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EC number: 285-360-9 | CAS number: 85085-29-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cupressus funebris, Cupressaceae.
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation in bacteria (OECD TG 471): not mutagenic
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26-SEPT-2016 until 16-OCT-2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Official Journal of the European
Union No. L142, 31 May 2008. - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OECD principles of Good Laboratory Practice, EC Council Directive 2004/10/EC
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot /batch No.of test material: Sponsor Batch: 1002515317
- Expiration date of the lot/batch: until 31 August 2017 (expiry date)
- Purity/Composition: 100.0% (UVCB)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: until 31 August 2017 (expiry date)
OTHER SPECIFICS:
Test item: 207805/A
Identification: Cedarwood Oil China
Appearance:Pale yellow to yellow liquid
Purity/composition correction factor: No correction factor required
Test item handling: No specific handling conditions required
Chemical name (IUPAC), synonym or trade name: Essential oil of Chamaecyparis funebris (Cupressaceae) obtained from the wood by steam distillation
CAS Number: 85085-29-6
Molecular structure: UVCB
Molecular formula: UVCB - Target gene:
- - S. typhimurium: Histidine gene
- Escherichia coli: Tryptophan gene - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- -
- Additional strain / cell type characteristics:
- other: rfa : deep rough (defective lipopolysaccharide cellcoat) gal : mutation in the galactose metabolism chl : mutation in nitrate reductase bio : defective biotin synthesis uvrB : loss of the excision repair system (deletion of the ultraviolet-repair B gene)
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- -
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- -
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9-mix induced by Aroclor 1254
- Test concentrations with justification for top dose:
- Experiment 1: 17, 52, 164, 512, 1600 and 5000 μg/plate (Based on a dose range finding test with the strains TA100 and WP2uvrA, with and without 5% (v/v) S9-mix.)
Experiment 2: 86, 154, 275, 492, 878 and 1568 μg/plate (Based on the results of the first mutation assay) - 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. - Untreated negative controls:
- no
- Remarks:
- Solvent control was the only negative control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: ICR-191, 2-aminoanthracene (all strains; with metabolic activation)
- Remarks:
- Solvents used for pos control: Saline, DMSO
- 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:
- Recommended test system in international guidelines (e.g.
OECD, EC). - Evaluation criteria:
- Test is considered negative if:
a. The total number of revertants in the tester strain TA100 or WP2uvrA < 2 times the concurrent vehicle control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is < than 3 times the concurrent vehicle control.
b. The negative response should be reproducible in at least one follow-up experiment.
Test is considered positive if:
a) The total number of revertants in the tester strain TA100 or WP2uvrA > 2 times the concurrent vehicle control, or the total number of revertants in tester strains TA1535, TA1537, TA98 is greater than 3 times the concurrent vehicle control.
b) In case a follow up 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. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At the highest tested concentration in experiment 1 5000µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Remarks:
- only vehicle control used
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At the highest tested concentration (5000µg/plate in Experiment 1) (1537 µg/plate, in absence of S9 mix in experiment 2)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Remarks:
- only vehicle control used
- Positive controls validity:
- valid
- Key result
- 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 examined
- Remarks:
- only vehicle contro used
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at the highest tested concentration in experiment 2 (1568 µg/plate) with and without S9 mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Remarks:
- only vehicle control used
- Positive controls validity:
- valid
- Key result
- 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 examined
- Remarks:
- only vehicle control used
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: 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.
- Precipitation: The test item precipitated on the plates at dose levels of 1568, 1600 and 5000 μg/plate, except in tester strains TA1537 and TA98 in the absence of S9-mix, where precipitation was already observed at 512 μg/plate.
RANGE-FINDING/SCREENING STUDIES:
Cedarwood Oil China was tested in the tester strains TA100 and WP2uvrA at concentrations of 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate in the absence and presence of S9-mix.
