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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
GLP compliance:
yes
Type of study:
direct peptide reactivity assay (DPRA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Product obtained by rectification during the manufacturing process of Dihydromyrcenol
EC Number:
947-968-9
Molecular formula:
C10H18
IUPAC Name:
Product obtained by rectification during the manufacturing process of Dihydromyrcenol

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
Run / experiment:
other: 1
Parameter:
other: Depletion % Lys-Peptide
Value:
26.21
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: %
Key result
Run / experiment:
other: 2
Parameter:
other: Depletion % Lys-Peptide
Value:
19.39
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: %
Key result
Run / experiment:
other: 3
Parameter:
other: Depletion % Cys- Peptide
Value:
79.43
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: %

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