Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
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 peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Mutagenic Activity from Nitrosation of Oligoamines
Author:
Michael Murphey-Corb, Hay-Long Kong, and Michael L. Murray
Year:
1983
Bibliographic source:
Environmental Mutagenesis 5101-109 (1983)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the mutagenic potential of N-Methyl-1,3-propanediamine in Salmonella typhimurium LT2 strains TA 1950 (hisG46, uvrB} ; TS24 (hisG46,recA); TA1537 (hisC3076, uvrB, $a); TA1538 (hisD3052, uvrB, $a}; TA1952(hisC3076, uvrB); and mutant hisG46.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material : (3-aminopropyl)(methyl)amine; 3-Amino-1-methylaminopropane
- Molecular formula : C4H12N2
- Molecular weight : 88.1528 g/mol
- Smiles notation : N(CCCN)C
- InChl : 1S/C4H12N2/c1-6-4-2-3-5/h6H,2-5H2,1H3
- Substance type: Organic
- Physical state: Liquid
Specific details on test material used for the study:
- Name of test material : (3-aminopropyl)(methyl)amine; 3-Amino-1-methylaminopropane
- Molecular formula : C4H12N2
- Molecular weight : 88.1528 g/mol
- Smiles notation : N(CCCN)C
- InChl : 1S/C4H12N2/c1-6-4-2-3-5/h6H,2-5H2,1H3
- Substance type: Organic
- Physical state: Liquid

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium LT2 strains TA 1950 (hisG46, uvrB} ; TS24 (hisG46,recA); TA1537 (hisC3076, uvrB, $a); TA1538 (hisD3052, uvrB, $a}; TA1952(hisC3076, uvrB); and mutant hisG46
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
not specified
Test concentrations with justification for top dose:
Not specified
Vehicle / solvent:
Not specified
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
Not specified
Rationale for test conditions:
Not specified
Evaluation criteria:
Evaluation was done considering a dose dependent increase in the number of revertants/plate.
Statistics:
Not specified

Results and discussion

Test results
Key result
Species / strain:
other: Salmonella typhimurium LT2 strains TA 1950 (hisG46, uvrB} ; TS24 (hisG46,recA); TA1537 (hisC3076, uvrB, $a); TA1538 (hisD3052, uvrB, $a}; TA1952(hisC3076, uvrB); and mutant hisG46
Metabolic activation:
not specified
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
Additional information on results:
The test substance result was considered to be negative when tested seprately.While oligoamine-nitrate reaction mixtures produce mutagenic effect in all strain tested for mutagenicity.
Remarks on result:
other: No mutagenic effect were observed.

Applicant's summary and conclusion

Conclusions:
N-Methyl-1,3-propanediamine (6291-84-5)was evaluated for its mutagenic potential inSalmonella typhimurium LT2 strains TA 1950 (hisG46, uvrB} ; TS24 (hisG46,recA); TA1537 (hisC3076, uvrB, $a); TA1538 (hisD3052, uvrB, $a}; TA1952(hisC3076, uvrB); and mutant hisG46. The test result was observed to be negative.
Executive summary:

Genetic toxicity in vitro study for N-Methyl-1,3-propanediamine was assessed for its possible mutagenic potential. For this purpose Bacterial reverse mutation assay was performed in Salmonella typhimurium LT2 strains TA 1950 (hisG46, uvrB} ; TS24 (hisG46,recA); TA1537 (hisC3076, uvrB, $a); TA1538 (hisD3052, uvrB, $a}; TA1952(hisC3076, uvrB); and mutant hisG46. No mutagenic effect were observed .Therefore N-Methyl-1,3-propanediamine was considered to be non mutagenic. Hence the test substance cannot be classified as gene mutant in vitro.