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EC number: 289-995-2 | CAS number: 90063-37-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lavandula angustifolia, Labiatae.
- 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:
- 01-22 August 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD test guideline No. 471 without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Linalyl acetate
- EC Number:
- 204-116-4
- EC Name:
- Linalyl acetate
- Cas Number:
- 115-95-7
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1,5-dimethyl-1-vinylhex-4-en-1-yl acetate
- Reference substance name:
- Linalool
- EC Number:
- 201-134-4
- EC Name:
- Linalool
- Cas Number:
- 78-70-6
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-1,6-dien-3-ol
- Reference substance name:
- p-menth-1-en-4-ol
- EC Number:
- 209-235-5
- EC Name:
- p-menth-1-en-4-ol
- Cas Number:
- 562-74-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1-isopropyl-4-methylcyclohex-3-en-1-ol
- Reference substance name:
- 4,11,11-trimethyl-8-methylenebicyclo[7.2.0]undec-4-ene
- Cas Number:
- 118-65-0
- Molecular formula:
- C15H24
- IUPAC Name:
- 4,11,11-trimethyl-8-methylenebicyclo[7.2.0]undec-4-ene
- Reference substance name:
- Cineole
- EC Number:
- 207-431-5
- EC Name:
- Cineole
- Cas Number:
- 470-82-6
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane
- Reference substance name:
- (Z)-3,7-dimethylocta-1,3,6,-triene
- EC Number:
- 222-081-3
- EC Name:
- (Z)-3,7-dimethylocta-1,3,6,-triene
- Cas Number:
- 3338-55-4
- Molecular formula:
- C10H16
- IUPAC Name:
- (3Z)-3,7-dimethylocta-1,3,6,-triene
- Reference substance name:
- (E)-3,7-dimethylocta-1,3,6-triene
- EC Number:
- 223-241-5
- EC Name:
- (E)-3,7-dimethylocta-1,3,6-triene
- Cas Number:
- 3779-61-1
- Molecular formula:
- C10H16
- IUPAC Name:
- (3E)-3,7-dimethylocta-1,3,6-triene
- Reference substance name:
- Dipentene
- EC Number:
- 205-341-0
- EC Name:
- Dipentene
- Cas Number:
- 138-86-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 4-isopropenyl-1-methylcyclohexene
- Reference substance name:
- Geranyl acetate
- EC Number:
- 203-341-5
- EC Name:
- Geranyl acetate
- Cas Number:
- 105-87-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (2E)-3,7-dimethylocta-2,6-dien-1-yl acetate
- Reference substance name:
- p-menth-1-en-8-ol
- EC Number:
- 202-680-6
- EC Name:
- p-menth-1-en-8-ol
- Cas Number:
- 98-55-5
- Molecular formula:
- C10H18O
- IUPAC Name:
- alpha,alpha-4-trimethyl-3-cyclohexene-1-methanol
- Test material form:
- liquid
- Details on test material:
- Product name: Lavender oil
Date: 03/27/2014
Number: 130050
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Research Institute for Fragrance Materials, Inc. / 130050
- Physical state: Clear colorless liquid
- Date of manufacture: 26 March 2014
- Date of receipt: 09 July 2014
- Expiration date of the lot/batch: 27 September 2015
- Purity test date: 30 June 2014
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature, protected from light
- Stability: Test substance was considered stable through 27 September 2015
Method
- Target gene:
- Histidine and tryptophan
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):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10 % S9: S9-mix from the livers of male Sprague-Dawley rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- Initial toxicity-mutation assay: 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 μg/plate (TA 98, TA 100, TA 1535 and WP2uvrA) with and without metabolic activation
Retest of the initial toxicity-mutation assay: 5.0, 15, 50, 150, 500, 1500 and 5000 μg/plate (TA 1537) with and without metabolic activation
Confirmatory mutagenicity assay: 5.0, 15, 50, 150, 500, 1500 and 5000 μg/plate (TA 98, TA 100, TA 1535, TA 1537 and WP2uvrA) with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Test substance dilutions were prepared immediately before use and delivered to the test system at room temperature under yellow light.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: methyl methanesulfonate
- Remarks:
- Without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With metabolic activation
- Details on test system and experimental conditions:
- TEST SYSTEM: Salmonella tester strains (TA98, TA100, TA1535 and TA1537) were derived from Dr.Bruce Ames’ cultures; E. coli tester strains (WP2 uvrA) were from the National Collection of Industrial and Marine Bacteria, Aberdeen, Scotland.
