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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in chemico
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
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
GLP compliance:
yes (incl. QA statement)
Type of study:
direct peptide reactivity assay (DPRA)

Test material

Constituent 1
Chemical structure
Reference substance name:
[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol
EC Number:
201-035-6
EC Name:
[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol
Cas Number:
77-53-2
Molecular formula:
C15H26O
IUPAC Name:
[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-6-ol
Test material form:
solid: particulate/powder

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Run / experiment:
other: Test item Rep. 1
Parameter:
other: Calculated peptide depletion values for the Lys-Peptide
Value:
0 %
Positive controls validity:
valid
Run / experiment:
other: Test item Rep. 2
Parameter:
other: Calculated peptide depletion values for the Lys-Peptide
Value:
0 %
Positive controls validity:
valid
Run / experiment:
other: Test item Rep. 3
Parameter:
other: Calculated peptide depletion values for the Lys-Peptide
Value:
0 %
Positive controls validity:
valid
Run / experiment:
other: Test item Rep. 1
Parameter:
other: Calculated peptide depletion values for the Cys-Peptide
Value:
6.45 %
Positive controls validity:
valid
Run / experiment:
other: Test item Rep. 2
Parameter:
other: Calculated peptide depletion values for the Cys-Peptide
Value:
10.73 %
Positive controls validity:
valid
Run / experiment:
other: Test item Rep. 3
Parameter:
other: Calculated peptide depletion values for the Cys-Peptide
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.