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EC number: 932-349-8 | CAS number: 8006-64-2
- 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
In GLP in vitro studies using Episkin model, alpha pinene and (-)-beta pinene lead to a cell viability of 39.6 ± 5.6, 38.5 ± 3.5 and 29.8 ± 1.3 %, respectively.
In a GLP in vitro study and a in vivo GLP study, alpha-pinene and respectively beta-pinene showed no irritating properties. However, in a GLP study conducted according to OECD Guideline 405, camphene had irritating properties in rabbit eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Beta-Pinene is a main constituent of UVCB substance gum tupentine oil. Therefore, data on beta-pinene can be used for extrapolation to gum turpentine oil. See read-across justification document in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Vehicle:
- unchanged (no vehicle)
- Irritation / corrosion parameter:
- other: other: viability % (MTT assay)
- Value:
- 38.5
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 min. Reversibility: no data. Remarks: ± 3.5. (migrated information)
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The percentage of viability is ≤ 50% and (-)-beta-pinene is classified as irritating to skin, R38, according to the criteria of Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) N° 1272/2008.
- Executive summary:
An in vitro GLP study conducted with human epidermis model EPISKIN was performed to assess the irritancy potential of (-)-beta-pinene similarly to ECVAM protocol version 1.8 of February 2009. 10 µL of the test item was applied directly on 3 epidermis for 15 min. 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 had a percentage of cell viability of 38.5 ± 3.5. As the percentage of viability is ≤ 50%, the test item is considered to be irritating for skin.
Therefore, (-)-beta-pinene is classified as irritating to skin, R38, according to the criteria of Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) n° 1272/2008.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Alpha-Pinene is a main constituent of UVCB substance gum tupentine oil. Therefore, data on alpha-pinene can be used for extrapolation to gum turpentine oil. See read-across justification document in section 13.
- Reason / purpose for cross-reference:
- read-across source
- 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)
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The percentage of viability is ≤ 50 % and alpha-pinene is classified as irritating to skin, R38, according to Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) N° 1272/2008.
- Executive summary:
An in vitro GLP study conducted 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 the test item was applied directly on 3 epidermis for 15 min. 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 had a percentage of cell viability of 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 Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) n° 1272/2008.
Referenceopen allclose all
Negative control (PBS+): mean OD = 0.821
Positive control (5% SDS): % viability (MTT assay) = 18.7 ± 3.0
Test item: % viability (MTT assay) = 38.5 ± 3.5
Table 1: MTT conversion assay in living epidermis
|
|
O.D. 1 |
O.D. 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 |
0.359 |
0.293 |
0.326 |
0.047 |
39.7 |
38.5 |
0.035 |
Epidermis 2 |
0.301 |
0.267 |
0.284 |
0.024 |
34.6 |
|||
Epidermis 3 |
0.358 |
0.318 |
0.338 |
0.028 |
41.2 |
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 vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Beta-Pinene is a main constituent of UVCB substance gum tupentine oil. Therefore, data on beta-pinene can be used for extrapolation to gum turpentine oil. See read-across justification document in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- - Moderate redness of the conjunctivae associated with moderate to severe chemosis was noted in all treated animals after 1 hour of instillation; irritation completely resolved within 8 days.
- See table 1 for more details - Other effects:
- No data
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- beta-Pinene is not classified as irritating to eyes according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
- Executive summary:
In an eye irritation study conducted according to OECD Guideline 405 and in compliance with GLP, three male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted beta-pinene in one of the eyes while the other eye corresponded to the control. The eyes were examined for irritation scores at 1 hour and 1, 2, 3, 4, 7 and 8 days after dosing.
Instillation of beta-pinene resulted in moderate redness of the conjunctivae associated with moderate to severe chemosis in all treated animals after 1 hour of instillation. The irritation completely resolved within 8 days. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for cornea score; 0, 0, 0 for iris score; 1, 1, 2 for conjunctivae score and 1.3, 1, 1 for chemosis score.
Therefore, beta-pinene is not classified as irritating to eyes according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Camphene is one of the minor constituents of UVCB substance gum turpentine oil. Therefore, data on camphene can be used for extrapolation to gum turpentine oil. See read-across justification document in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- See table 1
- Other effects:
- See table 1
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Camphene is classified as ‘Irritating to eyes (Category 2)’ according to CLP Regulation (EC) n° 1272/2008 but not classified according to the criteria of Directive 67/548/EEC.
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, three rabbits of the New Zealand White strain were exposed to 100 mg of undiluted camphene in one of the eyes while the other eye corresponded to the control. The eyes were examined for irritation scores at 1 hour and 1, 2, 3, and 7 days after application. Examination and scoring after instillation of fluoresceine was assessed at 24 h, 72 h and 7 days after test substance application.
