 1,00 | ||
158 mcg | 31 | 311 | 0,89 | ||
500 mcg | 31 | 326 | 0,94 | ||
1580 mcg | 21 | 319 | 0,95 | ||
5000 mcg | 31 | 336 | 0,97 |
In the toxicity experiment with PYRIDIN-2-ETHANOL, neither quantitative nor qualitative evidence of a cytotoxic effect was observed.
In the described bacterial mutagenicity tests, no relevant increase of the revertant colony numbers was obtained in the Salmonella typhimurium strains used at all dose levels tested when compared with the corresponding controls. The presence of liver microsomal activation did not influence these findings.
These results were confirmed in a second, independent experiment for the strains TA 98, TA 1535, TA 1537 and TA 1538. The increased rate of revertants in the strain TA 100 in the second experiment compared with the corresponding controls are considered to be not relevant.This must be concluded because the control rates are at the lower limit of control rates cited in the literature and of historical controls gathered in the testing laboratory. There is also no clear-cut dose dependency, and the revertant rates after application of the test article are in the medium range compared to revertant rates of historical controls.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article induced no point mutations by base-pair changes or frameshifts in the genome of the strains used.
Therefore, PYRIDIN-2 -ETHANOL is not considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The study was performed according to the OECD Guideline 471 and EU Method B13/14 with deviations (5 Salmonella strains tested) and still considered to be of high quality quality (reliability Klimisch 2). The vehicle and the positive control substances fulfilled validity criteria of the test system. The test was performed with and without liver microsomal activation. The test article was tested at the following concentrations: 1.58, 5, 15.8, 50, 158, 500, 1580 and 5000 micrograms per plate. Each concentration, including the controls, was tested in triplicate.
No toxic effect of the test article was observed. - Executive summary:
Pyridin-2-ethanol was investigated using the Salmonella/microsome test for point mutagenic effects in doses up to 5000 µg per plate on five Salmonella typhimurium LT2 mutants (TA98, TA 100, TA 1535, TA 1537 and TA 1538). The study was performed according to the OECD Guideline 471 and EU Method B13/14 with deviations (five Salmonella strains tested) and considered to be of the high quality (reliability Klimisch 2). The strains have the following genotypes : S. typhimurium TA 1535 his G46 rfa- uvrB-, S. typhimurium TA 1537 his C3076 rfa- uvrB-, S. typhimurium TA 1538 his D3052 rfa- uvrB-, S. typhimurium TA 98 his D3052 rfa- uvrB- R + and S. typhimurium TA 100 his G46 rfa- uvrB- R +. The bacteria were treated with the test material using the Ames plate incorporation method at up to eight dose levels (1.58, 5, 15.8, 50, 158, 500, 1580 and 5000 µg per plate), in triplicate, both with and without the addition of a rat liver homogenate metabolising system (cofactor-supplemented post-mitochondrial fraction prepared from the livers of rats treated with the enzyme-inducing agent Aroclor 1254.). Results for the negative controls (spontaneous mutation rates) were considered to be acceptable. The vehicle (water) control plates gave counts of revertant colonies within the normal range. The positive controls methyl methanesulfonate (MMS), 9 -Aminoacridine (9 -AMA), 2 -nitrofluorene (2 -NF), N-ethyl-N'-nitro-N-nitrosoguanidine (ENNG), 2-Aminoanthracene (2-AA) and benzo(a)pyrene (BaP) had a marked mutagenic effect, as was seen by a biologically relevant increase of induced revertant colonies compared to the corresponding negative controls. So all of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9 -mix were validated. No cytotoxic effect of the test article was observed. In the described bacterial mutagenicity tests, no relevant increase of the revertant colony numbers was obtained in the Salmonella typhimurium strains used at all dose levels tested when compared with the corresponding controls. The presence of liver microsomal activation did not influence these findings.
These results were confirmed in a second, independent experiment for the strains TA 98, TA 1535, TA 1537 and TA 1538. The increased rate of revertants in the strain TA 100 in the second experiment compared with the corresponding controls are considered to be not relevant.This must be concluded because the control rates are at the lower limit of control rates cited in the literature and of historical controls gathered in the testing laboratory. There is also no clear-cut dose dependency, and the revertant rates after applicationof the test article are in the medium range compared to revertant rates of historical controls.In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article induced no point mutations by base-pair changes or frameshifts in the genome of the strains used.
Therefore, PYRIDIN-2 -ETHANOL is not considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.
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