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EC number: 947-711-0 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2000-11-08 to 2000-12-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 1-[rac-(1R,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol isomer 1 and 1-[rac-(1S,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol
- EC Number:
- 947-711-0
- Molecular formula:
- C14H28O
- IUPAC Name:
- Reaction mass of 1-[rac-(1R,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol isomer 1 and 1-[rac-(1S,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: besides being histidine auxotrophic, all strains carry an additional mutation (loss of outer lipopolysaccharide barrier) which increases cell permeability
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix, Aroclor 1254 induced
- Test concentrations with justification for top dose:
- 0, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: distilled water and DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Aminoanthracene
- Remarks:
- 9-Aminoacridine, mitomycin C, and sodium azide were dissolved in distilled water. 2-Aminoanthracene, and 2-nitrofluorene were dissolved in DMSO.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation);
DURATION
- Exposure duration: 48 - 72 h
NUMBER OF REPLICATIONS: 3 parallel plates (2 independent experiments)
DETERMINATION OF CYTOTOXICITY
- Method: counting of the number of revertant colonies (his+ revertants)
OTHER EXAMINATIONS:
- Examination for the existente of a normal background lawn and/or precipitates and microscopically for microcolony growth - Evaluation criteria:
- The number of spontaneous revertants observed using each of the five strains and the results with the positive controls were compared to historical control data. Differences between the number of revertants in the negative controls and the test plates were tested for significance.
- Statistics:
- Estimation of the statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level was performed using a X2-test.
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:
- with S9 mix - at 5000 µg/plate; without S9 mix - at 1500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- with and without S9 mix - at 1500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- with S9 mix - at 5000 µg/plate; without S9 mix - at 1500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- with S9 mix - at 1500 µg/plate; without S9 mix - at 500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- with S9 mix - at 500 µg/plate; without S9 mix - at 150 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation of the test substance on the plates was observed at 5000 μg/plate. The test substance failed to induce a significant increase in the mutation frequency of the tester strains in the absence and presence of a metabolic activation system. The X2 test did not reveal a significant effect at any of the test points.
HISTORICAL CONTROL DATA
- historical overview of the revertant frequencies of the strains used of the years 1998 to 2000
- TA1535 -S9: 30 ± 14, +S9: 19 ± 5
- TA1537 -S9: 10 ± 4, +S9: 16 ± 5
- TA98 -S9: 29 ± 8, +S9: 40 ± 10
- TA100 -S9: 134 ± 31, +S9: 118 ± 26
- TA102 -S9: 279 ± 41, +S9: 307 ± 45
Any other information on results incl. tables
Table 1: Number of revertants per plate (mean of three plates), Experiment 1
Substance |
conc. [µg/plate] |
strain TA 98 |
Strain TA 100 |
strain TA 102 |
strain TA 1535 |
strain TA 1537 |
|||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
||
Control |
0 |
18 |
24 |
133 |
129 |
309 |
284 |
22 |
10 |
10 |
11 |
Solvent control |
0 |
17 |
24 |
123 |
122 |
250 |
268 |
23 |
10 |
9 |
13 |
Test item 1 |
5 |
20 |
25 |
|
|
251 |
