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EC number: 290-792-6 | CAS number: 90244-88-5
- 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:
- 17-12- 2014 to 13-02-2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- in accordance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bulnesia sarmienti, ext.
- EC Number:
- 289-632-8
- EC Name:
- Bulnesia sarmienti, ext.
- Cas Number:
- 89958-10-1
- Molecular formula:
- This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molecular weight, and structural formula canoot be given.
- IUPAC Name:
- Essential oil of Guaiacwood obtained from the wood of Bulnesia sarmientoi by steam distillation
- Test material form:
- other: waxy solid
- Details on test material:
- - Name of test material (as cited in study report): Guaiacwood oil
- Appearance: Yellow-brown waxy solid
- Storage condition of test material: at room temperature in the dark
Constituent 1
Method
- Target gene:
- Histidine or tryptophan locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Vogel-Bonner Minimal Plates, Top Agar. - Properly maintained: yes- Periodically checked for viability, spontaneous reversion rate characteristics.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- Experiment 1 (direct plate incorporation method): 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plateExperiment 2 (pre-incubation method): 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO- Justification for choice of solvent/vehicle: immiscible in sterile distilled water at 50 mg/mL but fully miscible in dimethyl sulphoxide (DMSO).
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Remarks:
- N-ethyl-N-nitro-N-nitrosoguanidine (2, 3 and 5 µg/plate), 9-aminoacridine (80 µg/plate) and 4-nitroquinoline-1-oxide (0.2µg/plate ) without S9 -mix. Benzo(a)pyrene (µg/plate) and 2-Aminoanthracene (1, 2 and 10 µg/plate) with S9-mix
- Details on test system and experimental conditions:
- DURATION
- Pre-incubation period: with and without S9-mix 20 minutes (prior to exposure in experiment 2 only)
- Exposure duration: 48 hours (experiment 1 and 2)
NUMBER OF REPLICATIONS:
-Test for mutagenicity (exp 1 and 2): in triplicate
DETERMINATION OF MUTAGENICITY
- Method: Evaluate reduction in number of spontaneous revertants and negative effect on the growth of the bacterial background lawn (thinning).
DETERMINATION OF CYTOTOXICITY
- Method: Each culture was monitored spectrophotometrically for turbidity with titres determined by viable count analysis on nutrient agar plates. - Evaluation criteria:
- 1. A dose-related increase in mutant frequency over the dose range tested
2. A reproducible increase at one or more concentrations
3. Biological relevance against in-house historical control ranges
4. Statistical analysis of data as determined by UKEMS
5. Fold increase greater than two times the concurrent solvent control for any tester strain.
ACCEPTANCE CRITERIA
- All bacterial strains must have demonstrated required characteristics as determined by their respective strains according to Ames et al. (1975)
- Tester strain cultures should exhibit characteristic number of spontaneous revertants per plate in the vehicle and untreated controls.
- Tester strain culture density should be in the range of 0.9 to 9x10E9 bacteria/mL
- Positive control values must demonstrate intrinsic sensitivity of the test strains and integrity of the S9-mix
- A minimum of four non-toxic test item dose levels is required- No evidence of excessive contamination - Statistics:
- No further information provided
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Direct Plate Incorporation Method (exp. 1)
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Pre-Incubation Method (exp. 2)
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON TEST RESULTS
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method in exp 1 (direct plate method) or exp 2 (pre-incubation method). A small significant increase in WP2uvrA revertant colony frequency was observed in the absence of S9 -mix at 15 µg/plate in the 2nd experiment but is was considered of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the individual colony counts at 15 µg/plate were within the in-house historical untreated/vehicle control range for the tester strain and the fold increase was only 1.7 time the concurrent vehicle control.
TEST-SPECIFIC CONFOUNDING FACTORS
Precipitation: No test item precipitate was observed on the plates after the plate incorporation method at any of the doses tested in either the presence or absence of S9-mix. A light test item precipitate (globular in appearance) was noted under an inverted microscope at 5000 µg/plate after employing the pre-inclubation method (exp 2). This observation did not prevent the scoring of revertant colonies.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Experiment 1: Reductions in growth of bacterial background lawns of all tester strains (except WP2uvrA in presence of S9-mix) from 1500 µg/plate (with S9-mix) and 5000 µg/plate (without S9-mix). No weakening of background lawn for E. coli at any test item dose level with S9-mix.
Experiment 2: Reductions in growth of bacterial background lawns of TA 1535 and TA 1537 from 150 µg/plate, TA 100 from 500 µg/plate, and TA98 and WP2uvrA from 5000 µg/plate, all without S9-mix.Reductions in growth of bacterial background lawns ( of TA 100, TA 1535 and TA 1537 from 1500 µg/plate and TA98 from 5000 µg/plate, all with S9-mix. No toxicity was noted for WP2uvrA dosed in the presence of S9-mixThe test item was tested up to the maximum recommended level of 5000 µg/plate.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this test, no significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with or without metabolic activation. Therefore, Guaiacwood oil was considered to be non-mutagenic under the conditions of this test and should not be classified in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
The genotoxicity of the test substance Guaiacwood oil was tested in bacteria strains TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvrA according to OECD guideline 471 (Ames test) and under GLP conditions. Two experiments (using the plate incorporation methodology and the pre-incubation methodology) were performed with concentrations of the test substance ranging from 1.5 - 5000 µg/plate, with and without metabolic activation. Negative, vehicle and positive controls were included as well. The frequency of revertant colonies was recorded.
The positive and negative control were valid: all positive control chemicals induced increase in frequency of revertant colonies and the increase observed for the negative control substance was considered acceptable. Cytotoxicity was observed in both experiments by a reduction in growth of the bacterial background lawns, being more apparent in experiment 2 (using the pre-incubation methodology). No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation in exp. 1 and 2 using different exposure methods.
A small significant increase in WP2uvrA revertant colony frequency was observed in the absence of S9-mix at 15 µg/plate in the 2nd experiment but was considered of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the individual colony counts at 15 µg/plate were within the in-house historical untreated/vehicle control range for the tester strain and the fold increase was only 1.7 time the concurrent vehicle control.
Under the conditions of this test, no significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with or without metabolic activation. Therefore, Guaiacwood oil was considered to be non-mutagenic under the conditions of this test and should not be classified in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP).
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