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Key value for chemical safety assessment

Additional information

Gene mutation in bacteria

The substance propylamine was tested for mutagenicity in the Salmonella typhimurium / Escherichia coli reverse mutation assay both in the standard plate test(SPT)and in the preincubation test(PIT)with and without the addition of a metabolizing system (liver S-9 mix) obtainedfrom phenobarbital and β-naphthoflavone-induced male Sprague-Dawley ratsusing the Salmonella strains TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli WP2 uvrA.The test substance was not mutagenic in both test systems with and without metabolic activation according to OECD guideline 471 (tested up to 5000 µg/plate in the standard plate test and the preincubation test using the pure product with and without metabolic activation. A bacteriotoxic effect (reduced his- background growth, decrease in the number of his revertants) was observed in a dose-dependent manner. Based on these results the test substance was judged negative in the Ames test by the authors.

 

Gene mutation in mammalian cells

Actually, there is no information available for Propylamine CAS 107 -10 -8. However, read-across to the close structural analogues Butylamine CAS 109 -73 -9 and Isopropylamine CAS 75 -31 -0 show negative results in two available HPRT tests (OECD 476).

 

Cytogenicity in mammalian cells

Actually, there is no information available for Propylamine CAS 107 -10 -8. However, read-across to a close structural analogue Butylamine CAS 109 -73 -9 shows in an available in vivo MNT (OECD 474) no effects on cytogenicity.

 

Other studies

Actually, there is no information available.

 

Cytogenicity in vivo

Actually, there is no information available for Propylamine CAS 107 -10 -8. However, read-across to a close structural analogue Butylamine CAS 109 -73 -9 shows in an available in vivo MNT (OECD 474) no effects on cytogenicity.


Short description of key information:
Gene mutation in bacteria
S. typhimurium TA 1535, TA 1537, TA 98, TA 100, with and without metabolic activation: negative (OECD 471, BASF AG 2009) (preincubation test and plate incorporation method)
E.coli WP2 uvrA with and without metabolic activation: negative (OECD 472, BASF AG 2009) (preincubation test and plate incorporation method)

Gene mutation in mammalian cells
Actually, there is no information available for Propylamine CAS 107-10-8. Read across is proposed to the close structural analogues CAS 109-73-9 and CAS 75-31-0.

Cytogenicity in mammalian cells
Actually, there is no information available to cover this endpoint. However, in vivo data on a close structural analogue CAS 109-73-9 are being used to cover this endpoint.


Cytogenicity in vivo
Actually, there is no information available for Propylamine CAS 107-10-8. Read across is proposed to the close structural analogues CAS 109-73-9 and CAS 75-31-0.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test substance was not genotoxic in an in vitro experiment using 5 different strains of bacteria. Therefore, based on the information currently available,there is no need for classification of the test article for mutagenic effects according to the criteria defined by the EU and the GHS system.