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EC number: 202-680-6 | CAS number: 98-55-5
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is non-GLP and similar to OECD TG 426. It well documented, meets generally accepted scientific principles and is therefore acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Method: Popliteal lymph node assay (PLNA)
- Principles of method if other than guideline:
- Method: Popliteal lymph node assay (PLNA)
- GLP compliance:
- not specified
- Type of study:
- other: Popliteal lymph node assay (PLNA)
- Species:
- other: rat
- Strain:
- other: Wistar
- Sex:
- female
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these test conditions, alpha-terpineol was not considered as a sensitiser.
- Executive summary:
In a popliteal lymph node assay (PLNA), a group of 10 female Wistar rats were injected subcutaneously with alpha-Terpineol at 5 mg/paw into the right hind footpad while the contralateral footpad was injected with the vehicle (DMSO) alone. Chlorpromazine (CPZ) and barbital were used as positive and negative controls, respectively. Weight (WI) and cellularity (CI) indices for draining PLNs were determined 7 days after treatment.
Weight (WI) and cellularity (CI) indices for alpha-Terpineol was determined to be 1.32 ± 0.71 and 2.00 ± 3.32, respectively. Alpha-terpineol was classified as negative because group mean values for WI and CI were lower than 2 and 5, respectively.
Under these test conditions, alpha-terpineol was not considered as a sensitiser.
Reference
Table 1: Primary PLNA responses
Criteria |
Negative controls |
Vehicle |
Chlorpromazine |
||||
|
Terpineol |
Barbital |
DMSO |
Saline |
0.5 mg/paw |
2.5 mg/paw |
5.0 mg/paw |
N |
10 |
8 |
47 |
50 |
4 |
6 |
11 |
WI |
1.32 ± 0.71 |
1.06 ± 0.36 |
1.48 ± 0.65 |
1.12 ± 0.90 |
1.30 ± 0.35 |
2.06 ± 0.81* |
3.22 ± 1.13* |
CI |
2.00 ± 3.32 |
1.34 ± 0.92 |
2.95 ± 3.68 |
2.04 ± 2.03 |
1.26 ± 0.81 |
8.49 ± 8.91* |
8.28 ± 8.19* |
IPR, no. (%) |
2 (20) |
0 (0) |
5 (10.6) |
3 (6) |
0.0 |
50.0 |
63.6* |
* indicates that the value differs from that of the lowest dose group (0.5 mg/paw)
- Injected doses were 5 mg/paw (monoterpenes and barbital) or 50 µL /paw (vehicles).
- Values are means ± SD;
- Weight (WI) and Cellularity (CI) indices: values for the draining popliteal lymph node of the treated (right paw) side divided by that of the control (left paw) side.
- IPR, number (%) of rats within the group with WI ≥ 2 and CI ≥ 5.
- Substances were classified as negative because group mean values for WI and CI were lower than 2 and 5, respectively.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
In a popliteal lymph node assay (PLNA), a group of 10 female Wistar rats were injected subcutaneously with alpha-Terpineol at 5 mg/paw into the right hind footpad while the contralateral footpad was injected with the vehicle (DMSO) alone (Friedrich 2007). Chlorpromazine (CPZ) and barbital were used as positive and negative controls, respectively. Weight (WI) and cellularity (CI) indices for draining PLNs were determined 7 days after treatment. Weight (WI) and cellularity (CI) indices for alpha-Terpineol was determined to be 1.32 ± 0.71 and 2.00 ± 3.32, respectively. Alpha-Terpineol was classified as negative because group mean values for WI and CI were lower than 2 and 5, respectively. Under these test conditions, alpha-Terpineol was not considered to be a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
The one skin sensitisation study with alpha-Terpineol is sufficiently adequate for this assessment of this end point.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
Since alpha-Terpineol is not a skin sensitiser, it is unlikely that it is a respiratory sensitiser as can be derived when following the ITS scheme in the REACH guidance: Scheme of R7A, Fig. 7.3 -2.
Justification for selection of respiratory sensitisation endpoint:
Alpha-Terpineol is not considered a respiratory sensitiser because it is not a skin sensitiser.
Justification for classification or non-classification
Alpha-Terpineol is negative in the skin sensitisation study and therefore classification of alpha-Terpineol for skin and respiratory sensitisation is not warranted according to EU Directive 67/548 and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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