Registration Dossier
Registration Dossier
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EC number: 225-035-0 | CAS number: 4621-04-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- December 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- In vitro testing sufficient to conclude on the sensitization potential of Folrosia.
Test material
- Reference substance name:
- 4-isopropylcyclohexanol
- EC Number:
- 225-035-0
- EC Name:
- 4-isopropylcyclohexanol
- Cas Number:
- 4621-04-9
- Molecular formula:
- C9H18O
- IUPAC Name:
- 4-(propan-2-yl)cyclohexan-1-ol
- Test material form:
- liquid
Constituent 1
In chemico test system
- Details on the study design:
- Skin sensitizing chemicals have the ability to covalently modify skin proteins or to be biotically or abiotically activated to become protein-reactive. Chemical-modified proteins are recognized by the immune system as foreign and trigger a specific T-cell mediated immune response.
A key step in the skin sensitization process is therefore the formation of a covalent adduct between the skin sensitizer and endogenous proteins and/or peptides in the skin. Based on this well established toxicity mechanism, the most straightforward approach to predict skin sensitization
involves the measurement of the reactivity of a test compound towards peptides and proteins (reviewed in [8]). Gerberick et al. [2, 6] therefore developed a peptide depletion assay using different heptapeptides (later coined the DPRA or ‘direct peptide reactivity assay’) to assess a chemicals
ability to react with and deplete a test peptide. Depletion is measured as the loss of the peptide signal as determined by HPLC-UV.
Results and discussion
In vitro / in chemico
Results
- Parameter:
- other: Average depletion Cys-and Lys-peptide
- Value:
- 2.6
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
FOLROSIA 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.
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