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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
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))
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

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Parameter:
other: Calculated peptide depletion values for the Lys-Peptide
Run / experiment:
Test item Rep. 1
Value:
0
Positive controls validity:
valid
Parameter:
other: Calculated peptide depletion values for the Lys-Peptide
Run / experiment:
Test item Rep. 2
Value:
0
Positive controls validity:
valid
Parameter:
other: Calculated peptide depletion values for the Lys-Peptide
Run / experiment:
Test item Rep. 3
Value:
0
Positive controls validity:
valid
Parameter:
other: Calculated peptide depletion values for the Cys-Peptide
Run / experiment:
Test item Rep. 1
Value:
6.45
Positive controls validity:
valid
Parameter:
other: Calculated peptide depletion values for the Cys-Peptide
Run / experiment:
Test item Rep. 2
Value:
10.73
Positive controls validity:
valid
Parameter:
other: Calculated peptide depletion values for the Cys-Peptide
Run / experiment:
Test item Rep. 3
Value:
7.72
Positive controls validity:
valid
Other effects / acceptance of results:
Mean depletion of both peptides after incubation with the test item: 4.15 %

Any other information on results incl. tables

Evaluation of results according to the Cysteine 1:10/Lysine 1:50 prediction model

Mean peptide depletion
[%]

Reactivity Class

DPRA Prediction

0 – ≤ 6.38

Minimal

Negative

> 6.38 – ≤ 22.62

Low

Positive

> 22.62 – ≤ 42.47

Moderate

> 42.47 - ≤ 100

High

 

The mean peptide depletion in the Lys-peptide and Cys-peptide assay was 4.15 %, therefore the test item was classified with:

 

DPRA Prediction: Negative

Reactivity class: Minimal

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
All acceptance criteria were fulfilled. Therefore, the test was considered valid. The DPRA prediction for the test item [3R-(3α, 3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol (Cedrol) was negative with reactivity class minimal according to the Cysteine 1:10/Lysine 1:50 prediction model.
No observations arousing doubts concerning the accuracy of the results and the validity of the study were made.