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EC number: 814-113-5 | CAS number: 253454-23-8
- 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:
- 18 January 2006 - 17 February 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 21 November 2005
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- rel-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- EC Number:
- 814-113-5
- Cas Number:
- 253454-23-8
- Molecular formula:
- C15H30O
- IUPAC Name:
- rel-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Hysandol called Timberol in the test report may be a multi of the cis and trans-isomer, while Hysandol is a mono-trans isomer. The cis isomer is expected to have the same results for this endpoint because it is stereo isomer.
Method
- Target gene:
- Histidine
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:
- S9 from livers of male Sprague-Dawley rats which had received phenobarbitone/β-naphtoflavone
- Test concentrations with justification for top dose:
- Dose range finding study: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Main study (with and without S9 mix): 50, 150, 500, 1500 and 5000 µg/plate for both tests.
Top dose was choosen according toe OECD guideline 471. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: test substance was fully soluble in DMSO compared to insoluble in sterile distilled water at the same concentration (50 mg/mL).
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- with S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- with S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- with S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- with S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- without S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
DURATION
- Exposure duration: 48 hours at 37°C
NUMBER OF REPLICATIONS: 3
METHODS OF SLIDE PREPARATION: Top agar was prepared using 0.6% Difco Bacto agar and 0.5% sodium chloride with 5 mL of 1.0 mM histidine and 1.0 mM biotin solution added to each 100 mL of top agar.
DETERMINATION OF CYTOTOXICITY
- Method: growth of bacterial background lawn using a Domino colony counter. - Evaluation criteria:
- According to OECD guideline 471 there are several criteria for determining a positive result, such as a dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. Biological relevance of the results will be considered first, statistical methods can also be used as an aid to evaluation, however, statistical significance will not be the only determining factor for a positive response.
A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
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:
- no cytotoxicity
- 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:
- no cytotoxicity
- 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:
- no cytotoxicity
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- 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: at and above 1500 µg/plate
RANGE-FINDING/SCREENING STUDIES: yes, using concentrations of 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate. In addition 0.1 mL of the maximum concentration of the test material on 2mLof molten, trace histidine supplemented top agar was overlaid onto a sterile nutrient agar plate in order to assess the sterility of the test material.
ACCEPTABILITY CRITERIA:
- Results of solvent and positive controls were within historical data.
- Other acceptance criteria were met.
Any other information on results incl. tables
