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EC number: 233-986-8 | CAS number: 10482-56-1
- 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
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- Nanomaterial pour density
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- 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
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 20 September 2012 – 22 March 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Terpineol
- EC Number:
- 232-268-1
- EC Name:
- Terpineol
- Cas Number:
- 8000-41-7
- Molecular formula:
- C10H18O
- IUPAC Name:
- 2-(4-methylcyclohex-3-en-1-yl)propan-2-ol
Constituent 1
Method
- Target gene:
- Histidine-requiring gene in Salmonella typhimurium and tryptophan-requiring gene in Escherichia coli
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction prepared from male Sprague-Dawley rat liver and induced by Phenobarbital (PB) and 5,6-benzoflavone (BF)
- Test concentrations with justification for top dose:
- Preliminary experiment: 19.5, 78.1, 313, 1250 and 5000 μg/plate.
In the preliminary test, growth inhibition was observed at 1250 μg/plate for all strains without metabolic activity. When tested with metabolic activity, growth inhibition was observed at 313 μg/plate for strains TA 98, TA 1535 and TA 1537, and at 1250 μg/plate for strains TA 100 and E. Coli.
The highest dose selected for the main experiments for each strain was the lowest dose showing growth inhibition in the preliminary test. This dose was further diluted 5 times with the ratio of 2 to obtain 6 doses.
Main tests 1 and 2 (all strains -S9 and TA 98, TA 1535 and TA 1537 +S9): 39.1, 78.1, 156, 313, 625 and 1250 μg/plate
Main tests 1 and 2 (TA 100 and E. Coli +S9): 9.77, 19.5, 39.1, 78.1, 156 and 313μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to solubility in water of 1.98 g/L, a solubility test was performed on DMSO. As a result, the test substance was dissolved in DMSO at 50 mg/mL and no reactivity such as generation of heat or gas was observed, so the test was conducted using DMSO as a solvent.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2); 2-Methoxy-6-chloro-9-[ 3-(2-chloro ethyl)-aminopropylamino] acridine 2HCL (ICR-191); 2-Aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation: 0.1 mL of solvent or positive control or test solution, 0.5 mL of S9 mix or 0.1 M phosphate buffer solution (pH 7.4) and 0.1 mL of culture solution of each strain were added to the test tube. Preincubation was carried out with shaking (80 rpm) for 20 minutes at 37ºC. After completion of the preincubation 2.0 mL of top agar were added and after stirring the mixture was uniformly layered on a minimum glucose agar plate medium. Once confirmed that the top agar layered on the minimum glucose agar plate medium was solidified, the plate was turned upside down, placed in the incubator, and incubate at 37ºC for 49 hours in preliminary test and for 48.5 h in the main tests.
- Cell density at seeding (if applicable): 1 x 10^9 cells/mL.
DURATION
- Preincubation period: 20 min.
- Exposure duration: 48.5 h
SELECTION AGENT (mutation assays): the lack of amino-acid in the medium. Only the mutants (revertant bacteria) can grow due to their capability to synthesize the essential amino acid.
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition. The presence or absence of growth inhibition was observed using a stereoscopic microscope. - Evaluation criteria:
- A result was considered positive when the number of revertant colonies in the test substance treated group showed an increase of 2 times or more as compared with the number of spontaneous revertant colonies (negative control value) and a dose response and reproducibility were observed. Also, a positive result was decided when a clear dose response was not shown but an increase of more than twice the number of spontaneously reversed mutant colonies was counted and when reproducibility was confirmed in two main tests.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at 625 μg/plate and above)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at 625 μg/plate and above)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at 313 μg/plate and above)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at 1250 μg/plate and above)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at 625 μg/plate and above)
- 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
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at 313 μg/plate and above)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at 625 μg/plate and above)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at 313 μg/plate and above)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Results of Test 1 (-S9Mix)
Metabolic activation |
Dose of test substance (μg/plate) |
Number of revertants (colony count / plate) |
|||||
Base pair substitution type |
Frameshift type |
||||||
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA 1537 |
|||
S9 Mix (-) |
Negative control (DMSO) |
100 115 120 (112±10.4) |
12 13 9 (11±2.1) |
29 23 25 (26±3.1) |
19 13 13 (15±3.5) |
8 5 7 (7±1.5) |
|
39.1 |
90 99 97 (95±4.7 |
5 7 5 (6±1.2) |
26 31 38 (32±6.0) |
15 11 13 (13±2.0) |
4 5 6 (5±1.0) |
||
78.1 |
97 95 108 (100±7.0) |
7 12 10 (10±2.5) |
23 27 25 (25±2.0) |
13 12 13 (13±0.6) |
6 5 4 (5±1.0) |
||
156 |
100 103 99 (101±2.1) |
5 9 5 (6 ±2.3) |
36 29 42 (36±6.5) |
10 12 15 (12±2.5) |
8 5 11 (8±3.0) |
||
313 |
98 101 99 (99±1.5) |
5 6 11 (7±3.2) |
22 30 36 (29±7.0) |
13 10 11 (11±1.5) |
6 4 7 (6±1.5) |
||
625 |
46* 50* 47* (48±2.1) |
0* 0* 0* (0±0) |
27 21 27 (25±3.5) |
8* 8* 8* (8±0.0) |
0* 0* 0* (0±0) |
||
1250 |
0* 0* 0* (0±0) |
0* 0* 0* (0±0) |
0* 0* 0* (0±0) |
0* 0* 0* (0±0) |
0* 0* 0* (0±0) |
||
Positive controls |
S9Mix (without) |
Name |
AF-2 |
SAZ |
AF-2 |
AF-2 |
ICR-191 |
Dose (μg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
1.0 |
||
Number of colonies/ plate |
712 690 641 (681± 36.3) |
358 304 374 (345±36.7) |
115 123 117 (118±4.2) |
461 428 425 (438±20.0) |
1993 1905 1810 (1903±91.5) |
Notes:
AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
SAZ: Sodium azide
ICR-191: 2-Methoxy-6-chloro-9-[ 3-(2-chloro ethyl)-aminopropylamino] acridine · 2HCL
*: Growth inhibition by the test substance was observed.
