Registration Dossier
Registration Dossier
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EC number: 278-562-3 | CAS number: 76836-02-7
Skin sensitisation
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:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Disodium piperazine-1,4-diethanesulphonate
- EC Number:
- 278-562-3
- EC Name:
- Disodium piperazine-1,4-diethanesulphonate
- Cas Number:
- 76836-02-7
- Molecular formula:
- C8H18N2O6S2.2Na
- IUPAC Name:
- disodium 2-[4-(2-sulfonatoethyl)piperazin-1-yl]ethane-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Chemical name 1,4 piperazinediethanesulfonic acid disodium salt
CAS number 76836-02-7
Purity/Composition ≥ 98%
UVCB: No
In vitro test system
- Details on the study design:
- For the DPRA assay, 1,4 piperazinediethanesulfonic acid disodium salt dissolved completely in milli-Q, no precipitate was observed in any of the samples. Furthermore, no co-elution of the test item and the peptides occurred.
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Parameter:
- other: Cystine Reactivity Assay
- Value:
- 0.1
- Remarks on result:
- no indication of skin sensitisation
- Parameter:
- other: lysine reactivity assay
- Value:
- 0.8
- Parameter:
- other: mean of the synthetic peptides containing either cysteine (SPCC) or lysine (SPCL) depletion
- Value:
- 0.5
Any other information on results incl. tables
In the cysteine reactivity assay the test item showed 0.1 ± 0.2% SPCC depletion while in the lysine reactivity assay the test item showed 0.8 ± 1.2% SPCL depletion. The mean of the synthetic peptides containing either cysteine(SPCC) or lysine (SPCL) depletion was 0.5% and as a result the test item was considered to be negative in the DPRA and classified in the “no or minimal reactivity class”when using the Cysteine 1:10 / Lysine 1:50 prediction model.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The objective of this study was to reach an overall conclusion on the endpoint skin sensitization based on all available relevant information, including in silico/in chemico/in vitro data. A DPRA assay assay were performed in accordance with Section 8.3 of Annex VII of Regulation (EC) No 1907/2006 as amended in Commission Regulation (EU) 2016/1688 of 20 September 2016 and the strategy presented in ECHA Guidance on information requirements and chemical safety assessment Chapter R.7a. The test item 1,4 piperazinediethanesulfonic acid disodium salt was negative in the DPRA, therefore it can be concluded that the substance will not interfere with protein moieties. Based on the current data-set it is concluded that there are no indications that 1,4 piperazinediethanesulfonic acid disodium salt has skin sensitizing properties. The data are considered sufficient to conclude that the substance does not have to be classified for skin sensitizing properties
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