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Toxicological information

Basic toxicokinetics

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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:
2005

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 417 (Toxicokinetics)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): policosanol
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals 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.