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EC number: 200-607-2 | CAS number: 65-31-6
- 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
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Genetic mutation in vitro;
Based on the data available for the test chemicals, Nicotine dihydrogen ditartrate (CAS no 65 -31 -6) did not induce gene mutation in vitro using Salmonella typhimurium bacterial strains in the presence and absence of S9 metabolic activation system is negative and hence the chemical is not likely to classify as a gene mutant in vitro.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- WoE derived based on the experimental data from structurally and functionally similar read across chemicals for the target chemical.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- - Name of test material (IUPAC name): nicotine dihydrogen ditartrate
- Common name: Nicotine tartrate
- Molecular formula: C10H14N2.2C4H6O6
- Molecular weight: 462.4054 g/mol
- Smiles notation: CN1CCC[C@H]1c2cccnc2.O[C@H]([C@@H](O)C(=O)O)C(=O)O.O[C@H]([C@@H](O)C(=O)O)C(=O)O
- InChl: 1S/C10H14N2.2C4H6O6/c1-12-7-3-5-10(12)9-4-2-6-11-8-9;2*5-1(3(7)8)2(6)4(9)10/h2,4,6,8,10H,3,5,7H2,1H3;2*1-2,5-6H,(H,7,8)(H,9,10)/t10-;2*1-,2-/m011/s1
- Substance type: Organic - Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Remarks:
- 1/2
- Details on mammalian cell type (if applicable):
- Not specified
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (5%) from male Sprague-Dawley rats given a single 500 mg/kg injection i.p. of Aroclor 1254
- Test concentrations with justification for top dose:
- 1/2: 0 , 62.5, 125.0, 250.0, 500.0, 750.0 and 1000.0 µg/plate
- Vehicle / solvent:
- 1/2
- Vehicle(s)/solvent(s) used: Phosphate buffer
- Justification for choice of solvent/vehicle: The test chemical was soluble in phosphate buffer - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine 2-nitrofluorene sodium azide 2-aminoanthracene
- Remarks:
- 1/2
- Details on test system and experimental conditions:
- 1/2
METHOD OF APPLICATION: Preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
- Triplicate plates at each concentration - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- 1/2
A sample was considered to be mutagenic if it induced a concentration-dependent increase in revertants number with at least one concentration being at least two times the solvent control. - Statistics:
- 1/2
Yes ,Mean standard deviation was observed - Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Remarks:
- 1/2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- Not specified
- Remarks on result:
- other: No mutagenic effect were observed
- Conclusions:
- Nicotine dihydrogen ditartrate did not induce gene mutation in vitro using Salmonella typhimurium bacterial strains in the presence and absence of S9 metabolic activation system is negative and hence the chemical is not likely to classify as a gene mutant in vitro.
- Executive summary:
Data for the test chemicals was reviewed to determine the mutagenic nature of nicotine dihydrogen ditartrate. The studies are as mentioned below:
Genetic toxicity in vitro study was assessed for two test chemicals. The test material was exposed to Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 in the presence and absence of metabolic activation S9, and 20 min standard preincubation time. The test chemical was exposed at the concentration of 0, 62.5, 125, 250, 500, 750 and 1000 µg/plate. No mutagenic effects were observed in all strains, in the presence and absence of metabolic activation. Therefore the test chemical was considered to be non mutagenic in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 by Ames test. Hence the two substances cannot be classified as gene mutants in vitro.
Based on the data available for the test chemicals, Nicotine dihydrogen ditartrate (CAS no 65 -31 -6) did not induce gene mutation in vitro using Salmonella typhimurium bacterial strains in the presence and absence of S9 metabolic activation system is negative and hence the chemical is not likely to classify as a gene mutant in vitro.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic mutation in vitro:
Ames test:
Data for the test chemicals was reviewed to determine the mutagenic nature of nicotine dihydrogen ditartrate. The studies are as mentioned below:
Genetic toxicity in vitro study was assessed for two test chemicals. The test material was exposed to Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 in the presence and absence of metabolic activation S9, and 20 min standard preincubation time. The test chemical was exposed at the concentration of 0, 62.5, 125, 250, 500, 750 and 1000 µg/plate. No mutagenic effects were observed in all strains, in the presence and absence of metabolic activation. Therefore the test chemical was considered to be non mutagenic in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 by Ames test. Hence the two substances cannot be classified as gene mutants in vitro.
Based on the data available for the test chemicals, Nicotine dihydrogen ditartrate (CAS no 65 -31 -6) did not induce gene mutation in vitro using Salmonella typhimurium bacterial strains in the presence and absence of S9 metabolic activation system is negative and hence the chemical is not likely to classify as a gene mutant in vitro.
Justification for classification or non-classification
Based on the data available for the test chemicals, Nicotine dihydrogen ditartrate (CAS no 65 -31 -6) did not induce gene mutation in vitro using Salmonella typhimurium bacterial strains in the presence and absence of S9 metabolic activation system is negative and hence the chemical is not likely to classify as a gene mutant in vitro as per the criteria mentioned in CLP regulation.
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