Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
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:
- 2 019
- 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
- Reference substance name:
- Product obtained by rectification during the manufacturing process of Dihydromyrcenol
- Molecular formula:
- C10H18
- IUPAC Name:
- Product obtained by rectification during the manufacturing process of Dihydromyrcenol
Constituent 1
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
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