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EC number: 939-728-7 | CAS number: -
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 April - 6 June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to OECD Guideline 471 with minor deviation: temperature of the incubator rose to 38.1 °C overnight, just above the 37 ± 1 °C limit
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- temperature of the incubator rose to 38.1 °C overnight, just above the 37 ± 1 °C limit
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (1r,4r)-1-methyl-4-(propan-2-yl)cyclohexyl acetate; (1s,4s)-1-methyl-4-(propan-2-yl)cyclohexyl acetate; 2-[(1r,4r)-4-methylcyclohexyl]propan-2-yl acetate; 2-[(1s,4s)-4-methylcyclohexyl]propan-2-yl acetate
- EC Number:
- 939-728-7
- Molecular formula:
- C12H22O2
- IUPAC Name:
- (1r,4r)-1-methyl-4-(propan-2-yl)cyclohexyl acetate; (1s,4s)-1-methyl-4-(propan-2-yl)cyclohexyl acetate; 2-[(1r,4r)-4-methylcyclohexyl]propan-2-yl acetate; 2-[(1s,4s)-4-methylcyclohexyl]propan-2-yl acetate
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- - Name of test material (as cited in study report): Menthanyl acetate multiconstituent
- Physical state: Colourless to slightly amber liquid
- Analytical purity: 98.3 %
- Lot/batch No.: 110996
- Date of receipt: 21 February 2012
- Expiration date of the lot/batch: 9 September 2012
- Storage condition of test material: Stored at 2-8 °C, protected from light and under nitrogen
Constituent 1
Method
- Target gene:
- Histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: All strains were checked for characteristics (histidine dependence, rfa character, uvrB character and resistance to ampicillin or ampicillin plus tetracycline).
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10 % S9 mix; S9 fraction prepared from liver homogenates of male Sprague Dawley rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- Mutagenicity tests:
- Experiment 1: 5, 15.81, 50, 158.1, 500, 1581 and 5000 μg/plate, with and without S9 mix in all 5 strains (plate incorporation method)
- Experiment 2a: 1.563, 3.125, 6.25, 12.5, 25, 50 and 100 μg/plate, without S9 mix in strains TA100 and TA1535 (plate incorporation method)
- Experiment 2b: 4.096, 10.24, 25.6, 64, 160 and 400 μg/plate; strains TA 98, TA 1537 and TA 102 in the absence (plate incorporation method) and presence of S9 (preincubation method) and strains TA 100 and TA 1535 in the presence of S9 (preincubation method) [1.638 μg/plate used in strains TA98 and TA1537 in the absence of S9 and strain TA102 in the presence of S9 only; 1000 μg/plate used in strain TA 102 in the absence of S9 and strains TA 98, TA 100, TA 1535 and TA 1537 in the presence of S9 only]
- Experiment 3: 1.563, 3.125, 6.25, 12.5, 25, 50 and 100 μg/plate, with S9 mix in strain TA1537 (preincubation method)
- Experiment 4: 1.563, 3.125, 6.25, 12.5, 25 and 50 μg/plate, with S9 mix in strains TA 1535, TA 98, TA 100 and TA 102 (preincubation method) [0.7813 μg/plate used in strain TA 102; 100 μg/plate used in strains TA 98, TA 100 and TA 1535] - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethanol
Formulation procedure:
- Test article stock solutions were prepared by formulating Menthanyl acetate multiconstituent in ethanol under subdued lighting conditions with the aid of vortex mixing and warming to 30 °C as required, immediately prior to assay to give the maximum required treatment solution concentration. Subsequent dilutions were made using ethanol. The test article solutions were protected from light and used within approximately 5.5 h of initial formulation.
Volume addition: 0.1 mL volume additions of vehicle/test article solution were used for all plate-incorporation treatments, 0.05 mL volume additions of vehicle/test article solution were used for pre-incubation treatments.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2- Aminoanthracene
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM: Strains TA 98, TA 1535 and TA 1537 were originally obtained from the UK NCTC. Strains TA 100 and TA 102 were derived from cultures originally obtained from Covance Laboratories Inc., USA.
METHOD OF APPLICATION: In agar (plate incorporation and preincubation method)
DURATION
- Preincubation period: 20 minutes at 37 ± 1 °C
- Incubation period: Plates were inverted and incubated at 37 ± 1 °C in the dark for 3 days.
NUMBER OF REPLICATIONS:
- Treatment and positive control groups: 3 plates/dose
- Vehicle control group: 5 plates/dose
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn was inspected for signs of toxicity.