( ): The inside shows the average value and standard deviation of three plates
Table 2: Results of Test 1 (+S9Mix)
Metabolic activation |
Dose of test substance (μg/plate) |
Number of revertants (colony count / plate) |
|||||
Base pair substitution type |
Frameshift type |
||||||
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA 1537 |
|||
S9 Mix (+) |
Negative control (DMSO) |
114 123 138 (125±12.1) |
8 9 7 (8±1.0) |
30 30 33 (31±1.7) |
22 27 26 (25±2.6) |
6 7 10 (8±2.1) |
|
9.77 |
NT |
11 10 7 (9±2.1) |
NT |
20 20 19 (20±0.6) |
8 7 10 (8±1.5) |
||
19.5 |
NT |
9 8 9 (9±0.6) |
NT |
18 21 26 (22±4.0) |
8 6 9 (8±1.5) |
||
39.1 |
116 121 110 (116±5.5) |
5 11 10 (9±3.2) |
22 31 38 (30±8.0) |
24 23 20 (22±2.1) |
5 8 8 (7±1.7) |
||
78.1 |
116 100 109 (108±8.0) |
11 10 8 (10±1.5) |
33 24 29 (29±4.5) |
21 20 24 (22±2.1) |
9 11 7 (9±2.0) |
||
156 |
110 91 111 (104±11.3) |
8 11 8 (9±1.7) |
26 25 23 (25±1.5) |
17 18 23 (19±3.2) |
7 6 8 (7±1.0) |
||
313 |
123 112 105 (113±9.1) |
5* 7* 7* (6±1.2) |
31 27 39 (32±6.1) |
22* 24* 18* (21±3.1) |
5* 7* 8* (7±1.5) |
||
625 |
90* 91* 103* (95±7.2) |
NT |
21 34 23 (26±7.0) |
NT |
NT |
||
1250 |
0* 0* 0* (0±0.0) |
NT |
0* 0* 0* (0±0.0) |
NT |
NT |
||
Positive controls |
S9Mix (with) |
Name |
B[α] P |
2AA |
2AA |
B[α] P |
B[α] P |
Dose (μg/plate) |
5.0 |
2.0 |
10.0 |
5.0 |
5.0 |
||
Number of colonies/ plate |
782 731 725 (746 ± 31. 3) |
359 288 344 (330±37.4) |
556 717 633 (635±80.8) |
338 337 376 (350±22.2) |
58 55 77 (63±11.9) |
Notes:
B[α] P: Benzo [α] pyrene
2AA: 2-Aminoanthracene
*: Growth inhibition by the test substance was observed.
NT: not tested
( ): The inside shows the average value and standard deviation of three plates.
