Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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
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
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
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.
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
Qualifier:
according to
Guideline:
other: OECD 442E - human Cell Line Activation Test (h-CLAT)
Deviations:
no
GLP compliance:
yes
Type of study:
activation of dendritic cells
Key result
Parameter:
other: RFI (CD86)
Remarks:
1500 μg/mL
Run / experiment:
1, 2
Value:
> 139 - < 143
Vehicle controls validity:
valid
Negative controls validity:
not valid
Positive controls validity:
valid
Key result
Parameter:
other: RFI (CD54)
Remarks:
1500 μg/mL
Run / experiment:
1, 2
Value:
> 112 - < 134
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
not valid
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The test article, 2,2'-ethylenedithiodiethanol, was considered to be positive in the
human Cell Line Activation Test.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification