Registration Dossier
Registration Dossier
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EC number: 200-193-3 | CAS number: 54-11-5
Endpoint summary
Administrative data
Link to relevant study record(s)
- 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.
- 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.
Reference
Description of key information
Assessment of toxicokinetics was made on base of a literature review.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Default values for bioavailability for the same exposure route in animals and humans are used for chemical safety assessment:
-oral-to-oral extrapolation: 1 (=100%/100%)
-dermal-to-dermal extrapolation: 1 (=100%/100%)
-inhalation-to-inhalation extrapolation: 1 (=100%/100%)
Default values for route-to-route extrapolation:
-oral-to-inhalation extrapolation: 0.5 (=50%/100%)
-inhalation-to-oral extrapolation: 1 (=100%/100%)
-oral-to-dermal extrapolation: 1 (=100%/100%)
-dermal-to-oral extrapolation: 1 (=100%/100%)
-inhalation-to-dermal extrapolation: 1 (=100%/100%)
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
