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EC number: 701-188-3 | CAS number: -
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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:
- 7 March 2006 - 9 May 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study in compliance with OECD guideline 471 without any deviation.
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:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (R)-α,α,4-trimethylcyclohex-3-ene-1-methanol
- EC Number:
- 232-081-5
- EC Name:
- (R)-α,α,4-trimethylcyclohex-3-ene-1-methanol
- Cas Number:
- 7785-53-7
- Molecular formula:
- C10H18O
- IUPAC Name:
- α,α-4-trimethyl-(1R)-3-cyclohexene-1-methanol
- Reference substance name:
- p-menth-1-en-8-ol
- EC Number:
- 233-986-8
- EC Name:
- p-menth-1-en-8-ol
- Cas Number:
- 10482-56-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- α,α-4-trimethyl-(1S)-3-cyclohexene-1-methanol
- Reference substance name:
- 1-methyl-4-(1-methylethylidene)cyclohexan-1-ol
- EC Number:
- 209-584-3
- EC Name:
- 1-methyl-4-(1-methylethylidene)cyclohexan-1-ol
- Cas Number:
- 586-81-2
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1-methyl-4-(1-methylethylidene)-cyclohexanol
- Reference substance name:
- cis-4-isopropenyl-1-methylcyclohexanol
- Cas Number:
- 7299-41-4
- Molecular formula:
- C10H18O
- IUPAC Name:
- cis-4-isopropenyl-1-methylcyclohexanol
- Reference substance name:
- 4-(isopropyl)-1-methylcyclohex-3-en-1-ol
- EC Number:
- 209-585-9
- EC Name:
- 4-(isopropyl)-1-methylcyclohex-3-en-1-ol
- Cas Number:
- 586-82-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- 4-isopropyl-1-methyl-3-cyclohexen-1-ol
- Reference substance name:
- 1-methyl-4-[1-1-(1-methylethoxy)ethyl]-cyclohexene
- Cas Number:
- 27153-55-5
- Molecular formula:
- C13H24O
- IUPAC Name:
- 1-methyl-4-[1-1-(1-methylethoxy)ethyl]-cyclohexene
- Reference substance name:
- trans-1-methyl-4-(1-methylethenyl)-cyclohexanol
- Cas Number:
- 7299-40-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- trans-1-methyl-4-(1-methylethenyl)-cyclohexanol
- Reference substance name:
- (1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
- EC Number:
- 208-135-9
- EC Name:
- (1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 512-13-0
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,3,3-trimethyl-(1S,2S,4R)-bicyclo[2.2.1]heptan-2-ol
- Reference substance name:
- 1,3,3-trimethyl-(1R,2R,4S)-bicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 2217-02-9
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,3,3-trimethyl-(1R,2R,4S)-bicyclo[2.2.1]heptan-2-ol
- Reference substance name:
- (1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol
- EC Number:
- 207-353-1
- EC Name:
- (1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 464-45-9
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,7,7-trimethyl-(1S,2R,4S)- bicyclo[2.2.1]heptan-2-ol
- Reference substance name:
- (1R,2S,4R)-borneol
- EC Number:
- 207-352-6
- EC Name:
- (1R,2S,4R)-borneol
- Cas Number:
- 464-43-7
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,7,7-trimethyl-(1R,2S,4R)-bicyclo[2.2.1]heptan-2-ol
- Test material form:
- liquid
- Details on test material:
- Batch No.: 049807
Purity: 67.2% (sum of the three main constituents)
Name of test material (as cited in study report): TERPINEOL MULTICONSTITUENT
Physical state: colourless liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 30 November 2017
Constituent 1
Constituent 2
Constituent 3
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
impurity 7
impurity 8
Method
- Target gene:
- Not applicable
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: bacterial broth medium
- Properly maintained: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- - Type and identity of media: bacterial broth medium
- Properly maintained: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 fraction from Sprague Dawley rats treated with beta-naphtoflavone and phenobarbital
- Test concentrations with justification for top dose:
- Cytotoxicity test: 50, 150, 500, 1500 and 5000 µg/plate
Main test: 19, 56, 167, 500 and 1500 µg/plate - Vehicle / solvent:
- DMSO
- Justification for choice of solvent/vehicle: test substance not soluble in aqueous vehicles
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: See table 1
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period (before treatment): 13 h at 37°C
- Preincubation period (with test substance) in the second main experiment with S9: 30 min
- Exposure duration: 48 h at 37 °C
- Expression time (cells in growth medium): 48 h at 37 °C
SELECTION AGENT (mutation assays): minimum medium
NUMBER OF REPLICATIONS:
- cytotoxicity test: 1
- main test: 3
DETERMINATION OF CYTOTOXICITY
- Method: number of revertants
OTHER: 2 mL agar, 0.1 mL of test substance dilution, 0.1 mL of bacterial culture and 0.5 mL of S9 mix (when appropriate) were plated on solid minimum medium - Evaluation criteria:
- - statistically significant ratio (revertants with test substance / revertants with solvent) higher than 2 for TA 98, TA 100 and TA 102, and higher than 3 for TA 1535 and TA 1537
- increase in the number of revertants linked with the increase in test substance concentration
- reproducible results - Statistics:
- Dunett's test on revertants with test substance / revertants with solvent ratios.
