Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

1,4 Butanedamine did not demonstrate mutagenic activity in any of the bacterial assays with or without metabolic activation (S9) in Salmonella typhimurium TA-1535, TA-1537, TA-1538, TA-98, TA-100, and Saccharomyces cerevisiae D4, in Eschericia coli WP2uvrA,   W3110/pol A+,  P3478/pol A- and was considered not mutagenic under these test conditions.

1,4 -Diaminobutane (67%) is also not clastogenic in human lymphocytes under the experimental conditions described in the report, nor in the mouse lymphoma L5178Y test system under the experimental conditions described in these reports.


Short description of key information:
1,4 Butanedamine did not demonstrate mutagenic activity in any of the assays with or without metabolic activation (S9) in Salmonella typhimurium TA-1535, TA-1537, TA-1538, TA-98, TA-100, and Saccharomyces cerevisiae D4, and was considered not mutagenic under these test conditions.
1,4 Butanedamine did not demonstrate mutagenic activity in any of the assays with or without metabolic activation (S9) in Eschericia coli WP2uvrA,   W3110/pol A+,  P3478/pol A- and was considered not mutagenic under these test conditions.
1,4-Diaminobutane (67%) is not clastogenic in human lymphocytes under the experimental conditions described in the report.
It is concluded that 1,4 -Diaminobutane (67%) is not mutagenic in the mouse lymphoma L5178Y test system under the experimental conditions described in this report.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Not classified, based on the test results with 1,4 diaminobutene of all in vitro bacterial assays, and the in vitro chromosome abberration test in cultured peripheral human lymphocytes (with repeat experiment), and in vitro mammalian cell gene mutation test with mouse lymphoma cells (with independent repeat), 1,4 diaminobutane is considered not to be genetic toxic.