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EC number: 289-621-8 | CAS number: 89957-99-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Boswellia papyrifera, Burseraceae.
- 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:
- 10 October 2018 - 31 October 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Boswellia papyrifera, ext.
- EC Number:
- 289-621-8
- EC Name:
- Boswellia papyrifera, ext.
- Cas Number:
- 89957-99-3
- Molecular formula:
- Not applicable (UVCB)
- IUPAC Name:
- Essential oil of Boswellia papyrifera (Burseraceae) obtained from gum by distillation
- Test material form:
- liquid
- Details on test material:
- Test item: Boswellia Papyrifera Oil
Other names: Frankincense Papyrifera Oil
Batch No.: FRP.17124.297.6989.0.T0
Content: 100% UVCB Substance
Physical state: Clear yellowish liquid
Storage conditions: Ambient temperature (10 °C to 30 °C), dry, in the dark
Expiry date: September 03, 2020
Certificate: Certificate of analysis dated September 05, 2018, Laboratory of Esseterre Bulgaria EOOD Distillery, Bulgaria
Constituent 1
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
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction, microsome fraction prepared from Sprague Dawley rat liver homogenate, is provided by MOLTOX
- Test concentrations with justification for top dose:
- Test for Mutagenicity (Experiment 1) – Direct Plate Incorporation Method:
Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2uvrA (with and without S9 mix): 1000, 300, 100, 30 and 10 μg/plate
Test for Mutagenicity (Experiment 2) - Pre-incubation Test:
Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2uvrA (with and without S9 mix): 1000, 300, 100, 30 and 10 μg/plate - Vehicle / solvent:
- Aboslute ethanol
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 9-aminoacridine
- sodium azide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: cis-Platinum (II) Diammine Dichloride (1 µg/plate E. coli - S9), 2-Nitrofluorene (2 µg/plate, TA98 - S9) and 2-Anthramine (1 or 2 µg/plate, TA strains + S9)
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM:
Strains of Salmonella typhimurium and Escherichia coli are purchased from MOLTOX
METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period:
37 °C for 30 minutes (with shaking)
- Exposure duration:
Plates were incubated at 37 °C ± 3 °C for approximately 48-72 hours
NUMBER OF REPLICATIONS:
Triplicate plates per dose level.
DETERMINATION OF CYTOTOXICITY
- Method: The plates were viewed microscopically for evidence of thinning (toxicity) - Rationale for test conditions:
- The highest dose tested was 1000 μg/plate due to over toxicity from 1500 µg/plate
- Evaluation criteria:
- The following validity criteria were checked to validate each experiment:
the bacteriostatic activity of the highest concentration tested shall be equal to or less than 75 %.
The spontaneous reversion rate of the absolute negative control shall comply with the historical values of the laboratory,
the spontaneous reversion rate of the solvent shall not be statistically different from absolute negative control,
the mean number of revertant colonies obtained for each strain and the corresponding positive control, with and/or without metabolic activation shall comply with the historical values of the laboratory.
Negative and positive values should not show significant difference with the historical values of the laboratory (± 2 standard deviations).
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- STERILITY CONTROLS:
absence of any bacterial growth in the presence of the various concentrations of the test item.
absence of any bacterial growth in the presence of "S9-mix".
BACTERIOSTATIC ACTIVITY CONTROL:
Results showed a high toxicity from 1500 to 5000 μg/plate in TA 100. Therefore the test item was tested at these doses (1000, 300, 100, 30 and 10 μg/plate).
MUTATION ASSAY
- There was no significant difference between the number of spontaneous reversions, the number of reversions obtained for the positive controls (without and with metabolic activation), and the mean of corresponding experimental historical values obtained in the laboratory.
- There was no evidence of any increase in the number of revertant colonies in the presence and absence of metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and in E. coli WP2(uvrA-) (pKM101) at any dose tested with the test item up to cytotoxic concentrations.
- thinning of the bacterial lawn and a high decrease of the number of revertant colonies with metabolic activation and pre-incubation for all strains according to the toxicity measured can be observed at the highest doses tested.
- Results were confirmed in an independent experiment.
Applicant's summary and conclusion
- Conclusions:
- There is no evidence of any increase in the number of revertant colonies in the presence and absence of metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and in E. coli WP2(uvrA-) (pKM101) at any dose tested with the test item up to cytotoxic concentrations.
- Executive summary:
The test item was tested for its capacity to induce reverse mutation in four Salmonella typhimurium strains and one Escherichia coli WP2(uvr A¯) (pKM101) strain. This study was performed in the absence and presence of metabolic activation. Two independent assays were carried out.
For assay n° 1, various concentrations (from 10 to 1000 µg/plate) of test item in absolute ethanol were put in contact with the strains in the absence and presence of a metabolic activation system (S9-mix 10% (v/v)).
For assay n° 2, various concentrations (from 10 to 1000 µg/plate) of test item in absolute ethanol were put in contact with the strains in the absence of metabolic activation and with pre-incubation in the presence of metabolic activation system (S9-mix 10% (v/v)).
For the two assays, negative and positive controls were carried out in parallel. Positive controls induced a significant increase in the number of revertant colonies compared to negative controls. There was no significant difference between the number of spontaneous reversions, the number of reversions obtained in the positive controls (without and with metabolic activation), and the mean of corresponding experimental “historical” values obtained in the laboratory.
There was no evidence of any increase in the number of revertant colonies in the presence and absence of metabolic activation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and in E. coli WP2(uvrA-) (pKM101) at any dose tested with the test item up to cytotoxic concentrations.
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