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EC number: 232-444-8 | CAS number: 8030-55-5 Extractives and their physically modified derivatives. It consists primarily of resins, essential oils, and usually cinnamic and benzoic acids. (Dipterocarpus, Dipterocarpaceae).
- 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:
- 29-08-2016 to 21-09-2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Balsams, gurjun
- EC Number:
- 232-444-8
- EC Name:
- Balsams, gurjun
- Cas Number:
- 8030-55-5
- IUPAC Name:
- Essential oil of Gurjun obtained from the resin tapped from Dipterocarpus trees (Dipterocarpaceae) by steam distillation (Copaene quality)
- Test material form:
- liquid
- Remarks:
- Clear colourless to pale yellow liquid
- Details on test material:
- - Name of test material (as cited in study report): Gurjun Balsam oil
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: confidential information
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Test item: 207786/A
- Source and lot/batch No.of test material:L4285828
- Expiration date of the lot/batch:30 April 2018 (retest date)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:At room temperature protected from light
OTHER SPECIFICS: UVCB
Method
- Target gene:
- - S. typhimurium: Histidine gene
- Escherichia coli: Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix induced by Aroclor 1254
- Test concentrations with justification for top dose:
- Direct plate:
- Dose-range finding test: TA 100 and WP2uvrA (without and with S9): 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate
Based on the results of experiment 1, the following dose levels were used:
- Experiment 1: TA 1535, TA 1537 and TA 98 (without and with S9): 17, 52, 164, 512, 1600 and 5000 μg/plate
- Experiment 2: Based on the results of experiment 1, the following dose levels were used: TA 1535, TA 1537, TA 98, TA 100 and WP2uvrA (without and with S9): 492, 878, 1568, 2800 and 5000 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: A solubility test was performed. The test item could not be dissolved in water or dimethyl sulfoxide. The test item was soluble in ethanol. Therefore ethanol was used as solvent in this project.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: ICR191 (TA1537; without metabolic activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Experiment 1: in agar (plate incorporation)
- Experiment 2: (independent repeat) preincubation
DURATION
- Preincubation period: minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain (in all experiments)
DETERMINATION OF CYTOTOXICITY
- Method: on the basis of a decline in the number of spontaneous revertants, a thinning of the background
lawn or a microcolony formation - Rationale for test conditions:
- According to guideline.
- Evaluation criteria:
- A test item is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is not greater than two (2) times the
concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not
greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one follow up experiment.
A test item is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is greater than two (2) times the
concurrent control, or the total number of revertants in tester strains TA1535, TA1537 or TA98 is greater
than three (3) times the concurrent control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester
strains, the positive response should be reproducible in at least one follow up experiment.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In experiment 2
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test item on the plates was observed at the start of the incubation period at concentrations of 2800 and 5000 μg/plate and at 5000 μg/plate at the end of the incubation period at experiment 2
RANGE-FINDING/SCREENING STUDIES: Cytotoxicity, as evidenced by a decrease in the number of revertants, was observed in tester strain TA100 (absence and presence of S9-mix). No increase in the number of revertants was observed upon treatment with testing material under any conditions tested.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data:
TA1535 TA1537 TA98 TA100 WP2uvrA
S9-mix - + - + - + - + - +
Range 78 - 1381 78 - 1058 55 – 1565 55 – 1112 410 – 2057 263 - 1907 549 – 1848 620 - 2651 127 – 1951 85 - 1390
Mean 785 228 653 387 1155 860 892 1404 1263 342
SD 167 105 290 143 370 323 178 327 461 165
n 1684 1662 1448 1536 1646 1686 1650 1677 1370 1410
SD = Standard deviation
n = Number of observations
Historical control data from experiments performed between 31 May 2014 and 31 May 2016.
- Negative (solvent/vehicle) historical control data:
TA1535 TA1537 TA98 TA100 WP2uvrA
S9-mix - + - + - + - + - +
Range 4 - 36 3 - 34 3 – 25 3 - 28 9 - 50 9 - 57 63 - 153 60 - 156 12 – 68 12 - 70
Mean 14 13 7 9 17 25 100 103 26 32
SD 6 5 3 4 5 7 16 18 7 8
n 1662 1677 1548 1547 1662 1703 1659 1691 1421 1424
SD = Standard deviation
n = Number of observations
Historical control data from experiments performed between 31 May 2014 and 31 May 2016.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Experiment 1: Cytotoxicity, as evidenced by a decrease in the number of revertants and/or a reduction in the bacterial background lawn was observed in all Salmonella typhimurium bacterial strains. In tester strain WP2uvrA, no toxicity was observed at any of the dose levels tested.
Experiment 2:Cytotoxicity, as evidenced by a decrease in the number of revertants, was only observed in tester strain TA100 in the absence and presence of S9-mix. In all other test strains, there was no reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants at any of the concentrations tested in the absence and presence of
S9-mix.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, Gurjun balsam oil was determined to be not mutagenic and does not need to be classified for mutagenicity in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay in accordance with the criteria outline in Annex I of CLP (1272/2008/EC).
- Executive summary:
The mutagenic activity of Gurjun balsam oil was evaluated in accordance with OECD 471 (1997) guideline 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 up to and including 5000 μg/plate. The dose levels were selected based on a dose range finding test with strain TA100 and WP2uvrA.
In experiment 1, Cytotoxicity, as evidenced by a decrease in the number of revertants and/or a reduction in the bacterial background lawn was observed in all Salmonella typhimurium bacterial strains. In tester strain WP2uvrA, no toxicity was observed at any of the dose levels tested.
In experiment 2 in all strains, cytotoxicity was only observed in tester strain TA100 in the absence and presence of S9-mix. In all other test strains, there was no reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants at any of the concentrations tested in the absence and presence of S9-mix.
Adequate negative and positive controls were included. The substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100) and E. coli tester strain (WP2uvrA), 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 Gurjun balsam oil is not mutagenic and does not need to be classified for mutagenicity in accordance with the criteria outline in Annex I of CLP (1272/2008/EC).
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