Registration Dossier
Registration Dossier
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EC number: 200-607-2 | CAS number: 65-31-6
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: literature review
- Adequacy of study:
- key study
- Reliability:
- other: not applicable
- Justification for type of information:
- According to Annex VIII to REACH, 8.8 'Toxicokinetics', column 1, 8.8.1 'an assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information' needs to be conducted. To comply with this requirement, a literature review on the toxicokinetic behaviour of nicotine bitartrate covered by this registration has been conducted.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Nicotine absorption is highly depended on pH. Pharmacokinetics and pharmacodynamics are influenced by several variables. Absorption is for instance determined by the efficiency and species-dependent nicotine metabolism by CYP450 enzymes, velocity of uptake into the organism, influence of physiological effects on nicotine metabolism and the pathways of nicotine excretion. The major route for nicotine uptake from nicotine bitartrate is via the mucous membranes of the oral cavity. After oral or i.p. administrations first-pass metabolism of nicotine takes place. These effects must be considered on the relative dose exposure to nicotine. Plasma half-lives of nicotine in rodents are shorter than in humans/primates. Therefore, higher daily doses of nicotine are necessary in rodent models to achieve nicotine concentrations which are comparable to those seen in smokers.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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