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EC number: 815-521-6 | CAS number: 72691-24-8
- 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 vivo
- Type of information:
- experimental study
- Remarks:
- Test substance represents a main component (stereoisomer) of the registered substance
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP and non guideline study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Resorption, Verteilung und Metabolismus von [14C] markierter Testsubstanz in der Haut
- Author:
- Hahn B., Hölzl J.
- Year:
- 1 987
- Bibliographic source:
- Arzneim.-Forsch./Drug res. 37(19), Nr. 6
Materials and methods
- Principles of method if other than guideline:
- no data
- GLP compliance:
- no
Test material
- Reference substance name:
- Levomenol
- EC Number:
- 245-423-3
- EC Name:
- Levomenol
- Cas Number:
- 23089-26-1
- Molecular formula:
- C15H26O
- IUPAC Name:
- (2S)-6-methyl-2-[(1S)-4-methylcyclohex-3-en-1-yl]hept-5-en-2-ol
- Details on test material:
- - Name of test material (as cited in study report): Levomenol
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Central Institute for Laboratory Animals, Hannover
- Weight at study initiation: 13 g
- Fasting period before study: 15 hours
- Water: ad libitum
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- other: Water with Arlatone 975 or Aceton
- Duration of exposure:
- 1, 3 and 5 hours
- Doses:
- 122 kBq of the radiolabelled test substance (1.44 kBq/µmol) were added with 90 mg Arlatone 975 (atlas Chemie, Essen) and then dissolved in 450 µL of water. Daily 150 µL of the test solution were applied to the neck area of the animals (40.6 kBq [14C]-test substance).
- No. of animals per group:
- no data
- Details on study design:
- SUBSTANCE PREPARATION
- For the production of 185 kBq [14C]-test substance, 150 chamomile flowers (Spanish origin; designation H29) were mixed with 370 kBq [2-14C-Acetate] and 20 µg saccharose in 10 µL tap water. After three days the essential oil was separated from the flowers by distillation. The isolation of the [14C]-test substance was carried out by chromatography. The radiochemical purity was determined by thin-layer chromatography on silica gel 60 and RP-18, followed by autoradiography. The purity was 96%.
DOSE PREPARATION
- Method for preparation of dose suspensions: 122 kBq of the radiolabelled test substance (1.44 kBq/µmol) were added with 90 mg Arlatone 975 (atlas Chemie, Essen) and then dissolved in 450 µL of water. Daily 150 µL of the test solution were applied to the neck area of the animals (40.6 kBq [14C]-test substance).
TEST SITE
- Area of exposure: neck area
SAMPLE COLLECTION
After 1, 3 and 5 hours, the animals were killed, bleed and skin areas of the application site and the lower extremities were removed. In addition, fat and muscle tissue was obtained below the neck skin.
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- Skin test site: 1 hour after application, 80% of the radioactivity were measured on and in the skin of the application site. Over the test period, the radioactivity decreased after 3 hours of incubation to 57% and after 5 hours to about 50%.
Any other information on results incl. tables
Table: Radioactivity on the application side [%]
|
Application of the [14C]-test substance in water with Arlatone |
Application of the [14C]-test substance in Acetone |
||
1 h |
3 h |
5 h |
3 h |
|
Skin in the neck area (adsorption, mean+/- SD permeation) |
82.34 (+/- 7.35) |
57.22 (+/- 1.93) |
48.73 (+/- 2.79) |
60.52 (-) |
Extractable radioactivity of the neck skin |
96.9 |
96.4 |
96.3 |
96.9 |
Extractable intact [14C]-test substance |
91.4 |
90.4 |
89.0 |
92.5 |
The aim of the study was to evaluate the absorption, distribution and metabolism of the test substance in the skin. The radiolabeled compound was prepared by biochemical incorporation of [14C] acetate into the molecule.The test substance was applied to the skin of nude mice of the NMRI strain. The mice were sacrified at 1, 3 and 5 hours after application and radioactivity was measured. Five hours after topical application of the [C14] labelled test substance onto nude mice, half of the radioactivity was detected in the skin. The other part was measured in tissue and organs. Ninety percent of this radioactivity was analysed as intact test substance.
In order to demonstrate the distribution of the test substance in the skin, a part of this tissue was cut into horizontal slices by a cryotome. Autoradiograms of these sliced were produced. Densitometric measurement showed that there was a fast penetration of the test substance into the skin. Five hours after the topical application, the test substance was displaced from outermost to innermost areas. According to the authors, these results suggest that a fast cutaneous absorption and a long therapeutic effect of the antiphlogistic spasmolytic test substance in the skin can be expected.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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