Registration Dossier
Registration Dossier
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EC number: 237-857-7 | CAS number: 14024-56-7
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:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
Test material
- Reference substance name:
- Bis(pentane-2,4-dionato-O,O')magnesium
- EC Number:
- 237-857-7
- EC Name:
- Bis(pentane-2,4-dionato-O,O')magnesium
- Cas Number:
- 14024-56-7
- Molecular formula:
- C10H14MgO4
- IUPAC Name:
- magnesium;4-oxopent-2-en-2-olate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- The KeratinoSens™ in vitro skin sensitisation assay uses an immortalised adherent cell line derived from HaCaT human keratinocytes stably transfected with a selectable plasmid. The cell line contains the luciferase gene under the transcriptional control of a constitutive promoter fused with an ARE element from a gene that is known to be up-regulated by contact sensitisers. The luciferase signal reflects the activation by sensitisers of endogenous Nrf2 dependent genes, and the dependence of the luciferase signal in the recombinant cell line on Nrf2 has been demonstrated. This allows quantitative measurement (by luminescence detection) of luciferase gene induction, using well established light producing luciferase substrates, as an indicator of the activity of the Nrf2 transcription factor in cells following exposure to electrophilic test chemicals.
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Run / experiment:
- other: 1
- Parameter:
- other: EC1.5
- Value:
- 177.93
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Run / experiment:
- other: 2
- Parameter:
- other: EC1.5
- Value:
- 237.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Run / experiment:
- other: 1
- Parameter:
- other: Imax
- Value:
- 15.24
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Run / experiment:
- other: 2
- Parameter:
- other: Imax
- Value:
- 57.55
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Executive summary:
The skin sensitization test was performed according to the OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method);
It was concluded that the test substance is a skin sensitizer.
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