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EC number: 295-223-5 | CAS number: 91845-48-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Santalum austro-caledonicum, 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 431 without any deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 13 April 2004
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
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:
- (Z)-5-(4,6-dimethyl-6-bicyclo[3.1.1]hept-3-enyl)-2-methylpent-2-en-1-ol
- Cas Number:
- 88034-74-6
- Molecular formula:
- C15H24O
- IUPAC Name:
- (Z)-5-(4,6-dimethyl-6-bicyclo[3.1.1]hept-3-enyl)-2-methylpent-2-en-1-ol
- Reference substance name:
- (2E)-2-methyl-6-[(1S)-4-methylcyclohex-3-en-1-yl]hepta-2,6-dien-1-ol
- Cas Number:
- 942226-77-9
- Molecular formula:
- C15H24O
- IUPAC Name:
- (2E)-2-methyl-6-[(1S)-4-methylcyclohex-3-en-1-yl]hepta-2,6-dien-1-ol
- Reference substance name:
- (Z)-2-Methyl-5-((1R,2R,4S)-2-methyl-3-methylenebicyclo[2.2.1]heptan-2-yl)pent-2-en-1-ol
- Cas Number:
- 79081-90-6
- Molecular formula:
- C15H24O
- IUPAC Name:
- (Z)-2-Methyl-5-((1R,2R,4S)-2-methyl-3-methylenebicyclo[2.2.1]heptan-2-yl)pent-2-en-1-ol
- Test material form:
- liquid
- Details on test material:
- Manufacturing date: 30/05/2008
Expiry date: 30/05/2010
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Robertet / 1733624
- Appearance: Yellow liquid
- Production date: 30 May 2008
- Date received: 28 October 2008
- Expiration date of the lot/batch: 30 May 2010
STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstituted epidermis
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: 0.38 cm2 reconstituted epidermis (Episkin®)
- Tissue batch number(s): Episkin® - Batch No. 09-EKIN-006
- Delivery date: 10 February 2009
- The insert (filter + epidermis) was gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter. The insert was placed in a 12 wells culture plated which has been previously filled with 2.2 mL of assay medium (Skinethic 09-ESSC-006).
- Date of initiation of testing: 10 February 2009
EXPOSURE
- The test item has been applied to the epidermal surface of 2 human skin model, during 3 minutes and during 1 hour.
REMOVAL OF TEST MATERIAL AND CONTROLS
- 3 minutes and 1 hour after the test item application, the human epidermis was washed with PBS (3 x 0.5 mL).
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
The cell viability was quantified by measurement of the cell succinate dehydrogenase activity. This enzyme was responsible for the MTT [3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue; CAS No. 298-93-1)] reduction into blue formazan crystal. The skin sample was placed in MTT solution of 0.5 mg/mL concentration for 3 hours at 37 °C. The precipitated blue formazan product is then extracted using acidic isopropanol between 2 and 4 hours under agitation in the dark, and the concentration of formazan was measured by determining the Optical Density (OD) at 570 nm.
The absorbance was measured in triplicate of MTT extract. The measured absorbances are proportional to the number of live cells.
NUMBER OF REPLICATE TISSUES:
Duplicate skin tissues for test item, negative and positive controls
VIABILITY
Viability = (OD test item / OD negative control) x 100
For each tissue, OD values and calculated percentage cell viability data for the test item, positive and negative controls, should be reported in tabular form, including data from replicate repeat experiments as appropriate, mean and individual values.
PREDICTION MODEL / DECISION CRITERIA
The optical density (OD) values obtained for each test sample were used to calculate a percentage of viability relative to the negative control, which was arbitrarily set at 100%. The cut-off values for the prediction of corrosion associated with the EPISKlN models were as follows:
The item is to be classified as non-corrosive: If the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%
The item is to be classified as corrosive R35: Causes severe burns: If the viability after 3 minutes exposure is strictly less than 50%,
The item is to be classified as corrosive R34: Causes burus: If the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is strictly less than 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL
- Concentration (if solution): Undiluted
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL distilled water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL 8N KOH
TREATMENT
- The test item has been applied, as supplied, at the dose of 10 µL, to the epidermal surface of 2 human skin model, during 3 minutes and during 1 hour. In the same experimental conditions, the positive and negative controls have been carried out. - Duration of treatment / exposure:
- Test item has been applied to the epidermal surface of human skin models during 3 minutes and during 1 hour.
- Number of replicates:
- Duplicate skin tissues for test item, negative and positive controls
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test (3 minutes)
- Value:
- 99
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 34.7% of viability
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test (1 hour)
- Value:
- 106
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 10.9% of viability
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- VIABILITY
- 3 minutes and 1 hour after the test item application, the viability of the human skin model has been 99% and 106% (considering as 100%) respectively.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes; 3 minutes and 1 hour after the negative control application, the viability of the human skin model has been 100%.
- Acceptance criteria met for positive control: Yes; 3 minutes and 1 hour after the positive control application, the viability of the human skin model has been 34.7% and 10.9%, respectively.
Any other information on results incl. tables
Table 7.3.1/1: Assessment of the skin corrosion
Items |
Skin |
Absorbances # |
Mean |
Viability% |
Conclusion |
Individual and average values of OD after 3 minutes exposure |
|||||
Negative control |
1 |
0.471 |
0.464 |
100.0 |
Non Corrosive |
2 |
0.457 |
||||
Positive control |
3 |
0.158 |
0.161 |
34.7 |
Corrosive |
4 |
0.164 |
||||
Test item |
5 |
0.427 |
0.460 |
99.0 |
Non Corrosive |
6 |
0.492 |
||||
Individual and average values of OD after 1 hour exposure |
|||||
Negative control |
1 |
0.514 |
0.523 |
100.0 |
Non Corrosive |
2 |
0.531 |
||||
Positive control |
3 |
0.055 |
0.057 |
10.9 |
Corrosive |
4 |
0.059 |
||||
Test item |
5 |
0.538 |
0.555 |
106.2 |
Non Corrosive |
6 |
0.572 |
#: mean of 3 values
OD: optical density
Note:
30 minutes exposure: If the viability obtained for the test substance is greater than 50%, then it is non-corrosive.
1 hour exposure: If the viability obtained for the test substance is greater than15%, then it is non-corrosive.
Applicant's summary and conclusion
- Interpretation of results:
- other: the test item must not be classified in category 1"Corrosive".
- Conclusions:
- Under the experimental conditions adopted and in accordance with the Globally Harmonized System (Regulation (EC) No.1272/2008), the test item must not be classified in category 1"Corrosive".
- Executive summary:
An in vitro skin corrosion study was performed according to OECD Guideline 431 and in compliance with GLP to evaluate the possible corrosive effects of the test item after topical administration on in vitro human reconstituted epidermis (Episkin®model).
The test item was applied, as supplied, at the dose of 10 µL, to 2 Human skin model surfaces (Episkin®), during 3 minutes and 1 hour (n=4).
3 minutes and 1 hour after the test item application, the viability of the human skin model has been 99% and 106% (considering as 100%) respectively, versus 34.7% and 10.9% respectively in the positive control (8NKOH).
Under the experimental conditions adopted and in accordance with the Globally Harmonized System (Regulation (EC) No.1272/2008), the test item must not be classified in category 1"Corrosive".
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