OTHER:
Colony counting: Colonies were counted electronically using a Sorcerer Colony Counter (Perceptive Instruments) or manually where confounding factors such as bubbles or splits in the agar affected the accuracy of the automated counter. - Evaluation criteria:
- - For valid data, the test article was considered to be mutagenic if:
1. When assessed using Dunnett's test, an increase in revertant numbers gave a significant response (p ≤ 0.01) which was concentration related.
2. The positive trend/effects described above were reproducible.
- Test article was considered positive in this assay if all of the above criteria were met.
- Test article was considered negative in this assay if none of the above criteria were met.
- Results which only partially satisfied the above criteria were dealt with on a case-by-case basis. Biological relevance was taken into account, for example consistency of response within and between concentrations and (where applicable) between experiments. - Statistics:
- - Dunnett's test was used to compare the counts at each concentration with the control. The presence or otherwise of a concentration response was checked by non-statistical analysis, up to limiting levels (for example toxicity, precipitation or 5000 μg/plate).
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Mean vehicle control counts fell within the normal historical ranges (historical control data of February 2008 - July 2009).
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Experiment 1: Toxicity was observed at concentrations of 50 μg/plate and above in strains TA 100 and TA 1535 in the absence of S9; 158.1 μg/plate and above in strains TA 98 and TA 1537 in the absence of S9 and strain TA 102 in the presence of S9; and 500 μg/plate and above in strains TA 98, TA 100, TA 1535 and TA 1537 in the presence of S9 and strain TA 102 in the absence of S9.
- Experiment 2: Toxicity was observed at 1000 μg/plate in strains TA 98, TA 100, TA 1535 and TA 1537 in the presence of S9 and TA 102 in the absence of S9; 400 μg/plate in strains TA 98 and TA 1537 in the absence of S9 and strain TA 102 in the presence of S9; and 100 μg/plate in strains TA 100 and TA 1535 in the absence of S9. Toxicity was observed at concentrations of 10.24 and/or 25.6 μg/plate and above in all strains in the presence of S9; 50 μg/plate and above in strain TA 100 in the absence of S9, 64 μg/plate and above in strain TA 98 in the absence of S9, 100 μg/plate and above in strain TA 1535 in the absence of S9, and 160 μg/plate and above in strains TA 1537 and TA 102 in the absence of S9.
- Experiment 3 and 4: Toxicity was observed at concentrations of 25 μg/plate and above in all strains. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 7.6.1/2: Results of mutagenicity
Group |
Concentration (µg/plate) |
Mean revertant numbers/plate |
Concentration (µg/plate) |
Mean revertant numbers/plate |
Experiment 1 |
Experiment 2 |
|||
TA 98 -S-9 |
||||
Ethanol |
|
27.6 |
|
26.8 |
Test item |
5 |
26.7 |
1.638 |
18.7 |
15.81 |
27.3 |
4.096 |
28.7 |
|
50 |
28.3 |
10.24 |
27.7 |
|
158.1 |
27.7 |
25.6 |
22.3 |
|
500 |
30.0 |
64 |
33.0 |
|
1581 |
25.0 |
160 |
22.7 |
|
5000 |
16.3 |
400 |
28.7 |
|
2NF |
5 |
1070.3 |
5 |
1134.3 |
TA 98 +S-9 |
||||
Ethanol |
|
37.8 |
|
32.0 |
Test item |
5 |
29.0 |
4.096 |
30.7 |
15.81 |
32.3 |
10.24 |
25.0 |
|
50 |
32.0 |
25.6 |
31.0 |
|
158.1 |
36.7 |
64 |
17.0 |
|
500 |
34.0 |
