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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
direct peptide binding assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

In chemico test system

Details on study design:
Solutions of DEXGLUTACYCLE were successfully analyzed by the validated DPRA analytical method (Envigo analytical method FIA/M101/15) in both Cysteine and Lysine containing synthetic peptides. With minimal (Cysteine) and no depletion (Lysine) of either peptide (an overall mean depletion 0.15% was achieved) in the presence of DEXGLUTACYCLE

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Key result
Parameter:
other: Mean peptide depletion by DEXGLUTACYCLE (%)
Remarks:
The DPRA prediction and the reactivity of DEXGLUTACYCLE based on the overall mean and the individual depletion values in the Cysteine peptide and the Lysine peptide
Run / experiment:
Cysteine
Value:
ca. 0.3
Key result
Parameter:
other: Mean peptide depletion by DEXGLUTACYCLE (%)
Remarks:
The DPRA prediction and the reactivity of DEXGLUTACYCLE based on the overall mean and the individual depletion values in the Cysteine peptide and the Lysine peptide
Run / experiment:
Lysine
Value:
ca. -0.781

Applicant's summary and conclusion

Interpretation of results:
other: no reactivity in either peptide therefore the prediction is a non-sensitiser
Conclusions:
Solutions of DEXGLUTACYCLE were successfully analysed by the validated DPRA analytical method (Envigo analytical method FIA/M101/15) in both Cysteine and Lysine containing synthetic peptides. There was minimal reactivity in the cysteine peptide and no reactivity in the Lysine peptide so DEXGLUTACYCLE with a mean depletion value of 0.15% is placed in the reactivity class of “no or minimal” and hence it is predicted by DPRA not to be a skin sensitizer.