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EC number: 267-008-6 | CAS number: 67762-27-0 This substance is identified by SDA Substance Name: C16-C18 alkyl alcohol and SDA Reporting Number: 19-060-00.
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- other: published data
- 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:
- review article or handbook
- Title:
- Direct and indirect effects of docosanol (IK.2), the active principle in Tadenan, on the rat prostate
- Author:
- Muentzing J et al
- Year:
- 1 979
- Bibliographic source:
- Invest. Urology 17(3):176-180
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Type: other: Effects on the rat prostate
- GLP compliance:
- not specified
- Type of method:
- in vivo
Test material
- Reference substance name:
- Docosan-1-ol
- EC Number:
- 211-546-6
- EC Name:
- Docosan-1-ol
- Cas Number:
- 661-19-8
- IUPAC Name:
- docosan-1-ol
- Details on test material:
- EC# : 211-546-6
CAS# : 661-19-8
Substance Name : docosan-1-ol
Molecular Formula : C22H46O
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
- Duration of test:
- Duration of test: 28 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1, 10, 100 mg/kg
Basis:
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Duration of test: 28 days
Results and discussion
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Docosanol had no effect on the weight or histology of the prostate in intact rats but increased the RNA/DNA quotient in the ventral prostate.
- Remarks on result:
- not determinable
- Remarks:
- no NOAEC identified
Any other information on results incl. tables
Docosanol administered by gavage to rats aged 6-7 months for 28 days did not affect bodyweight
or the weights of any of the organs weighed other than a statistically significant increase in weight of
the seminal vesicles at the lower dose levels (1 and 10 mg/kg/day). There were no histological
differences in the accessory sexual organs.
The concentration of radioactive zinc was decreased at 1 and 10 mg/kg in the dorsolateral prostate
and increased in muscle at 10 and 100 mg/kg. At 100 mg/kg RNA concentration of the ventral
prostate was increased but RNA content remained unchanged. The DNA content and concentration
was also unchanged, the quotient between the conentrations of RNA and DNA was increased at 100 mg/kg.
Protein concentration was unchanged. Plasma LH was increased at 100 mg/kg while FSH and prolactin
were unaffected.
In the older rats the weight of the dorsal prostate was decreased to 85% of the weight of controls by
1 mg/kg and the weight of the seminal vesicles increase to 125% at 10 mg/kg. Spleen weight was
decreased to 80% by 1 and 100 mg/kg docosanol. The quotient between RNA and DNA concentration
was increased (130%) in the ventral prostate at 100 mg/kg. There were no histopathological changes in the
organs examined. Plasma testosterone was reduced at 100 mg/kg and prolactin cncentration at 1 or 10 mg/kg.
Orchidectomy resulted in a significant increase in weight of prostate, seminal vesicles and adrenals at 100 mg/kg
docosanol but not at lower dose levels. The concentration of radioactive zinc was reduced in the dorsolateral
prostate at 10 or 100 mg/kg.
Docosanol did not increase the prostrate weight in rats which had been both orchidectomised and adrenalectomised
suggesting a role for the adrenals in stimulating the prostrate.
Studies in young rats suggested a thymolytic effec as 100 mg/kg docosanol reduced the weith of both thymus and
splenn in intact animals.
Applicant's summary and conclusion
- Conclusions:
- Docosanol had no effect on the weight or histology of the prostate in intact rats but increased the RNA/DNA quotient in the ventral prostate. Plasma LH and testosterone were reduced. In orchidectomised rats docosanol increased the prostate and adrenal weight but there was no increase in orchidectomised adn adrenalectomised rats, a weight reduction being observed. Also docosanol had a thymolytic effect in intact rats but not in adrenalectomised rats where the thymus weight was increased. These results suggest a stimulation of adrenal steroid secretion but this may not be the only effect of docosanol.
Docosanol is closely related to the registered substance, Alcohols, C16-18, and it is considered that read-across is valid.
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