Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 279-815-0 | CAS number: 81782-77-6
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 September to 03 October 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-methyl-3-decen-5-ol
- EC Number:
- 279-815-0
- EC Name:
- 4-methyl-3-decen-5-ol
- Cas Number:
- 81782-77-6
- Molecular formula:
- C11H22O
- IUPAC Name:
- 4-methyldec-3-en-5-ol
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- Histidine requirement
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Samples of frozen stock cultures of bacteria were transferred into enriched nutrient broth (Oxoid no. 2) and incubated in a shaking incubator (37 °C, 150 spm), until the cultures reached an optical density of 1.0 ± 0.1 at 700 nm (10^9 cells/mL). Freshly grown cultures of each strain were used for a test.- Properly maintained: yes stock cultures were stored in liquid nitrogen (-196 °C).- Periodically "cleansed" against high spontaneous background: yes (strains were also checked for other genotypic properties)
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-1254 induced rat liver S9 mix
- Test concentrations with justification for top dose:
- 3, 10, 33, 100, 333, 1000, 3330, 5000 µg/plate (Rangefinding test I - TA 100 - direct plate assay) both in the presence and absence of metabolic activation3, 10, 33, 100, 333, 1000, 3330, 5000 µg/plate (Rangefinding test II - TA 100 - preincubation assay) both in the presence and absence of metabolic activation1, 3, 10, 33, 100, 333 µg/plate (Direct plate assay I - TA 1535, TA 1537, TA 98 and TA 102 - without metabolic activation); 3, 10, 33, 100, 333, 1000 µg/plate (Direct plate assay I - TA 1535, TA 1537, TA 98 and TA 102 - with metabolic activation)100, 333, 1000, 2000 µg/plate (Direct plate assay II - TA 102 - without metabolic activation)0.3, 1, 3, 10, 33, 100 µg/plate (Preincubation assay I - TA 1535, TA 1537, TA 98 and TA 102 - without metabolic activation); 1, 3, 10, 33, 100, 333 µg/plate (Preincubation assay I - TA 1535, TA 1537, TA 98 and TA 102 - with metabolic activation)33, 100, 166, 333 µg/plate (Preincubation assay II - TA 1535 without metabolic activation)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- cumene hydroperoxide
- methylmethanesulfonate
- other: daunomycin, 2-aminoanthracene, 1,8 dihydroxyanthraquinone
- Details on test system and experimental conditions:
- The mutagenicity of the test material was evaluated using two methods, the plate incorporation method and the preincubation method.PLATE INCORPORATION ASSAYMETHOD OF APPLICATION: in agar (plate incorporation)0.1 mL of a fresh bacterial culture (10⁹ cells/mL) of one of the tester strains was added to 0.1 mL of a dilution of the test material in DMSO and either 0.5 mL of S9 mix or 0.5 mL 0.1 M phosphate buffer, dependant if the test was with metabolic activation or without. Top agar in top agar tubes was molten and heated to 45 °C. The culture/test material solution was added successively to 3 mL molten top agar. This mixture was then mixed in a Vortex and the content of the top agar tube was poured onto a selective agar plate. After solidification of the top agar, the plates were turned and incubated in the dark at 37 °C.DURATION- Exposure duration: 48 hoursNUMBER OF REPLICATIONS: triplicateDETERMINATION OF CYTOTOXICITY- Method: Reduction in background lawn, increase in size of microcolonies and reduction of the revertant colonies.PREINCUBATION ASSAYMETHOD OF APPLICATION: preincubation0.1 mL of a fresh bacterial culture (10⁹ cells/mL) of one of the tester strains was added to 0.1 mL of a dilution of the test material in DMSO and either 0.5 mL of S9 mix or 0.5 mL 0.1 M phosphate buffer, dependant if the test was with metabolic activation or without. The solution was preincubated for at 70 rpm and 37 °C. After the preincubation period the solution was added to 3 mL of molten top agar. The ingredients were mixed in a Vortex and incubated at 37 °C.DURATION- Preincubation period: 30 minutes- Exposure duration: 48 hoursNUMBER OF REPLICATIONS: TriplicateDETERMINATION OF CYTOTOXICITY- Method: Reduction in background lawn, increase in size of microcolonies and reduction of the revertant colonies.
