Registration Dossier
Registration Dossier
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EC number: 943-154-2 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- other: expert statement
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- other: expert statement
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Principles of method if other than guideline:
- The LuSens is an in vitro test method designed to discriminate between skin sensitising and non -sensitising chemicals. The test method is based on the same concepts as the OECD adopted KeratinoSens™ (TG 442D) by quantifying luciferase gene induction as a measure of the activation of the Keap1-Nrf2-antioxidant/electrophile response element (ARE)-dependant pathway in a genetically modified keratinocyte cell -line (Bauch et al, 2012).
- GLP compliance:
- no
- Type of study:
- other: Lusens
- Run / experiment:
- other: Lu Sens
- Parameter:
- other: as reported in the section
- Remarks on result:
- other: solubilities issues did not allow to assess skin sensitization in vitro
- Interpretation of results:
- other: not applicable
- Conclusions:
- The substance was tested for in-vitro skin sensitization following OECD 442D. Under the experimental conditions the substance was not soluble in any of the prescribed solvents used for the testing and it was not possible to assess the skin sensitisation properties.
- Executive summary:
The substance was tested for in-vitro skin sensitization following OECD 442D. The solubilisation of the test substance was determined first in DMSO, under different dilution factors, water (cell culture) and also ethanol (not recommended by the guideline). The test substance always showed precipitation after a short time ot separation of the formed emulsion. Therefore under the experimental conditions the test substance is not in the applicability domain of the test guideline and it was not possible to assess its skin sensitizing properties.
see attached expert statement
No running of the experiment was possible due to insolubility of the substance in the recommended solvents
Data source
Reference
- Reference Type:
- other: expert statement
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Principles of method if other than guideline:
- The LuSens is an in vitro test method designed to discriminate between skin sensitising and non -sensitising chemicals. The test method is based on the same concepts as the OECD adopted KeratinoSens™ (TG 442D) by quantifying luciferase gene induction as a measure of the activation of the Keap1-Nrf2-antioxidant/electrophile response element (ARE)-dependant pathway in a genetically modified keratinocyte cell -line (Bauch et al, 2012).
- GLP compliance:
- no
- Type of study:
- other: Lusens
Test material
- Reference substance name:
- 944-415-3 disidratato
- IUPAC Name:
- 944-415-3 disidratato
- Details on test material:
- sample was dehydrated before testing
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Run / experiment:
- other: Lu Sens
- Parameter:
- other: as reported in the section
- Remarks on result:
- other: solubilities issues did not allow to assess skin sensitization in vitro
Any other information on results incl. tables
see attached expert statement in the summary section
No running of the experiment was possible due to insolubility of the substance in the recommended solvents
Applicant's summary and conclusion
- Interpretation of results:
- other: not applicable
- Conclusions:
- The substance was tested for in-vitro skin sensitization following OECD 442D. Under the experimental conditions the substance was not soluble in any of the prescribed solvents used for the testing and it was not possible to assess the skin sensitisation properties.
- Executive summary:
The substance was tested for in-vitro skin sensitization following OECD 442D. The solubilisation of the test substance was determined first in DMSO, under different dilution factors, water (cell culture) and also ethanol (not recommended by the guideline). The test substance always showed precipitation after a short time ot separation of the formed emulsion. Therefore under the experimental conditions the test substance is not in the applicability domain of the test guideline and it was not possible to assess its skin sensitizing properties.
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