Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
GLP compliance:
yes (incl. certificate)
Type of study:
other: cysteine (Cys-) and lysine (Lys-) containing peptides.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vitro / in chemico

Results
Parameter:
other: Mean peptide depletion [%]
Value:
3.31

Any other information on results incl. tables

Several experiments were performed, one of them was invalid. The peptide depletion values after incubation of valid experiments are shown in Table 3-a:

 

Table3-a      Results

 

Cys-peptide
depletion [%]

Lys-Peptide
depletion [%]

Mean peptide
depletion [%]

First experiment

6.46

0.16

3.31

Verification

3.11

0.01

1.56

 

 

The DPRA prediction is “negative” with minimal reactivity according to the Cysteine 1:10/Lysine 1:50 prediction model.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
negative