Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 200-193-3 | CAS number: 54-11-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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.