160 |
30.7 |
|
1581 |
32.7 |
400 |
25.7 |
|
5000 |
19.3 |
1000 |
23.7 |
|
B[a]P |
10 |
440.3 |
10 |
548.7 |
TA 100 -S-9 |
||||
Ethanol |
|
93.2 |
|
87.2 |
Test item |
5 |
82.0 |
1.563 |
94.3 |
15.81 |
111.7* |
3.125 |
93.7 |
|
50 |
92.7 |
6.25 |
72.7 |
|
158.1 |
76.0 |
12.5 |
85.7 |
|
500 |
69.3 |
25 |
77.0 |
|
1581 |
49.0 |
50 |
92.7 |
|
5000 |
26.0 |
100 |
53.7 |
|
NaN3 |
2 |
690.3 |
2 |
789.0 |
TA 100 +S-9 |
||||
Ethanol |
|
105.0 |
|
98.4 |
Test item |
5 |
119.7 |
4.096 |
91.0 |
15.81 |
106.0 |
10.24 |
80.7 |
|
50 |
86.0 |
25.6 |
75.3 |
|
158.1 |
100.3 |
64 |
58.0 |
|
500 |
85.3 |
160 |
68.0 |
|
1581 |
27.0 |
400 |
72.7 |
|
5000 |
T |
1000 |
56.7 |
|
AAN |
5 |
1443.0 |
5 |
1139.7 |
TA 1535 -S-9 |
||||
Ethanol |
|
21.8 |
|
17.8 |
Test item |
5 |
22.0 |
1.563 |
15.3 |
15.81 |
20.3 |
3.125 |
11.3 |
|
50 |
21.0 |
6.25 |
15.0 |
|
158.1 |
12.0 |
12.5 |
14.7 |
|
500 |
10.0 |
25 |
15.3 |
|
1581 |
9.0 |
50 |
15.7 |
|
5000 |
8.0 |
100 |
15.0 |
|
NaN3 |
2 |
690.7 |
2 |
653.0 |
TA 1535 +S-9 |
||||
Ethanol |
|
22.6 |
|
17.4 |
Test item |
5 |
22.0 |
4.096 |
15.3 |
15.81 |
27.3 |
10.24 |
20.7 |
|
50 |
25.0 |
25.6 |
18.0 |
|
158.1 |
36.7 |
64 |
13.0 |
|
500 |
21.3 |
160 |
11.7 |
|
1581 |
17.7 |
400 |
8.3 |
|
5000 |
15.0 |
1000 |
9.3 |
|
AAN |
5 |
251.3 |
5 |
193.3 |
TA 1537 -S-9 |
||||
Ethanol |
|
8.2 |
|
8.4 |
Test item |
5 |
8.3 |
1.638 |
5.3 |
15.81 |
11.0 |
4.096 |
6.3 |
|
50 |
8.0 |
10.24 |
6.3 |
|
158.1 |
8.0 |
25.6 |
6.7 |
|
500 |
6.3 |
64 |
5.7 |
|
1581 |
T |
160 |
7.3 |
|
5000 |
T |
400 |
3.3 |
|
AAC |
50 |
183.3 |
50 |
126.7 |
TA 1537 +S-9 |
||||
Ethanol |
|
19.8 |
|
14.2 |
Test item |
5 |
17.7 |
4.096 |
20.7 |
15.81 |
20.0 |
10.24 |
6.0 |
|
50 |
15.7 |
25.6 |
12.3 |
|
158.1 |
17.7 |
64 |
T |
|
500 |
14.7 |
160 |
T |
|
1581 |
T |
400 |
T |
|
5000 |
T |
1000 |
T |
|
AAN |
5 |
294.3 |
5 |
120.3 |
TA 102 -S-9 |
||||
Ethanol |
|
246.2 |
|
246.8 |
Test item |
5 |
267.7 |
4.096 |
216.0 |
15.81 |
261.7 |
10.24 |
220.3 |
|
50 |
217.0 |
25.6 |
231.3 |
|
158.1 |
196.0 |
64 |
232.0 |
|
500 |
198.0 |
160 |
196.3 |
|
1581 |
200.0 |
400 |
155.0 |
|
5000 |
200.3 |
1000 |
107.3 |
|
MMC |
0.2 |
875.3 |
0.2 |
962.3 |
TA 102 +S-9 |
||||
Ethanol |
|
251.0 |
|
215.0 |
Test item |
5 |
264.3 |
1.638 |
250.0 |
15.81 |
248.0 |
4.096 |
256.7 |
|
50 |
244.3 |
10.24 |
190.3 |
|
158.1 |
199.7 |
25.6 |
182.0 |
|
500 |
195.7 |
64 |
92.3 |
|
1581 |
264.0 |
160 |
105.7 |
|
5000 |
243.7 |
400 |
131.3 |
|
AAN |
20 |
1751.0 |
20 |
1134.3 |
Experiment 3 (TA 1537 +S-9) |
Experiment 4 (TA 98 +S-9) |
|||
Ethanol |
|
16.4 |
|
36.0 |
Test item |
1.563 |
14.7 |
1.563 |
38.0 |
3.125 |
7.7 |
3.125 |
30.7 |
|
6.25 |
15.3 |
6.25 |
25.7 |
|
12.5 |
9.3 |
12.5 |
29.3 |
|
25 |
11.3 |
25 |
22.3 |
|
50 |
T |
50 |
27.3 |
|
100 |
T |
100 |
T |
|
AAN |
5 |
178.0 |
B[a]P 10 |
455.7 |
Experiment 4 (TA 100 +S-9) |
Experiment 4 (TA 1535 +S-9) |
|||
Ethanol |
|
108.2 |
|
16.6 |
Test item |
1.563 |
96.7 |
1.563 |
16.3 |
3.125 |
93.7 |
3.125 |
16.0 |
|
6.25 |
99.7 |
6.25 |
20.7 |
|
12.5 |
115.7 |
12.5 |
14.0 |
|
25 |
91.7 |
25 |
7.7 |
|
50 |
77.0 |
50 |
12.0 |
|
100 |
T |
100 |
12.0 |
|
AAN |
5 |
901.0 |
AAN 5 |
197.0 |
Experiment 4 (TA 102 +S-9) |
||||
Ethanol |
|
195.4 |
NA |
|
Test item |
0.7813 |
162.7 |
||
1.563 |
154.3 |
|||
3.125 |
148.3 |
|||
6.25 |
129.7 |
|||
12.5 |
140.3 |
|||
25 |
128.7 |
|||
50 |
112.3 |
|||
AAN |
20 |
901.0 |
T: Toxic, no revertant colonies; * p ≤ 0.05
