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EC number: 204-622-5 | CAS number: 123-35-3
- 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:
- 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- GLP study conducted equivalent or similar to OECD Guideline 471 with deviations: one stain missing and no individual plate counts available.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- one stain missing and no individual plate counts
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 7-methyl-3-methyleneocta-1,6-diene
- EC Number:
- 204-622-5
- EC Name:
- 7-methyl-3-methyleneocta-1,6-diene
- Cas Number:
- 123-35-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 7-methyl-3-methylideneocta-1,6-diene
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10 or 30% S9 fraction of Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver
- Test concentrations with justification for top dose:
- 0, 33, 100, 333, 1000, 3333 or 10000 µg/plate
- Vehicle / solvent:
- No data
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (with all strains)
- Remarks:
- with metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (TA100 and TA1535), 9-aminoacridine (TA97), 4-nitro-o-phenylenediamine (TA98)
- Remarks:
- without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation)
DURATION
- Exposure duration: 20 minutes at 37 °C and 2 days at 37 °C
NUMBER OF REPLICATIONS: Triplicate - Evaluation criteria:
- - A positive response is defined as a reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination.
- An equivocal response is defined as an increase in revertants that is not dose related, is not reproducible, or is not of sufficient magnitude to support a determination of mutagenicity.
- A negative response is obtained when no increase in revertant colonies is observed following chemical treatment.
- There is no minimum percentage or fold increase required for a chemical to be judged positive or weakly positive.
- Statistics:
- No data
Results and discussion
Test results
- 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 or above 3333 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- None
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Mutagenicity of β-Myrcene in Salmonella typhimuriuma
Strain |
Dose (µg/plate) |
Revertants/Plateb |
|||||
–S9 |
+hamster S9 |
+rat S9 |
|||||
Trial 1 |
Trial 2 |
10% |
30% |
10% |
30% |
||
Study performed at SRI International |
|||||||
TA100 |
0 |
103 ± 2.0 |
114 ± 6.0 |
104 ± 8.0 |
108 ± 6.0 |
107 ± 8.0 |
110 ± 5.0 |
|
33 |
113 ± 6.0 |
96 ± 11.0 |
98 ± 6.0 |
|
126 ± 22.0 |
|
|
100 |
100 ± 6.0 |
116 ± 0.0 |
103 ± 7.0 |
94 ±6.0 |
116 ± 10.0 |
119 ± 4.0 |
|
333 |
96 ± 8.0 |
107 ± 10.0 |
101 ± 10.0 |
101 ± 4.0 |
115 ± 21.0 |
113 ± 4.0 |
|
1000 |
100 ± 6.0 |
117 ± 3.0 |
81 ± 4.0 |
111 ± 4.0 |
90 ± 14.0 |
111 ± 10.0 |
|
3333 |
66 ± 6.0c |
70 ± 9.0c |
59 ± 4.0c |
107 ± 10.0 |
55 ± 8.0c |
103 ± 4.0 |
|
10000 |
|
|
|
75 ± 6.0c |
|
77 ± 2.0c |
Trial summary |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
|
Positive controld |
781 ± 17.0 |
765 ± 39.0 |
597 ± 8.0 |
663 ± 31.0 |
488 ± 23.0 |
553 ± 52.0 |
|
TA1535 |
0 |
9 ± 2.0 |
13 ± 2.0 |
10 ± 2.0 |
9 ± 0.0 |
9 ± 1.0 |
12 ± 1.0 |
|
33 |
9 ± 2.0 |
8 ± 2.0 |
12 ± 3.0 |
|
10 ± 1.0 |
|
|
100 |
6 ± 1.0 |
10 ± 2.0 |
9 ± 1.0 |
11 ± 1.0 |
12 ± 1.0 |
11 ± 1.0 |
|
333 |
10 ± 1.0 |
9 ± 1.0 |
8 ± 3.0 |
9 ± 1.0 |
11 ± 1.0 |
10 ± 1.0 |
|
1000 |
9 ± 1.0 |
9 ± 1.0 |
9 ± 2.0 |
