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EC number: 233-986-8 | CAS number: 10482-56-1
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Assessment of sensitization potential of monoterpenes using the rat popliteal lymph node assay
- Author:
- Friedrich K
- Year:
- 2 007
- Bibliographic source:
- Food and Chemical Toxicology 45 (2007) 1516–1522
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test:
Rat popliteal lymph node assay (PLNA). Although the predictive value of PLNA was initially focused on auto-immune-like reactions, more recently it has been regarded as a screening test useful for detecting a broader class of sensitizing or immuno-stimulating chemicals (Pieters and Albers, 1999; Ravel and Descotes, 2005). In this study, the rat PLNA was used to evaluate the immuno-sensitizing potential of 10 monoterpenes found in the essential oils of a variety of aromatic, edible and medicinal plants.
- GLP compliance:
- not specified
- Type of study:
- other: Popliteal lymph node assay (PLNA)
- Justification for non-LLNA method:
- The PLNA seems to be a reliable test for screening chemicals causing sensitization via routes of exposure other than the skin (Goebel et al., 1996; Tuschl et al., 2002).
Test material
- Reference substance name:
- p-menth-1-en-8-ol
- EC Number:
- 202-680-6
- EC Name:
- p-menth-1-en-8-ol
- Cas Number:
- 98-55-5
- Molecular formula:
- C10H18O
- IUPAC Name:
- 2-(4-methylcyclohex-3-en-1-yl)propan-2-ol
Constituent 1
In vivo test system
Test animals
- Species:
- other: rat
- Strain:
- other: Wistar
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Oswaldo Cruz Foundation (FIOCRUZ) breeding stock
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7–8 week-old
- Weight at study initiation: 145 ± 23 g
- Housing: All rats were individually housed in standard plastic cages with stainless steel cover lids and wood shavings as bedding.
- Diet (e.g. ad libitum): ad libitum (Nuvitall, Nuvilab, Curitiba, PR, Brazil)
- Water (e.g. ad libitum): ad libitum (tap water)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1ºC,
- Humidity (%): 70%
- Photoperiod (hrs dark / hrs light): 12-h dark/light cycle
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: subcutaneous
- Vehicle:
- DMSO
- Concentration / amount:
- 5 mg/paw of test substance (50 µL of test substance in vehicle)
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- other: It is of note that, as a rule, 5 mg/paw has been the highest dose of a test compound assayed in the rat PLNA (Vial et al., 1997; Descotes et al., 1997).
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: one per animal
- Exposure period: Seven days after footpad injection, rats were killed by CO2 inhalation
- Test groups: one treated group (10 animals)
- Control group: barbital (negative control), saline (vehicle control for negative) and DMSO (vehicle control for treated group)
- Site: right footpad (treated group). The contralateral (left) hind footpad was used as the control and thus it was injected with 50 µL of vehicle alone. When the vehicles were tested, the right hind footpad was injected with 50 µL of DMSO or saline while the left hind footpad remained untreated.
OTHER:
Seven days after footpad injection, rats were killed by CO2 inhalation. The popliteal lymph nodes (PLN) were carefully removed, placed in phosphate buffer saline (PBS), freed from adherent fatty tissue and weighed. PLNs were then transferred to a glass tube where cells were extracted by agitation and gentle grinding using a micropestle and suspended in a known volume of PBS on ice. PLN cell number (cellularity) was counted using a Neubauer chamber. Results were expressed as weight
(WI) and cellularity (CI) indices. WI and CI were calculated by dividing the value (weight or cellularity) obtained for the treated (right) side PLN by that obtained for the control (left) side PLN. - Positive control substance(s):
- yes
- Remarks:
- (chlorpromazine)
Results and discussion
- Positive control results:
- see table on "any other information on results incl. tables"
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 5 mg
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- 5 mg
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 5 mg
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
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 (terpineol 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.
- Terpineol was classified as negative because group mean values for WI and CI were lower than 2 and 5, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- other: No category (CLP Regulation EC no. 1272/2008)
- 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 and 2.00, 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.
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