Registration Dossier
Registration Dossier
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EC number: 226-045-8 | CAS number: 5244-34-8
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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.
Referenceopen allclose all
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