Tabel 1 Test results
S9 mix |
Substance concentration (µg/plate) |
Number of revertants (mean number of colonies per plate ± standard deviation) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||||
TA100 |
TA1535 |
TA102 |
TA98 |
TA1537 |
|||||||
Experiment 1 |
|
|
|
|
|
|
|
|
|
|
|
|
Negative controls |
87 |
110 |
19 |
18 |
313 |
330 |
36 |
31 |
19 |
15 |
117 |
13 |
381 |
29 |
16 |
|||||||
126 |
21 |
297 |
27 |
11 |
|||||||
- |
0 |
120 |
(114 ±7.4) |
27 |
(23 ±4.0) |
345 |
(332 ±14.1) |
20 |
(21 ±5.6) |
16 |
(16 ±3.5) |
117 |
19 |
317 |
16 |
19 |
|||||||
106 |
23 |
334 |
27 |
12 |
|||||||
- |
50 |
118 |
(109 ±19.5) |
23 |
(22 ±0.6) |
330 |
(293 ±39.7) |
32 |
(24 ±6.7) |
16 |
(13 ±3.0) |
87 |
22 |
251 |
21 |
13 |
|||||||
123 |
22 |
297 |
20 |
10 |
|||||||
- |
150 |
101 |
(99 ±3.8) |
26 |
(21 ±4.6) |
304 |
(256 ±41.6) |
14 |
(22 ±6.8) |
16 |
(15 ±3.6) |
102 |
18 |
231 |
27 |
18 |
|||||||
95 |
18 |
233 |
24 |
11 |
|||||||
- |
500 |
80 |
(96 ±17.7) |
25 |
(21 ±4.7) |
269 |
(265 ±9.3) |
25 |
(19 ±5.5) |
9 |
(12 ±2.3) |
93 |
23 |
254 |
14 |
13 |
|||||||
115 |
16 |
271 |
19 |
13 |
|||||||
- |
1500 |
131 P |
(105 ±22.7) |
23 P |
(20 ±4.4) |
278 P |
(242 ±34.1) |
21 P |
(20 ±2.1) |
12 P |
(13 ±4.6) |
95 P |
15 P |
239 P |
18 P |
18 P |
|||||||
89 P |
22 P |
210 P |
22 P |
9 P |
|||||||
- |
5000 |
98 P |
(85 ±11.0) |
24 P |
(23 ±1.2) |
298 P |
(264 ±33.0) |
20 P |
(21 ±2.1) |
13 P |
(12 ±2.3) |
78 P |
22 P |
232 P |
22 P |
9 P |
|||||||
80 P |
22 P |
262 P |
20 P |
13 P |
|||||||
Positive controls |
Name (concentration(µg/plate)) |
ENNG (3) |
|
ENNG (5) |
|
MMC (0.5) |
|
4NQO (0.2) |
|
9AA (80) |
|
S9 mix |
Number of colonies per plate |
432 |
(479 ±50.8) |
406 |
(382 ±25.7) |
1739 |
(1739 ±6.5) |
264 |
(275 ± 16.8) |
566 |
(756 ±230.1) |
- |
473 |
355 |
1745 |
266 |
691 |
||||||
533 |
386 |
1732 |
294 |
1012 |
|||||||
|
|
|
|
|
|
|
|
|
|
|
|
+ |
0 |
92 |
(88 ±6.4) |
14 |
(14 ±0.0) |
341 |
(328 ±14.2) |
37 |
(32 ±5.0) |
23 |
(19 ±3.5) |
81 |
14 |
331 |
33 |
16 |
|||||||
92 |
14 |
313 |
27 |
19 |
|||||||
+ |
50 |
86 |
(93 ±6.5) |
15 |
(14 ±1.7) |
307 |
(336 ±30.1) |
33 |
(32 ±1.7) |
23 |
(18 ±4.7) |
99 |
15 |
333 |
30 |
16 |
|||||||
93 |
12 |
367 |
33 |
14 |
|||||||
+ |
150 |
91 |
(89 ±18.6) |
13 |
|
307 |
(285 ±23.1) |
36 |
(30 ±5.5) |
22 |
(20 ±2.1) |
107 |
9 |
287 |
26 |
19 |
|||||||
70 |
9 |
261 |
27 |
18 |
|||||||
+ |
500 |
88 |
(88 ±12.5) |
10 |
(10 ±2.3) |
307 |
(308 ±19.0) |
25 |
(28 ±5.5) |
21 |
(14 ±6.7) |
75 |
12 |
328 |
34 |
12 |
|||||||
100 |
18 |
290 |
24 |
8 |
|||||||
+ |
1500 |
90 P |
(83 ±7.6) |
13 P |
(13 ±4.2) |
265 P |
(296 ±27.1) |
30 P |
(23 ± 5.9) |
11 P |
(11 ±0.6) |
85 P |
9 P |
312 P |
21 P |
11 P |
|||||||
75 P |
9 P |
312 P |
19 P |
10 P |
|||||||
+ |
5000 |
79 P |
(89 ±9.6) |
15 P |
(10 ±2.3) |
274 P |
(286 ±11.0) |
25 P |
(26 ±2.3) |
9 P |
(12 ±3.5) |
91 P |
10 P |
295 P |
29 P |
12 P |
|||||||
98 P |
13 P |
290 P |
25 P |
16 P |
|||||||
Positive controls |
Name (concentration(µg/plate)) |
2AA (1) |
|
2AA (2) |
|
DAN (10) |
|
BP (5) |
|
2AA (2) |
|
S9 mix |
Number of colonies per plate |
2820 |
(2762 ±93.6) |
125 |
(174 ±42.2) |
1127 |
(1010 ±101.7) |
200 |
(158 ± 36.7) |
228 |
(210 ±19.6) |
+ |
|||||||||||
|
2654 |
199 |
946 |
142 |
189 |
||||||
|
2812 |
197 |
456 |
132 |
212 |
||||||
Experiment 2 |
|
|
|
|
|
|
|
|
|
|
|
|
Negative controls |
112 |
(109) |
25 |
(22) |
296 |
(298) |
19 |
(18) |
17 |
(13) |
101 |
27 |
317 |
17 |
11 |
|||||||
115 |
15 |
280 |
17 |
10 |
|||||||
- |
0 |
107 |
(92 ±13.9) |
23 |
(25 ±5.3) |
294 |
(293 ±33.0) |
20 |
(21 ±1.0) |
15 |
(13 ±5.9) |
88 |
21 |
260 |
22 |
17 |
|||||||
80 |
31 |
326 |
21 |
6 |
|||||||
- |
50 |
82 |
(98 ±17.1) |
22 |
(19 ±5.2) |
341 |
(321 ±17.6) |
19 |
(14 ±5.7) |
16 |
(13 ±3.8) |
116 |
13 |
307 |
16 |
15 |
|||||||
96 |
22 |
316 |
8 |
9 |
|||||||
- |
150 |
109 |
(103 ±5.3) |
20 |
(19 ±2.6) |
285 |
(284 ±8.5) |
11 |
(11 ±3.5) |
14 |
(11 ±2.6) |
99 |
21 |
275 |
15 |
9 |
|||||||
101 |
16 |
292 |
8 |
10 |
|||||||
- |
500 |
93 |
(91 ±13.1) |
9 |
(9 ±3.5) |
280 |
(272 ±16.2) |
11 |
(12 ±4.0) |
8 |
(8 ±1.5) |
103 |
6 |
282 |
8 |
6 |
|||||||
77 |
13 |
253 |
16 |
9 |
|||||||
- |
1500 |
84 P |
(78 ±7.4) |
17 P |
(12 ±4.2) |
311 P |
(288 ±22.5) |
9 P |
(9 ±0.6) |
11 P |
(11 ±1.5) |
81 P |
9 P |
286 P |
9 P |
13 P |
|||||||
70 P |
11 P |
266 P |
8 P |
10 P |
|||||||
- |
5000 |
70 P |
(83 ±14.2) |
20 P |
(14 ±5.1) |
275 P |
(274 ±7.5) |
6 P |
(8 ±2.0) |
18 P |
(17 ±2.3) |
80 P |
10 P |
266 P |
8 P |
14 P |
|||||||
98 P |
13 P |
281 P |
10 P |
18 P |
|||||||
Positive controls |
Name (concentration(µg/plate)) |
ENNG (3) |
|
ENNG (5) |
|
MMC (0.5) |
|
4NQO (0.2) |
|
9AA (80) |
|
S9 mix |
Number of colonies per plate |
712 |
(673 ±76.4) |
929 |
(859 ±123.0) |
1269 |
(1341 ±95.8) |
149 |
(128 ±28.4) |
322 |
(323 ±32.5) |
- |
585 |
931 |
1305 |
140 |
356 |
||||||
|
722 |
717 |
1450 |
96 |
291 |
||||||
|
|
|
|
|
|
|
|
|
|
|
|
+ |
0 |
73 |
(84 ±12.7) |
9 |
(11 ±2.1) |
275 |
(310 ±30.7) |
18 |
(15 ±4.2) |
11 |
(11 ±3.5) |
98 |
12 |
326 |
10 |
7 |
|||||||
82 |
13 |
330 |
16 |
14 |
|||||||
+ |
50 |
81 |
(84 ±9.8) |
15 |
(17 ±2.0) |
303 |
(315 ±10.1) |
16 |
(17 ±1.2) |
7 |
(10 ±3.1) |
95 |
19 |
321 |
16 |
13 |
|||||||
76 |
17 |
320 |
18 |
9 |
|||||||
+ |
150 |
77 |
(81 ±4.0) |
13 |
(9 ±4.0) |
269 |
(283 ±16.5) |
27 |
(20 ±6.1) |
6 |
(7 ±2.1) |
82 |
5 |
301 |
16 |
5 |
|||||||
85 |
10 |
278 |
17 |
9 |
|||||||
+ |
500 |
52 |
(61 ±7.8) |
11 |
(11 ±0.0) |
296 |
(291 ±20.4) |
21 |
(17 ±5.1) |
8 |
(8 ±1.0) |
67 |
11 |
269 |
11 |
9 |
|||||||
63 |
11 |
309 |
18 |
7 |
|||||||
+ |
1500 |
61 P |
(57 ±5.5) |
15 P |
(10 ±4.2) |
255 P |
(268 ±12.1) |
16 P |
(14 ±2.6) |
9 P |
(11 ±2.9) |
51 P |
9 P |
269 P |
15 P |
9 P |
|||||||
60 P |
7 P |
279 P |
11 P |
14 P |
|||||||
+ |
5000 |
66 P |
(59 ±7.0) |
11 P |
(10 ±2.3) |
270 P |
(272 ±12.6) |
18 P |
(14 ±3.6) |
14 P |
(10 ±3.6) |
52 P |
7 P |
260 P |
13 P |
9 P |
|||||||
60 P |
11 P |
285 P |
11 P |
7 P |
|||||||
Positive controls |
Name (concentration(µg/plate)) |
2AA (1) |
|
2AA (2) |
|
DAN (10) |
|
BP (5) |
|
2AA (2) |
|
S9 mix |
Number of colonies per plate (± standard deviation) |
1411 |
(1536 ±162.9) |
114 |
(174 ±52.5) |
748 |
(733 ±22.6) |
192 |
(173 ±17.7) |
515 |
(568 ±46.2) |
+ |
1476 |
199 |
707 |
157 |
589 |
||||||
|
1720 |
210 |
744 |
170 |
600 |
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay performed according to OECD 471 and GLP principles.
- Executive summary:
The mutagenic activity of the substance was evaluated in accordance with OECD 471 and according to GLP principles. The test was performed in two independent direct plate assays. The dose levels were 50, 150, 500, 1500 and 5000 µg/plate. Adequate negative 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 five S. typhimurium tester strains (TA1535, TA1537, TA98, TA100 and TA102), both in the absence and presence of S9-metabolic activation. These results were confirmed in independently repeated experiments. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
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