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EC number: 289-839-3 | CAS number: 90028-48-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Eucalyptus dives, Myrtaceae.
- 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:
- 1999-12-31 to 2000-02-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Eucalyptus dives, ext.
- EC Number:
- 289-839-3
- EC Name:
- Eucalyptus dives, ext.
- Cas Number:
- 90028-48-1
- Molecular formula:
- not applicable - UVCB
- IUPAC Name:
- (5R)-2-methyl-5-(propan-2-yl)cyclohexa-1,3-diene; (6R)-3-methyl-6-(propan-2-yl)cyclohex-2-en-1-one
- Test material form:
- other: liquid
Constituent 1
Method
- Target gene:
- Histidine (his+)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 fraction induced by Aroclor 1254
- Test concentrations with justification for top dose:
- 15, 50, 150, 500, 1500 and 5000 μg per plate without metabolic activation (-S9 mix)
50, 150, 500, 1500 and 5000 μg per plate with metabolic activation (+S9 mix) - Vehicle / solvent:
- DMSO for test material and positive controls 2-aminoanthracene and 2-nitrofluorene
Distilled water for all other positive controls
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
- Details on test system and experimental conditions:
- Metabolic activation system (S9 mix)
9000g supernatants of rat liver homogenate fractions (S9 mix) were prepared from livers of rats induced by Aroclor 1254 (500 mg/kg bw). S9 mix was prepared for each assay as follows: 0.335 ml distilled water); 0.5ml phosphate buffer pH 7.4 (NADP (0.1M, 0.04 ml), glucose-6-phosphate (1M, 0.005 ml), MgCl2/KCl (0.4M/1.65M, 0.02ml)) and S9 fraction (0.1ml).
Preparation of bacterial strains
TA1535, TA1537, TA98, TA100 and TA102 tester strains of Salmonella typhimurium grown in oxoid nutrient broth No 2 (2.5%) on a shaker for 14-15 hours at 37°C to a density of 0.5-3 x9 cells per ml, then kept at 4°C. Only fresh cultures were used for mutagenicity studies.
For determination of the cell titer, 0.1ml aliquotes of the 1 x 10^-6 dilution were spread over the completed medium plates and incubated overnight at 37°C.
Test procedure
The Salmonella mutagenicity test was performed by the standard plate-incorporation assay, with and without S9 activation. In brief, 0.1ml bacteria was added to 2 ml of top-agar followed by the test substance/vehicle/positive control, and 0.5ml S9 mix or phosphate buffer, for assays with and without metabolic activation, respectively. The test components were mixed throughly then poured immediately onto minimal agar plates and carefully spread to achieve a uniform spread of top agar. The minimal agar plates contained 20-25ml of 1.5% agar in Vogel-Bonner medium E with 2% glucose. Plates were kept for 48-72 hours at 37°C in the dark dark prior to scoring for revertant his+ bacteria colonies. Plates were prepared in triplcate for each experimental point and the experiment ran in full twice, with an interval of 3 days in between each experiment. Plates were also examined for the existence of a normal background lawn and/or precipitates and microscopically for microcolony growth.
Positive controls were run simultaneously per experiment and the genotypes of the tester strains were checked each experiment. - Evaluation criteria:
- Spontaneous revertants observed using the five strains were compared to historical data established previously in the laboratory and with data obtaed by Ames.
- Statistics:
- Mean and standard deviation were calculated.
