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EC number: - | CAS number: 20126-76-5
- 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
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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:
- 6 - 22 Dec 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- June 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Niedersächsisches Umweltministerium, Hannover, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (1R)-1-isopropyl-4-methyl-cyclohex-3-en-1-ol
- Cas Number:
- 20126-76-5
- Molecular formula:
- C10H18O
- IUPAC Name:
- (1R)-1-isopropyl-4-methyl-cyclohex-3-en-1-ol
Constituent 1
Method
- Target gene:
- his operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium, other: TA 97a
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats treated with phenobarbital (i.p.) and β-naphthoflavone (oral)
- Test concentrations with justification for top dose:
- Experiment 1:
16, 50, 160, 500 and 1600 µg/plate with and without metabolic activation
Experiment 2:
16, 50, 160, 500 and 1600 µg/plate with and without metabolic activation in TA 97a
50, 160, 500, 1600 and 5000 µg/plate with and without metabolic activation in TA 98 and TA 102
16, 50, 160, 500 and 1600 µg/plate without metabolic activation in TA 100 and TA 1535
50, 160, 500, 1600 and 5000 µg/plate with metabolic activation in TA 100 and TA 1535 - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: ICR 191 acridine mutagen dihydrochloride (ICR 191), 2-aminoanthracene (2-AA), 4-nitro-1,2-phenylenediamine (4-NOPD), nitrofurantoine (NF), cumene hydroperoxide (CUHP), dantron
- Remarks:
- +S9: 2-AA (2.0 µg/plate, TA97a, TA98, TA100 and TA1535); dantron (30 µg/plate, TA102); -S9: ICR 191 (0.5 µg/plate, TA97a); NaN3 (0.25 µg/plate, TA1535); 4-NOPD (0.5 µg/plate, TA98); NF (0.2 µL/plate, TA100); CUHP (100 µg/plate, TA102)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: at least 48 h
NUMBER OF REPLICATIONS: triplicates each in 2 independent experiment
DETERMINATION OF CYTOTOXICITY
- Method: reduced bacterial background lawn - Evaluation criteria:
- Since a reduced background lawn is regarded to be a cytotoxic effect, plates with reduced background Iawn were not included into evaluation procedures.
The test substance is considered as mutagenic if there is a concentration effect relationship and the induction rate is ≥ 2. - Statistics:
- Mean values and standard deviations were calculated.
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:
- cytotoxicity
- Remarks:
- Exp. 1: -S9: at 1600 µg/plate; Exp. 2: -S9: at 1600 µg/plate, +S9: at 5000 µg/plate
- 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:
- cytotoxicity
- Remarks:
- Exp. 2: -S9 and +S9: at 5000 µg/plate
- 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:
- cytotoxicity
- Remarks:
- Exp. 1: -S9: at 1600 µg/plate; Exp. 2: -S9: at 1600 µg/plate, +S9: at 5000 µg/plate
- 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:
- Exp. 2: -S9 and +S9: at 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. 1 and 2: -S9 and +S9: at 1600 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Test results of Experiment 1 (plate incorporation).
With or without S9-Mix |
Test substance concentration [μg/plate] |
Mean number of revertant colonies per plate (average of 3 plates ± SD) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA1535 |
TA100 |
TA102 |
TA97a |
TA98 |
||
- |
0 (DMSO) |
24 ± 6.1 |
151 ± 42.2 |
427 ± 73.1 |
391 ± 9.9 |
34 ± 0.6 |
- |
16 |
17 ± 4.4 |
143 ± 6.1 |
465 ± 65.9 |
441 ± 72.6 |
26 ± 7.8 |
- |
50 |
19 ± 7.5 |
141 ± 5.9 |
400 ± 24.0 |
422 ± 7.1 |
28 ± 4.0 |
- |
160 |
8 ± 3.0 |
145 ± 12.9 |
435 ± 54.0 |
386 ± 11.7 |
28 ± 1.7 |
- |
500 |
14 ± 2.0 |
119 ± 20.2 |
388 ± 14.5 |
354 ± 15.6 |
27 ± 3.2 |
- |
1600 |
t |
t |
177 ± 18.7 |
t |
18 ± 8.7 |
Positive controls, –S9 |
Name |
NaN3 |
NF |
CUHP |
ICR 191 |
4-NOPD |
Concentration [μg/plate] |
0.25 |
0.2 |
100 |
0.5 |
0.5 |
|
Induction rate |
9.0 |
2.4 |
> 2.8 |
> 3.1 |
3.6 |
|
+ |
0 (DMSO) |
14 ± 2.1 |
130 ± 2.1 |
538 ± 57.5 |
315 ± 66.2 |
37 ± 4.5 |
+ |
16 |
8 ± 4.0 |
136 ± 2.0 |
454 ± 49.2 |
371 ± 23.4 |
34 ± 2.6 |
+ |
50 |
12 ± 4.0 |
137 ± 11.0 |
406 ± 38.2 |
347 ± 27.2 |
35 ± 2.1 |
+ |
160 |
10 ± 5.5 |
140 ± 15.5 |
443 ± 46.3 |
358 ± 62.4 |
35 ± 7.6 |
+ |
500 |
11 ± 2.5 |
127 ± 8.4 |
439 ± 41.6 |
262 ± 86.7 |
39 ± 1.2 |
+ |
1600 |
10 ± 5.0 |
75 ± 9.1 |
337 ± 23.8 |
t |
51 ± 14.6 |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
Dantron |
2-AA |
2-AA |
Concentration [μg/plate] |
2.0 |
2.0 |
30 |
2.0 |
2.0 |
|
Induction rate |
9.8 |
> 9.3 |
> 2.2 |
> 3.8 |
> 32.1 |
NaN3: sodium azide
4-NOPD: 4-nitro-1,2-phenylene-diamine
2-AA: 2-aminoanthracene
ICR 191: ICR 191 acridine mutagen dihydrochloride
NF: nitrofurantoine
CUHP: cumene hydroperoxide
t: toxic (reduced background lawn; not counted)
Table 2. Test results of Experiment 2 (plate incorporation).
