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EC number: 814-338-9 | CAS number: 1913285-57-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- no
- Remarks:
- GLP equivalent
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- 2,4,7-trimethyloct-6-en-1-ol
- EC Number:
- 814-338-9
- Cas Number:
- 1913285-57-0
- Molecular formula:
- C11H22O
- IUPAC Name:
- 2,4,7-trimethyloct-6-en-1-ol
- Test material form:
- liquid
Constituent 1
In chemico test system
- Details on the study design:
- The Direct peptide reactivity Assay (DPRA) is an in chemico test to determine the reactivity of test a
substance towards peptides.
This assay has been validated for a broad range of low-molecular weight chemicals and it was found
to detect reactive skin sensitizers from a broad range of so called applicability domains, i.e.
chemicals reacting with proteins by different mechanisms. It was validated by ECVAM and proposed
to be used as part of an integrated approach for testing and assessment (IATA).
The test substance was dissolved in acetonitrile and mixed with a Cysteine- and a
Lysine-containing peptide according to the standard operating procedure of the DPRA. One study
with three replicates was conducted. After 24 h incubation time, peptide depletion induced by was determined by HPLC-UV.
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: Average depletion Cys-and Lys-peptide
- Value:
- 0.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The result of the DPRA assay should be used as part of an integrated approach for testing and assessment (IATA). A parallel test in the KeratinoSens™ assay may indicate whether congruent results are obtained by both test methods. According to a detailed analysis on large set of chemicals, two congruent results in these two tests give a good prediction of the sensitizer hazard [3-5] particularly when predicting human data, while an additional test in a dendritic cell line assessing expression of surface markers may be needed in case of discordant results.
The test substance was non-reactive and classified into the MINIMAL reactivity class according to the prediction model. It is therefore considered a non-sensitizer according to the prediction model of the DPRA. - Executive summary:
The test substance was not reactive in the DPRA assay and can be considered a non-sensitiser in this assay.
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