Based on the results of the dose range finding test, the following dose range was selected for the first mutation experiment 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. No increase in the number of revertants was observed upon treatment with Cedarwood Oil China under all conditions tested.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive/negative historical control data: 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.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: To determine the toxicity of the test item, the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined. - Conclusions:
- Based on the results of this study it is concluded that Cedarwood Oil China is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay, and should not be classified according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
The genotoxicity of the test substance Cedarwood Chinese oil was tested in bacteria strains TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A according to OECD guideline 471 (Ames test) and under GLP conditions. The test was performed in two independent experiments in the presence and absence of S9-mix.
A dose range finding test for Cedarwood Chinese oil, was performed in in the strains TA100 and WP2uvrA, with and without S9 metabolic activation (1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate). Precipitate was found at 1600 and 5000 µg/plate. Cytotoxicity was observed in tester strain TA100 in the absence and presence of S9-mix. In tester strain WP2uvrA, no toxicity was observed.
Subsequently, Cedarwood Chinese oil was tested in the tester strains TA1535, TA1537 and TA98 at a concentration range of 17 to 5000 μg/plate in the absence and presence of 5% (v/v) S9 metabolic activation. Negative, vehicle and positive controls were included. Cytotoxicity was observed in tester strains TA1535 and TA1537 at the highest tested concentration. Precipitation was observed at 1600 and 5000 μg/plate, except in tester strains TA1537 and TA98 in the absence of S9-mix, where precipitation was already observed at 512 μg/plate.
In a follow-up experiment, a concentration range of 86 to 1568 μg/plate was used, in the absence and presence of 10% (v/v) S9-mix in the tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. The test item precipitated on the plates at the top dose of 1568 μg/plate. Cytotoxicity was observed in tester strain TA1537 in the absence of S9-mix and TA100 in the absence and presence of S9-mix.
All the negative and strain-specific positive controls were within the laboratory historical control data. No significant increases were observed in the frequency of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) or in the number of revertant (Trp+) colonies in the tester strain WP2uvrA, in the absence or presence of S9-metabolic activation. Under the conditions of this study, the test item Cedarwood Chinese oil was considered to be non-mutagenic and hence, it does not need to be classified for mutagenicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The genotoxicity of the test substance Cedarwood Chinese oil was tested in bacteria strains TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A according to OECD guideline 471 (Ames test) and under GLP conditions. The test was performed in two independent experiments in the presence and absence of S9-mix. A dose range finding test for Cedarwood Chinese oil, was performed in in the strains TA100 and WP2uvrA, with and without S9 metabolic activation (1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate). Precipitate was found at 1600 and 5000 µg/plate. Cytotoxicity was observed in tester strain TA100 in the absence and presence of S9-mix. In tester strain WP2uvrA, no toxicity was observed. Subsequently, Cedarwood Chinese oil was tested in the tester strains TA1535, TA1537 and TA98 at a concentration range of 17 to 5000 μg/plate in the absence and presence of 5% (v/v) S9 metabolic activation. Negative, vehicle and positive controls were included. Cytotoxicity was observed in tester strains TA1535 and TA1537 at the highest tested concentration. Precipitation was observed at 1600 and 5000 μg/plate, except in tester strains TA1537 and TA98 in the absence of S9-mix, where precipitation was already observed at 512 μg/plate.
In a follow-up experiment, a concentration range of 86 to 1568 μg/plate was used, in the absence and presence of 10% (v/v) S9-mix in the tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. The test item precipitated on the plates at the top dose of 1568 μg/plate. Cytotoxicity was observed in tester strain TA1537 in the absence of S9-mix and TA100 in the absence and presence of S9-mix.
All the negative and strain-specific positive controls were within the laboratory historical control data. No significant increases were observed in the frequency of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) or in the number of revertant (Trp+) colonies in the tester strain WP2uvrA, in the absence or presence of S9-metabolic activation. Under the conditions of this study, the test item Cedarwood Chinese oil was considered to be non-mutagenic.
Justification for classification or non-classification
Based on the available data, Cedarwood oil Chinese does not need to be classified for mutagenicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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