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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Deviations:
yes
Remarks:
see free text
Principles of method if other than guideline:
Cytotoxicity Assessment
The incubation period following addition of MTT was 4 hours
10 minutes in Experiment 1 and not 4 hours as specified in the
protocol. This deviation was considered not to have affected the
integrity or outcome of the study as all acceptance criteria were met.
GLP compliance:
yes (incl. certificate)
Type of study:
other: induce genes that are regulated by the antioxidant response element

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Key result
Parameter:
other: Luminescence Readings
Run / experiment:
1
Value:
> 0.75 - < 1.01
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Parameter:
other: Luminescence Readings
Run / experiment:
2
Value:
> 0.99 - 1.2
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Parameter:
other: -
Run / experiment:
n.a.
Value:
> 83.67 - < 102.29
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The Imax values were less than 1.5 in both experiments, therefore 2,2'-
ethylenedithiodiethanol was considered to be negative in the ARE-Nrf2 Luciferase
Test.