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48-72 h at 37 ± 2 °C
NUMBER OF REPLICATIONS:
Duplicate plates/dose
DETERMINATION OF CYTOTOXICITY
- Method: The condition of the bacterial background lawn was evaluated for evidence of test substance toxicity by using a dissecting microscope. Precipitate was evaluated after the incubation period by visual examination without magnification.
- OTHER:
- Solubility Test: A solubility test was conducted using sterile water and DMSO to determine the vehicle, selected in order of preference, that permitted preparation of the highest soluble or workable stock concentration up to 50 mg/mL for aqueous solvents and up to 500 mg/mL for organic solvents.
- Revertant colonies for a given tester strain and activation condition, except for positive controls, were counted either entirely by automated colony counter or entirely by hand unless the plate exhibited toxicity.
- Sterility of the test substance and the vehicle, all test substance dose levels and the vehicle used in the initial toxicity-mutation and confirmatory mutagenicity assays were plated on selective agar with an aliquot volume equal to that used in the assay. These plates were incubated under the same conditions as the assay. - Evaluation criteria:
- The following criteria must be met for the initial toxicity-mutation and the confirmatory mutagenicity assays to be considered valid.
All Salmonella tester strain cultures must demonstrate the presence of the deep rough mutation (rfa) and the deletion in the uvrB gene. Cultures of tester strains TA98 and TA100 must demonstrate the presence of the pKM101 plasmid R-factor. All WP2 uvrA cultures must demonstrate the deletion in the uvrA gene.
All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls as follows (inclusive): TA98, 10 - 50; TA100, 80 - 240; TA1535, 5 - 45; TA1537, 3 - 21; WP2 uvrA, 10 - 60.
To ensure that appropriate numbers of bacteria are plated, tester strain culture titers must be greater than or equal to 0.3x10^9 cells/mL.
The mean of each positive control must exhibit at least a 3.0-fold increase in the number of revertants over the mean value of the respective vehicle control.
A minimum of four non-toxic dose levels is required to evaluate assay data.
A dose level is considered toxic if one or both of the following criteria are met: (1) A >50 % reduction in the mean number of revertants per plate as compared to the mean vehicle control value. This reduction must be accompanied by an abrupt dose-dependent drop in the revertant count. (2) At least a moderate reduction in the background lawn (background code 3, 4 or 5). - Statistics:
- None
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- 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
-Solubility: DMSO was selected as the solvent of choice based on the solubility of the test substance and compatibility with the target cells. The test substance formed a clear solution in DMSO at approximately 500 mg/mL, the maximum concentration tested in the solubility test.
- Precipitation: No precipitate was observed.
MUTATION ASSAY
Initial Toxicity-Mutation Assay: In Experiment B1 (Initial Toxicity-Mutation Assay), the maximum dose tested was 5000 μg/plate; this dose was achieved using a concentration of 100 mg/mL and a 50 μL plating aliquot. The dose levels tested were 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 μg/plate. No positive mutagenic responses were observed with tester strains TA98, TA100, TA1535 or WP2 uvrA in either the presence or absence of S9 activation. No precipitate was observed. Toxicity was observed beginning at 1500 or at 5000 μg/plate with all Salmonella tester strains. Due to confluent bacterial growth, tester strain TA1537 was not evaluated for mutagenicity but was retested in Experiment B2 based on the precipitate and toxicity profile observed (i.e., toxicity at 5000 μg/plate and no precipitate). Based on the findings of the initial toxicity-mutation assay, the maximum dose plated in the retest and confirmatory mutagenicity assays was 5000 μg/plate.
