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EC number: 201-291-9 | CAS number: 80-56-8
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from June 22 to July 27, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study well conducted and in compliance with GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: ECVAM protocol version 1.8 of february 2009
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Pin-2(3)-ene
- EC Number:
- 201-291-9
- EC Name:
- Pin-2(3)-ene
- Cas Number:
- 80-56-8
- Molecular formula:
- C10H16
- IUPAC Name:
- 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
- Reference substance name:
- (1R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- EC Number:
- 227-336-2
- EC Name:
- (1R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Cas Number:
- 5794-03-6
- Molecular formula:
- C10H16
- IUPAC Name:
- (1R,4S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Reference substance name:
- (1S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- EC Number:
- 227-337-8
- EC Name:
- (1S)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Cas Number:
- 5794-04-7
- Molecular formula:
- C10H16
- IUPAC Name:
- (1S,4R)-2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Reference substance name:
- (-)-pin-2(10)-ene
- EC Number:
- 242-060-2
- EC Name:
- (-)-pin-2(10)-ene
- Cas Number:
- 18172-67-3
- Molecular formula:
- C10H16
- IUPAC Name:
- (1S,5S)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
- Reference substance name:
- (1R,5R)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
- Cas Number:
- 19902-08-0
- Molecular formula:
- C10H16
- IUPAC Name:
- (1R,5R)-6,6-dimethyl-2-methylenebicyclo[3.1.1]heptane
- Reference substance name:
- 7,7-dimethyl-2-methylene-(1R,4S)-bicyclo[2.2.1]heptane
- Cas Number:
- 116724-26-6
- Molecular formula:
- C10H16
- IUPAC Name:
- 7,7-dimethyl-2-methylene-(1R,4S)-bicyclo[2.2.1]heptane
- Reference substance name:
- 7,7-dimethyl-2-methylene-, (1S,4R)-bicyclo[2.2.1]heptane
- Cas Number:
- 7378-37-2
- Molecular formula:
- C10H16
- IUPAC Name:
- 7,7-dimethyl-2-methylene-, (1S,4R)-bicyclo[2.2.1]heptane
- Test material form:
- liquid
- Details on test material:
- Batch No. : 108348
Purity : 96.6% (sum of the two main constituents)
Name of test material (as cited in study report): alpha-pinene (CAS 80-56-8)
Physical state: colourless liquid
Storage Conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry Date: 20 April 2011
Constituent 1
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- Three-dimensional human epidermis model, supplied by SkinEthic Laboratories, Nice, France constituted by:
- a collagen type I matrix, coated with type IV collagen
- a differentiated and stratified epidermis model from human keratinocytes, obtained after 13-day culture period.
All biological components of the epidermis and the kit culture medium have been tested for the absence of viruses, bacteria and mycoplasma
Test system
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 10 µL - Duration of treatment / exposure:
- 15 ± 0.5 min
- Number of animals:
- 3 epidermis/product
- Details on study design:
- Before the beginning of the study, the non-specific MTT reduction by the test item was checked by incubating MTT solution and 10 µL test item for 3 hours ± 30 minutes and checking the colour of the solution.
Application of the test item and control:
- negative control: 10 µL of PBS+ to each epidermis surface
- positive control: 10 µL of SDS solution at 5% (w/v) in distilled water; after 7 minutes contact time, an intermediate re-spreading is done
- test substance: 10 µL of the test item, as supplied
- contact timepoint for all products: 15 ± 0.5 minutes at room temperature
Rinsing:
- epidermis rinsed thoroughly with 25 mL of PBS+
- remaining product removed with a cotton-bud
Incubation: plates incubated during 42 ± 1 hours in CO2 incubator with maintenance medium
MTT assay:
- epidermis incubated for 3 hours ± 5 minutes in MTT solution in the CO2 incubator
- formazan extraction in 500 µL of acidic isopropanol stored at 4 hours ± 30 minutes at room temperature, protected from light or during 70 ± 5 hours at 4 °C
- measurement of OD at 570 nm
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: viability % (MTT assay)
- Value:
- 39.6
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 min. Reversibility: no data. Remarks: ± 5.6. (migrated information)
In vivo
- Irritant / corrosive response data:
- No data
- Other effects:
- No data
Any other information on results incl. tables
Negative control (PBS+): mean OD = 0.821
Positive control (5% SDS): % viability (MTT assay) = 18.7 ± 3.0
Test item: % viability (MTT assay) = 39.6 ± 5.6
Table 1: MTT conversion assay in living epidermis
|
|
OD 1 |
OD 2 |
Mean |
Standard deviation |
Viability % |
Mean Viability % |
Standard deviation |
Negative control |
Epidermis 1 |
0.768 |
0.808 |
0.788 |
0.028 |
96.0 |
100 |
0.044 |
Epidermis 2 |
0.855 |
0.864 |
0.860 |
0.006 |
104.7 |
|||
Epidermis 3 |
0.819 |
0.811 |
0.815 |
0.006 |
99.3 |
|||
Positive control |
Epidermis 1 |
0.124 |
0.145 |
0.135 |
0.015 |
16.4 |
18.7 |
0.030 |
Epidermis 2 |
0.158 |
0.131 |
0.145 |
0.019 |
17.6 |
|||
Epidermis 3 |
0.191 |
0.172 |
0.182 |
0.013 |
22.1 |
|||
Test item |
Epidermis 1 |
0.327 |
0.310 |
0.319 |
0.012 |
38.8 |
39.6 |
0.056 |
Epidermis 2 |
0.365 |
0.382 |
0.374 |
0.012 |
45.5 |
|||
Epidermis 3 |
0.273 |
0.292 |
0.283 |
0.013 |
34.4 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- alpha-Pinene is classified as irritating to skin, R38, according to the criteria of Directive 67/548/EEC and in category 2 according to Regulation (EC) n° 1272/2008 (CLP).
- Executive summary:
A GLP study conducted in vitro with human epidermis model EPISKIN was performed to assess the irritancy potential of alpha-pinene similarly to ECVAM protocol version 1.8 of February 2009. 10 µL of test item was applied directly on epidermis for 15 min on 3 epidermis. Positive control was 10 µL of 5% (w/v) SDS solution and negative control was 10 µL of PBS (each tested on 3 epidermis). MTT conversion assay was peformed to evaluate the percentage of cellular viability of the epidermis. Positive control had a percentage of cell viability of 18.7 ± 3.0 and test item 39.6 ± 5.6. As the percentage of viability is ≤ 50 %, the test item is considered to be irritating for skin.
Therefore, alpha-pinene is classified as irritating to skin, R38, according to the criteria of Directive 67/548/EEC and in category 2 according to Regulation (EC) n° 1272/2008 (CLP).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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