- Evaluation criteria:
- Colonies were counted automatically with a Protos model 50000 colony counter or manually, if there were < 40 colonies per plate.The test is considered negative or not mutagenic if it meets the following criteria:- The total number of revertants in any tester strain at any concentration if not greater than two times the solvent control value, with or without metabolic activation.- The negative response should be reproducible in at least one repeated experiment.The test is considered positive or mutagenic if it meets the following criteria;- It induces at least a 2 fold, dose related increase in the number of revertants with respect to the number induced by the solvent control in any of the tester strains, either with or without metabolic activation (any mean plate count of less that 20 is not considered significant).- The positive response should be reproducible in at least one repeated experiment.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- The test material did not induce a dose-related increase in the number of revertant colonies in each of the five tester strains, both in the presence and absence of metabolic activation. These results were confirmed in separate experiments.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- With the exception of the TA 102 in the 1st plate incorporation assay and TA 1535 in the preincubation assay in the absence of S9, toxicity was observed. Additional plate incorporation and preincubation assays were performed with a higher dose range
- 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 and without
- Genotoxicity:
- negative
- Remarks:
- The test material did not induce a dose-related increase in the number of revertant colonies in each of the five tester strains, both in the presence and absence of metabolic activation. These results were confirmed in separate experiments.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- With the exception of the preincubation assay in the absence of S9, toxicity was observed. Additional plate incorporation and preincubation assays were performed with a higher dose range
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- With the exception of the TA 102 in the 1st plate incorporation assay and TA 1535 in the preincubation assay in the absence of S9, toxicity was observed. Additional plate incorporation and preincubation assays were performed with a higher dose range
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- 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
- Remarks:
- With the exception of the TA 102 in the 1st plate incorporation assay and TA 1535 in the preincubation assay in the absence of S9, toxicity was observed. Additional plate incorporation and preincubation assays were performed with a higher dose range
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- 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
- Remarks:
- With the exception of the TA 102 in the 1st plate incorporation assay and TA 1535 in the preincubation assay in the absence of S9, toxicity was observed. Additional plate incorporation and preincubation assays were performed with a higher dose range
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- 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
- Remarks:
- The test material did not induce a dose-related increase in the number of revertant colonies in each of the five tester strains, both in the presence and absence of metabolic activation. These results were confirmed in separate experiments.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- With the exception of the TA 102 in the 1st plate incorporation assay, toxicity was observed. Additional plate incorporation and preincubation assays were performed with a higher dose range
