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EC number: 296-618-5 | CAS number: 92875-02-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Fusanus spicatus, Santalaceae.
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- see Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1) as amended B.46
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 18.6.2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer
- EC Number:
- 204-102-8
- EC Name:
- 5-(2,3-dimethyltricyclo[2.2.1.02,6]hept-3-yl)-2-methylpent-2-en-1-ol, stereoisomer
- Cas Number:
- 115-71-9
- Molecular formula:
- C15H24O
- IUPAC Name:
- 5-(2,3-dimethyltricyclo[2.2.1.0~2,6~]hept-3-yl)-2-methylpent-2-en-1-ol
- Reference substance name:
- [1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
- EC Number:
- 201-027-2
- EC Name:
- [1S-[1α,2α(Z),4α]]-2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)-2-penten-1-ol
- Cas Number:
- 77-42-9
- Molecular formula:
- C15H24O
- IUPAC Name:
- 2-methyl-5-(2-methyl-3-methylenebicyclo[2.2.1]hept-2-yl)pent-2-en-1-ol
- Reference substance name:
- (2E,6E)-3,7,11-trimethyldodeca-2,6,10-trien-1-ol
- Cas Number:
- 106-28-5
- Molecular formula:
- C15H26O
- IUPAC Name:
- (2E,6E)-3,7,11-trimethyldodeca-2,6,10-trien-1-ol
- Reference substance name:
- (Z,6S)-2-methyl-6-(4-methylphenyl)hept-2-en-1-ol
- Cas Number:
- 78339-53-4
- Molecular formula:
- C15H22O
- IUPAC Name:
- (Z,6S)-2-methyl-6-(4-methylphenyl)hept-2-en-1-ol
- Reference substance name:
- (Z,6R)-2-methyl-6-(4-methylcyclohexa-1,4-dien-1-yl)hept-2-en-1-ol
- Cas Number:
- 698365-10-5
- Molecular formula:
- C15H24O
- IUPAC Name:
- (Z,6R)-2-methyl-6-(4-methylcyclohexa-1,4-dien-1-yl)hept-2-en-1-ol
- Reference substance name:
- (2R)-6-methyl-2-[(1S)-4-methylcyclohex-3-en-1-yl]hept-5-en-2-ol
- Cas Number:
- 78148-59-1
- Molecular formula:
- C15H26O
- IUPAC Name:
- (2R)-6-methyl-2-[(1S)-4-methylcyclohex-3-en-1-yl]hept-5-en-2-ol
- Reference substance name:
- (2Z,6S)-2-Methyl-6-(4-methyl-1,3-cyclohexadien-1-yl)-2-hepten-1-ol
- Cas Number:
- 698365-09-2
- Molecular formula:
- C15H24O
- IUPAC Name:
- (2Z,6S)-2-Methyl-6-(4-methyl-1,3-cyclohexadien-1-yl)-2-hepten-1-ol
- Reference substance name:
- Nerolidol
- EC Number:
- 205-540-2
- EC Name:
- Nerolidol
- Cas Number:
- 142-50-7
- Molecular formula:
- C15H26O
- IUPAC Name:
- 3,7,11-trimethyldodeca-1,6,10-trien-3-ol
- Test material form:
- liquid
- Details on test material:
- Batch no. SS181004
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- EpiDerm™ Reconstructed Human Epidermis, provided by MatTek, Lot.-No. 30804, Keratinocyte strain 00267.
All cells used to produce EpiDerm™ are purchased or derived form tissue obtained form MatTek Corporation from accredited institutions. In all cases, consent was obtained by these institutions from the donor or donor's legal next of kin, for use of the tissues or derivatives of the tissues for research purposes. The cells used to produce EpiDerm™ are screened for potential biological contaminants.
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratisla-va.
Designation of the kit: EPI-200-SIT, Day of delivery: 02. Jul. 2019, Batch no.: 30804 - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Test System Specification
The test system is a commercially available EpiDermTM-Kit, procured by MatTek. The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava (Designation of the kit: EPI-200-SIT, Day of delivery: 02. Jul. 2019, Batch no.: 30804).
Negative Control: Dulbecco’s Phosphate Buffered Saline (DPBS buffer without CaCl2 and without MgCl2, Composition see below)
Positive Control: Sodium dodecyl sulphate (SDS), CAS No. 151-21-3, solution in demineralised water containing 5% SDS. Procured from MatTek In Vitro Life Science Laboratories, batch no.: 032119ALD.
Chemicals and Media
MTT: 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide (= MTT), which can be reduced to a blue formazan. A MTT stock solution of 5 mg/mL in DPBS buffer was prepared and stored in aliquots of 2 mL in the freezer (–20 ±5 °C).
2 mL of the stock solution were thawed and diluted with 8 mL of medium. This MTT-solution with the resulting concentration of 1 mg/mL was used in the test. For the pre-test (testing the ability of direct MTT reduction), the stock solution was thawed and diluted with serum-free MEM directly before use. For the main test, the stock solution was thawed and diluted with assay medium directly before use.