Chi squared test
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxic at the two highest concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test compound was observed on the plates at 1500 and 5000 μg/plate μg/plate
COMPARISON WITH HISTORICAL CONTROL DATA: The number of spontaneous revertants observed for all five strains were similar to those previously reported in the laboratory and were within the same range as those cited by Ames et al., (1975). Results with the positive controls were also comparable/
ADDITIONAL INFORMATION ON CYTOTOXICITY: The test substance was cytotoxic to strains TA1535, TA1437 and TA102 at 500 μg/plate, to TA98 at 1500μg/plate and TA100 at 5000 μg/plate. - Remarks on result:
- other: strain/cell type:
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experiment 1 | |||||||||||
Number of revertants (Mean± SD) | |||||||||||
TA98 | TA100 | TA102 | TA1535 | TA1537 | |||||||
Substance | Doses (μg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
Control | 0 | 35±3 | 55±13 | 154±16 | 148±21 | 305±8 | 348±23 | 56±7 | 27±5 | 13±5 | 23±7 |
Solvent control | 0 | 34±6 | 51±12 | 157±5 | 150±18 | 304±7 | 325±13 | 48±2 | 24±6 | 12±8 | 25±5 |
Test item | 15 | ||||||||||
50 | 36±3 | 51±11 | 142±14 | 138±7 | 284±18 | 313±16 | 48±9 | 24±7 | 12±1 | 24±4 | |
150 | 28±9 | 45±4 | 163±19 | 150±4 | 270±41 | 315±35 | 38±7 | 25±8 | 13±3 | 26±3 | |
500 | 28±9 | 47±7 | 159±7 | 125±8 | 216±1* | 282±29* | 35±13* | 22±5* | 11±3* | 23±4* | |
1500** | 35±5 | 50±7 | 150±10 | 148±19 | 217±11* | 305±24* | 35±10* | 23±3* | 11±2* | 24±2* | |
5000** | 25±4* | 37±5* | 57±19* | 111±28* | 28±33* | 114±35* | 35±3* | 14±5* | 1±3* | 10±4* | |
NaN3 | 0.7 | 434±10 | 688±123 | ||||||||
2-NF | 2.5 | 427±14 | |||||||||
9-AA | 59 | 153±26 | |||||||||
Mitomycin C | 0.15 | 810±67 | 810±67 | ||||||||
2-AA | 0.7 | 1496±126 | 1330±122 | ||||||||
2-AA | 1.5 | 1799±243 | 794±47 | 191±39 | |||||||
*bacteriotoxic | |||||||||||
**precipitation seen | |||||||||||
Experiment 2 | |||||||||||
Number of revertants (Mean± SD) | |||||||||||
TA98 | TA100 | TA102 | TA1535 | TA1537 | |||||||
Substance | Doses (μg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
Control | 0 | 23±3 | 32±7 | 157±5 | 150±10 | 245±28 | 248±10 | 582±2 | 26±4 | 11±3 | 17±5 |
Solvent control | 0 | 20±5 | 33±3 | 162±6 | 148±14 | 272±37 | 246±7 | 62±10 | 28±4 | 11±3 | 16±5 |
Test item | 15 | 10±4 | |||||||||
50 | 26±3 | 31±8 | 132±9 | 137±12 | 227±8 | 233±30 | 227±8 | 27±5 | 13±5 | 19±3 | |
150 | 15±3 | 29±3 | 132±8 | 146±20 | 182±5 | 194±50 | 182±5 | 18±3 | 6±2 | 17±3 | |
500 | 12±3 | 35±2 | 121±11 | 35±2 | 137±29* | 132±3* | 137±29* | 16±3* | 8±3* | 13±3* | |
1500** | 13±3* | 32±3* | 135±13 | 32±3 | 181±27* | 159±6* | 181±27* | 18±4* | 5±3* | 13±5* | |
5000** | 0±0* | 26±2* | 34±19* | 26±2* | 0±0* | 3±3* | 0±0* | 10±4* | 0±0* | 5±5* | |
NaN3 | 0.7 | 437±17* | 657±29 | ||||||||
2-NF | 2.5 | 559±39 | |||||||||
9-AA | 59 | 282±29 | |||||||||
Mitomycin C | 0.15 | 777±33 | 777±33 | ||||||||
2-AA | 0.7 | 1028±12 | 1955±337 | ||||||||
2-AA | 1.5 | 961±175 | 557±63 | 543±29 | |||||||
*bacteriotoxic | |||||||||||
**precipitation seen |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
The substance, under the conditions of the study, was not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102. ollowing Regulation (EC) 1272/2008, the substance is not classified as mutagenic.
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