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS- Precipitation: The test material precipitated in the top agar at concentrations above 333 µg/plate in the plate incorporation assays and the first preincubation assay. In the first plate incorporation assay, precipitate of the test material was noticed on top of the agar at 1000 µg/plate and in the second plate incorporation assay at 1000 and 2000 µg/plate. This was not observed in the preincubation assays.RANGE-FINDING/SCREENING STUDIES:- The toxicity of the test material was assessed in TA 100 with and without S9, to identify a suitable range of concentrations for the main test for which the test material did not inhibit bacterial growth. These tests were performed in triplicate at 8 concentrations. The test was performed according to the direct plate assay and the preincubation assay methods.- Test I: The test material precipitated on the plates at dose levels of 3330 and 5000 µg/plate. Toxicity was observed at dose levels of 333 µg/plate and above.- Test II: The test material did not precipitate on the plates at dose levels up to 5000 µg/plate. Toxicity was observed at dose levels of 33 and 100 µg/plate and upwards in the absence and presence of metabolic activation, respectively.COMPARISON WITH HISTORICAL CONTROL DATA:All control results were within the historical control range. ADDITIONAL INFORMATION ON CYTOTOXICITY:The second direct plate incorporation assay was performed due to the low of toxicity observed in the TA 102 strain in the absence of S9, a higher dose range was selected for the second assay. The second preincubation assay was performed due to the low toxicity observed in the TA 1535 strain in the absence of S9 mix in the first assay.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 2. Mutagenic Response in the Direct Plate Assay 1
Dose (µg/plate) |
Mean number of revertant colonies/3 replicates plates (± S.D.) |
|||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
||
Without S9 |
Positive Control |
610 ± 39 |
255 ± 58 |
369 ± 37 |
433 ± 54 |
528 ± 22 |
Solvent Control |
12 ± 2 |
4 ± 2 |
34 ± 4 |
101 ± 12 |
180 ± 3 |
|
1 |
12 ± 3 |
6 ± 3 |
36 ± 7 |
184 ± 18 |
||
3 |
10 ± 3 |
6 ± 4 |
36 ± 11 |
112 ± 12 |
183 ± 10 |
|
10 |
13 ± 4 |
5 ± 1 |
23 ± 3 |
108 ± 7 |
186 ± 23 |
|
33 |
8 ± 2 s |
6 ± 2 s |
16 ± 3 |
119 ± 10 |
163 ± 23 |
|
100 |
9 ± 2 s |
3 ± 2 m |
24 ± 6 |
109 ± 11 |
155 ± 17 |
|
333 |
MC, e |
4 ± 2 m |
19 ± 7 s |
MC e |
164 ± 12 |
|
1000 |
0 ± 0 a |
|||||
3330 SP |
0 ± 0 a |
|||||
5000 SP |
0 ± 0 a |
|||||
With S9 |
Positive Control |
112 ± 5 |
396 ± 34 |
665 ± 74 |
454 ± 23 |
763 ± 155 |
Solvent Control |
9 ± 5 |
8 ± 2 |
37 ± 11 |
117 ± 19 |
210 ± 5 |
|
3 |
12 ± 5 |
5 ± 3 |
35 ± 4 |
95 ± 10 |
192 ± 10 |
|
10 |
7 ± 2 |
5 ± 1 |
35 ± 8 |
107 ± 5 |
184 ± 18 |
|
33 |
11 ± 3 |
5 ± 2 |
29 ± 4 |
91 ± 12 |
193 ± 7 |
|
100 |
8 ± 2 |
5 ± 2 |
32 ± 5 |
97 ± 9 |
183 ± 16 |
|
333 |
10 ± 2 s |
4 ± 3 s |
43 ± 4 |
60 ± 8 s |
184 ± 26 |
|
1000 |
9 ± 1 m |
3 ± 2 m |
16 ± 4 s |
MC e |
100 ± 16 s |
|
3330 SP |
0 ± 0 a |
|||||
5000 SP |
0 ± 0 a |
|||||
s = Bacterial background lawn slightly reduced m = Bacterial background lawn moderately reduced e = Bacterial background lawn extremely reduced a = Bacterial background lawn absent SP = Slight Precipitate MC = Microcolonies - Toxicity was observed in all tester strains, 3except tester strain TA 102 in the absence of metabolic activation. |
Table 3. Mutagenic Response in the Direct Plate Assay 2
Dose µg/plate |
Mean number of revertant colonies / 3 replicate plates ( ± S.D.) with TA 102 without S9 mix |
Positive control |
