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EC number: 204-317-7
CAS number: 119-36-8
A study was performed to investigate the potential of Salicylic acid
pharmaceutical grade to induce mutations at the mouse lymphoma thymidine
kinase locus using the cell line L5178Y. The assay was performed in two
independent experiments, using two parallel cultures each at 87.5,
175.0, 350.0, 1400.0 µg/ml SA. The first experiment was performed with
and without liver microsomal activation and a treatment period of 4 h.
The second experiment was solely performed in the absence of metabolic
activation with a treatment period of 24 hours. The highest
concentration (1400 µg/ml) was chosen with regard to the molecular
weight of the test item corresponding to a molar concentrations of about
10 mM. Relevant cyto-toxic effects were solely noted following 24 h
treatment in the second experiment at 700 µg/ml and above. No
substantial and reproducible dose dependent increase in mutant colony
numbers was observed in both main experiments. No relevant shift of the
ratio of small versus large colonies was observed up to the maximal
concentration of the test item. Appropriate reference mutagens were used
as positive controls and showed a distinct increase in induced mutant
colonies, indicating that the tests were sensitive and valid.
In conclusion it can be stated that during the mutagenicity test
described and under the experimental conditions reported the test item
did not induce mutations in the mouse lymphoma thymidine kinase locus
assay using the cell line L5178Y in the absence and presence of
metabolic activation. Therefore, salicylic acid pharmaceutical grade is
considered to be non-mutagenic in this mouse lymphoma assay.
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