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EC number: 609-462-3
CAS number: 376653-37-1
The objective of this study was to
evaluate the reactivity of the test item to synthetic cysteine and
lysine peptides as part of a tiered strategy for skin sensitization
The reactivity of the test item was
evaluated in chemico by monitoring peptide depletion following a
24-hour contact between the test item and synthetic cysteine and lysine
peptides. A diluted solution of cysteine or lysine was incubated with
the test item for 24 hours. At the end of the incubation, the
concentration of residual peptides in the solution was evaluated by HPLC
with Ultra-Violet detection at 220 nm.
Peptide reactivity was reported as
percent depletion from the solution basedon the peptide peak area of the
replicate injection and the mean peptide peak area in the three relevant
reference control C samples (in the appropriate solvent).
The test item was dissolved at 100 mM
inacetonitrile without sonication.
The acceptance criteria for the
calibration curve samples, the reference and positive controls as well
as for the study samples satisfied the requirements of the assay. The
study was therefore considered to be valid.
Analysis of the chromatograms of the
co-elution samples indicated that the test item did not co-elute with
either the lysine or the cysteine peptides. As a result, the mean
percent depletion values were calculated for each peptide using the
formula described in § Data analysis and calculation:
the cysteine peptide, the mean depletion value was 98.91% which was
linked to high cysteine dimerisation,
the lysine peptide, the mean depletion value was 26.78%.
The mean of the percent cysteine and
percent lysine depletions was equal to 62.84%. Accordingly, the
test item was considered tohave ahigh peptide reactivity. Therefore, the
DPRA prediction is considered as positive and the test item may have
potential to cause skin sensitization.
Under the experimental conditions of
this study, the test item was considered to have ahighpeptidereactivity
and therefore the test item is considered to be positive in the DPRA
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