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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
Endpoint summary
Administrative data
Description of key information
alpha-Pinene multiconstituent is classified as irritating to skin, category 2 according to CLP Regulation (EC) n° 1272/2008.
alpha-Pinene multiconstituent does not require classification as eye irritant or serious eye damage according to CLP Regulation (EC) n° 1272 /2008.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- 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)
- 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 - 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 - 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)
- Irritant / corrosive response data:
- No data
- Other effects:
- No data
- 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).
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- October 2015
- Species:
- human
- Strain:
- other: reconstructed human Cornea-like Epithelium
- Details on test animals or tissues and environmental conditions:
- EpiOcular TM tissue Model OCL-212-ver2.0 supplied by MatTek
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Test item alpha-pinene multiconstituent was applied as supplied at the dose of 50 µL.
- Duration of treatment / exposure:
- 30 minutes
- Duration of post- treatment incubation (in vitro):
- A 12-minute post exposure immersion period at room temperature and a 1-hour and 58-minute post exposure incubation at standard culture conditions.
- Number of animals or in vitro replicates:
- 2 replicates
- Irritation parameter:
- other: percent tissue viability
- Value:
- 80.39
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- percent tissue viability = 31.99%
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- alpha-Pinene multiconstituent does not need classification as eye irritant or serious eye damage according to Regulation (EC) n° 1272/2008 and UN GHS.
- Executive summary:
In a GLP study conducted according to the OECD 492 guideline the irritant potential of alpha-pinene multiconstituent was evaluated. The method is based on viability of Reconstructed Human Cornea-like Epithelium (RhCE) when exposed to the test substance. The mean percent tissue viability of the RhCE replicates treated with test item alpha-pinene multiconstituent was 80.39% versus 31.99% in the positive control (Methyl acetate). In conclusion, in accordance with Regulation (EC) n° 1272/2008 and UN GHS, the test item does not require classification as eye irritant or serious eye damage. No hazard statement or signal word is required.
Reference
Table 1:
INDIVIDUAL AND AVERAGE VALUES OF OD AFTER 30 MINUTES EXPOSURE
|
Tissue |
OD |
Mean OD/disc |
Mean OD/ product |
Viability % |
Mean viability % |
Difference of viability % |
Negative control |
1 |
1.035 1.023 0.961 |
1.006 |
1.079 |
93.28 |
100.00 |
13.44 |
2 |
1.158 1.128 1.167 |
1.151 |
106.72 |
||||
Positive control |
3 |
0.367 0.351 0.357 |
0.358 |
0.345 |
31.19 |
31.99 |
2.41 |
4 |
0.335 0.333 0.328 |
0.332 |
30.78 |
||||
Test item |
7 |
0.896 0.879 0.862 |
0.879 |
0.867 |
81.50 |
80.39 |
2.33 |
8 |
0.873 0.853 0.841 |
0.855 |
79.28 |
OD: optical density
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Information on skin irritation:
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. Under the test conditions, alpha-pinene multiconstituent is classified as irritating to skin, category 2 in CLP Regulation (EC) n° 1272/2008.
Information on eye irritation:
In a GLP study conducted according to OECD 492 guideline the irritant potential of alpha-pinene multiconstituent was evaluated. The method is based on viability of Reconstructed Human Cornea-like Epithelium-(RhCE) when exposed to the test substance. The mean percent tissue viability of the RhCE replicates treated with test item alpha-pinene multiconstituent was 80.39% versus 31.99% in the positive control (Methyl acetate). In conclusion, in accordance with Regulation EC n° 1272/2008 and UN GHS the test item does not require classification as eye irritant or serious eye damage. No hazard statement or signal word is required.
Justification for classification or non-classification
According to GLP studies performed on alpha-pinene multiconstituent, the substance is classified as irritating to skin category 2 (H315) according to Regulation (EC) n° 1272/2008. The substance is not classified for eye irritation according to Regulation (EC) n° 1272/2008.
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