Table 3: Results of Test 2 (-S9Mix)
Metabolic activation |
Dose of test substance (μg/plate) |
Number of revertants (colony count / plate) |
|||||
Base pair substitution type |
Frameshift type |
||||||
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA 1537 |
|||
S9 Mix (-) |
Negative control (DMSO) |
103 104 116 (108±7.2) |
10 7 10 (9±1.7) |
38 38 41 (39±1.7) |
24 21 19 (21±2.5) |
7 10 8 (8±1.5) |
|
39.1 |
85 91 112 (96±14.2) |
10 13 12 (12±1.5) |
39 36 33 (36±3.0) |
22 20 20 (21±1.2) |
6 7 10 (8±2.1) |
||
78.1 |
92 88 95 (92±3.5) |
10 10 12 (11±1.2) |
39 49 38 (42±6.1) |
21 22 16 (20±3.2) |
8 8 8 (8±0.0) |
||
156 |
116 97 111 (108±9.8) |
7 10 7 (8±1.7) |
44 44 28 (39±9.2) |
18 21 20 (20±1.5) |
15 10 11 (12±2.6) |
||
313 |
104 117 112 (111±6.6) |
6 10 8 (8±2.0) |
41 38 47 (42±4.6) |
19 13 18 (17±3.2) |
10 10 9 (10±0.6) |
||
625 |
53* 44* 69* (55±12.7) |
2* 5* 3* (3±1.5) |
34 31 30 (32±2.1) |
10* 11* 10* (10±0.6) |
0* 0* 0* (0±0) |
||
1250 |
0* 0* 0* (0±0) |
0* 0* 0* (0±0) |
0* 0* 0* (0±0) |
0* 0* 0* (0±0) |
0* 0* 0* (0±0) |
||
Positive controls |
S9Mix (without) |
Name |
AF-2 |
SAZ |
AF-2 |
AF-2 |
ICR-191 |
Dose (μg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
1.0 |
||
Number of colonies/ plate |
637 692 650 (660± 28.7) |
293 309 353 (318±31.1) |
118 102 106 (109±8.3) |
439 428 474 (447±24.0) |
1548 1594 1489 (1544±52.6) |
Notes:
AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
SAZ: Sodium azide
ICR-191: 2-Methoxy-6-chloro-9-[ 3-(2-chloro ethyl)-aminopropylamino] acridine · 2HC1
*: Growth inhibition by the test substance was observed.
( ): The inside shows the average value and standard deviation of three plates.
Table 4: Results of Test 2 (+S9Mix)
Metabolic activation |
Dose of test substance (μg/plate) |
Number of revertants (colony count / plate) |
|||||
Base pair substitution type |
Frameshift type |
||||||
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA 1537 |
|||
S9 Mix (+) |
Negative control (DMSO) |
120 108 114 (114±6.0) |
14 10 11 (12±2.1) |
42 44 30 (39±7.6) |
27 27 28 (27±0.6) |
13 10 10 (11±1.7) |
|
9.77 |
NT |
10 7 10 (9±1.7) |
NT |
28 25 22 (25±3.0) |
10 7 13 (10±3.0) |
||
19.5 |
NT |
7 10 6 (8±2.1) |
NT |
29 27 24 (27±2.5) |
9 7 8 (8±1.0) |
||
39.1 |
105 119 100 (108±9.8) |
11 11 10 (11±0.6) |
42 47 43 (44±2.6) |
25 30 27 (27±2.5) |
10 10 13 (11±1.7) |
||
78.1 |
125 114 116 (118±5.9) |
8 10 13 (10±2.5) |
51 40 39 (43±6.7) |
31 23 29 (28±4.2) |
7 6 7 (7±0.6) |
||
156 |
106 122 123 (117±9.5) |
8 9 6 (8±1.5) |
54 42 53 (50±6.7) |
30 29 29 (29±0.6) |
7 11 10 (9±2.1) |
||
313 |
119 133 114 (122±9.8) |
8* 10* 12* (10±2.0) |
39 37 41 (39±2.0) |
26* 27* 23* (25±2.1) |
8* 7* 7 (7±0.6) |
||
625 |
90* 104* 75* (90±14.5) |
NT |
38 38 47 (41±5.2) |
NT |
NT |
||
1250 |
0* 0* 0* (0±0.0) |
NT |
0* 0* 0* (0±0.0) |
NT |
NT |
||
Positive controls |
S9Mix (with) |
Name |
B[α] P |
2AA |
2AA |
B[α] P |
B[α] P |
Dose (μg/plate) |
5.0 |
2.0 |
10.0 |
5.0 |
5.0 |
||
Number of colonies/ plate |
727 771 804 (767 ± 38.6) |
379 339 352 (357±20.4) |
852 841 890 (861±25.7) |
288 266 253 (269±17.7) |
79 82 93 (85±7.4) |
Notes:
B[α] P: Benzo [α] pyrene
2AA: 2-Aminoanthracene
*: Growth inhibition by the test substance was observed.
NT: not tested
( ): The inside shows the average value and standard deviation of three plates.
Applicant's summary and conclusion
- Conclusions:
- Terpineol did not show any mutagenic effect in bacteria under test conditions with and without metabolic activation.
- Executive summary:
Terpineol was tested for mutagenecity on Salmonella typhimurium strains TA100, TA98, 1535 and TA1537 and Escherichia coli strain WP2 uvrA with and without metabolic activation (S9). The experiment was performed according to OECD guideline 471 with GLP. Based on growth inhibition examined in a preliminary test up to a maximum dose of 5000μg/plate, tested concentrations in the main test were: 39.1, 78.1, 156, 313, 625 and 1250μg/plate for all strains without metabolic activationand for strains TA 98, TA 1535 and TA 1537 with metabolic activation, and 9.77, 19.5,39.1, 78.1, 156 and 313μg/plate for strains TA 100 and E. Coli WP2 with metabolic activation. Two main tests were performed in triplicate using preincubation method and DMSO as solvent. Negative and positive controls were within background data of the test laboratory. Under test conditions, terpineol was found not mutagenic in all strains tested with and without metabolic activation.
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