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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- A toxicologic and dermatologic assessment of linalool and related esters when used as fragrance ingredients
- Author:
- Bickers D., Calow P., Greim H., Hanifin J.M., Rogers A.E., Saurat J.H., Sipes I.G., Smith R.L. and Tagami H.
- Year:
- 2 003
- Bibliographic source:
- Food and Chemical Toxicology 41:919-942
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline required
- GLP compliance:
- no
Test material
- Reference substance name:
- Lavender, Lavandula angustifolia, ext.
- EC Number:
- 289-995-2
- EC Name:
- Lavender, Lavandula angustifolia, ext.
- Cas Number:
- 90063-37-9
- Molecular formula:
- not relevant for a UVCB substance
- IUPAC Name:
- Essential oil of Lavandula angustifolia Mill. (Lamiaceae) obtained from flowering tops by steam distillation
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: Not relevant
- Strain:
- other: Not relevant
- Details on species / strain selection:
- Not relevant
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Not relevant
Administration / exposure
- Route of administration:
- other: Not relevant
- Vehicle:
- other: Not relevant
- Details on exposure:
- Not relevant
- Duration and frequency of treatment / exposure:
- Not relevant
- No. of animals per sex per dose / concentration:
- Not relevant
- Positive control reference chemical:
- Not relevant
- Details on study design:
- Not relevant
- Details on dosing and sampling:
- Not relevant
- Statistics:
- Not relevant
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Not relevant
- Details on distribution in tissues:
- Groups of 4 mice were exposed to an atmosphere containing 5 mg/L lavender oil (which contained 37.3% linalool and 41.6% linalyl acetate). After lavender oil inhalation, the serum linalool levels were 3 ng/mL and the serum linalyl acetate levels were 11 ng/mL. The addition of b-glucuronidase to these one hour samples resulted in an increase of serum linalool to 4 ng/mL after lavender oil inhalation.
- Details on excretion:
- Tertiary alcohols such as linalool are excreted in the urine and to a lesser extent feces.
Biliary excretion of conjugated linalool was determined in male rats that received a single intraperitoneal dose of 20 mg linalool. More than 25% of the dose appeared exclusively in the form of polar conjugates in the bile within 6–11 h,principally in the first 4 h; no free linalool was detected.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- In general, esters are hydrolyzed to their corresponding alcohol and carboxylic acid. Hydrolysis is catalyzed by carboxylesterases or esterases. Linalyl esters are expected to be hydrolyzed in humans to yield linalool and the corresponding carboxylic acid. Linalyl acetate hydrolyzes in gastric juice to yield linalool which, to some extent, is rapidly ring closed to yield alpha-terpineol. Both linalool and alpha-terpineol may then be either conjugated and excreted or oxidized to more polar excretable metabolites.
The metabolic fate of linalool has been studied in mammals. Tertiary alcohols such as linalool are metabolized primarily through conjugation with glucuronic acid. In rats, the majority (55%) of an orally administered 14C-labelled dose of 500 mg/kg linalool was excreted in the urine as the glucuronic acid conjugate,while 23% of the dose was excreted in expired air,and 15% was excreted in the feces within 72 h of dose administration. Only 3% was detected in tissues after 72 h,with 0.5% in the liver,0 .6% in the gut, 0.8% in the skin and 1.2% in the skeletal muscle. Linalool and its P-450 derived metabolites are converted to glucuronide conjugate by rat liver homogenates.
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- Not relevant
Applicant's summary and conclusion
- Executive summary:
Groups of 4 mice were exposed to an atmosphere containing 5 mg/L lavender oil (which contained 37.3% linalool and 41.6% linalyl acetate). After lavender oil inhalation, the serum linalool levels were 3 ng/mL and the serum linalyl acetate levels were 11 ng/mL. The addition of b-glucuronidase to these one hour samples resulted in an increase of serum linalool to 4 ng/mL after lavender oil inhalation.
In general, esters are hydrolyzed to their corresponding alcohol and carboxylic acid. Hydrolysis is catalyzed by carboxylesterases or esterases. Linalyl esters are expected to be hydrolyzed in humans to yield linalool and the corresponding carboxylic acid. Linalyl acetate hydrolyzes in gastric juice to yield linalool which, to some extent, is rapidly ring closed to yield alpha-terpineol. Both linalool and alpha-terpineol may then be either conjugated and excreted or oxidized to more polar excretable metabolites.
The metabolic fate of linalool has been studied in mammals. Tertiary alcohols such as linalool are metabolized primarily through conjugation with glucuronic acid. In rats, the majority (55%) of an orally administered 14C-labelled dose of 500 mg/kg linalool was excreted in the urine as the glucuronic acid conjugate,while 23% of the dose was excreted in expired air,and 15% was excreted in the feces within 72 h of dose administration. Only 3% was detected in tissues after 72 h, with 0.5% in the liver, 0.6% in the gut, 0.8% in the skin and 1.2% in the skeletal muscle. Linalool and its P-450 derived metabolites are converted to glucuronide conjugate by rat liver homogenates.
Tertiary alcohols such as linalool are excreted in the urine and to a lesser extent feces. Biliary excretion of conjugated linalool was determined in male rats that received a single intraperitoneal dose of 20 mg linalool. More than 25% of the dose appeared exclusively in the form of polar conjugates in the bile within 6-11 h, principally in the first 4 h; no free linalool was detected.
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