Results and discussion
Test resultsopen allclose all
- Key result
- 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:
- cytotoxicity
- Remarks:
- at 5000 µg/plate for all strains and slightly to strong at 1500 µg/plate depending on the strains
- 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:
- cytotoxicity
- Remarks:
- strong at 1500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation of the test substance was observed
RANGE-FINDING/SCREENING STUDIES: see table 4 for cytotoxicity results - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 2: results of the first main experiment
Strain |
Compound |
Dose level (µg/plate) |
S9 mix |
Mean revertant colony counts |
SD |
Ratio treated/solvent |
Individual revertant colony counts |
TA 98 |
DMSO
2 nitrofluorene
DMSO
2-aminoanthracene |
19 56 167 500 1500 1
19 56 167 500 1500 2 |
- - - - - - -
+ + + + + + + |
19 18 17 17 17 5 319
22 23 25 25 24 20 2653 |
4 2 3 3 4 5 46
5 6 7 4 7 4 150 |
0.9 0.9 0.9 0.9 0.3 *
1.0 1.1 1.1 1.1 0.9
|
23, 16, 19 19, 20, 16 14, 18, 20 19, 19, 14 13, 21, 17 3, 2, 11 320, 364, 273
27, 22, 18 16, 27, 25 29, 17, 29 30, 22, 23 18, 23, 32 24, 19, 17 2520, 2624, 2816 |
TA 100 |
DMSO
Sodium azide
DMSO
2-aminoant-racene |
19 56 167 500 1500 1.5
19 56 167 500 1500 2 |
- - - - - - -
+ + + + + + + |
74 81 79 90 85 60 155
94 137 140 105 120 102 3397 |
6 6 16 12 12 17 15
12 3 3 3 14 9 411 |
1.1 1.0 1.2 1.1 0.8
1.5 * 1.5 * 1.1 1.3 * 1.1
|
71, 81, 70 74, 86, 82 65, 76, 97 79, 102, 89 95, 71, 88 79, 46, 55 141, 154, 171
102, 80, 101 135, 140, 136 140, 137, 142 106, 107, 102 105, 125, 131 107, 108, 92 3152, 3872, 3168 |
TA 102 |
DMSO
Mitomycine C
DMSO
Benzo(a)pyrene |
19 56 167 500 1500 0.125
19 56 167 500 1500 4 |
- - - - - - -
+ + + + + + + |
192 193 225 125 73 0 1339
214 232 266 158 153 5 436 |
8 30 8 50 29 0 368
16 35 23 9 32 3 26 |
1.0 1.2 0.7 * 0.4 * 0.0 *
1.1 1.2 0.7 * 0.7 * 0.0 *
|
188, 186, 201 228, 172, 180 232, 216, 228 156, 68, 152 63, 51, 106 1060, 1200, 1756
208, 232, 201 212, 272, 212 288, 268, 242 158, 167, 149 176, 167, 116 3, 4, 8 464, 414, 429 |
TA 1535 |
DMSO
Azide sodium
DMSO
2-aminoanthracene |
19 56 167 500 1500 1.5
19 56 167 500 1500 2 |
- - - - - - -
+ + + + + + + |
13 13 14 16 10 2 685
11 6 8 9 9 4 111 |
4 1 1 7 4 2 24
2 1 2 1 1 1 35 |
1.1 1.1 1.3 0.8 0.1 *
0.5 * 0.7 * 0.8 0.8 0.3 * |
14, 8, 16 13, 13, 14 14,14, 15 9, 22, 17 5, 12, 12 0, 4, 1 658, 704, 694
11, 12, 9 6, 6, 5 7, 10, 6 8, 9, 9 8, 8, 10 3, 4, 4 149, 81, 103 |
TA 1537 |
DMSO
9-aminoacridine
DMSO
2-aminoanthracene |
19 56 167 500 1500 40
19 56 167 500 1500 2 |
- - - - - - -
+ + + + + + + |
10 6 7 10 6 7 957
7 6 4 9 8 3 192 |
6 4 2 1 2 2 93
3 1 1 2 3 3 28 |
0.5 0.7 1.0 0.5 0.6
0.8 0.6 1.3 1.1 0.4 *
|
17, 5, 9 3, 4, 10 5, 7, 9 10, 10, 11 7, 4, 6 9, 6, 5 1002, 1018, 850
10, 5, 7 5, 6, 7 4, 4, 5 7, 11, 10 6, 7, 12 6, 2, 1 161, 202, 214 |
* statistically significant (p<0.05)
Table 3: results of the second main experiment
Strain |
Compound |
Dose level (µg/plate) |
S9 mix |
Mean revertant colony counts |
SD |
Ratio treated/solvent |
Individual revertant colony counts |
TA 98 |
DMSO
nitro-2-fluorene
DMSO
2-aminoanthracene |
19 56 167 500 1500 1.5
19 56 167 500 1500 1 |
- - - - - - -
+ + + + + + + |
22 22 15 22 16 6 360
21 28 28 27 13 2 1229 |
5 4 2 2 3 2 60
9 6 2 9 6 4 85 |
1.0 0.7 * 1.0 0.7 0.3 *
1.3 1.3 1.3 0.6 0.1 *
|
