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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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Conducted according to the up and down procedure (UDP) recommended by the US EPA Health Effects Test Guidelines (EPA, 2002). However, the duration of exposure to nicotine mist (20 minutes) was 12-fold shorter than 4 hours (240 minutes).
Data source
Reference
- Reference Type:
- publication
- Title:
- Nicotine Delivery to Rats via Lung Alveolar Region-Targeted Aerosol Technology Produces Blood Pharmacokinetics Resembling Human Smoking
- Author:
- Xuesi M. Shao, MD; Bin Xu, PhD; Jing Liang, MD, PhD; Xinmin (Simon) Xie, MD, PhD; Yifang Zhu, PhD and Jack L. Feldman, PhD
- Year:
- 2 012
- Bibliographic source:
- Nicotine Tob Res. 2013 Jul; 15(7): 1248-1258
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other:
- Version / remarks:
- The study was performed equivalent or similar to EPA Health Effects Test Guidelines: Acute inhalation toxicity (1998).
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Different exposure time of 20 min (cf. 4h) than recommended in relevant inhalation guidelines.
- GLP compliance:
- not specified
- Remarks:
- No statement about the GLP status of the study was published.
- Test type:
- other: Up and down procedure
- Limit test:
- no
Test material
- Reference substance name:
- Nicotine
- EC Number:
- 200-193-3
- EC Name:
- Nicotine
- Cas Number:
- 54-11-5
- Molecular formula:
- C10H14N2
- IUPAC Name:
- 3-(1-methylpyrrolidin-2-yl)pyridine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- -(s)-(-)-nicotine freebase (liquid, 99%), ordered from Alfa Aesar Co.
-pH 7.4 and 8.0.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-8–11-week-old
-body weight 250–400g
-housed in the vivarium under a 12-hr light/dark cycle
-ad libitum access to food and water.
ENVIRONMENTAL CONDITIONS:
no data
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: water
- Mass median aerodynamic diameter (MMAD):
- 2.5 µm
- Geometric standard deviation (GSD):
- 1.8
- Details on inhalation exposure:
- - 3-jet Collison nebulizer (BGI Inc.)
- air pressure gauge (Ashcroft@ filled gauge, 0–100 psi, Cole-Parmer)
- air flowmeter with a valve (150-mm Direct Reading, 23 LPM, Cole-Parmer) that regulated the airflow rate and the pressure entering the nebulizer
- homemade nose-only exposure chamber
- rat holders (Model #: CHT-250, CH Technologies Inc.). About 30ml nicotine solution was put in the nebulizer jar.
- Exposure of rats to the aerosol in a nose-only system, one at a time with a fixed air pressure (40 psi). - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Mass concentrations measured with a one-stage cascade impactor (SKC Inc.).
- Duration of exposure:
- 20 min
- Concentrations:
- Ordered concentration progression in a rage of 5%-56% nicotine. Concentration progression factor of antilog 0.25=1.78.
- No. of animals per sex per dose:
- 7 male rats in sum
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 24 hours
- Necropsy of survivors performed: no
- Other examinations performed: Arterial blood sample collection and plasma nicotine level measurement - Statistics:
- Computer program (AOT425StatPgm, US EPA) was used to calculate the LC50 and its confidence intervals
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 2.3 mg/L air
- Based on:
- test mat.
- 95% CL:
- >= 1.24 - <= 4.07
- Exp. duration:
- 20 min
- Remarks on result:
- other: Using the Habers law, according to point 3.1.2.1. (c) of the CLP Regulation (Cn x t = constant), the converted LC50 (4 hours) of nicotine is 0.19 mg/L.
- Mortality:
- Exposure to 2.3 mg/L nicotine in air for 20 min causes death in 50% of rats.
Some of the rats died within 1-3 min after the end of nicotine aerosol exposure period of 20 min. - Clinical signs:
- other: Exposure in the high concentration range caused a Straub tail within 20-60 s. Within 1-2.5 min rats became apneic, interspersed with gasps.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- An LC50 (20 min) of 2.3 mg/L air was reported for nicotine aerosol, with a confidence interval of 1.24 - 4.07 mg/L (pH 8.0), based on the mass concentration of aerosol at the breathing zone 7.17 mg/L at 40 psi.
Using the Habers law, according to point 3.1.2.1. (c) of the CLP Regulation (Cn x t = constant), the converted LC50 (4 hours) of nicotine is 0.19 mg/L. - Executive summary:
Nicotine was tested using the up and down procedure (UDP) recommended by the US EPA Health Effects Test Guidelines (2002). Seven rats were exposed to nicotine aerosol in a nose-only system. The mass median aerodynamic diameter (MMAD) was within the range of respirable droplet size recommended by USEPA. Exposure to 2.3 mg/L for 20 minutes caused death in 50% of rats.Signs and symptoms were observed. Furthermore, arterial and venous blood samples were collected and plasma level was measured after a 2 min exposure period.
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