10 ± 2.0 |
10 ± 1.0 |
9 ± 0.0 |
|
3333 |
6 ± 0.0c |
7 ± 1.0c |
4 ± 1.0c |
5 ± 1.0 |
5 ± 0.0c |
10 ± 1.0 |
|
10000 |
|
|
|
5 ± 2.0c |
|
8 ± 0.0c |
Trial summary |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
|
Positive controld |
700 ± 13.0 |
819 ± 48.0 |
92 ± 11.0 |
363 ± 5.0 |
89 ± 12.0 |
196 ± 8.0 |
|
TA97 |
0 |
106 ± 0.0 |
126 ± 16.0 |
162 ± 9.0 |
144 ± 4.0 |
172 ± 7.0 |
145 ± 7.0 |
|
33 |
104 ± 7.0 |
111 ± 9.0 |
167 ± 5.0 |
|
157 ± 6.0 |
|
|
100 |
100 ± 8.0 |
127 ± 10.0 |
159 ± 3.0 |
149 ± 4.0 |
154 ± 10.0 |
128 ± 11.0 |
|
333 |
96 ± 4.0 |
142 ± 13.0 |
151 ± 16.0 |
112 ± 2.0 |
161 ± 7.0 |
106 ± 5.0 |
|
1000 |
106 ± 6.0 |
144 ± 14.0 |
142 ± 18.0 |
117 ± 11.0 |
153 ± 8.0 |
121 ± 10.0 |
|
3333 |
63 ± 29.0c |
77 ± 6.0c |
106 ± 3.0c |
125 ± 7.0 |
89 ± 21.0c |
132 ± 2.0 |
|
10000 |
|
|
|
117 ± 9.0c |
|
124 ± 2.0c |
Trial summary |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
|
Positive controld |
293 ± 22.0 |
575 ± 53.0 |
689 ± 1.0 |
609 ± 28.0 |
648 ± 15.0 |
431 ± 35.0 |
|
TA98 |
0 |
22 ± 4.0 |
16 ± 2.0 |
19 ± 4.0 |
16 ± 1.0 |
19 ± 3.0 |
17 ± 2.0 |
|
33 |
12 ± 2.0 |
9 ± 1.0 |
23 ± 2.0 |
|
26 ± 1.0 |
|
|
100 |
16 ± 2.0 |
11 ± 1.0 |
19 ± 1.0 |
18 ± 2.0 |
20 ± 3.0 |
13 ± 2.0 |
|
333 |
19 ± 5.0 |
11 ± 2.0 |
22 ± 4.0 |
18 ± 4.0 |
19 ± 1.0 |
16 ± 1.0 |
|
1000 |
24 ± 5.0 |
11 ± 1.0 |
20 ± 1.0 |
23 ± 4.0 |
18 ± 0.0 |
13 ± 2.0 |
|
3333 |
8 ± 2.0c |
7 ± 1.0c |
8 ± 1.0c |
22 ± 2.0 |
12 ± 3.0c |
18 ± 3.0 |
|
10000 |
|
|
|
9 ± 1.0c |
|
11 ± 3.0c |
Trial summary |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
|
Positive controld |
294 ± 8.0 |
269 ± 5.0 |
278 ± 21.0 |
237 ± 16.0 |
206 ± 26.0 |
251 ± 21.0 |
a The detailed protocol for the SRI International study is presented by Zeiger et al. (1992); the study performed at SITEK Research
Laboratories used a modification of that protocol, 0 µg/plate was the solvent control
b Revertants are presented as mean ± standard error from three plates.
c Slight toxicity
d The positive controls in the absence of metabolic activation were sodium azide (TA100 and TA1535), 9-aminoacridine (TA97) and 4-nitro-o-phenylenediamine (TA98. The positive control for metabolic activation with all strains was 2-aminoanthracene.
Applicant's summary and conclusion
- Conclusions:
- β-Myrcene was not mutagenic in S. typhimurium TA1535, TA 1537, TA 98 and TA 100 with and without metabolic activation.
- Executive summary:
An Ames test was performed to determine the mutagenicity potential of β‑myrcene according to a method equivalent or similar to Guideline OECD 471 in compliance with Good Laboratory Practice Regulations.
Salmonella typhimurium strains TA1535, 1537, 98 and 100 were treated with β‑myrcene using the plate incorporation method at concentration range of 33 - 10000 µg/plate both with and without metabolic activation (10 or 30% S9 fraction of Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver). Concurrent strain-specific positive and solvent controls, both with and without metabolic activation, were included in each assay.
Positive controls induced appropriate responses in the corresponding strains. β-Myrcene showed no substantial increase in revertant colony members over control at any concentrations in presence and absence of metabolic activation.
Therefore, β-myrcene is not considered as mutagenic according to Directive 67/548/EEC and CLP regulation (EC) N° 1272/2008.
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