Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
GLP compliance:
yes
Type of study:
direct peptide binding assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Positive control results:
The following positive controls were used:
• Cinnamaldehyde was used as 100 mM (± 10 %) solution in acetonitrile for the Cys-peptide.
• 2,3-Butanedione was used as 100 mM (± 10 %) solution in acetonitrile for the Lys-peptide

In vitro / in chemico

Resultsopen allclose all
Key result
Parameter:
other: Depletion % Lys-Peptide
Run / experiment:
1
Value:
> 26.21 - < 29.47
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Parameter:
other: Depletion % Lys-Peptide
Run / experiment:
2
Value:
> 19.39 - < 27.34
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Parameter:
other: Depletion % Cys- Peptide
Run / experiment:
3
Value:
> 79.43 - < 82.54
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The DPRA prediction for the test item TERPENIC BASE was positive with reactivity class high according to the Cysteine 1:10/Lysine 1:50 prediction model. The result of the Lys-peptide assay was verified in a second experiment.
It can be stated that in this study and under the experimental conditions reported, the test item TERPENIC BASE possesses a high skin sensitisation potential