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Toxicological information

Genetic toxicity: in vitro

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Administrative data

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

Data source

Reference
Reference Type:
secondary source
Title:
In-vitro gene toxicity study of 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., inner salts
Author:
EPA
Year:
2018
Bibliographic source:
United States Environmental Protection Agency, 2018

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material : 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts- Molecular formula : C19H38N2O3- Molecular weight : 342.52 g/mol- Smiles notation : CCCCCCCCCCCC(=O)NCCCN{+}(C)(C)CC(=O)O{-}- Substance type : Organic - Physical state : Solid

Method

Target gene:
not specified
Species / strain
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
Controls
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

Results and discussion

Test results
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

Applicant's summary and conclusion

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.