676 ± 33 |
Solvent control |
297 ± 21 |
100 |
296 ± 27 |
333 |
230 ± 31 |
1000 SP |
168 ± 15 s |
2000 SP |
148 ± 15 s |
s = Bacterial background lawn slightly reduced SP = Slight Precipitate - Toxicity was observed in this strain. |
Table 4.Mutagenic Response in the Preincubation Assay 1
Dose (µg/plate) |
Mean number of revertant colonies/3 replicates plates (± S.D.) |
|||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
||
Without S9 |
Positive Control |
718 ± 70 |
82 ± 7 |
311 ± 44 |
586 ± 75 |
861 ± 21 |
Solvent Control |
9 ± 6 |
5 ± 2 |
17 ± 5 |
120 ± 9 |
282 ± 18 |
|
0.3 |
8 ± 1 |
5 ± 3 |
19 ± 4 |
241 ± 53 |
||
1 |
8 ± 1 |
5 ± 2 |
18 ± 1 |
237 ± 27 |
||
3 |
9 ± 1 |
6 ± 3 |
17 ± 5 |
105 ± 14 |
231 ± 23 |
|
10 |
8 ± 1 |
5 ± 3 |
18 ± 6 |
105 ± 4 |
239 ± 28 |
|
33 |
6 ± 1 |
6 ± 2 s |
14 ± 5 |
97 ± 10 s |
225 ±26 |
|
100 |
8 ± 2 |
0 ± 0 a |
4 ± 2 m |
MC e |
109 ± 26 |
|
333 |
0 ± 0 a |
|||||
1000 |
0 ± 0 a |
|||||
3330 |
0 ± 0 a |
|||||
5000 |
0 ± 0 a |
|||||
With S9 |
Positive Control |
105 ± 20 |
199 ± 18 |
526 ± 33 |
362 ± 41 |
901 ± 58 |
Solvent Control |
10 ± 4 |
8 ± 4 |
20 ± 5 |
115 ± 9 |
282 ± 7 |
|
1 |
7 ± 2 |
6 ± 3 |
29 ± 5 |
274 ± 16 |
||
3 |
11 ± 2 |
6 ± 1 |
20 ± 3 |
110 ± 11 |
280 ± 8 |
|
10 |
14 ± 1 |
8 ± 5 |
23 ± 5 |
96 ±1 12 |
277 ± 21 |
|
33 |
12 ± 2 |
9 ± 2 |
22 ± 6 |
98 ± 10 |
265 ± 33 |
|
100 |
9 ± 2 |
4 ± 2 |
13 ± 2 |
89 ± 9 m |
239 ± 28 |
|
333 |
7 ± 2 m |
MC e |
7 ± 4 m |
MC e |
155 ± 47 |
|
1000 |
0 ± 0 a |
|||||
3330 |
0 ± 0 a |
|||||
5000 |
0 ± 0 a |
|||||
s = Bacterial background lawn slightly reduced m = Bacterial background lawn moderately reduced e = Bacterial background lawn extremely reduced a = Bacterial background lawn absent SP = Slight Precipitate MC = Microcolonies - Toxicity was observed in all test strains except TA 1535 in the absence of metabolic activation |
Table 5. Mutagenic Response in the Preincubation Assay 2
Dose µg/plate |
Mean number of revertant colonies / 3 replicate plates ( ± S.D.) with TA 1535, without S9 mix |
Positive Control |
536± 27 |
Solvent Control |
7 ± 3 |
33 s |
6 ± 3 |
100 m |
MC |
166 m |
MC |
333 m |
0 ± 0 |
s = Bacterial background lawn slightly reduced m = Bacterial background lawn moderately reduced e = Bacterial background lawn extremely reduced MC = Microcolonies - Toxicity was observed in this strain |
Mutagenicity
The test material did not induce a dose-related increase in the number of revertant colonies in each of the five tester strains, both in the presence and absence of metabolic activation. These results were confirmed in separate experiments. Based on these results, it is concluded that the test material is non-mutagenic in the Salmonella typhimurium reverse mutation assay.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negative with and without metabolic activationUnder the conditions of the study, the test material was non-mutagenic in the Salmonella typhimurium reverse mutation assay both in the presence and in the absence of metabolic activation.
- Executive summary:
In a GLP compliant genetic toxicity study conducted in accordance with standardised guidelines OECD 471 and EU Method B. 13/14 the mutagenicity of the test material was determined in an Ames test using both the direct plate and preincubation methods. Salmonella typhimurium strains TA98, TA 100, TA 102, TA 1535 and TA 1537 were exposed to varying concentrations of the test material in the presence and absence of metabolic activation. Under the conditions of the study, the test material was non-mutagenic in the Salmonella typhimurium reverse mutation assay both in the presence and in the absence of metabolic activation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.