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EC number: 208-011-4 | CAS number: 505-52-2
History Profile of Negative and Positive Control Values (n = 37 studies) of the year 2012
Data obtained from plate incorporation and preincubation tests
Negative Reference Item
Positive Reference Item
Study report attachment:
LPT 28722 (Tables)
The purpose of this study was to evaluate the test item for mutagenic activity (gene mutation) in bacteria without and with the addition of a mammalian metabolic activation system as originally described by AMES et al. (1973, 1975) and revised by MARON and AMES (1983). Tridecanedioic acid was examined in the 5 Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254 -induced rat liver). The first experiment was carried out as a plate incorporation test and the second as a preincubation test. Tridecanedioic Acid was completely dissolved indimethylsulfoxide (DMSO). A correction factor of 1.01 was used in order to correct for the purity of the test item of 99.0%. The vehicle served as the negative control.
Tridecanedioic acid was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA 100. Ten concentrations ranging from 0.316 to 5000 µg tridecanedioic acid/plate were tested.Cytotoxicity (reduction of the number of revertants by more than 50%) was notedat the top concentration of 5000 µg/plate. In addition, test item precipitation was noted starting at 1000 µg/plate. Hence, 1000 µg tridecanedioic acid/plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
Six concentrations ranging from 3.16 to 1000 µg tridecanedioic acid/plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation.
In the plate incorporation test and in the preincubation test, each carried out without and with metabolic activationtest item precipitationwas noted at the top concentration of 1000 µg/plate in all test strains.No signs of cytotoxicity were noted up to the top concentration of 1000 µg/plate.
No increase in revertant colony numbers as compared with control counts was observed for tridecanedioic acid, tested up to a concentration of 1000 µg/plate, that led to test item precipitation, in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation and preincubation test). The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.
In conclusion, under the present test conditions tridecanedioic acid tested up to a concentration of 1000 µg/plate, that led to test item precipitation, caused no mutagenic effect in the Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
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