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Diss Factsheets
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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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- Studies on the contact dermatitic properties of pakistani medicinal plants. Part VI. Dermal irritating properties of Lavandula stoechas L
- Author:
- Saeed M A
- Year:
- 1 994
- Bibliographic source:
- J.Pharm. Univ.Mar., 10 (1), 39 - 49
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test:
open mouse ear assay. The pilot and main irritancy assay on mice ears were adopted from Evans and Schmidt (1979).
- GLP compliance:
- not specified
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
Test animals
- Species:
- mouse
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- None
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: intact skin (inner surface of animal’s ear)
- Vehicle:
- other: (acetone)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.15625, 0.3125, 0.625, 1.25, 2.5 and 5 µg
- Concentration (if solution): 0.15625, 0.3125, 0.625, 1.25, 2.5 and 5 µg/5 µL.
- Observation period:
- The ears were examined for redness after 30 minutes and then 15 minute interval until two observations indicated that further redness would not occur.
- Number of animals:
- 12 per dose
- Details on study design:
- TEST SITE
- Area of exposure: inner surface of animal's ear
OBSERVATION TIME POINTS : The ears were examined for redness after 30 minutes and then 15 minute interval until two observations indicated that further redness would not occur.
SCORING SYSTEM:
- Method of calculation:
The time of maximum erythema was noted. The number of ears eliciting the degree of redness corresponding to at least ++ intensity on Hecker's scale at peak irritancy (Hecker 1971) also mentioned by Evans and Schmidt (1979) were noted and expressed in μg / 5 μI per ear.
The chronic effects of the test compound on the animals skin were also recorded after one and two days to ascertain the chronic inflammatory dose. Animals with at least ++ intensity after 24 and 48 hours were recorded and denoted by IU (Irritant units) (Hecker 1971).
The total number of red ears per dilution was tabulated. ID50 (Irritant dose in 50% individuals ) along with the upper and lower confidence limits were calculated by probit analysis.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: ID50 (μg / 5 μL)
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 0.853
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Alpha terpineol was found irritant with ID50 (Irritant dose in 50% individuals) = 0.853 µg/5 µL. Its reaction lasted for 24 h, indicating IU = 0.625 µg/5 µL after 24 h. No effects were recorded after 48 h up to the highest dose tested (IU>5 µg/5 µL).
Any other information on results incl. tables
Table 1: irritant responses of the compounds Isolated from Lavandula stoechas oil on Albino Mice
Dose levels (μg / 5 μL) |
Alpha terpineol |
|
5 |
11/12 |
|
2.5 |
9/12 |
|
1.25 |
7/12 |
|
0.625 |
5/12 |
|
0.3125 |
3/12 |
|
0.15625 |
1/12 |
|
ID 50 |
μg / 5 μL |
0.853 |
S.D |
0.128 |
|
t |
3.25 |
|
U.C.L. |
1.369 |
|
L.C.L. |
0.552 |
|
IU (μg / 5μL) after |
24 h |
0.625 |
48 h |
>5 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the test conditions, alpha terpineol was found to be a skin irritant.
- Executive summary:
The irritant potentials of Lavandula stoechas were investigated on albino mice. Six of its components were evaluated for irritancy by open mouse ear assay. Alpha terpineol was dissolved in acetone (10 mg/10 mL (w /v) solution). Further dilutions were prepared. Doses of 0.15625, 0.3125, 0.625, 1.25, 2.5 and 5 µg/5 µL were applied to inner surface of animal’s ear. The ears were examined for redness after 30 minutes and then 15 minute interval until two observations indicated that further redness would not occur. The time of maximum erythema was noted. The number of ears eliciting the degree of redness according to Hecker's scale were noted and expressed in μg / 5 μI per ear. The chronic effects after 24 and 48 hours were recorded and denoted by IU (Irritant units). ID50 (Irritant dose in 50% individuals ) were calculated by probit analysis. ID50 of alpha terpineol was found to be 0.853 µg/5 µL and its reaction lasted for 24 h, indicating IU = 0.625 µg/5 µL after 24 h. It is concluded that alpha terpineol is a skin irritant.
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