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Under the test conditions, Menthanyl acetate multiconstituent is not considered as mutagenic in S. typhimurium strains (TA 1535, TA 1537, TA 98, TA 100 and TA 102). - Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) were exposed to Menthanyl acetate multiconstituent at the following concentrations:
- Experiment 1: 5, 15.81, 50, 158.1, 500, 1581 and 5000 μg/plate, with and without S9 mix in all 5 strains (plate incorporation method)
- Experiment 2a: 1.563, 3.125, 6.25, 12.5, 25, 50 and 100 μg/plate, without S9 mix in strains TA100 and TA1535 (plate incorporation method)
- Experiment 2b: 4.096, 10.24, 25.6, 64, 160 and 400 μg/plate; strains TA 98, TA 1537 and TA 102 in the absence (plate incorporation method) and presence of S9 (preincubation method) and strains TA 100 and TA 1535 in the presence of S9 (preincubation method) [1.638 μg/plate used in strains TA 98 and TA 1537 in the absence of S9 and strain TA102 in the presence of S9 only; 1000 μg/plate used in strain TA 102 in the absence of S9 and strains TA 98, TA 100, TA 1535 and TA 1537 in the presence of S9 only]
- Experiment 3: 1.563, 3.125, 6.25, 12.5, 25, 50 and 100 μg/plate, with S9 mix in strain TA1537 (preincubation method)
- Experiment 4: 1.563, 3.125, 6.25, 12.5, 25 and 50 μg/plate, with S9 mix in strains TA 1535, TA 98, TA 100 and TA 102 (preincubation method) [0.7813 μg/plate used in strain TA 102; 100 μg/plate used in strains TA 98, TA 100 and TA 1535]
Metabolic activation system used in this test was10 % S9 mix. S9 fraction was prepared from liver homogenates of male Sprague Dawley rats induced with Aroclor 1254. Vehicle control and positive control groups were also included in mutagenicity tests.
In experiment 1, toxicity was observed at concentrations of 50 μg/plate and above in strains TA 100 and TA 1535 in the absence of S9; 158.1 μg/plate and above in strains TA 98 and TA 1537 in the absence of S9 and strain TA 102 in the presence of S9; and 500 μg/plate and above in strains TA 98, TA 100, TA 1535 and TA 1537 in the presence of S9 and strain TA 102 in the absence of S9. In Experiment 2, toxicity was observed at 1000 μg/plate in strains TA 98, TA 100, TA 1535 and TA 1537 in the presence of S9 and TA 102 in the absence of S9; 400 μg/plate in strains TA 98 and TA 1537 in the absence of S9 and strain TA 102 in the presence of S9; and 100 μg/plate in strains TA 100 and TA 1535 in the absence of S9. Toxicity was observed at concentrations of 10.24 and/or 25.6 μg/plate and above in all strains in the presence of S9; 50 μg/plate and above in strain TA 100 in the absence of S9, 64 μg/plate and above in strain TA 98 in the absence of S9, 100 μg/plate and above in strain TA 1535 in the absence of S9, and 160 μg/plate and above in strains TA 1537 and TA 102 in the absence of S9. In Experiment 3 and 4, toxicity was observed at concentrations of 25 μg/plate and above in all strains. The positive and vehicle controls induced the appropriate responses in the corresponding strains. Test item did not induce statistically significant increases in revertant colony numbers over control count obtained with any of the tester strains at any concentrations in either presence or absence of metabolic activation.
Under the test conditions, Menthanyl acetate multiconstituent is not considered as mutagenic in this bacterial system.
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