Registration Dossier
Registration Dossier
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EC number: 942-135-6 | CAS number: -
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- policosanol
- IUPAC Name:
- policosanol
- Reference substance name:
- 142583-61-1
- IUPAC Name:
- 142583-61-1
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): policosanol
Constituent 1
Constituent 2
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Center for Laboratory Animal Production (CENPALAB, Havana, Cuba)
- Weight at study initiation: 250-300g
- Fasting period before study: 18 hours before administration
- Individual metabolism cages: yes/no
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 +/- 2 degrees C
- Humidity (%): 60 +/- 5 degrees C
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- other: gastric gavage
- Vehicle:
- other: acacia gum/water
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 10 mg/mL
- Amount of vehicle (if gavage): 5 ml/kg - Duration and frequency of treatment / exposure:
- single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
60 mg/kg
- Control animals:
- yes, concurrent vehicle
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Plasma peak of octacosanol occurred after 30 mins then decreased. Plasma peak of octacosanoic acid also occurred within 30 mins and was greater than peak for octacosanol. Liver values of octacosanol was lower than plasma values at the same time.
Applicant's summary and conclusion
- Conclusions:
- Octacosanoic acid is formed after oral dosing with rats
- Executive summary:
In a metabolism study, policosanol was administered to male Wistar Rats by gastric gavage at dose levels of 0 or 60 mg/kg.
Octacosanoic acid is formed after oral dosing with rats.
This metabolism study in therodentis classifiedacceptableand satisfies the guideline requirement for a metabolism study (OPPTS 870.7485); OECD 417 in rodents. Deficiencies include using one test dose and not providing the proper study documentation.
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