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EC number: 225-004-1 | CAS number: 4602-84-0
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Farnesol
- EC Number:
- 225-004-1
- EC Name:
- Farnesol
- Cas Number:
- 4602-84-0
- Molecular formula:
- C15H26O
- IUPAC Name:
- farnesol
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation:8 - 12 weeks (beginning of acclimatisation)
- Housing: Makrolon Type 1 with wire mesh top, single caging
- Diet: Pelleted standard diet, ad libitum
- Water: Tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hour photoperiod with artificial light
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5%, 10% and 25%
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA assay
- Criteria used to consider a positive response: Stimulation Index >3
TREATMENT PREPARATION AND ADMINISTRATION:
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear lobe (left and right) with different test item concentrations of 5, 10 and 25% (w/v) in acetone:olive oil (4:1). The application volume, 25 ul, was spread over the entire dorsal surface (0 - 8 mm) of each ear lobe once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals). A hair dryer was used to dry the ear's surface as quickly as possible to avoid loss of test item applied.
Five days after the first topical application, all mice were administered with 250 uL of 78.9 uCi/mL 3HTdR (corresponding to 19.73 uCi 3HTdR per mouse) by intravenous injection via a tail vein. Approximately five hours after treatment with 3HTdR all mice were euthanised by intraperitoneal injection of Na-thiopental. The draining lymph nodes were rapidly excised and pooled for each experimental group (8 nodes per group). The level of 3HTdR incorporation was measured on a ß-scintillation counter, expressed as the number of radioactive disintegrations per minute (DPM).
Mortality, bodyweights and clinical signs of toxicity were also recorded during the study. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A statistical analysis was conducted for assessment of the dose-response relationship and the EC3 value was calculated. EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining lymph node cell proliferative activity.
Results and discussion
- Positive control results:
- The validation/positive control study was performed with alpha-Hexylcinnamaldehyde in acetone:olive oil, 4:1 (v/v) using CBA/CaOlaHsd mice in a separate study (April 2004). Stimulation indices at 5, 10 and 25 % (w/v) positive control concentrations were determined to be 1.9, 6.1 and 11.5, respectively. An EC3 pf 6.3% (w/v) was calculated.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- > 3
- Parameter:
- SI
- Value:
- 3.8
- Test group / Remarks:
- 5% test item (w/v)
- Parameter:
- SI
- Value:
- 6.7
- Test group / Remarks:
- 10% test item (w/v)
- Parameter:
- SI
- Value:
- 12.7
- Test group / Remarks:
- 25% test item (w/v)
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 771.6
- Test group / Remarks:
- 5% test item (w/v)
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 1 359.3
- Test group / Remarks:
- 10% test item (w/v)
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 2 568.9
- Test group / Remarks:
- 25% test item (w/v)
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 202.2
- Test group / Remarks:
- Control
- Cellular proliferation data / Observations:
- No mortality was observed during the study and the test item had no significant effect on bodyweight. The ears of all animals treated with the highest concentration (25%) were slightly red after the second treatment and all four treated animals had red inflamed ears after the third treatment. Two animals treated with 10% test item had slightly red ears after the last application. No systemic findings were, however, observed during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Stimulation indices at 5, 10 and 25 % (w/v) test item concentrations were determined to be 3.8, 6.7 and 12.7, respectively. The EC3 could not be calculated as the SI of lowest concentration tested was above 3.
- Executive summary:
The skin sensitising potential of the test item was assessed by local lymph node assay (LLNA). Female mice were treated daily with the test item at concentrations of 5, 10 and 25% (w/v) in acetone:olive oil (4:1) by topical application to the dorsum of each ear lobe for three consecutive days. A control group of four mice was treated with the vehicle only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine. Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a beta-scintillation counter. No mortality or adverse effects on bodyweight were observed during the study period. Redness of the ear was observed at higher concentrations and with repeat dosing. The stimulation indices at 5, 10 and 25 % (w/v) test item concentrations were determined to be 3.8, 6.7 and 12.7, respectively. The EC3 could not be calculated as the SI of lowest concentration tested was above 3. This study is considered to be reliable without restriction (Klimisch 1) as the study was GLP-compliant and was conducted according to OECD 429.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentrations resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index, according to ECHA's Guidance on the Application of the CLP Criteria (2015, version 4.1). The EC3 was surpassed in the lowest concentration tested, therefore the test item is classified as a skin sensitiser.
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