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EC number: 202-589-1 | CAS number: 97-53-0
- 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
- Study period:
- 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study design reported to follow OECD Guideline 429 (2002) with deviations (no positive control was included in the experiment, group housing instead of individual housing, and acclimatisation period was not reported).
Data source
Reference
- Reference Type:
- publication
- Title:
- Investigation of the Dermal sensitization potential of various essential oils in the local lymph node assay.
- Author:
- Lalko J., and Api A.M.
- Year:
- 2 006
- Bibliographic source:
- Food and Chemical Toxicology. 2006; Volume 44: 736-746
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- No positive control was included in the experiment, group housing instead of individual housing, and acclimatisation period was not reported.
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Eugenol
- EC Number:
- 202-589-1
- EC Name:
- Eugenol
- Cas Number:
- 97-53-0
- Molecular formula:
- C10H12O2
- IUPAC Name:
- 2-methoxy-4-(prop-2-en-1-yl)phenol
- Details on test material:
- - Name of test material (as cited in study report): Eugenol
- Analytical purity: 99.9%
Further details not reported.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna UK, Shaw's Farm, Blackthorne, Bicester, Oxon, UK
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 17 to 21 g
- Housing: Housed in groups of 4 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- other: 1:3 ethanol:diethyl phthalate
- Concentration:
- 0, 2.5, 5, 10, 25, 50%
- No. of animals per dose:
- 4 mice/dose group
- Details on study design:
- RANGE FINDING TESTS: none
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: A test material was considered a sensitizer if at least one concentration was observed to have a stimulation index value of 3 or more.
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of female mice (n=4) were dosed topically on the dorsum of both ears with 25 µL eugenol. Each group received one of five test concentrations (2.5, 5, 10, 25, or 50%). A vehicle control group was similarly treated with 1:3 EtOH:DEP. Dosing occurred daily for 3 consecutive days. The animals “rested” for 2 days and on the 6th day after the first application, all mice were injected intravenously by the tail vein with phosphate buffered saline containing [3H]methyl thymidine. Five hours later, the mice were euthanized and the draining auricular lymph nodes were excised and pooled for each experimental group.
For each concentration, a stimulation index relative to the concurrent vehicle-control was calculated. The stimulation index value was calculated by dividing the mean dpm at a given dose level by the mean dpm of the vehicle control group. - Positive control substance(s):
- other: Study was reported to be performed according to OECD guideline 429, which requires that a positive experiment be conducted. Therefore, it was assumed that a positive control experiment was performed but was not reported.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- EC3
- Value:
- 5.4
- Test group / Remarks:
- eugenol
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 2.5% eugenol
- Parameter:
- SI
- Value:
- 2.7
- Test group / Remarks:
- 5.0% eugenol
- Parameter:
- SI
- Value:
- 6
- Test group / Remarks:
- 10.0% eugenol
- Parameter:
- SI
- Value:
- 14.3
- Test group / Remarks:
- 25.0% eugenol
- Parameter:
- SI
- Value:
- 19.4
- Test group / Remarks:
- 50.0% eugenol
Any other information on results incl. tables
Mean values of DPM per dose group are provided below.
Vehicle group = 386 dpm/lymph node
2.5% eugenol = 464 dpm/lymph node
5.0% eugenol = 1,051 dpm/lymph node
10.0% eugenol = 2,322 dpm/lymph node
25.0% eugenol = 5,534 dpm/lymph node
50.0% eugenol = 7,476 dpm/lymph node
A stimulation index value greater than or equal to 3 are considered to result in a positive response.
Mean values of SI per dose group are provided below.
Vehicle group = not applicable
2.5% eugenol = 1.2
5.0% eugenol = 2.7
10.0% eugenol = 6.0
25.0% eugenol = 14.3
50.0% eugenol = 19.4
The estimated concentration (EC3) giving rise to a stimulation index of 3 was calculated by linear interpretation of the dose response data for each assay. The lower the EC3 value, the greater the skin sensitization potential.
The EC3 for eugenol was reported to be 5.4%.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Category 1B Criteria used for interpretation of results: EU
- Executive summary:
The potential for skin sensitisation following exposure to eugenol was assessed using the local lymph node assay in groups of 4 female mice at test concentrations of 0, 2.5, 5, 10, 25, or 50%. The estimated concentration (EC3) giving rise to a stimulation index of 3 was calculated by linear interpretation of the dose response data for each assay. The lower the EC3 value, the greater the skin sensitization potential. The authors concluded that eugenol was regarded as a potential skin sensitizer at concentrations at and above 10.0%
(specifically, based on the data for the EC3, at a concentration >5.4%).
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