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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
GLP compliance:
yes (incl. certificate)
Type of study:
other: In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vitro test system

Details on study design:
This in vitro study was performed to assess the potential of the test item Methyl Cyclopentenolone to activate the Nrf2 transcription factor by using the genetically modi-fied keratinocyte cell-line “LuSens” (Bauch et al. 2012).
It employs the use of a reporter gene for luciferase placed under the control of the antiox-idant response element (ARE) and hence monitors Nrf2 transcription factor activity. The measured endpoint is the up-regulation of luciferase activity after 48 h of incubation with the test substance at different concentrations. This up-regulation is an indicator for the activation of the Keap1/Nrf2/ARE signaling pathway (Ade et al. 2009, Natsch 2012, Natsch & Emter 2008, Vandebriel et al. 2010). In order to conclude on the Nrf2 transcrip-tion factor activity of the test substance, at least two, but a maximum of three independent and valid experiments are performed.

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: induction of the luciferase
Value:
< 1.5
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, it can be stated that under the experimental conditions of this study, the test item, Methyl Cyclopentenolone, was negative in the LuSens assay and is therefore considered not having the potential to activate the Nrf2 transcription factor (no sensitizing potential).