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Diss Factsheets
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EC number: 209-235-5 | CAS number: 562-74-3
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- 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:
- Correlations of the components of tea tree oil with its antibacterial effects and skin irritation
- Author:
- Lee C. J., Chen L. W., Chen L. G., Chang T. L., Huang C. W., Huang M. C., Wang C. C.
- Year:
- 2 013
- Bibliographic source:
- Journal of Food and Drug analysis 21 (2013) 169-176
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: Draize skin irritation test as described in Draize et al. (1944) Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes; Journal of Pharmacology and Experimental Therapeutics, Nov 1944, 82 (3) 377-390
- Parameters analysed / observed: erythema and oedema using a scoring system by Draize et al. (1944) - GLP compliance:
- not specified
Test material
- Reference substance name:
- p-menth-1-en-4-ol
- EC Number:
- 209-235-5
- EC Name:
- p-menth-1-en-4-ol
- Cas Number:
- 562-74-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- 4-methyl-1-(propan-2-yl)cyclohex-3-en-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Sigma Aldrich, Milan, Italy
- Purity: analytical-grade
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BioLASCO, Taiwan
- Age at study initiation: 8-10 weeks
- Females non-pregnant and nulliparous: yes
- Weight at study initiation: 200-220
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 +/- 1
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- Amount applied: 50 µl
Concentrations: 0.094%, 0.188%, 0.375%, 0.750%, 1.500% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 24, 48 h
- Number of animals:
- Each group consisted of five female rats
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm at each site of the back
- Site preparation: 24 h before the test, the backs of the animals were shaved and checked for any abnormalities the next day.
REMOVAL OF TEST SUBSTANCE
- Washing: with distilled water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
- 24 and 48 h
SCORING SYSTEM:
- Method of calculation: Scoring system by Draize et al. (1944)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no evidence of any skin reaction
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no evidence of any skin reaction
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The prepared tea tree oil from leaves and from twigs contained 47.31% and 39.09% terpinen-4 -ol, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions chosen, the test substance did not induce skin irritancy.
- Executive summary:
Five female Wistar rats per concentration group were treated with 0.094%, 0.188%, 0.375%, 0.750%, 1.500% of terpinen-4 -ol. Exposure duration was 4 hours and the test substance was removed with distilled water after the exposure period. Twenty-four and 48 h after application, skin irritation was observed and quantified through the scoring system by Draize et al. (1944). No evidence of erythema, oedema, or any other skin reaction was observed at 24 h and 48 h.
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