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 chemico
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
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Deviations:
no
GLP compliance:
yes
Type of study:
direct peptide reactivity assay (DPRA)
Key result
Run / experiment:
other: 1
Parameter:
other: Cysteine Depletion
Value:
0
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: 2
Parameter:
other: Lysine Depletion
Value:
0.04
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
GHS criteria not met
Conclusions:
The test article, 2,2'-ethylenedithiodiethanol, was considered to be negative with no or
minimal reactivity in the Direct Peptide Reactivity Assay.
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
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
Run / experiment:
other: 1, 2
Parameter:
other: RFI (CD86)
Remarks:
1500 μg/mL
Value:
139
Vehicle controls validity:
valid
Negative controls validity:
not valid
Positive controls validity:
valid
Key result
Run / experiment:
other: 1, 2
Parameter:
other: RFI (CD54)
Remarks:
1500 μg/mL
Value:
112
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:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification