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EC number: 700-990-0
CAS number: 68937-40-6
- One Bacterial Reverse
Mutation Assays (Ames test). The results of the tests conducted on the
compound in the absence and in the presence of a metabolic activation
system were all negative. The test compound, S-154 Lot QH-30701
B0-78-82, did not demonstrate genetic activity in any of the assays
conducted in this evaluation and was considered not mutagenic under
these test conditions.
- A Sister Chromatid Exchange
(SCE) assay in mammalian cells and In vitro mammalian Chromosome
Aberration test. Chromosome aberration results were negative at all dose
levels both with and without the enzyme activation system. No
significant increases were observed in the frequency of cells with
aberrations, and so the compound is concluded to be non-clastogenic. SCE
frequencies also failed to increase with dose, both with and without the
activation system, and so the test compound was clearly negative in this
assay. In conclusion, Phosflex 51B failed to induce visible chromosome
damage under the conditions of these assays.
- An vitro Mammalian Cell
Gene Mutation Test. The test compound, Phosflex 51B, did not induce an
increase in mutations at the TK locus in L5178Y mouse lymphoma cells at
concentrations of 0.975 to 125.0 nl/ml with and without activation. The
concentration of 125 nl/ml was highly toxic and insufficient survivors
were obtained at 250 nl/ml to perform the assay. Therefore the test
compound is considered to be inactive in this Mouse Lymphoma Forward
The following 2 in vitro
tests are considered supporting studies:
- In vitro Mammalian Cell
Gene Mutation Test (similar to OECD 476): S-154 BO-78-86 was not
mutagenic in the mouse lymphoma L5178Y cells when tested under the
conditions outlined in this report.
- In vitro Mammalian Cell
Transformation assay: The test material, Phosflex 51B, did not induce a
significant increase in transformed foci over the applied concentration
range of 0.00125 ul/ml to 0.02 ul/ml. This concentration range
corresponded to approximately 90% to 52% survival in the cytotoxicity
test. Therefore, the test material is considered to be inactive in this
Balb/3T3 In Vitro Transformation Assay.
In all available key and
supporting studies t-BuTTP did not show any genotoxic potential.
Therefore, it can be concluded that the substance is not mutagenic and
therefore does not need to be classified for mutagenicity according to
the criteria outlined in 1272/2008/EC (CLP/EU-GHS).
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