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Diss Factsheets
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EC number: 701-246-8 | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Report on the toxicokinetics of alpha-pinene in human volunteers exposed by inhalation, published in a peer-reviewed scientific journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Uptake, distribution and elimination of alpha-pinene in man after exposure by inhalation
- Author:
- Falk, A.A. et al
- Year:
- 1 990
- Bibliographic source:
- Scand. J. Work Environ. Health 16: 372-8
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Human volunteers exposed by inhalation to alpha-pinene during two hours of light exercise, on four occasions. Pulmonary uptake, blood clearance and bioelimination monitored, together with lung function.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- alpha-pinene
- IUPAC Name:
- alpha-pinene
- Details on test material:
- Alpha-pinene (Aldrich), purity 98%. (+)- and (-) isomers used separately
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 8 healthy men aged 24-39 years
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Volunteers exposed by inhalation, on four occasions: three (+)-alpha –pinene exposures (10, 225, and 450 mg/cu.m) plus one (-)- alpha –pinene exposure (450 mg/cu.m)). Exposure chamber 12 cu.m with 10 airchanges/h and slight negative pressure.
- Duration and frequency of treatment / exposure:
- 2 x 4h exposures
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10, 225, and 450 mg/cu.m (+ isomer), 450 mg/cu.m (- isomer). Monitored continuously during exposure period by IR spectrophotometer.
- No. of animals per sex per dose / concentration:
- 2 volunteers/treatment on each of four occasions of exposure
- Control animals:
- no
- Details on study design:
- Volunteers exposed during 2h light exercise (on bicycle ergometer). Exhaled air sampled: 4 x 4 min collection periods. Volunteer heart rates monitored and fingertip blood samples taken at intervals during exposure for GC-FID analysis. Urine collected prior to exposure, 30 mins after and then on 3 further occasions up to 21h post-exposure. Volunteers self-rated for irritation and CNS effects. Lung function tested before exposure and 20-30 mins post-exposure.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Relative pulmonary uptake averaged 59% at 225 and 450 mg/cu.m, with absolute uptake increasing linearly with increasing (+)-alpha –pinene concentration.
No difference in uptake was seen between the two alpha-pinene isomers investigated. - Details on distribution in tissues:
- A long half-life in poorly perfused tissues indicated a high affinity to adipose tissues.
- Details on excretion:
- Blood clearance post exposure was triphasic: over 21h post-exposure the clearance rate was high at 1.1 l/h/kg. Elimination of pinene by respiration after the exposure period amounted to 7.5-7.7% of uptake, and urinary elimination of unchanged pinene was minimal (<0.001% of uptake during 30 minutes post-exposure, then undetectable). After exposure was terminated, less than 0.001% of the total uptake was eliminated unchanged in the urine and about 8% in exhaled air.
Toxicokinetic parametersopen allclose all
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 1st: 4.8 mins (triphasic, phase 1: (+) isomer)
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 2nd: 38 mins (triphasic, phase2: (+) isomer)
- Test no.:
- #1
- Toxicokinetic parameters:
- half-life 3rd: 695 mins (triphasic, phase 2: (+) isomer
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 1st: 5.6 mins (triphasic, phase 1: (-) isomer)
- Test no.:
- #2
- Toxicokinetic parameters:
- half-life 2nd: 40 mins (triphasic, phase 2: (-) isomer)
- Test no.:
- #3
- Toxicokinetic parameters:
- half-life 3rd: 555 mins (triphasic, phase 3: (-) isomer)
Any other information on results incl. tables
No differences in uptake, distribution or elimination were seen between the two alpha-pinene isomers investigated. Time for near-complete body clearance estimated at >2 days.
No acute changes in lung function were seen during or immediately after exposure.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
Alpha-pinene, a direct analogue of the monomer unit within pinene oligomers, was well absorbed following inhalational exposure. Rapid clearance was obsrved, indicating that it is readily metabolised.
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