With or without S9-Mix |
Test substance concentration [μg/plate] |
Mean number of revertant colonies per plate (average of 3 plates ± SD) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA1535 |
TA100 |
TA102 |
TA97a |
TA98 |
||
- |
0 (DMSO) |
15 ± 4.7 |
118 ± 8.3 |
354 ± 34.8 |
368 ± 72.3 |
18 ± 3.0 |
- |
16 |
11 ± 1.5 |
103 ± 14.2 |
- |
467 ± 47.3 |
- |
- |
50 |
8 ± 4.0 |
122 ± 25.3 |
338 ± 33.2 |
419 ± 7.1 |
30 ± 3.6 |
- |
160 |
8 ± 2.0 |
110 ± 4.6 |
315 ± 18.3 |
396 ± 17.1 |
28 ± 2.6 |
- |
500 |
15 ± 6.6 |
101 ± 15.0 |
312 ± 24.2 |
392 ± 100.1 |
28 ± 5.7 |
- |
1600 |
t |
t |
151 ± 22.6 |
t |
36 ± 3.6 |
- |
5000 |
- |
- |
t |
- |
t |
Positive controls, –S9 |
Name |
NaN3 |
NF |
CUHP |
ICR 191 |
4-NOPD |
Concentration [μg/plate] |
0.25 |
0.2 |
100 |
0.5 |
0.5 |
|
Induction rate |
9.9 |
3.2 |
> 3.4 |
> 3.3 |
5.3 |
|
+ |
0 (DMSO) |
13 ± 3.5 |
134 ± 4.9 |
488 ± 107.0 |
338 ± 38.8 |
34 ± 6.1 |
+ |
16 |
- |
- |
- |
368 ± 31.4 |
- |
+ |
50 |
10 ± 3.2 |
107 ± 22.5 |
279 ± 26.0 |
354 ± 11.1 |
32 ± 4.0 |
+ |
160 |
11 ± 3.5 |
97 ± 11.1 |
314 ± 16.4 |
311 ± 21.2 |
35 ± 0.6 |
+ |
500 |
9 ± 2.1 |
105 ± 22.3 |
294 ± 8.3 |
329 ± 12.0 |
34 ± 6.1 |
+ |
1600 |
8 ± 2.0 |
75 ± 4.2 |
192 ± 27.2 |
t |
50 ± 7.0 |
+ |
5000 |
t |
t |
t |
- |
t |
Positive controls, +S9 |
Name |
2-AA |
2-AA |
Dantron |
2-AA |
2-AA |
Concentration [μg/plate] |
2.0 |
2.0 |
30 |
2.0 |
2.0 |
|
Induction rate |
6.3 |
> 8.9 |
> 2.5 |
> 3.6 |
> 35.3 |
NaN3: sodium azide
4-NOPD: 4-nitro-1,2-phenylene-diamine
2-AA: 2-aminoanthracene
ICR 191: ICR 191 acridine mutagen dihydrochloride
NF: nitrofurantoine
CUHP: cumene hydroperoxide
t: toxic (reduced background lawn; not counted)
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted test the substance was not mutagenic in any of the five strains (TA 97a, TA 98, TA 100, TA 102 and TA 1535) tested with and without metabolic activation up to cytotoxic concentrations or 5000 µg/plate.
- Executive summary:
A bacterial gene mutation assay with the test substance was performed in accordance with OECD Guideline 471 and in compliance with GLP (2001). In this study the substance was not mutagenic in any of the five strains (TA 97a, TA 98, TA100, TA 102 and TA 1535) tested with and without metabolic activation up to cytotoxic concentrations or 5000 µg/plate.
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