MEM with Phenol Red for Pre-Test: Serum-free MEM (Minimum Essential Medium), procured by Life Technologies GmbH, batch no.: 2033578
Assay Medium: Serum-free DMEM (Dulbecco’s Modified Eagle’s Medium), procured by MatTek In Vitro Life Science Laboratories, batch no.: 062719MSD
Isopropanol: CH3-CH(OH)-CH3, p.A., 99.9 %, batch no.: 457264070, used as extracting solvent for formazan
DPBS-buffer: Solution for the rinsing of the tissues and solvent for MTT concentrate, also used as negative control. A subset was procured by MatTek In Vitro Life Science Laboratories; the other subset was prepared by LAUS GmbH.
Composition of the subset from MatTek In Vitro Life Science Laboratories (batch no.: 031219MSA): KCl 0.2 g, KH2PO4 0.2 g, NaCl 8.0 g, Na2HPO4 * 7H2O 2.16 g, and H2O ad to 1 L
Composition of the subset from LAUS GmbH (batch no.: 20181022): KCl 0.2 g, KH2PO4 0.2 g, NaCl 8.0 g, Na2HPO4 * 2H2O 1.44 g, and H2O ad to 1 L
The buffer which was procured by MatTek Corporation was used as negative control and for rinsing the test item from the tissues. The buffer which was prepared by LAUS GmbH was used as solvent for MTT concentrate and for rinsing the outside of the inserts at the end of the incubation time with MTT.
Test Vessels: All vessels used are made of glass or sterilised plastic. The glassware was sterilised before use by autoclaving. The following vessels were used: 6-well-plates, 24-well plates, and 96-well-plate. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 µL test item (unchanged, no vehicle) were applied, and a nylon mesh was added in order to ensure sufficient contact with the tissue surface.
- Duration of treatment / exposure:
- Tissues were dosed in 1-minute-intervals. After dosing the last tissue, all plates were transferred into the incubator for 35 minutes at 37 ±1 °C and 5.0 ±1% CO2 and ≥ 95% relative humidity. 1 hour after the first application, the inserts were removed from the plates using sterile forceps and rinsed immediately in 1-minute-intervals.
- Duration of post-treatment incubation (if applicable):
- Tissues were dosed in 1-minute-intervals. After dosing the last tissue, all plates were transferred into the incubator for 35 minutes at 37 ±1 °C and 5.0 ±1% CO2 and ≥ 95% relative humidity.
- Number of replicates:
- two replicates using on each of three tissues.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: Absorbance Values
- Run / experiment:
- test item mean of three tissues
- Value:
- 2.047
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- mean of three tissues: 2.047
- Positive controls validity:
- valid
- Remarks:
- mean of three tissues: 0.061
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 1
- Value:
- 5.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 3.0 %
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 2
- Value:
- 5.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 3.0%
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 3
- Value:
- 5.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 2.9%
- Other effects / acceptance of results:
- Validity criteria and results are stated as follows:
OD of negative control was found to be 2.0 (validity criterion: ≥0.8 and ≤ 2.8)
% tissue viability of positive control SDS was found to be 3.0% (validity criterion ≤20% of negative control)
SD of mean viability of the tissue replicates (%) were found to be 0.6% (negative control), 0.0% (positive control), and 0.2% (test item) (validity criteria ≤18%)
All validity criteria were met.
Values for negative control and for positive control were within the range of historical data of the test facility. Therefore, the experiment is considered valid.
Any other information on results incl. tables
In the following table the outcome of the proficiency chemical testing is stated. All 10 proficiency chemicals were correctly classified.
The demonstration of proficiency was performed under non-GLP conditions but within the GLP-environment at LAUS GmbH.
Results of Proficiency Chemicals
Chemical Name |
CAS No. |
Physical State |
Prediction OECD 439 UN GHS Category |
Findings LAUS GmbH |
Naphthalene acetic acid |
86-87-3 |
solid |
No category |
No category |
Isopropanol |
67-63-0 |
liquid |
No category |
No category |
Methyl stearate |
112-61-8 |
solid |
No category |
No category |
Heptyl butyrate |
5870-93-9 |
liquid |
No category |
No category |
Hexyl salicylate |
6259-76-3 |
liquid |
No category |
No category |
Cyclamen aldehyde |
103-95-7 |
liquid |
Category 2 |
Category 2 |
1-bromohexane |
111-25-1 |
liquid |
Category 2 |
Category 2 |
Potassium hydroxide (5% aq.) |
1310-58-3 |
liquid |
Category 2 |
Category 2 |
1-methyl-3-phenyl-1-piperazine |
5271-27-2 |
solid |
Category 2 |
Category 2 |
Heptanal |
111-71-7 |
liquid |
Category 2 |
Category 2 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The mean value of relative tissue viability of the test item was reduced to 5.7% after the treatment. This value is below the threshold for skin irritation (50%). Therefore, the test item is considered as at least irritant to skin.
- Executive summary:
Three tissues of the human skin model EpiDerm™ were treated with the test item for 60 minutes. The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm²; as indicated by the supplier). DPBS-buffer was used as negative control and 5% SDS solution was used as positive control.
After treatment with the negative control, the mean absorbance value was within the required acceptability criterion of 0.8 ≤ mean OD ≤2.8, OD was 2.0.
The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 3.0% (required: ≤20%).
The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: ≤18%).
After the treatment with the test item, the mean value of relative tissue viability was reduced to 5.7%. This value is below the threshold for skin irritation potential (50%). Test items that induce values below the threshold of 50% are considered at least irritant to skin.
Therefore, the test item Fusanus spicatus, ext. is considered at least irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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