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EC number: 947-652-0
CAS number: 943986-70-7
Acceptability criteria (which were all met):
Cysteine reactivity assay
Lysine reactivity assay
Results for SPCC
Results for SPCL
Correlation coefficient (r2) standard calibration curve
Mean peptide concentration RC-A samples (mM)
0.50 ± 0.05
0.504 ± 0.001
0.497 ± 0.002
Mean peptide concentration RC-C samples (mM)
0.504 ± 0.002
CV (%) for RC samples B and C
Mean peptide depletion cinnamic aldehyde (%)
SD of peptide depletion cinnamic aldehyde (%)
SD of peptide depletion for the test item (%)
RC = Reference Control; CV =
Coefficient of Variation; SD = Standard Deviation.
an in chemico study, performed according to OECD guideline 442C and GLP
principles, the reactivity of the substance towards model synthetic
peptides containing either cysteine (SPCC) or lysine (SPCL) was
determined to assign the substance to one of four reactivity classes
used to support the discrimination between skin sensitisers and non skin
sensitisers. Following incubation of the test substance with either SPCC
or SPCL, the relative peptide concentration was determined by HPLC with
gradient elution and spectrophotometric detection at 220 nm and 258 nm.
SPCC and SPCL Percent Depletion Values were calculated and used in the
prediction model. Acetonitrile was found to be an appropriate solvent to
dissolve the test substance. Cinnamic aldehyde was used as a positive
control. All acceptability criteria were met and therefore, the study
was considered to be valid. Upon preparation as well as after incubation
of the SPCC and SPCL test item samples, no precipitate or phase
separation was observed in any of the samples. No co-elution of the test
item with SPCC or SPCL was observed. In the cysteine reactivity assay,
as well as in the lysine reactivity assay, the test item showed 0.0%
depletion. The mean of the SPCC and SPCL depletion was therefore also
0.0% and as a result the test item was considered to be negative in the
DPRA and classified in the “no or minimal reactivity class” when using
the Cysteine 1:10 / Lysine 1:50 prediction model.
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