292 |
|
|
|
|
Test item 2 |
15 |
15 |
21 |
102 |
|
259 |
295 |
|
|
|
|
Test item 3 |
50 |
17 |
23 |
92 |
126 |
205 |
299 |
28 |
11 |
6 |
14 |
Test item 4 |
150 |
17 |
28 |
101 |
119 |
193 |
270 |
16 |
10 |
7 |
14 |
Test item 5 |
500 |
16 |
21 |
100 |
95 |
171 T |
204 T |
10 |
9 |
6 |
11 |
Test item 6 |
1500 |
17 |
22 |
87 T |
98 |
95 T |
161 T |
6 T |
7 |
4 T |
9 |
Test item 7 |
5000 P |
8 T |
15 T |
|
92 T |
|
|
5 T |
6 T |
4 T |
4 T |
Sodium azide |
0.7 |
|
|
560 |
|
|
|
817 |
|
|
|
2-Nitrofluorene 2-NF |
2.5 |
283 |
|
|
|
|
|
|
|
|
|
9-Aminoacridine |
50 |
|
|
|
|
|
|
|
|
583 |
|
Mitomycin C |
0.15 |
|
|
|
|
959 |
|
|
|
|
|
2-aminoanthracene |
0.8 1.7 |
|
687
|
|
1035
|
|
747
|
|
207
|
|
231 |
-MA: absence of metabolic activation
+MA: presence of metabolic activation
P: precipitation of test item
T: bacteriotoxic
solvent control: DMSO, 50 µL/plate
Table 2: Number of revertants per plate (mean of three plates), Experiment 2
Substance |
conc. [µg/plate] |
strain TA 98 |
Strain TA 100 |
strain TA 102 |
strain TA 1535 |
strain TA 1537 |
|||||
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
||
Control |
0 |
24 |
24 |
115 |
123 |
351 |
293 |
16 |
9 |
14 |
15 |
Solvent control |
0 |
21 |
22 |
106 |
106 |
326 |
308 |
20 |
10 |
16 |
15 |
Test item 1 |
5 |
|
|
112 |
|
273 |
294 |
19 |
|
10 |
|
Test item 2 |
15 |
|
|
92 |
99 |
270 |
287 |
22 |
|
13 |
15 |
Test item 3 |
50 |
16 |
18 |
98 |
124 |
205 |
270 |
20 |
13 |
9 |
14 |
Test item 4 |
150 |
14 |
20 |
81 |
120 |
168 T |
246 |
14 |
9 |
9 |
16 |
Test item 5 |
500 |
9 |
19 |
71 T |
113 |
150 T |
224 T |
17 |
9 |
8 |
13 |
Test item 6 |
1500 |
10 T |
19 |
|
83 T |
|
|
|
6 |
|
7 T |
Test item 7 |
5000 P |
12 T |
14 T |
|
|
|
|
|
7 |
|
|
Sodium azide |
0.7 |
|
|
317 |
|
|
|
789 |
|
|
|
2-Nitrofluorene 2-NF |
2.5 |
355 |
|
|
|
|
|
|
|
|
|
9-Aminoacridine |
50 |
|
|
|
|
|
|
|
|
333 |
|
Mitomycin C |
0.15 |
|
|
|
|
855 |
|
|
|
|
|
2-aminoanthracene |
0.8 1.7 |
|
453
|
|
735
|
|
383
|
|
141
|
|
197 |
-MA: absence of metabolic activation
+MA: presence of metabolic activation
P: precipitation of test item
T: bacteriotoxic
solvent control: DMSO, 50 µL/plate
Applicant's summary and conclusion
- Conclusions:
- The test substance was not mutagenic in the bacterial reverse mutation assay.
- Executive summary:
The genetic toxicity of the test item was tested according to OECD 471 and Regulation (EC) No. B13/14. The mutagenicity of the test substance was studied with five mutant strains of Salmonella typhimurium (TA1535, TA1537, TA98; TA100, and TA102). The investigations were carried using the standard plate incorporation assay with and without liver homogenate (S9) from Aroclor 1254 pretreated male rats as metabolic activation system. The test substance was dissolved in DMSO and tested in concentrations 5, 15, 50, 150, 500, 1500 and 5000 µg/plate in the presence and absence of S9 mix. The test substance was basteriotoxic towards all tested strain at different concentration levels in the presence and absence of S9 mix. Sodium azide, 2-nitrofluorene, 9-aminoacridine, mitomycin C, and 2-aminoanthracene served as positive controls to confirm the reversion properties and the specificity of the bacterial strains as well as the efficacy of the metabolizing system.
In the tested concentration range, the test substance did not induce a significant increase in the mutation frequency of the tester strains with and without metabolic activation. In conclusion, these results indicate that the test substance under the experimental conditions described, was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA102 in the presence and absence of a metabolizing system.
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