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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:
2018
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)
Version / remarks:
This study is carried out according the OECD Guideline 442D dated February, 04th, 2015, the ECVAM DBALM protocol 155: KeratinoSensTM, C(81)30 OECD Guidelines and the article annex II to article D-523-8 of the French Environment
Deviations:
not specified
GLP compliance:
yes
Remarks:
not mentioned on study reports but on IDEAtest group website www.groupeideatests.com
Type of study:
activation of keratinocytes
Justification for non-LLNA method:
Alternative study to in-vivo as the first intention, in accordance with REACH annex VII and the Adverse Outcome Pathway (AOP) for Skin Sensitisation Initiated by Covalent Binding to Proteins (OECD, 2014)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
solid

In vitro test system

Details on study design:
see OECD 442D guidelinae and enclosed study plan

Results and discussion

Positive control results:
Cinnamaldehyde EC1.5 7.92 and Imax 7.64

In vitro / in chemico

Resultsopen allclose all
Key result
Parameter:
other: IC70 is concentration in μM for which we obtained 70% cell viability
Run / experiment:
mean on 2 runs
Value:
ca. 23.31
Vehicle controls validity:
not examined
Remarks:
control solvent as negative control
Negative controls validity:
valid
Remarks:
control solvent
Positive controls validity:
valid
Remarks:
Cinnamaldehyde Imax is 7.64
Remarks on result:
positive indication of skin sensitisation
Key result
Parameter:
other: EC1.5, value representing the concentration for which induction of luciferase activity is above 1.5 threshold was obtained
Run / experiment:
Linear EC1.5 μM and EC1.5 Lin/Log μM
Value:
>= 2.97 - <= 3.1
Vehicle controls validity:
not examined
Remarks:
constrol solvent as negative control
Negative controls validity:
valid
Remarks:
control solvent
Positive controls validity:
valid
Remarks:
cinnamaldehyde EC1.5 is 7.92 μM
Remarks on result:
positive indication of skin sensitisation
Other effects / acceptance of results:
Since all validity criteria are met, study is considered as valid.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
In both repetition, Imax is higher than 1.5, the EC1.5 is lower than 1000 μM and, at the EC1.5 concentration, viability is higher than 70%.

Under the retained experimental conditions, the test item may be classified as sensitizer.
Executive summary:

In vitro sensitization KeratinoSens™ assay OECD 442D is performed with Keratinocytes based on the signaling pathway Keap1-Nrf2-ARE coupled to the luciferase reporter gene. Under the retained experimental conditions, the test item may be classified as sensitizer.