23, 16, 26 24, 24, 17 16, 15, 13 23, 20, 24 19, 13, 15 8, 5, 6 316, 428, 336
30, 13, 20 33, 22, 28 29, 29, 26 35, 27, 18 20, 8, 11 0, 0, 7 1140, 1308, 1240 |
TA 100 |
DMSO
Sodium azide
DMSO
2-aminoanthracene |
19 56 167 500 1500 1.5
19 56 167 500 1500 1 |
- - - - - - -
+ + + + + + + |
90 80 67 90 78 54 201
94 92 97 129 82 36 808 |
8 8 7 12 18 1 20
3 8 19 23 16 49 78 |
0.9 0.7 * 1.0 0.9 0.6 *
1.0 1.0 1.4 0.9 0.4 *
|
92, 82, 97 72, 87, 80 72, 59, 70 91, 78, 101 59, 80, 95 54, 54, 55 223, 185, 195
92, 93, 97 98, 83, 95 114, 100, 77 102, 138, 146 64, 95, 86 0, 16, 92 812, 884, 728 |
TA 102 |
DMSO
Mitomycine C
DMSO
Benzo(a)pyrene |
19 56 167 500 1500 0.125
19 56 167 500 1500 2 |
- - - - - - -
+ + + + + + + |
180 205 159 154 105 4 1131
107 137 110 98 93 0 214 |
47 33 15 10 8 4 110
10 4 19 14 19 0 18 |
1.1 0.9 0.9 0.6 * 0.0 *
1.3 * 1.0 0.9 0.9 0.0 *
|
228, 178, 134 228, 168, 220 175, 147, 154 150, 147, 165 95, 110, 109 0, 8, 4 1192, 1004, 1196
100, 118, 103 142, 136, 134 93, 131, 106 113, 85, 95 76, 88, 114 0, 0, 0 218, 229, 194 |
TA 1535 |
DMSO
Azide sodium
DMSO
2-aminoanthracene |
19 56 167 500 1500 1.5
19 56 167 500 1500 1 |
- - - - - - -
+ + + + + + + |
13 16 18 13 11 6 647
9 11 10 5 3 0 218 |
2 2 2 1 3 2 50
3 2 3 2 2 0 12 |
1.2 1.3 1.0 0.8 0.4 *
1.2 1.1 0.6 0.3 * 0.0 * |
15, 12, 13 15, 15, 18 19, 18, 16 12, 13, 13 11, 8, 14 7, 7, 3 670, 590, 682
6, 10, 12 10, 11, 13 13, 9, 8 7, 5, 4 2, 5, 1 0, 0, 0 205, 229, 219 |
TA 1537 |
DMSO
9-aminoacridine
DMSO
2-aminoanthracene |
19 56 167 500 1500 40
19 56 167 500 1500 1 |
- - - - - - -
+ + + + + + + |
10 7 10 6 7 3 336
6 9 7 7 9 0 45 |
1 4 3 4 4 3 118
2 0 1 2 14 0 6 |
0.7 1.0 0.6 0.6 0.3 *
1.4 1.2 1.1 1.5 0.0 * |
11, 11, 9 12, 4, 5 13, 10, 8 11, 4, 4 3, 10, 7 0, 3, 6 468, 242, 298
5, 8, 6 9, 9, 9 7, 8, 7 5, 7, 8 26, 2, 0 0, 0, 0 38, 49, 48 |
* statistically significant (p<0.05)
Applicant's summary and conclusion
- Conclusions:
- Terpineol multiconstituent was found not to be mutagenic in TA 98, TA 100, TA 102, TA 1535 and TA 1537 with and without metabolic activation.
- Executive summary:
In a reverse gene mutation assay in bacteria, performed according to OECD Guideline 471 and in compliance with GLP, strains of S. typhimurium (TA 98, TA 100, TA 102, TA 1535 and TA 1537) were exposed to Terpineol multiconstituent at concentrations of 50, 150, 500, 1500 and 5000 µg/plate in both the absence and presence of S9 metabolic activation according to the direct plate incorporation method for a preliminary cytotoxicity test. In the main test, two experiments were performed at 19, 56, 167, 500 and 1500 µg/plate (up to cytotoxic concentrations) in both the absence and presence of S9. These experiments were performed according to the direct plate incorporation method except for the second experiment with S9 which was performed with a pre incubation period of 30 min with the test substance and S9 mix.
The positive controls induced the appropriate responses in the corresponding strains. Terpineol multiconstituent showed no biologically 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 S9 mix.
This study is classified as acceptable and satisfies the requirement for bacterial reverse gene mutation endpoint.
Therefore, Terpineol multiconstituent is not considered as mutagenic in this bacterial system according to CLP Regulation (EC) No 1272/2008.
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