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EC number: 950-480-9
CAS number: -
FOR Genetic Traits
Defective DNA repair system (DuvrB)
P - Character should be /
found to be present ; A
- Character should be / found to be absent
Desired – desired status for
the respective strain and the character.
Observed – observed status
for the character as observed when tested.
OF Spontaneous HISTIDINE REVERTANTS
Plate Counts of Spontaneous Histidine Revertants Colonies
Mutation Assay of ALGEA FERT SOLID K+ was carried out in
compliance with the OECD Guidelines for Testing of Chemicals (No. 471,
Section 4: Health Effects) on conduct of "Bacterial Reverse Mutation
Test", adopted 21 July 1997 and as per mutually agreed protocol.
ALGEA FERT SOLID K+ was
evaluated in the/ Salmonella
Pre-incubation Assay to determine its ability to induce reverse mutation
at selected histidine loci in five tester strains of Salmonella
typhimuriumviz. TA1535, TA97a, TA98, TA100 and TA102 in the presence
and absence of metabolic activation system (S9). Based upon the
preliminary tests conducted to assess the solubility / precipitation and
cytotoxicity of ALGEA FERT SOLID K+, the tester strains were
exposed to the test article in triplicate cultures at the doses of 5000
µg, 1500 µg, 500 µg, 150 µg and 50 µg/plate, both with and without
metabolic activation system (S9). Liver S9, induced in Sprague Dawley
rats by phenobarbitone withb-
naphthoflavone, was used for this purpose.
Analytical grade water was used as a vehicle.
The exposed bacteria were plated onto minimal glucose agar medium
supplemented with L-histidine. The plates were incubated at 37+1°Cfor 48-72
hours after which the histidine revertant colonies were counted and
their frequency was compared with that in the vehicle control group.
Concurrent positive control groups were also included in the experiment,
as specified by the test guideline. Results
of this test indicated that the frequencies of histidine revertant
colonies at all concentrations ofALGEA FERT SOLID K+instrains
TA1535, TA97a, TA98, TA100 and TA102, with and without the presence of a
metabolic activation system, were comparable to those observed in the
vehicle control group, as per the criteria employed for evaluation of
mutagenic potential, and this observation was confirmed by repetition of
the experiments. Plate counts for the
spontaneous histidine revertant colonies in the vehicle control groups
were found to be within the frequency ranges expected from the
laboratory historical control data at INTOX. They also compared well
with the range reported in the literature. Concurrent positive controls
demonstrated sensitivity of the assay with and without metabolic
activation. It is concluded that,
under the conditions of this study, ALGEA FERT SOLID K+ is
non-mutagenic in Salmonella
typhimurium strains TA1535, TA97a, TA98, TA100 and TA102.
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