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Diss Factsheets
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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- 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: Meets generally accepted scientific standards, limited documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- Pharmakologische Untersuchungen von Kamillen-Inhaltsstoffen
- Author:
- Habersang S., Leuschner F., Isaac O. & Thiemer K.
- Year:
- 1 979
- Bibliographic source:
- Planta medica, 37(2):115-123.
Materials and methods
- Principles of method if other than guideline:
- no data
- GLP compliance:
- not specified
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
- Test material form:
- other: oily liquid
- Details on test material:
- - Name of test material: (-)-alpha-Bisabolol, 6-methyl-2-(4-methylcyclohex-3-en-1-yl)hept-5-en-2-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S. Ivanovas, 7967 Kißlegg/Allgäu, Germany
- Weight at study initiation: 98 - 106 g (main study); 128 - 146 g (orientation study)
- Housing: test animals housed singly in a Makrolon cage Type II or in groups of two oder three in Makrolon cages type III
- Diet: Altromin® standard diet; ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 6 weeks (orientation study), 4 weeks (main study)
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Preliminary study: 1 mL/kg bw/d (approx. 930 mg/kg bw/d) for 6 weeks; Main study: 2, 3 mL/kg bw/d (approx. 1860, 2790 mg/kg bw/d) for 4 weeks
Basis:
- No. of animals per sex per dose:
- Preliminary study: two groups of 20 rats (10 per sex per dose)
Main study: three groups of 40 rats (20 per sex per dose) - Control animals:
- yes
- Details on study design:
- Post-exposure period: none
- Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- Observations/examinations included general state, behaviour, signs of intoxication, food consumption, body weight.
Hematological examination:
- Hemoglobin
- Erythrocyte, Leucocyte, Reticuocyte, Thrombocyte counts
- Differential blood count
- Hematokrit
- protombin time
Clinical chemical examination:
- SGPT
- SGOT
- alkaline phosphatase
- glucose
- uric acid / urea nitrogen
- creatinine
- total bilirubin
- total protein
- CO2
- sodium
- potassium
- chloride
Urinalysis:
- color
- specific gravity
- pH
- glucose
- hemoglobin
- bilirubin
- ketones
- sediment
Ophthalmoscopy, audition ability, dentition examination - Sacrifice and pathology:
- gross pathology
organ weights:
- heart
- liver
- lung
- spleen
- kidneys
- adrenals
- thymus
- hypophysis
- gonads
- thyroid
- brain
histology:
- heart
- liver
- lung
- spleen
- kidneys
- adrenals
- thymus
- hypophysis
- gonads
- thyroid
- brain
- prostate /uterus
- stomach / duodenum / jejunum / ileum / colon / rectum
- salival gland
- eye with optic nerve
- urinary blatter
- bone marrow
- trachea
- aorta
- pancreas
- mesenterial lymph nodes
- peripheral nerve
- skeletal muscle
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 1 other: ml/ kg bw/d
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: (approx. 930 mg/kg bw/d) based on the absence of effects observed in the orientation study
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
1) Orientating study:
There was no evidence of intolerance.
2) Main study:
Reduced body weights and motor restlessness was observed in the tested groups, the high dose animals being more affected than the low dose animals. The high dose level was lethal, mortality was 20% in this dose group. Urinalysis revealed a positive keton body reaction; however, since no clincochemical parameters indicated any impairment of the lipid metabolism, the presence of a test substance metabolite is suggested.
Clinical-chemical examination showed increases in SGOT and alkaline phosphatase (slightly increased in males and significantly increased in females). No other changes in urine and clinical chemical parameters were noted; hematological parameters were unaffected. The final examination revealed serve inflammatory effects in the liver, kidney, trachea, thymus, spleen and stomach, according the reduction of body weight. At the low dose level, these changes were only minimal. According to the authors, these inflammatory reactions were considered to be caused by reduced body weights leading to an impaired immune defense.
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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