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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Version / remarks:
OECD Guidelines for Testing of Chemicals, number 442c “In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)” (adopted: February 04, 2015)
GLP compliance:
yes (incl. QA statement)
Type of study:
direct peptide reactivity assay (DPRA)
Details on the study design:
Preparation of test item solution: the test item was dissolved in acetonitrile and a stock solution of 100 mM was prepared, whereby the purity of the registration substance in the test item was taken in account.
Incubation of test item with peptide solution: The test item solution were incubated with the cystein and lysine peptide solutions in glass vials using defined ratios of test item to peptide (10 cyctein peptide, 60 lysine peptide). The reaction solutions were lefr in the dark at 25 ± 2 hours before running the HPLC analysis. Reference controls, co-elution controls as well as the cynnamic aldehyde as positive control were set up in parallel.
Positive control results:
The mean percent peptide depletion value of the three replicates for the positive control (cinnamic aldehyde) was between 60.8% and 100% for the cysteine peptide.
The mean percent peptide depletion value of the three replicates for the positive control (cinnamic aldehyde) was between 40.2% and 69.0% for the lysine peptide.
Key result
Parameter:
other: percentage cyctein peptide depletion
Remarks:
mean of three replicates
Value:
0
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation
Key result
Parameter:
other: percentage lysine peptide depletion
Remarks:
mean of three replicates
Value:
0
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation

Results of the Cysteine Peptide Depletion

Sample

Peak Area at 220 nm

Peptide Concentration [mM]

Peptide Depletion [%]

Mean Peptide Depletion [%]

SD of Peptide Depletion [%]

CV of Peptide Depletion [%]

Positive Control

1320.4471

0.1577

70.95

71.10

0.18

0.25

1315.4908

0.1571

71.06

1304.7782

0.1559

71.29

Test Item

4599.0210

0.5435

0.00

0.00

0.00

-

4764.8755

0.5631

0.00

4555.8262

0.5385

0.00

 

 

 

 

 

 

 

Results of the Lysine Peptide Depletion

Sample

Peak Area at 220 nm

Peptide Concentration [mM]

Peptide Depletion [%]

Mean Peptide Depletion [%]

SD of Peptide Depletion [%]

CV of Peptide Depletion [%]

Positive Control

1660.4912

0.2034

59.71

60.33

0.55

0.92

1627.6788

0.1994

60.51

1616.5613

0.1980

60.78

Test Item

4253.7705

0.5204

0.00

0.00

0.00

-

4218.3535

0.5161

0.00

4216.4116

0.5158

0.00

 

 

 

 

 

 

 

Interpretation of results:
other: The obtained results in this study alone cannot be used for the classification
Conclusions:
The skin sensitization property of the registration substance was investigated using the Direct Pepride Reactivity Assay (DPRA) according to the Guideline 442c. A negative result was obtained. No significant binding affinity to the cysteine or lysine of the peptide was found, indicating no acitivation of one of the key events in the adverse outcome pathway.
Executive summary:

The skin sensitization property of the registration substance was investigated using the Direct Pepride Reactivity Assay (DPRA) according to the Guideline 442c. A negative result was obtained. No significant binding affinity to the cysteine or lysine of the peptide was found, indicating no acitivation of one of the key events in the adverse outcome pathway.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

The skin sensitization property of the registration substance was investigated using the Direct Pepride Reactivity Assay (DPRA) according to the Guideline 442c. A negative result was obtained, supporting no classification.