Registration Dossier
Registration Dossier
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EC number: 807-159-2 | CAS number: 69701-99-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 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
- Reference substance name:
- (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl acrylate
- Cas Number:
- 69701-99-1
- Molecular formula:
- C10H16O4
- IUPAC Name:
- (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl acrylate
- Test material form:
- liquid
Constituent 1
In chemico test system
- Details on the study design:
- Incubation: The appearance of the MEDOL-10 and positive control samples in the HPLC vials was documented after preparation and then the vials placed into the autosampler of the HPLC set at 25°C for a minimum of 22 hours incubation prior to initiation of the analysis run. Prior to initiation of the run the appearance of the samples in the vials was assessed and documented again.
Analysis: The concentration of both the Cysteine and Lysine peptides in the presence of MEDOL-10 and the associated positive controls was quantified by HPLC using UV detection as detailed in the chromatographic section.
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: depletion value
- Value:
- 65.6
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The overall depletion value of 65.6% places MEDOL-10 in the reactivity class of “high” and hence it is predicted by DPRA to be a skin sensitizer
Applicant's summary and conclusion
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