Registration Dossier

Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
other: Literature review
Adequacy of study:
key study
Study period:
2016-12-07
Reliability:
other: not applicable
Rationale for reliability incl. deficiencies:
other: Literature review to assess basic toxicokinetics of nicotine covered by this registration. For this review literature from official authorities, peer reviewed journals and others were used.

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Results and discussion

Applicant's summary and conclusion

Conclusions:
Absorption of nicotine depends on pH. Several variables are influencing the pharmacokinetics and pharmacodynamics of nicotine, e.g. the efficacy of metabolism, the rapidity of uptake, potential physiological effects of nicotine metabolites and nicotine excretion. The major route by which nicotine enter the body is via the lung. When nicotine is dosed orally or i.p., first-pass metabolism and its effect on the relative dose exposure to nicotine must be considered. Due to the fact that nicotine t1/2in rodents is generally shorter than in primates/humans necessitates the use of higher daily doses of nicotine in rodent models to achieve the nicotine concentration comparable to those seen in smokers.