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EC number: 947-839-7 | 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:
- weight of evidence
- Study period:
- 26 Apr 2018 - 18 Jun 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 31 May 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Essential oil of Gurjun obtained from the resin tapped from Dipterocarpus trees (Dipterocarpaceae) by steam distillation (Gurjunene quality)
- EC Number:
- 947-839-7
- IUPAC Name:
- Essential oil of Gurjun obtained from the resin tapped from Dipterocarpus trees (Dipterocarpaceae) by steam distillation (Gurjunene quality)
- Test material form:
- liquid
- Details on test material:
- Name in used in report: Gurjun Balsam oil (Gurjunene)
Test facility number 209144/A
Constituent 1
Method
- Target gene:
- His, Trp
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:
- S9
- Test concentrations with justification for top dose:
- Based on the results of the dose-range finding test, the following dose-range was selected for the mutation assay with the tester strains, TA1535, TA1537 and TA98 in the absence and presence of S9-mix: 17, 52, 164, 512, 1600 and 5000 μg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethanol
- Justification for choice of solvent/vehicle: It has been identified as a suitable solvent
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: ICR-191, 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation) and preincubation
- Cell density at seeding (if applicable): 10^9 cells/mL
DURATION
- Preincubation period: 30 ± 2 minutes by 70 rpm at 37 ± 1°C
- Exposure duration: 48 ± 4 h
SELECTION AGENT (mutation assays): Histidine and tryptophan absence
METHODS OF COLONY COUNTING: The revertant colonies were counted automatically with the Sorcerer Colony Counter. Plates with sufficient test item precipitate to interfere with automated colony counting were counted manually.
DETERMINATION OF CYTOTOXICITY : Reduction of the bacterial background lawn - Rationale for test conditions:
- According to the OECD guideline. Furthermore performing both the pre-incubation and the plate incorporation assay provide more information about the possible mutagenicity of the test item.
- 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. - Statistics:
- No statistical hypothesis testing was done.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Direct Plate Assay
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Direct Plate Assay
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Direct Plate Assay
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Direct Plate Assay
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- 3.4 fold increases
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Direct Plate Assay
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- 2 fold increase
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Direct Plate Assay
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- 3.4 fold increase
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Direct Plate Assay
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- 1.9 fold increase
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- highest concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- Direct Plate Assay
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Pre-Incubation Assay
- Metabolic activation:
- without
- Genotoxicity:
- not determined
- Remarks:
- Due to the cytotoxicity in the pre-incubation method, the highest dose(s) in the absence of S9-mix in the Salmonella strains resulted in the presence of microcolonies, and therefore the number of revertant colonies could not be determined.
- 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 1535
- Remarks:
- Pre-Incubation Assay
- Metabolic activation:
- with
- Genotoxicity:
- not determined
- Remarks:
- Due to the cytotoxicity in the pre-incubation method, the highest dose(s) in the absence of S9-mix in the Salmonella strains resulted in the presence of microcolonies, and therefore the number of revertant colonies could not be determined.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Pre-Incubation Assay
- Metabolic activation:
- without
- Genotoxicity:
- not determined
- Remarks:
- Due to the cytotoxicity in the pre-incubation method, the highest dose(s) in the absence of S9-mix in the Salmonella strains resulted in the presence of microcolonies, and therefore the number of revertant colonies could not be determined.
- 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
- Remarks:
- Pre-incubation assay
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- 2.9 fold increase
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Pre-Incubation Assay
- Metabolic activation:
- without
- Genotoxicity:
- not determined
- Remarks:
- Due to the cytotoxicity in the pre-incubation method, the highest dose(s) in the absence of S9-mix in the Salmonella strains resulted in the presence of microcolonies, and therefore the number of revertant colonies could not be determined.
- 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
- Remarks:
- Pre-Incubation Assay
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- 2.1 fold increase
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Pre-Incubation Assay
- Metabolic activation:
- without
- Genotoxicity:
- not determined
- Remarks:
- Due to the cytotoxicity in the pre-incubation method, the highest dose(s) in the absence of S9-mix in the Salmonella strains resulted in the presence of microcolonies, and therefore the number of revertant colonies could not be determined.
- 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 1537
- Remarks:
- Pre-Incubation Assay
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- Pre-incubation Assay
- Metabolic activation:
- without
- Genotoxicity:
- not determined
- Remarks:
- Due to the cytotoxicity in the pre-incubation method, the highest dose(s) in the absence of S9-mix in the Salmonella strains resulted in the presence of microcolonies, and therefore the number of revertant colonies could not be determined.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Slight precipitation is distinguished by a noticeable precipitate on the plate, however the precipitate does not influence automated counting of the plates.
RANGE-FINDING/SCREENING STUDIES: Based on the results of the dose-range finding test, the following dose-range was selected for the mutation assay with the tester strains, TA1535, TA1537 and TA98 in the absence and presence of S9-mix: 17, 52, 164, 512,1600 and 5000 μg/plate.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%) - refer to any other information
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: reduction in the background lawn
- Due to the cytotoxicity in the pre-incubation method, the highest dose(s) in the absence of S9-mix in the Salmonella strains resulted in the presence of microcolonies, and therefore the number of revertant colonies could not be determined.
Any other information on results incl. tables
Historical Control Data of the Solvent Control
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
|||||
S9-mix |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
Range |
3 – 29 |
3 – 27 |
3 – 20 |
3 – 23 |
8 - 41 |
8 – 55 |
61 – 176 |
60 - 160 |
10 – 59 |
9 - 67 |
Mean |
10 |
11 |
6 |
6 |
16 |
22 |
110 |
106 |
26 |
33 |
SD |
3 |
4 |
2 |
3 |
5 |
7 |
17 |
20 |
6 |
8 |
n |
2458 |
2426 |
2402 |
2352 |
2416 |
2458 |
2473 |
2398 |
2237 |
2217 |
SD = Standard deviation
n = Number of observations
Historical control data from experiments performed between May 2016 and May 2018.
Historical Control Data of the Positive Control Items
|
TA1535 |
TA1537 |
TA98 |
|||
S9-mix |
- |
+ |
- |
+ |
- |
+ |
Range |
128 – 1530 |
73 – 1206 |
58 – 1407 |
54 – 1051 |
365 – 1978 |
250 – 1977 |
Mean |
901 |
239 |
817 |
340 |
1355 |
903 |
SD |
174 |
115 |
354 |
160 |
230 |
357 |
n |
2400 |
2296 |
2051 |
2337 |
2357 |
2367 |
|
TA100 |
WP2uvrA |
||
S9-mix |
- |
+ |
- |
+ |
Range |
439 – 1993 |
408 - 2379 |
93 – 1958 |
111 - 1359 |
Mean |
905 |
1249 |
1059 |
444 |
SD |
163 |
371 |
506 |
144 |
n |
2402 |
2354 |
2153 |
2232 |
SD = Standard deviation
n = Number of observations
Historical control data from experiments performed between May 2016 and May 2018.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that Gurjun Balsam Oil (Gurjunene) is mutagenic in the Salmonella typhimurium reverse mutation assay in the tester strains TA100 and TA98, in the absence of S9.
The test item is not mutagenic in the tester strains TA1535 and TA1537, in the Salmonella typhimurium reverse mutation assay or in the Escherichia coli reverse mutation assay, with or without S9.
Although the test item induces a significant increase in the tester strain TA98 in the presence of S9, the increase is below three (3) times the concurrent control. It therefore does not fulfil the acceptability criterium, and is thus not considered mutagenic. The 1.9- and 2.1-fold increases observed in the TA100 strain, in the presence of S9 is considered equivocal, as the level is lower or very close to the two (2) times concurrent control acceptability criterium. - Executive summary:
The potential of Gurjun Balsam Oil (Gurjunene) and/or its metabolites to induce reverse mutations at the histidine locus was tested in a OECD TG 471, Ames study. Mutagenicity was determined in the presence or absence of an exogenous mammalian metabolic activation system (S9).
First mutation assay (direct plate assay): based on the results of the dose-range finding test, the test item was tested in the first mutation assay at a concentration range of 17 to 5000 µg/plate in the absence and presence of S9-mix in the tester strains TA1535, TA1537 and TA98.
- In the absence of S9-mix, the test item induced up to 3.4-fold increases in the number of revertant colonies compared to the solvent control in the tester strains TA100 and TA98. T
- In the presence of S9-mix, the test item induced up to 1.9-, 1.7- and 2.0-fold increases in the number of revertant colonies compared to the solvent control in the tester strains TA100, TA1535 and TA98, respectively.
In the second mutation experiment (pre-incubation assay): the test item was tested up to concentrations of 5000 µg/plate in the tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA in the pre-incubation assay.
- In the absence of S9-mix, no increases in the number of revertant colonies were observed at any of the dose levels tested in all tester strains. However, due to cytotoxicity in the absence of S9-mix,the number of revertant colonies could not be determined.
- In the presence of S9-mix, the test item induced up to 2.9- and 2.1-fold increases in the number of revertant colonies compared to the solvent control in the tester strains TA98 and TA100, respectively. Both increases were above the laboratory historical control data range.
The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Overall assessment of the results:
It is concluded that Gurjun Balsam Oil (Gurjunene) is mutagenic in the Salmonella typhimurium reverse mutation assay in the tester strains TA100 and TA98, in the absence of S9.
The test item is not mutagenic in the tester strains TA1535 and TA1537, in the Salmonella typhimurium reverse mutation assay or in the Escherichia coli reverse mutation assay, with or without S9.
Although the test item induces a significant increase in the tester strain TA98 in the presence of S9, the increase is below three (3) times the concurrent control. It therefore does not fulfil the acceptability criterium, and is thus not considered mutagenic. The 1.9- and 2.1-fold increases observed in the TA100 strain, in the presence of S9 is considered equivocal, as the level is lower or very close to the two (2) times concurrent control acceptability criterium.
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