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Diss Factsheets
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EC number: 911-428-0 | 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:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- Study on distribution and excretion of octacosanol after oral uptake
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Octacosan-1-ol
- EC Number:
- 209-181-2
- EC Name:
- Octacosan-1-ol
- Cas Number:
- 557-61-9
- IUPAC Name:
- octacosan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): octacosanol
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 8-[14C]
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Funabashi Farm, Japan
- Age at study initiation: 4 weeks
- Weight at study initiation: 63-65 g
- Individual metabolism cages: yes
- Diet (ad libitum): Funabashi F2 pellet diet, Funabashi, Japan
- Water (ad libitum): drinking water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: tricapropyl-glycerol
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 10 µCi 8-[14C]-octacosanol in 0,5 ml tricaproyl-glycerol
- Amount of vehicle (if gavage): 0,5 ml - Duration and frequency of treatment / exposure:
- single exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10 µCi 8-[14C]-octacosanol in 0,5 ml tricaproyl-glycerol
- No. of animals per sex per dose / concentration:
- 3
- Control animals:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, expired CO2
- Time and frequency of sampling: excreta continously for 7 days
- Other: distribution to organs and tissues (liver, kidneys, liver, spleen, heart, lungs, brain, gastrointestinal tract, muscle, adipose tissues: epididymal, perirenal and brown adipose tissue) sampling: 1, 2, 3 and 7 days after dosing
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- The amount of radioactivity (representing the octacosanol and metabolites content) in organs and tissues was generally low (< 4% of administered dose per organ or tissue). One day after exposure, the highest amount of radioactivity was observed in the liver, followed by muscle. Based on the concentration (per g tissue) the adipose tissues revealed the highest concentration, especially the brown adipose tissue. This value declined within 7 days. Lower amounts were detected in all examined organs and tissues (in decreasing order: liver, digestive tract, spleen, kidney, heart, lung, brain, muscle).
- Details on excretion:
- The excretion via faeces represented 32.1% of the administered dose within 7 days after exposure, tho predominant part of it within 2 days. The expiration of 14C-CO2 was 15.1% and the urine contained 1.3% (sum of about 50% of the administered dose within 7 days). The summarised contents of organs and tissues at day 7 after dosing was about 3% .
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
After oral application of rats octacosanol was excreted mostly in faeces, lower amounts in urine and expired air. The substance was distributed throughout the whole body. Only low amonuts of radioacitivity were retained in the individual organs or tissues at day 7 after dosing (highest amount per gram in adipose tissue) - Executive summary:
When 12 male Wistar rats were orally exposed to radioactively labelled octacosanol, the substance was distributed throughout the whole organism. The highest concentration per g tissue was found in brown adipose tissue at day 1 after dosing. Only minor amounts of radioactivity were retained in all tissues after 7 days. About 50% of the administered dose were detected in excreta within 7 days after exposure (32.1% in feces, 1.3% in urine and 15.1% as CO2 in expired air).
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