Registration Dossier
Registration Dossier
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EC number: 208-964-6 | CAS number: 549-18-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Amitriptyline HCl was evaluated for its genotoxicity. The evaluation was performed in somatic (bone marrow) and germ (spermatocytes) cells, as well as the sperm morphology (i.e., head and tail) and count of the resulting sperm. The results showed that the treatment induced structural and numerical chromosome abnormalities in somatic cells (bone marrow) and germ cells (spermatocytes). Moreover, the drug significantly reduced both the mitotic index and meiotic activity after the different treatments used. Amitriptyline was found to increase significantly the incidence of sperm-cell head and tail abnormalities. The sperm-cell count was also significantly decreased. These results showed that the effect of the drug was dose dependent. In another study, amitriptyline was found to be nongenotoxic at plasma levels. However, frequencies of chromosome aberrations and sister chromatid exchanges were significantly increased at concentrations 4 and 40 times the plasma level. Amitriptyline was tested for genotoxicity using the somatic mutation and recombination test (SMART) in wing cells of Drosophila melanogaster. The drug was not genotoxic at concentrations up to 100 mM.
Source: Hazardous Substances Data Bank [Internet]. Bethesda (MD): National Library of Medicine (US). Available from:
http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB
Justification for classification or non-classification
Overall, available data are inconclusive for the classification of the substance.
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