Coffee, bean, roasted, ext.

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

March 22, 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An assessment was performed based on experimental data on the constituents of Coffee, bean, roasted, ext identified in the literature, their toxicokinetics behaviour, and historical uses of the substance and its constituents.

Data source

Reference

Reference Type:

other: expert assessment

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Coffee, bean, roasted, ext. manufacturing process is similar to the manufacturing process of commercially available coffee; therefore, caffeine is used as reference substances for this endpoint.
Coffee is a widely consumed beverage and induces a series of metabolic and pharmacological effects, which are generally attributed to caffeine and its metabolites. Caffeine is a stimulant of the central nervous and respiratory system, and skeletal muscles; other activities include cardiac stimulation, coronary dilation, smooth muscle relaxation, and diuresis.
Toxicokinetics of caffeine is very well studied due to its wide use in prescribed and over-the-counter drugs, beverages, foodstuff and cosmetics.

GLP compliance:

no

Applicant's summary and conclusion

Conclusions:

As expert assessment was performed to determine the toxicokinetics behaviour of Coffee, bean, roasted, ext. based on experimental data on caffeine.

Executive summary:

Caffeine is physiologically the most active constituent of coffee. It is rapidly and completely absorbed within an hour following ingestion. It is distributed throughout body water and readily crosses cell membranes including the brain-blood barrier. Its primary mechanisms for stimulatory activity appear to be the blocking of adenosine receptors and inhibition of phosphodiesterases. Caffeine is metabolized and excreted in humans primarily as paraxanthine, which also has pharmacologic activity. With repeated caffeine dosing, paraxanthine may contribute to development of tolerance and withdrawal symptoms. Caffeine clearance rates may be affected by both environmental and physiological factors, such as use of oral contraceptives, smoking, and pregnancy.