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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test:

Test chemical did not induce mutation in Salmonella Typhimurium TA 1538, 1535, 1537, 98 and 100 with and without mammalian S-9 microsomal fraction. Hence it is not likely to classify as a gene mutant in vitro.

Chromosome aberration:

Test chemical did not induce mutation in L5178Y TK ± mouse lymphoma with and without mammalian S-9 microsomal fraction. Hence it is not likely to classify as a gene mutant in vitro.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is fom secondary source
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
In – vitro Bacterial reverse mutation assay of 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., inner salts in S. typhimurium
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Target gene:
not specified
Species / strain / cell type:
S. typhimurium, other: TA 1538, 1535, 1537, 98 and 100
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:
S-9 activation
Test concentrations with justification for top dose:
1, 4, 16, 64 and 256 mg/plate (without S-9 activation)4, 16, 64, 256 and 1024 mg/plate (with S-9 activation)
Vehicle / solvent:
Double deionized water
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Double deionized water
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Remarks:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)NUMBER OF REPLICATIONS: Three plates per dose level
Rationale for test conditions:
not specified
Evaluation criteria:
reverse mutations
Statistics:
not specified
Species / strain:
S. typhimurium, other: TA 1538, 1535, 1537, 98 and 100
Metabolic activation:
with and without
Genotoxicity:
negative
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
not specified
Additional information on results:
In the initial toxicity assays, the test substance without metabolic activation was cytotoxic to the tester strains TA 1535 and TA 1537 at 1000 mg/plate and cytotoxic to tester strain TA 1538 at 200 mg/plate. The test substance with metabolic activation was cytotoxic to the tester strains TA 1535 and TA 1538 at 5000 mg/plate and tester strain TA 1537 at 1000 mg/plate.
Remarks on result:
other: Non mutagenic
Conclusions:
Test chemical did not induce mutation in Salmonella Typhimurium TA 1538, 1535, 1537, 98 and 100 and hence it is not likely to classify as a gene mutant in vitro.
Executive summary:

Gene toxicity test was performed to determine the mutagenic nature oftest chemical. The study was performed usingSalmonella TyphimuriumTA 1538, 1535, 1537, 98 and 100 both in the presence and absence of mammalian S-9 microsomal fraction. The test material did not induce reverse mutations. Therefore,Test chemical did not induce mutation inSalmonella TyphimuriumTA 1538, 1535, 1537, 98 and 100 with and withoutmammalian S-9 microsomal fraction.Hence it is not likely to classify as a gene mutant in vitro.

Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
experimental study
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 is from publication
Qualifier:
according to
Version / remarks:
as below
Principles of method if other than guideline:
Gene toxicity study of 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., inner salts in L5178Y TK ±mouse lymphoma assay
GLP compliance:
not specified
Type of assay:
other: mammalian cell gene mutation assay
Species / strain / cell type:
mouse lymphoma L5178Y cells
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:
not specified
Test concentrations with justification for top dose:
0.001, 0.01, 0.1, 1.0, 10 and 100 µL/mL
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Remarks:
not specified
Details on test system and experimental conditions:
not specified
Rationale for test conditions:
not specified
Evaluation criteria:
Mutation frequency were observed
Statistics:
not specified
Species / strain:
mouse lymphoma L5178Y cells
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Conclusions:
Test chemical did not induce mutation in L5178Y TK ± mouse lymphoma and hence it is not likely to classify as a gene mutant in vitro.
Executive summary:

Gene toxicity test was performed to determine the mutagenic nature oftest chemical. The study was performed usingL5178Y TK ± mouse lymphomaboth in the presence and absence of mammalian S-9 microsomal fraction. The test material did not significantly increase Mutation frequency over the average mutation frequency of solvent control.Therefore,Test chemical did not induce mutation inL5178Y TK ± mouse lymphomawith and withoutmammalian S-9 microsomal fraction.Hence it 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

Gene toxicity – in-vitro

Data available for target and the read across chemicals was reviewed to determine the in- vitro gene toxicity of 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., inner salts (CAS no 61789-40-0). The studies are as mentioned below:

Ames test:

Study 1:

Gene toxicity test was performed to determine the mutagenic nature of test chemical. The study was performed using Salmonella Typhimurium TA 1538, 1535, 1537, 98 and 100 both in the presence and absence of mammalian S-9 microsomal fraction. The test material did not induce reverse mutations. Therefore, Test chemical did not induce mutation in Salmonella Typhimurium TA 1538, 1535, 1537, 98 and 100 with and without mammalian S-9 microsomal fraction. Hence it is not likely to classify as a gene mutant in vitro.

Study 2:

Gene toxicity test was performed to determine the mutagenic nature of test chemical. The study was performed using Salmonella Typhimurium other both in the presence and absence of mammalian S-9 microsomal fraction. The test material did not induce reverse mutations. Therefore, Test chemical did not induce mutation in Salmonella Typhimurium other with and without mammalian S-9 microsomal fraction. Hence it is not likely to classify as a gene mutant in vitro.

Study 3:

Gene toxicity test was performed to determine the mutagenic nature of test chemical. The study was performed using S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 both in the presence and absence of mammalian S-9 microsomal fraction. The test material did not induce reverse mutations. Therefore, Test chemical did not induce mutation in Salmonella Typhimurium TA 1535, TA 1537, TA 98 and TA 100 with and without mammalian S-9 microsomal fraction. Hence it is not likely to classify as a gene mutant in vitro.

Study 4:

Gene toxicity test was performed to determine the mutagenic nature of test chemical. The study was performed using S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 both in the presence and absence of mammalian S-9 microsomal fraction. The test material caused a visible reduction in the growth of the bacterial lawn to all of the strains tested. The first evidence of toxicity was observed at 150 mg/plate. No significant increase in the frequency of revertant colonies of bacteria was recorded for any of the strains used, at any dose level with or without metabolic activation. All of the positive control chemicals used in the test produced marked increases in the frequency of revertant colonies and the activity of the S9 fraction was found to be satisfactory. The test material did not induce reverse mutations. Therefore, Test chemical did not induce mutation in Salmonella Typhimurium TA 1535, TA 1537, TA 98 and TA 100 with and without mammalian S-9 microsomal fraction. Hence it is not likely to classify as a gene mutant in vitro.

Based on the data available from the read across, diphenylacetonitrile does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation. 

Chromosome aberration:

An in vitro mammalian cell gene mutation study was designed and conducted to determine the genotoxicity profile of 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., inner salts (CAS no 61789-40-0). when administered to L5178Y TK+/-Mouse Lymphoma.

Study 1:

Gene toxicity test was performed to determine the mutagenic nature of test chemical. The study was performed using L5178Y TK ± mouse lymphoma both in the presence and absence of mammalian S-9 microsomal fraction. The test material did not significantly increase Mutation frequency over the average mutation frequency of solvent control. Therefore, Test chemical did not induce mutation in L5178Y TK ± mouse lymphoma with and without mammalian S-9 microsomal fraction. Hence it is not likely to classify as a gene mutant in vitro.

Based on the data available for 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., inner salts does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.  

Justification for classification or non-classification

Based on the data available for 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., inner salts does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.