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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Genetic mutation in vitro;

Experimental data from read across chemical have been reviewed to determine the mutagenic nature of3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid; Nicotine sulphate (65-30-5).The studies are as mentioned below

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Genetic toxicity in vitro study was assessed for test chemical. 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 test chemical was considered to be non mutagenic in Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 by AMES test. Hence the substance cannot be classified as gene mutant in vitro.

 The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Genetic toxicity in vitro study was assessed for test chemical. 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 test chemical was considered to be non mutagenic in Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 by AMES test. Hence the substance cannot be classified as gene mutant in vitro.

 The data available for the target chemical based on its read across substance and applying weight of evidence 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid; Nicotine sulphate (65-30-5) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Link to relevant study records
Reference
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:
read-across source
Related information:
Composition 1
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: As mention below
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
Test material information:
Composition 1
Specific details on test material used for the study:
- Name of test material : Nicotine sulphate
- IUPAC name : 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid
- Molecular formula : C10H16N2O4S
- Molecular weight : 422.547 g/mol
- Smiles notation : CN1CCC[C@H]1c2cccnc2.CN 3CCC[C@H]3c4cccnc4.OS(=O)(=O)O
- InChl : 1S/2C10H14N2.H2O4S/c2* 1-12-7-3-5-10(12)9-4-2-6-11-8-9;1-5(2,3)4/h2*2,4,6,8,10H,3 ,5,7H2,1H3;(H2,1,2,3,4)/t2*10-;/m00./s1
- Substance type : Organic
- Physical state : Solid
Target gene:
Study 1 and 2
Histidine
Species / strain:
other: TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell lines (if applicable):
Not specified
Additional strain 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:
Study 1 and 2
0 ,62.5,125.0,250.0,500.0, 750.0 and 1000.0 µg/plate
Vehicle:
Study 1 and 2
phosphate buffer
Negative controls:
yes
Solvent controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 9-aminoacridine 2-nitrofluorene sodium azide 2-aminoanthracene
Details on test system and conditions:
Study 1 and 2
METHOD OF APPLICATION: Preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
- Triplicate plates at each concentration
Rationale for test conditions:
Study 1 and 2
Not specified
Evaluation criteria:
Study 1 and 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:
Study 1 and 2
Yes ,Mean standard deviation was observed
Species / strain:
other: TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: No mutagenic effect were observed.
Species / strain:
other: TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: No mutagenic effct were observed
Additional information on results:
Not specified
Conclusions:
Gene mutation toxicity study for 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid; Nicotine sulphate (65-30-5) predicted using data from read across chemicals for 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:

Genetic mutation in vitro;

Experimental data from read across chemical have been reviewed to determine the mutagenic nature of3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid; Nicotine sulphate (65-30-5).The studies are as mentioned below

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Genetic toxicity in vitro study was assessed for test chemical. 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 test chemical was considered to be non mutagenic in Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 by AMES test. Hence the substance cannot be classified as gene mutant in vitro.

 The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Genetic toxicity in vitro study was assessed for test chemical. 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 test chemical was considered to be non mutagenic in Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 by AMES test. Hence the substance cannot be classified as gene mutant in vitro.

 The data available for the target chemical based on its read across substance and applying weight of evidence 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid; Nicotine sulphate (65-30-5) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

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;

Experimental data from read across chemical have been reviewed to determine the mutagenic nature of3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid; Nicotine sulphate (65-30-5).The studies are as mentioned below

The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. Genetic toxicity in vitro study was assessed for test chemical. 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 test chemical was considered to be non mutagenic in Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 by AMES test. Hence the substance cannot be classified as gene mutant in vitro.

 The read across substances share high similarity in functional group .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. Genetic toxicity in vitro study was assessed for test chemical. 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 test chemical was considered to be non mutagenic in Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 by AMES test. Hence the substance cannot be classified as gene mutant in vitro.

 The data available for the target chemical based on its read across substance and applying weight of evidence 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid; Nicotine sulphate (65-30-5) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Thus based on the above annotation and CLP criteria for target substance 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine; sulfuric acid; Nicotine sulphate (65-30-5)does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.