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EC number: 237-438-9
CAS number: 13784-51-5
threshold = number of mutant colonies
per 106cells of each solvent control plus 126
was not continued since a minimum of only four analysable concentrations
was not continued due to exceedingly severe cytotoxic effects
The values printed in bold are judged as
invalid, since even the exception criteria of the IWGT are not met (RTG
< 1% in at least one of both parallel cultures).
The study was performed to investigate
the potential of 2,4-Pentanedione, peroxide (CAS 37187-22-7), 30% in
solvent mixture to induce mutations at the mouse lymphoma thymidine
kinase locus using the cell line L5178Y.
The assay was performed in three
independent experiments, using two parallel cultures each. The first
main experiment was performed with and without liver microsomal
activation and a treatment period of 4 hours. The second experiment was
performed in the absence of metabolic activation with a treatment period
of 24 hours in the absence and 4 hours in the presence of metabolic
activation. As only three analysed concentrations remained within the
acceptable cytotoxic range in the second experiment with metabolic
activation this experimental part was repeated as experiment three. So,
the third experiment was performed with a treatment period of 4 hours
solely in the presence of metabolic activation.
The main experiments were evaluated at
the following concentrations:
mix: 156.3: 312.5; 625.0; 937.5; 1260.0 µg/mL
with S9 mix: 312.5; 625.0; 1250.0; 2500.0; 3750.0
mix: 75.0; 150.0; 300.0; 400.0 µg/mL
with S9 mix: 600.0; 1200.0; 2400.0; 3000.0; 3600.0
mix: 300.0; 600.0; 1200.0; 2400.0; 3000.0 µg/mL
Relevant toxic effects indicated by a
relative total growth of less than 50% were observed in the first
experiment at 625 µg/mL and above with and at 1250 µg/mL without
metabolic activation. In the second experiment cytotoxic effects as
described were noted at 600 µg/mL and above with and at 150 µg/mL and
above without metabolic activation. In the third experiment cytotoxic
effects occurred at 2400 µg/mL and above. The recommended cytotoxic
range of approximately 10-20% relative total growth was covered with and
without metabolic activation. The data generated in experiment I at 3750
µg/mL with metabolic activation and in experiment II at 3000 and 3600
µg/mL with metabolic activation are not considered valid since the
relative total growth fell even short of the 1% limit set by the IWGT
substantial and reproducible dose dependent increase of the mutation
frequency was observed with and without metabolic activation at
acceptable levels of cytotoxicity. The isolated increase of the mutation
frequency noted at a severely cytotoxic concentration of 1250 µg/mL in
both cultures of the first experiment without metabolic activation was
not reproduced in the second experiment without metabolic activation at
about the same cytotoxic level generated at 400 µg/mL. Furthermore, this
increase was not dose dependent as indicated by the lacking statistical
significance in one of the parallel cultures and consequently judged as
biologically irrelevant. The increased mutation frequency exceeding the
threshold in just one of both parallel cultures (culture II of the first
experiment without metabolic activation at 156.3 and 312.5 µg/mL and
culture I of the third experiment at 3000 µg/mL) was not considered
relevant as the increase was not reproduced in the parallel cultures.
A linear regression analysis (least
squares) was performed to assess a possible dose dependent increase of
the mutation frequency using SYSTATâstatistics software.
A significant dose dependent trend of the mutation frequency indicated
by a probability value of <0.05 was solely determined in the first
culture of the first experiment without metabolic activation. However,
this trend was not reproduced in the parallel culture and therefore, not
considered biologically relevant as discussed above.
The highest solvent control value (201
colonies per 106cells) exceeded the recommended 50 – 170 x 106control
range as stated under paragraph 10.12,acceptability of the
assay of this report. The mean value of both parallel cultures however,
(201 and 83 equal to 142 colonies per 106cells) is fully
acceptable. The cloning efficiency (viability) slightly exceeded the
upper limit of 120% (127%) in the solvent control of the first culture
of the first experiment with metabolic activation. This minor deviation
was judged as irrelevant as it was rather minor and the cloning
efficiency of the parallel culture remained within the acceptable range.
MMS (19.5 µg/mL in experiment I and
13.0 µg/mL in experiment II) and CPA (3.0 and 4.5 µg/mL) were used as
positive controls and showed a distinct increase in induced total mutant
colonies and an increase of the relative quantity of small versus large
induced colonies with at least one of the concentrations.
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.
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