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Skin sensitisation

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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

see attached expert statement

No running of the experiment was possible due to insolubility of the substance in the recommended solvents

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.

Data source

Reference
Reference Type:
other: expert statement
Title:
Unnamed
Year:
2016
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

Constituent 1
Reference substance name:
944-415-3 disidratato
IUPAC Name:
944-415-3 disidratato
Details on test material:
sample was dehydrated before testing

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.