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EC number: 915-650-9 | 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:
- 13 August 2013 - 05 September 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: The Japanese Ministry of Economy Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW) and Ministry of the Environment (MOE) Guidelines
- Version / remarks:
- 31 March 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde
- EC Number:
- 915-650-9
- Molecular formula:
- C13H20O
- IUPAC Name:
- Reaction mass of 3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde and 4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde
- Test material form:
- liquid
- Details on test material:
- Batch No. VE0027614
Purity: 99.6% (sum of the two main constituents)
Name of the test item (as cited in the study report): MYRALDENE
Physical state: colourless to pale yellow liquid
Storage Conditions: +2°C to +8°C, protected from light
Expiry Date: 12 April 2014
Constituent 1
Method
- Target gene:
- Salmonella typhimurium: histidine gene (his- to his+ reversions)
Escherichia coli: tryptophan gene (trp- to trp+ reversions)
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:
- Phenobarbital/β-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Pre-experiment/Experiment 1:
- All strains, with and without S9 mix: 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment 2:
Without S9 mix
- Strains TA 1535 and WP2 uvrA: 1; 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
- Strains TA 1537, TA 98, TA 100: 0.3; 1; 3; 10; 33; 100; 333; 1000; and 2500 μg/plate
With S9 mix
- Strains TA 1537 and WP2 uvrA: 1; 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
- Strains TA 1535, TA 98, TA 100: 0.3; 1; 3; 10; 33; 100; 333; 1000; and 2500 μg/plate - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent/vehicle: the solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Remarks:
- (untreated plates)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- see section ''Any other information on materials and methods incl. tables''
- Details on test system and experimental conditions:
- A pre-experiment was performed to evaluate the toxicity of the test item. The pre-experiment was performed under the same conditions as the final experiment, using all strains, and was reported as main experiment 1. The main study was performed in two experiments: experiment 1 was a plate incorporation assay, experiment 2 was a pre-incubation assay.
METHOD OF APPLICATION: in agar
DURATION (Pre-incubation assay)
- Preincubation period: 60 minutes
- Exposure duration: at least 48 hours
NUMBER OF REPLICATIONS: 3 plates for each straind and dose level
DATA RECORDING
Colonies were counted using the Petri Viewer Mk2 with the software program Ames Study Manager (v.1.21). Due to precipitation of the test item and reduced background growth the colonies were partly counted manually. - Evaluation criteria:
- - A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
- A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
- An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
- A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.
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:
- At 333-5000 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:
- At 100-5000 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:
- At 100-5000 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:
- At 33-5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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 333-5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test item precipitated in the overlay agar in the test tubes from 2500 to 5000 μg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed in experiment II at 5000 μg/plate in strains TA 1535 and WP2 uvrA without S9 mix and in strains TA 1537 and WP2 uvrA with S9 mix. The undissolved particles had no influence on the data recording.
RANGE-FINDING/SCREENING STUDIES: The results of the pre-experiment were reported as experiment 1.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%): see table 1.
Any other information on results incl. tables
Table 1 Historical data
Strain |
|
Without S9 mix |
With S9 mix |
|||||||
|
|
Mean |
SD |
Min |
Max |
Mean |
SD |
Min |
Max |
|
TA 1535 |
Solvent control |
14 |
2.37 |
9 |
23 |
20 |
3.75 |
11 |
35 |
|
Untreated control |
14 |
2.87 |
7 |
25 |
20 |
3.82 |
10 |
32 |
||
Positive control |
1751 |
226.44 |
710 |
2385 |
367 |
93.12 |
126 |
703 |
||
TA 1537 |
Solvent control |
12 |
3.31 |
5 |
26 |
16 |
4.34 |
7 |
30 |
|
Untreated control |
12 |
4.03 |
5 |
29 |
18 |
4.92 |
6 |
33 |
||
Positive control |
88 |
38.92 |
61 |
448 |
342 |
144.31 |
77 |
809 |
||
TA 98 |
Solvent control |
30 |
5.60 |
17 |
47 |
40 |
6.08 |
21 |
58 |
|
Untreated control |
31 |
6.36 |
17 |
55 |
42 |
6.83 |
24 |
68 |
||
Positive control |
372 |
78.05 |
158 |
595 |
2167 |
717.60 |
249 |
4089 |
||
TA 100 |
Solvent control |
142 |
29.42 |
86 |
243 |
156 |
29.4 |
99 |
249 |
|
Untreated control |
150 |
28.19 |
86 |
248 |
163 |
31.26 |
94 |
281 |
||
Positive control |
1741 |
488.75 |
569 |
3082 |
2642 |
769.59 |
825 |
4503 |
||
WP2uvrA |
Solvent control |
49 |
7.67 |
32 |
69 |
60 |
8.55 |
31 |
86 |
|
Untreated control |
50 |
7.64 |
31 |
71 |
60 |
8.06 |
38 |
83 |
||
Positive control |
697 |
336.39 |
174 |
1435 |
368 |
108.91 |
176 |
1534 |
Applicant's summary and conclusion
- Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay performed according to OECD 471.
- Executive summary:
The mutagenic activity of the substance was evaluated in accordance with OECD 471 (1997) and according to GLP principles. The test was performed in two independent experiments, at first a direct plate assay was performed and secondly a pre-incubation assay, both in the absence and presence of S9-mix. The dose levels were selected based on observed cytotoxicity in all strains (>=250 μg/plate). Adequate negative, vehicle and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant colonies in neither each of the four S. typhimurium tester strains (TA1535, TA1537, TA98, TA100) nor in the E. coli tester strain (WP2 uvrA), both in the absence and presence of S9-metabolic activation. These results were confirmed in independently repeated experiments. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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