In Experiment B2 (Retest of the Initial Toxicity-Mutation Assay), no positive mutagenic responses were observed with tester strain TA1537 in either the presence or absence of S9 activation. The dose levels tested were 5.0, 15, 50, 150, 500, 1500 and 5000 μg/plate. No precipitate was observed. Toxicity was observed at 5000 μg/plate.
Confirmatory Mutagenicity Assay: In Experiment B3 (Confirmatory Mutagenicity Assay), no positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. The dose levels tested were 5.0, 15, 50, 150, 500, 1500 and 5000 μg/plate. No precipitate was observed. Toxicity was observed beginning at 1500 or at 5000 μg/plate with all Salmonella tester strains.
OTHERS:
Sterility results: No contaminant colonies were observed on the sterility plates for the vehicle control, the test substance dilutions or the S9 and Sham mixes.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Under the test condition, test substance is not mutagenic with and without metabolic activation in S.typhimurium strains (TA1535, TA1537, TA98 and TA100) and E.coli WP2 uvrA according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
- Executive summary:
In a reverse gene mutation assay performed according to the OECD test guideline No. 471 and in compliance with GLP, S. typhimurium strains TA1535, TA1537, TA98 and TA100 and E.coli strain WP2 uvrA were exposed to test substance both in the presence and absence of metabolic activation system (10% liver S9-mix) using the plate incorporation method. The first phase, the initial toxicity- mutation assay, was used to establish the dose-range for the confirmatory mutagenicity assay and to provide a preliminary mutagenicity evaluation. The second phase, the confirmatory mutagenicity assay, was used to evaluate and confirm the mutagenic potential of the test substance.
Initial toxicity-mutation assay: 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 μg/plate (TA 98, TA 100, TA 1535 and WP2uvrA) with and without metabolic activation
Retest of the initial toxicity-mutation assay: 5.0, 15, 50, 150, 500, 1500 and 5000 μg/plate (TA 1537) with and without metabolic activation
Confirmatory mutagenicity assay: 5.0, 15, 50, 150, 500, 1500 and 5000 μg/plate (TA 98, TA 100, TA 1535, TA 1537 and WP2uvrA) with and without metabolic activation
Vehicle (DMSO) and positive control groups were also included in mutagenicity assay.
The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
In the initial toxicity-mutation assay, the maximum dose tested was 5000 μg/plate; this dose was achieved using a concentration of 100 mg/mL and a 50 μL plating aliquot. The dose levels tested were 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 μg/plate. No positive mutagenic responses were observed with tester strains TA98, TA100, TA1535 or WP2uvrA in either the presence or absence of S9 activation. No precipitate was observed. Toxicity was observed beginning at 1500 or at 5000 μg/plate with all Salmonella tester strains. Due to confluent bacterial growth, tester strain TA1537 was not evaluated for mutagenicity but was retested based on the precipitate and toxicity profile observed (i.e., toxicity at 5000 μg/plate and no precipitate).
Based on the findings of the initial toxicity-mutation assay, the maximum dose plated in the retest and confirmatory mutagenicity assays was 5000 μg/plate.
In the retest of the initial toxicity-mutation assay, no positive mutagenic responses were observed with tester strain TA1537 in either the presence or absence of S9 activation. The dose levels tested were 5.0, 15, 50, 150, 500, 1500 and 5000 μg/plate. No precipitate was observed. Toxicity was observed at 5000 μg/plate.
In the confirmatory mutagenicity assay, no positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. The dose levels tested were 5.0, 15, 50, 150, 500, 1500 and 5000 μg/plate. No precipitate was observed. Toxicity was observed beginning at 1500 or at 5000 μg/plate with all Salmonella tester strains.
Under the test condition, test substance is not mutagenic with and without metabolic activation in S.typhimurium strains (TA1535, TA1537, TA98 and TA100) and E.coli WP2 uvrA according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP)..
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