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EC number: 294-470-6 | CAS number: 91722-69-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Lavandula hybrida, Labiatae.
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Not performed according to GLP. An equivalent or similar guideline to OECD 428 is used but recovery was not calculated and seems to be very low
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- yes
- Remarks:
- temperature 37°C instead of 32°C
- GLP compliance:
- no
Test material
- Reference substance name:
- Linalyl acetate
- EC Number:
- 204-116-4
- EC Name:
- Linalyl acetate
- Cas Number:
- 115-95-7
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1,5-dimethyl-1-vinylhex-4-en-1-yl acetate
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): LINALYL ACETATE
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): linalyl acetate
- Analytical purity: >97%
- Source: Fluka, Buchs, Switzerland - Radiolabelling:
- no
Test animals
- Species:
- other: human
- Strain:
- other: not relevant
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Human skin was obtained from the region of thorax of one 40-year-old woman
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- Absorption: 1, 2, and 4 hours
Elimination: 1 h - Doses:
- - Nominal dose: 500 mg
- No. of animals per group:
- The absorption and elimination experiments were repeated in quadruplicates and triplicates, respectively.
- Control animals:
- no
- Details on study design:
- DOSE PREPARATION
Test article applied undiluted
TEST SITE
Skin extracts of 0.65 cm2
REMOVAL OF TEST SUBSTANCE
- Washing procedures and type of cleansing agent: Skin was rinsed shortly with methanol
- Time after start of exposure: 1, 2 or 4 hours
SKIN PREPARATION AFTER EXPOSURE
After 1, 2, or 4 h exposure, the stratum corneum layers were separated using 21 fragments of an adhesive tape, and every fraction of the stratum corneum as well as the remaining skin were extracted with methanol and stored for analysis. The acceptor medium was also collected for analysis.
For the elimination assessment, the acceptor medium was replaced by a fresh portion after 1 h exposure, and its circulation was maintained. The donor chambers remained uncovered. The experiment was terminated after 1, 2, 3 or 4 h, and the skin layers were subjected to the extraction process.
ANALYSIS
- Method type(s) for identification: GC-MS - Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: 40-year old woman
- Ethical approval if human skin: Yes, ethics committee of the Medical University of Gdansk
- Type of skin: thorax
- Storage conditions: At -20°C
PRINCIPLES OF ASSAY
- Diffusion cell: flow-through Teflon diffusion cells
- Receptor fluid: isotonic phosphate buffer (pH 7.3) preserved with 0.005% sodium azide
- Solubility of test substance in acceptor fluid: 1.34 mg/mL
- Flow-through system: yes, constant rate of 10 mL/h
- Test temperature: 37 +/- 0.5 °C
- Humidity: No data
- Occlusion: Donor compartment occluded with parafilm
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Absorption in different matrices:
- At 1 hour after application (ug/cm2):
- Stratum corneum (tape strips): 61.6 +/- 9.9
- Skin preparation (epidermis + dermis): 62.4 +/- 9.2
- Acceptor fluid: 0
At 2 hours after application (ug/cm2):
- Stratum corneum (tape strips): 98.7 +/- 6.7
- Skin preparation (epidermis + dermis): 87.6 +/- 9.7
- Acceptor fluid: 0
At 4 hours after application (ug/cm2):
- Stratum corneum (tape strips): 86.4 +/- 6.8
- Skin preparation (epidermis + dermis): 129.9 +/- 15.9
- Acceptor fluid: 0 - Total recovery:
- - Total recovery: 0.028% (216.3/(769.2*1000)
- Recovery of applied dose acceptable: No, not within 100 +/- 10% as stated in the OECD guideline but washed fraction not measured
- Limit of detection (LOD): No data
- Conversion factor human vs. animal skin:
- Not relevant
Any other information on results incl. tables
Linalyl acetate easily penetrated into the skin, however it was not detected in the acceptor fluid.
The percutaneous absorption of linalyl acetate into the skin layers (ug/cm2), is summarised in the following table. The applied dose was 500 mg/0.65 cm2 (= 769.2 mg/cm2).
Skin layer |
Time |
||
1h |
2h |
4h |
|
Stratum corneum SC1 |
27.3±7.9 |
64.1±8.1 |
54.6±7.4 |
Stratum corneum SC2 |
19.5±4.3 |
19.1±2.5 |
19.3±0.7 |
Stratum corneum SC3 |
14.8±2.9 |
15.5±2.4 |
12.5±2.7 |
Total Stratum corneum |
61.6±9.9 |
98.7±6.7 |
86.4±6.8 |
Remaining skin (epidermis and dermis) |
62.4±9.2 |
87.6±9.7 |
129.9±15.9 |
Skin total |
124.0±5.8 |
186.3±16.4 |
216.3±18.5 |
Elimination of linalool from human skin layers following 1 h absorption is summarised in the following table:
Skin layer |
Time |
|||
1h |
2h |
3h |
4h | |
Stratum corneum SC1 |
30.5±4.9 |
24.1±4.6 |
17.2±8.0 |
3.8±1.5 |
Stratum corneum SC2 |
22.4±4.0 |
20.6±5.6 |
4.2±0.9 |
0 |
Stratum corneum SC3 |
14.2±4.3 |
11.6±4.6 |
0 |
0 |
Total Stratum corneum |
67.1±5.5 |
56.3±5.3 |
21.4±7.8 |
3.8±1.4 |
Remaining skin (epidermis and dermis) |
45.3±6.5 |
51.6±7.9 |
71.8±12.6 |
117.2±15.1 |
Skin total |
112.4±11.3 |
107.9±2.9 |
93.2±9.2 |
121.0±13.6 |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this in vitro penetration study in human skin, 0.028% of the applied dose could be recovered in epidermis and dermis. The maximum concentration in stratum corneum was reached after only 2 h.
The total amount of linalyl acetate in the skin was unchanged during the elimination phase, but the ratio of the amount in stratum corneum, epidermis and dermis was decreasing, and after 4 h, only 3% of linalyl acetate in total skin was found in stratum corneum. - Executive summary:
The in vitro skin absorption and elimination of linalyl acetate was studied by applying linalyl acetate (500 mg/0.65 cm2) to human skin and determine the amount of linalyl acetate in the stratum corneum and epidermis and dermis after 1, 2, and 4h. Linalyl acetate was analysed using gas chromatography.
Linalyl acetate easily penetrated into the skin, however it was not detected in the acceptor fluid. Additionally, 129.9 ug linalyl acetate/cm2 was found in epidermis and dermis. The percentage of applied dose in epidermis and dermis is therefore calculated to be 0.028%. The maximum concentration in stratum corneum was reached after only 2 h. Considering results of another in vitro penetration study conducted by Green et al (2007), it is likely that most of the applied material is evaporated. The total amount of linalyl acetate in the skin was unchanged during the elimination phase, but the ratio of the amount in stratum corneum, epidermis and dermis was decreasing, and after 4 h, only 3% of linalyl acetate in total skin was found in stratum corneum.
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