Registration Dossier

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
Study period:
2017
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: relative viability
Value:
>= 70
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Under the experimental conditions of this study, the test item, Thuj-4(10)-ene, was nega-tive in the LuSens assay and is therefore considered not having the potential to activate the Nrf2 transcription factor. However, due to the low test item concentrations (highest concentrations < 1000 µM), the result has to be considered as inconclusive in accordance to the OECD 442D.