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EC number: 232-433-8 | CAS number: 8028-48-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus sinensis, Rutaceae.
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16-Aug-2010 to 26-Aug-2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Orange, sweet, ext.
- EC Number:
- 232-433-8
- EC Name:
- Orange, sweet, ext.
- Cas Number:
- 8028-48-6
- Molecular formula:
- This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molcular weight, and structural formula cannot be given.
- IUPAC Name:
- Essential oil of orange obtained from the peel of Citrus sinensis (Rutaceae) by expression and/or distillation, including cold pressed, distilled, terpenes and essence qualities
- Reference substance name:
- Orange Oil Cold Pressed 1-Fold-Orange, ext. (Citrus sinensis, Rutaceae)
- IUPAC Name:
- Orange Oil Cold Pressed 1-Fold-Orange, ext. (Citrus sinensis, Rutaceae)
- Reference substance name:
- 8028-46-6
- IUPAC Name:
- 8028-46-6
- Details on test material:
- - Name of test material (as cited in study report): Orange Oil Cold Pressed 1-Fold-Orange, ext. (Citrus sinensis, Rutaceae)- Physical state: Liquid- Lot/batch No.: Confidential- Stability under test conditions: Stable- Storage condition of test material: At room temperature in the dark under nitrogen
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- S. typhimurium: Histidine gene
E. coli: Tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9-mix induced by a combination of phenobarbital and B-naphthoflavone
- Test concentrations with justification for top dose:
- Experiment 1:
Preliminary test (without and with S9) TA100 and WP2uvrA: 3, 10, 33, 100, 333, 1000, 3300, and 5000 ug/plate
Main study: TA1535, TA1537 and TA98:
Without S9-mix: 1, 3, 10, 33, 99, and 198 ug/plate
With S9-mix: 10, 33, 99, 329, 988 and 3290 ug/plate
Experiment 2:
TA1535, TA1537 and TA98:
Without S9-mix: 1, 3, 10, 33, 100, and 150 ug/plate
With S9-mix: 10, 33, 100, 333, 1000, and 2000 ug/plate
WP2uvrA:
Without and with S9-mix: 100, 333, 1000, 3330, and 5000 ug/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: Test compound was stable in ethanol and ethanol has been accepted and approved by authorities and international guidelines.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9: sodium azide (5 ug/plate in saline for TA1535); 9-aminoacridine (60 ug/plate in water for TA1537); 2-nitrofluorene (10 ug/plate in DMSO for TA98); methylmethanesulfonate (650 ug/plate in DMSO for TA100); 4-nitroquinoline-N-oxide (10 ug/plate i
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Selection time (if incubation with a selection agent): at least 48 hours
SELECTION AGENT (mutation assays): agar containing Histidine or Tryptophan
NUMBER OF REPLICATIONS: Doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
NUMBER OF CELLS EVALUATED: 10E8 per plate
DETERMINATION OF CYTOTOXICITY
- Method: The reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies.
OTHER EXAMINATIONS:
- The presence of precipitation of the test compound on the plates was determined. - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537, TA98 or WP2uvrA is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive if:
a) A two-fold (TA100) or more, or a three-fold (TA1535, TA1537, TA98, WP2uvrA) or more increase above solvent control in the mean number of revertant colonies is observed in the test substance group.
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 independently repeated experiment. - Statistics:
- Mean and Standard Deviation
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- 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
- 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 applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed up to and including the top dose of 5000 pg/plate.
RANGE-FINDING/SCREENING STUDIES: In test strain TA100, toxicity was observed at dose levels of 33 and 333 ug/plate and above in the absence and presence of S9-mix, resp. In test strain WP2uvrA, no toxicity was observed up to and including the top dose of 5000 pg/plate.
COMPARISON WITH 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:
TA1535, TA1537, and TA98: without S9: 100 ug/plate and above and with S9: 333 ug/plate and above.
TA100: without S9: 33 ug/plate and above, and with S9: 333 ug/plate and above
WP2uvrA: no toxicity was observed up to and including the top dose of 5000 ug/plate.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative with metabolic activation and negative without metabolic activation
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. It is concluded that this test is valid and that Orange Oil Cold Pressed 1-Fold-Orange, ext. (Citrus sinensis, Rutaceae) is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
Orange Oil Cold Pressed 1-Fold-Orange, ext. (Citrus sinensis, Rutaceae) was tested in the Salmonella typhimurium reverse mutation assay with 4 histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli (WP2uvrA). The test was performed in 2 independent experiments in the presence and absence of S9-mix (rat liver S9-mix induced by a combination of phenobarbital and B-naphthoflavone). The study procedures were based on the most recent OECD guideline 471 and EC guidelines. Orange Oil Cold Pressed 1-Fold-Orange, ext. (Citrus sinensis, Rutaceae) was a clear yellow liquid. The test substance was dissolved in ethanol. In the dose range finding test the test substance was tested up to concentrations of 5000 ug/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. The test substance did not precipitate on the plates at this dose level. Cytotoxicity, as evidenced by a decrease in the number of revertants and a reduction in the bacterial background lawn, was observed in both test strains. Results of this dose range finding test were reported as part of the first experiment of the mutation assay. Based on the results of the dose range finding test, the test substance was tested in the first mutation assay up to 198 and 3290 ug/plate in the absence and presence of 5% (v/v) S9-mix, resp. in test strains TA1535, TA1537 and TA98. In an independent repeat of the assay with additional parameters, the test substance was tested up to dose levels of 150 and 2000 ug/plate in the absence and presence of 10% (v/v) S9-mix, resp. in test strains TA1535, TA1537, TA98 and TA100. Test strain WP2uvrA was tested up to a concentration of 5000 ug/plate in the absence and presence of 10% (v/v) S9-mix. Cytotoxicity, as evidenced by a decrease in the number of revertants and a reduction in the bacterial background lawn, was observed in test strains TA1535, TA1537, TA98 and TA100. Orange Oil Cold Pressed 1-Fold-Orange, ext. (Citrus sinensis, Rutaceae) did not induce a significant dose-related increase in the number of revertant (His) colonies in each of the 4 test strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in test strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment. In this study, 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. Based on the results of this study it is concluded that Orange Oil Cold Pressed 1-Fold-Orange, ext. (Citrus sinensis, Rutaceae) is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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