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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation toxicity study for target chemical was performed by Michael Murphey-Corb et al.( Environmental Mutagenesis , 1983)to determine the mutagenic nature of N-Methyl-1,3-propanediamine (6291-84-5).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.

Link to relevant study records
Reference
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
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
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
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
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no study available

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Gene mutation - in vitro

Various publications were reviewed to determine the mutagenic nature of (3-aminopropyl) (methyl) amine; 3-Amino-1-methylaminopropane Other name; N-Methyl-1,3-propanediamine (6291-84-5). The studies are as summarised below:

Gene mutation toxicity study for target chemical was performed by Michael Murphey-Corb et al.( Environmental Mutagenesis , 1983)to determine the mutagenic nature of N-Methyl-1,3-propanediamine (6291-84-5).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.

In a study for structurally and functionally similar read across chemical, Gene mutation toxicity study was performed by Errol Zeiger et al.( Environmental Mutagenesis, 1987)to determine the mutagenic nature of Iminobis 3isopropylamine (56-18-8). The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance. Genetic toxicity study for Iminobis 3isopropylamine was assessed for its mutagenic potential .For this purpose Bacterial reverse mutation assay was performed on Salmonella typhimurium TA98, TA100, TA1535, and TA1537.The test material was exposed at the concentration of 0,33,100,333,1000 and1666µg/plate in the absence and presence of S9.No mutagenic effect were observed. Therefore Iminobis 3 isopropylamine was considered to be non mutagenic in Salmonella typhimurium TA98, TA100, TA1535, and TA1537 in the presence and absence of S9. Hence the substance cannot classify as gene mutant in vitro.

In a study for structurally and functionally similar read across chemical, Gene mutation toxicity study was performed by Errol Zeiger et al.( Environmental Mutagenesis, 1987)to determine the mutagenic nature of Dimethylamine (124-40-3). The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance. Genetic toxicity study for Dimethylamine was assessed for its mutagenic potential .For this purpose Bacterial reverse mutation assay was performed on Salmonella typhimurium TA98, TA100, TA1535, and TA1537.The test material was exposed at the concentration of -S9;0,33,100,333,1000 and 3333µg/plate in the absence of S9 while 0,10,100,333,1000,2000,3333 and 4500 µg/plate in the presence of S9.No mutagenic effect were observed.Therefore Dimethylamine was considered to be non mutagenic in Salmonella typhimurium TA98, TA100, TA1535, and TA1537 in the presence and absence of S9. Hence the substance cannot classify as gene mutant in vitro.

Based on the data available for the target chemical and its read across substance and applying weight of evidence (3-aminopropyl) (methyl) amine; 3-Amino-1- methylaminopropane  Other name; N-Methyl-1,3-propanediamine (6291-84-5) 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 the target chemical . (3-aminopropyl) (methyl) amine; 3-Amino-1- methylaminopropane  Other name; N-Methyl- 1,3- propanediamine (6291-84-5) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.