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EC number: 294-461-7 | CAS number: 91722-61-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Juniperus mexicana, 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20-07-2017 to 21-07-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Essential oil of Cedarwood Texas obtained from the wood of Juniperus mexicana (Cupressaceae) by distillation - Cedrol
- IUPAC Name:
- Essential oil of Cedarwood Texas obtained from the wood of Juniperus mexicana (Cupressaceae) by distillation - Cedrol
- Test material form:
- solid
- Remarks:
- LIGHT YELLOW, SOLID MASS
- Details on test material:
- Name of test material as cited in study report: Cedrol - Cedarwood Texas oil distilled
Mfg Date 01/26/2016
Exp Date 01/25/2019
- Identification: Cedrol, Cedarwood Texas oil distilled
- Appearance: Light yellow, solid mass
- Batch: B-64530
- Purity/Composition: UVCB
- Test item storage: At room temperature
- Stable under storage conditions until: 25 January 2019 (expiry date)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature protected from light
ODOUR DESCRIPTION: CONFORMS TO STANDARD
Constituent 1
- Specific details on test material used for the study:
- - Identification: Cedrol, Cedarwood Texas oil distilled
- Appearance: Light yellow, solid mass
- Batch: B-64530
- Purity/Composition: UVCB
- Test item storage: At room temperature
- Stable under storage conditions until: 25 January 2019 (expiry date)
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test item should be equilibrated to 100°C for several minutes until completely liquefied to obtain a homogeneous sample.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek Corporation
- Source strain:
- other: Keratinocyte strain 00267
- Justification for test system used:
- Recommended test system in international guidelines (OECD and EC).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model
- Tissue batch number(s): Lot no.: 26708 Kit L and Kit M
- Production date: 19-07-2017
- Date of initiation of testing: 20-07-2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 min room temperature, 1 hour 37ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing step: washed with phosphate buffered saline
- Damage: no visual damage
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT concentrate (5 mg/ml) diluted (1:5) with MTT diluent (supplemented DMEM)
- Incubation time: 3 hours
- Spectrophotometer: TECAN Infinite® M200 Pro Plate Reader
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The absolute mean OD570 of the two tissues of the negative control should reasonably be within the laboratory historical control data range. The mean relative tissue viability following 1-hour exposure to the positive control should be <15 %.
- Reproducibility: In the range 20 - 100% viability, the Coefficient of Variation (CV) between tissue replicates should be 30%.
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
- 1 experiment with 3 minute application (in duplicate)
- 1 experiment with 1 hour application (in duplicate)
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if
a) The relative mean tissue viability obtained after 3-minute treatment compared to the negative control tissues is decreased below 50%.
b) In addition, a test item considered non-corrosive (viability >= 50%) after the 3-minute treatment is considered corrosive if the relative tissue viability after 1-hour treatment with the test item is decreased below 15%.
- The test substance is considered to be non-corrosive to skin if
a) The relative mean tissue viability obtained after the 3-minute treatment compared to the negative control tissues is not decreased below 50%.
b) In addition, the relative tissue viability after the 1-hour treatment is not decreased below 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50µL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50µL
- Concentration (if solution):8N - Duration of treatment / exposure:
- 3 min / 1 hour
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 104
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour exposure
- Value:
- 116
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS: no
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative/positive control:
The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit <=2.8) and the laboratory historical control data range.
- Acceptance criteria met for variability between replicate measurements: The mean relative tissue viability following the 1-hour exposure to the positive control was 10%.
In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was <=8.0%, indicating that the test system functioned properly.
- Range of historical values (OD570):
Negative control Positive control Positive control
3-minute treatment 1-hour treatment 3-minute treatment 1-hour treatment 3-minute treatment 1-hour treatment
Range 1.324 – 2.615 1.361 – 2.352 0.0172 – 0.56 0.046 – 0.339 6 – 25 3 – 13
Mean 1.84 1.85 0.19 0.14 11.03 7.45
SD 0.26 0.22 0.09 0.06 4.39 2.51
n 81 83 80 77 38 38
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria
- Conclusions:
- Under the conditions of the test, the Cedrol, Cedarwood Texas oil distilled was not corrosive. Based on this result, the substance does not need to be classified for skin corrosion in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
Cedrol, Cedarwood Texas oil distilled was evaluated for its ability to induce skin corrosion on a human three dimensional epidermal model according to OECD TG 431. Cedrol, Cedarwood Texas oil distilled was applied topically for 3 minutes and 1 hour. The test substance was equilibrated to 100°C for several minutes until completely liquefied to obtain a homogeneous liquid sample. Cedrol, Cedarwood Texas oil distilled (50 µl) was applied directly on top of the skin tissue.
The positive control had a mean relative tissue viability of 10% after the 1-hour exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥ 0.8 and upper acceptance limit ≤ 2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between tissue replicates was ≤ 8.0%, indicating that the test system functioned properly.
The relative mean tissue viability obtained after 3-minute and 1-hour treatments with Cedrol, Cedarwood Texas oil distilled compared to the negative control tissues was 104% and 116%, respectively. Because the mean relative tissue viability for Cedrol, Cedarwood Texas oil distilled was above 50% after the 3-minute treatment and above 15% after the 1-hour treatment Cedrol, Cedarwood Texas oil distilled is considered to be not corrosive.
In conclusion, Cedrol, Cedarwood Texas oil distilled is not corrosive in the in vitro skin corrosion test under the experimental conditions described.
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