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EC number: 481-880-7 | CAS number: 949495-68-5
- 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:
- 23-28 April 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted according to OECD test Guideline No. 431. However, functional model conditions and references to historical control data are not included in the report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- Adopted April 13, 2004
- Deviations:
- yes
- Remarks:
- functional model conditions and references to historical control data are not included in the report.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- yes
- Remarks:
- functional model conditions and references to historical control data are not included in the report.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- UK GLP Compliance Programme (inspected on 05 July 2016 / signed on 28 October 2016)
Test material
- Reference substance name:
- -
- EC Number:
- 481-880-7
- EC Name:
- -
- Cas Number:
- 949495-68-5
- Molecular formula:
- not available (UVCB)
- IUPAC Name:
- Essential oil of Schinus Terebinthifolius (Anacardiaceae) obtained from red berries by supercritical carbon dioxide extraction
- Test material form:
- liquid
- Details on test material:
- - Storage conditions: In the refrigerator at 2 – 8 °C, protected from light in N2 atmosphere
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Following the REACH bottom-up strategy, the EpiDerm™ Human Skin Model method was used to assess skin corrosion as recommended in the OECD test guideline No. 431.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epi-200-Kit, MatTek Corporation (Ashland, MA 01721, USA).
- Lot number: 10504 Kit N
- Production Date: no data
- Shipping date: no data
- Delivery date: no data
- Date received: April 24, 2008
- Date of initiation of testing: April 25, 2008
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 and 60 minutes at 37 °C in a humidified atmosphere of 5% CO2
- Temperature of post-treatment incubation: 3 h at 37 °C in a humidified atmosphere of 5% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: At the end of the exposure period the first insert was removed from the 6-well plate. Using a wash bottle the tissue was gently rinsed with PBS Rinse Solution to remove any residual test material. Excess PBS Rinse Solution was removed by gently shaking the insert and
blotting the lower surface with blotting paper.
- Observable damage in the tissue due to washing: none reported
- Modifications to validated SOP: none reported
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL MTT solution
- Incubation time: 3 hours at 37 °C, 5% CO2 in air
- Spectrophotometer: Versamax® Molecular Devices, D-85737 Ismaning
- Wavelength: 570 nm
- Filter: without reference filter
- Linear OD range of spectrophotometer: not reported
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
Not reported
NUMBER OF REPLICATE TISSUES: Duplicate tissues for test item, negative and positive controls
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Not needed
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin 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%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL of the undiluted test item.
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL of sterile distilled water was used as supplied
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL of 8.0 N Potassium Hydroxide was used as supplied - Duration of treatment / exposure:
- 3 and 60 minutes.
- Duration of post-treatment incubation (if applicable):
- not applicable
- Number of replicates:
- Duplicate tissues for test item, negative and positive controls
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes exposure
- Value:
- 92.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 26.4%
- Remarks on result:
- other: No indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes exposure
- Value:
- 85.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 12.4%
- Remarks on result:
- other: No indication of corrosion
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: none reported
- Direct-MTT reduction: none.
DEMONSTRATION OF TECHNICAL PROFICIENCY: not included in the report
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD570 for the negative control treated tissues was 1.637 for the 3 Minute exposure period and 1.703 for the 60 Minute exposure period. The negative control acceptance criteria were therefore satisfied (≥ 0.8).
- Acceptance criteria met for positive control: The relative mean tissue viability for the positive control treated tissues was 26.4% and 12.4% relative to the negative control following the 3 and 60 Minute exposure period, respectively. The positive control acceptance criterion was therefore satisfied (≤ 30%).
Any other information on results incl. tables
Table 7.3.1/1: Mean OD570 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Dose group |
Treatment Interval |
Absorbance 570 nm Tissue 1* |
Absorbance 570 nm Tissue 2* |
Mean Absorbance of 2 Tissues |
Rel. Absorbance [% of Negative Control]** |
Negative Control |
3 min |
1.628 |
1.647 |
1.637 |
100.0
|
Positive Control |
3 min |
0.494 |
0.369 |
0.432 |
26.4 |
Pink Pepper (ST 08 C 08) |
3 min |
1.547 |
1.486 |
1.517 |
92.6
|
Negative Control |
1 hour |
1.755 |
1.650 |
1.703 |
100.0
|
Positive Control |
1 hour |
0.191 |
0.231 |
0.211 |
12.4
|
Pink Pepper (ST 08 C 08) |
1 hour |
1.436 |
1.477 |
1.456 |
85.5
|
* Mean of three replicate wells after blank correction
** relative absorbance [rounded values]: 100 x (absorbance test item) / (absorbance negative control)
Applicant's summary and conclusion
- Interpretation of results:
- other: Non-corrosive base don GHS criteria
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified as corrosive, according to EU CLP Regulation (EC) No 1272/2008 and to the GHS.
- Executive summary:
An in vitro skin irritation study was performed according to the OECD Guideline 431 and in compliance with GLP, using the EpiDerm™ Human Skin Model.
Duplicate tissues were treated with 50 µL of the undiluted test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT‑loading. After MTT loading each tissue was placed in 2 mL Isopropanol for MTT extraction. At the end of the formazan extraction period each well was mixed thoroughly and triplicate 200 mL samples were transferred to the appropriate wells of a pre-labeled 96‑well plate. The optical density (OD) was measured at 570 nm. Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
The relative mean viability of the test item treated tissues was 92.6% and 85.5% after 3 and 60 minutes exposure, respectively. The relative mean viability of the positive control treated tissues was 26.4% and 12.4% after 3 and 60 minutes exposure. The quality criteria required for acceptance of results in the test were satisfied.
Under the experimental conditions of this study, the test substance is not classified as corrosive according to EU CLP Regulation (EC) No 1272/2008 and to the GHS.
This study is considered as acceptable and satisfies the requirement for skin corrosion endpoint.
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