Application of camphene resulted in severe redness of the conjunctivae associated with slight to moderate chemosis in all treated animals. The irritation completely resolved within 7 days. Mean individual scores at 24, 48 and 72 hours after exposure for the 3 animals were 1.3, 0.7, 0.7 for cornea score; 0.7, 0.7, 0.3 for iris score; 2.3, 3, 2.3 for conjunctivae score and 2, 1.7, 0.7 for chemosis score.
Therefore, camphene is classified as ‘Irritating to eyes (Category 2)’ according to CLP Regulation (EC) n° 1272/2008 but not classified according to the criteria of Directive 67/548/EEC.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- Alpha-Pinene is a main constituent of UVCB substance gum tupentine oil. Therefore, data on alpha-pinene can be used for extrapolation to gum turpentine oil. See read-across justification document in section 13.
- Reason / purpose for cross-reference:
- read-across source
- 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 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 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.
Referenceopen allclose all
Table 1: Individual and mean scores of conjunctivae, iris and cornea
Animal |
Time after treatment |
Conjunctivae |
Iris |
Cornea |
|
Chemosis |
Redness |
Lesion |
Opacity |
||
1 |
1 hour |
2 |
2 |
0 |
0 |
24 hours |
1 |
1 |
0 |
0 |
|
48 hours |
1 |
1 |
0 |
0 |
|
72 hours |
2 |
1 |
0 |
0 |
|
Day 4 |
2 |
1 |
0 |
0 |
|
Day 7 |
1 |
1 |
0 |
0 |
|
Day 8 |
0 |
0 |
0 |
0 |
|
Mean (24, 48 and 72 hours) |
1.3 |
1 |
0 |
0 |
|
2 |
1 hour |
3 |
2 |
0 |
0 |
24 hours |
2 |
1 |
0 |
0 |
|
48 hours |
1 |
1 |
0 |
0 |
|
72 hours |
0 |
1 |
0 |
0 |
|
Day 4 |
0 |
0 |
0 |
0 |
|
Mean (24, 48 and 72 hours) |
1 |
1 |
0 |
0 |
|
3 |
1 hour |
3 |
2 |
0 |
0 |
24 hours |
2 |
2 |
0 |
0 |
|
48 hours |
1 |
2 |
0 |
0 |
|
72 hours |
0 |
2 |
0 |
0 |
|
Day 4 |
0 |
1 |
0 |
0 |
|
Day 7 |
0 |
0 |
0 |
0 |
|
Mean (24, 48 and 72 hours) |
1 |
2 |
0 |
0 |
Table 1: individual scores and observations
Time after application |
1 h |
24 h |
48 h |
72 h |
7 days |
Animal number |
1 2 3 |
1 2 3 |
1 2 3 |
1 2 3 |
1 2 3 |
Chemosis |
3 3 2 |
3 2 1 |
2 2 1 |
1 1 0 |
0 0 0 |
Conjunctival redness |
3 3 3 |
3 3 3 |
2 3 2 |
2 3 2 |
0 0 0 |
Iris |
1 1 1 |
1 1 1 |
1 1 0 |
0 0 0 |
0 0 0 |
Cornea |
1 1 1 |
2 1 1 |
1 1 1 |
1 0 0 |
0 0 0 |
Fluorescein test |
|
3 2 1 |
|
1 0 0 |
0 0 0 |
Ocular discharge: - Clear, colorless -white and slimy
Red iris |
X X X
X X X |
X X X
X X X |
X X |
|
|
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:
- adverse effect observed (irritating)
Additional information
In GLP in vitro studies using Episkin model, exposure of epidermis to alpha pinene and (-)-beta pinene for 15 min lead to a cell viability, measured by MTT conversion, of 39.6 ± 5.6 and 38.5 ± 3.5 respectively.
In a GLP study conducted according to OECD Guideline 492, application of alpha-pinene resulted in mean percent tissue viability of the RhCE replicates of 80.39%. In a GLP study conducted according to OECD Guideline 405 application of beta-pinene resulted in moderate redness of the conjunctivae associated with moderate to severe chemosis in all treated animals after 1 hour of instillation. The irritation completely resolved within 8 days. However, in a GLP study conducted according to OECD Guideline 405, application of camphene resulted in severe redness of the conjunctivae associated with slight to moderate chemosis in all treated animals. The irritation completely resolved within 7 days.
Justification for classification or non-classification
As the percentage of cell viability obtained in Episkin model was ≤ 50 % for alpha pinene and beta pinene, they are considered to be irritating for skin. Based on a read across approach, gum turpentine oil is classified as irritating to the skin, R38, according to the criteria of Directive 67/548/EEC and in category 2 according to CLP Regulation (EC) n° 1272 /2008.
As camphene was found to be eye irritating in an in vivo study, gum turpentine oil is classified as ‘Irritating to eyes (Category 2)’ according to CLP Regulation (EC) n° 1272/2008 but not classified according to the criteria of Directive 67/548/EEC.
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