Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
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
Key result
Parameter:
other: relative viability
Value:
>= 70
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification