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EC number: 242-958-4 | CAS number: 19321-38-1
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- first strain (TA 1535) missing
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- L-menthol
- EC Number:
- 218-690-9
- EC Name:
- L-menthol
- Cas Number:
- 2216-51-5
- Molecular formula:
- C10H20O
- IUPAC Name:
- 2-isopropyl-5-methylcyclohexanol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- purchased from Sigma Chemical St. Louis, MO, USA
Method
- Target gene:
- histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Remarks:
- TA97a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : Lyophilized rat liver S9 fraction induced by Aroclor 1254 was purchased from Moltox Molecular Toxicology, Annapolis, USA..
- method of preparation of S9 mix: The S9 mixture [21 mL] was prepared for use as follows: 7.0 ml of distilled water; 10.5 ml of 100 mM phosphate buffer pH 7.4; 0.84 ml of 100 mM NADP; 0.105 ml of 1 M glucose-6-phosphate; 0.420 ml of 1.65 M KCl + 0.4
M MgCl2 salt solution and 2.1 ml of lyophilized S9 fraction reconstituted with distilled water.
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): enzymatic activity was confirmed by the specific positive control substances - Test concentrations with justification for top dose:
- 0, 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, 700 µg/plate; doses up to 600–700 µg/plate(TA97a, TA98 and TA100) and 200–400 µg/plate (TA102)
Toxicity to S. typhimurium was investigated in a preliminary test carried out with TA100 strain without and with addition of S9 mixture. Toxicity was observed at doses of 600 µg/plate and higher in the preliminary assay. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: nitro-o-phenilene-diamine (NPD), TA98, -S9; 2-Aminofluorene (2AF), TA97a, +S9 and 2-aminoanthracene (2AA), TA100, +S9
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate) : triplicate
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 1.2 x 10E9 bacteria/mL
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 72 h
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Remarks:
- TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES (if applicable):
Toxicity to S. typhimurium was investigated in a preliminary test carried out with TA100 strain without and with addition of S9 mixture. In all subsequent assays, the upper limit of the dose interval tested was either the highest non-toxic dose or the lowest toxic dose determined in this preliminary assay. Toxicity was apparent either as a reduction in the number of revertants, and or as an alteration of the auxotrophic background growth i.e., background lawn. Please refer to the results in Table 1.
Ames test:
- Mean number of revertant colonies per plate and standard deviation : please refer to Table 2
Any other information on results incl. tables
Table 1: Toxicity of (-)-menthol to S. typhimurium TA100 strain
Dose (µg/plate) |
(-)-Menthol |
|
|
- S9 |
+ S9 |
3000 |
|
|
2750 |
|
|
2500 |
|
|
2000 |
|
|
1500 |
|
|
1250 |
|
|
1000 |
|
|
900 |
|
101 * /0/0+ |
800 |
93 ±39* |
167* /0/0+ |
700 |
134±29* |
77±6* |
600 |
159±14 |
120±10* |
500 |
165±12 |
166±17 |
400 |
|
|
300 |
|
|
200 |
|
|
0 |
174±15a |
184±26b |
PC |
924±41a |
591±69b |
(*) Toxicity apparent as an alteration of the background lawn. (a,b) Toxicity assays carried out concomitantly shared the same solvent- and positive controls. (-) Dose not tested. (/ + ) Mutant counts of individual plates. Data are shown as mutant counts (mean±SD) of three plates. |
Table 2: Mutagenicity testing of (-)-menthol (5-methyl-2-(1-methyl-ethyl)cyclohexanol) in the Salmonella/microsome assay [TA100, TA98, TA97a and TA102 tester strains]
NUMBER OF REVERTANTS (Mean ±S.D.) |
|||||||||
(-) - MENTHOL |
DOSE (µg/plate) |
TA100 |
TA98 |
TA97a |
TA102 |
||||
|
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
800 |
- |
- |
- |
43/0/0+ |
- |
93±4* |
- |
- |
|
700 |
- |
168 ± 15 |
- |
48±6 |
86±54* |
154±8 |
- |
- |
|
600 |
161 ± 7 |
170 ± 10 |
41±4 |
50±10 |
132 ± 11 |
181 ± 8 |
- |
- |
|
500 |
161±10 |
179 ± 11 |
46±1 |
64±3 |
137±6 |
186±11 |
- |
552±114* |
|
400 |
183 ± 3 |
182 ± 18 |
40 ± 8 |
57 ± 12 |
148±11 |
198 ±13 |
312±135 |
826±21 |
|
300 |
199 ± 17 |
182±13 |
39 ± 8 |
57 ± 9 |
155 ± 6 |
209±14 |
409±152 |
754±33 |
|
200 |
205 ± 11 |
183 ± 7 |
35±4 |
55 + 10 |
169±13 |
209 ± 16 |
643±62 |
897±18 |
|
100 |
211 ± 12 |
- |
42 ± 2 |
- |
149±2 |
- |
665±34 |
873±66 |
|
50 |
- |
- |
- |
- |
- |
- |
686±35 |
738±19 |
|
25 |
- |
- |
- |
- |
- |
- |
574±50 |
- |
|
10 |
- |
- |
- |
- |
- |
- |
648±32 |
- |
|
5 |
- |
- |
- |
- |
- |
- |
708±34 |
- |
|
0 |
219 ± 21 |
196 ± 18 |
47±3 |
63 ± 1 |
160±22 |
172±6 |
719±25 |
832±67 |
|
PC |
860 ± 1 |
1003 ± 66 |
159±16 |
343 ± 57 |
998±52 |
844±18 |
5967±1198 |
1589±157 |
Dose 0 — Negative Control: 100 µL ethanol PA; PC — Positive Control: TA100/-S9, SA (0.5 µg/plate); TA100/+S9, 2AA (1 µg/plate); TA98/-S9, NPD (1 µg/plate); TA98/+S9, 2AA (0.5 µg/plate); TA97a/-S9, 4-NQNO (1 µg/plate); TA97a/+S9, 2AF (10 µg/plate); TA102/+S9, MC (0.5 µg/plate); TA102/+S9, B-[a]-P (50 µg/plate)
(-) Dose not tested.
(*) Toxicity apparent as an alteration of the background lawn.
(/+) mutant counts of individual plates.
Values are the means ± SD of three plates of one (out of two) representative experiment.
Applicant's summary and conclusion
- Conclusions:
- In a bacterial reverse mutation assay d-menthol was negative in S. typhimurium strains TA 97a, TA98, TA100 and TA102 with and without metabolic activation.
- Executive summary:
In this study similar to OECD Test Guideline 471 d-menthol was tested in S. typhimurium strains TA 97a, TA98, TA100 and TA102 with and without rat liver S9 fraction. As a result, d-menthol was negative in all test strains with and without metabolic activation.
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