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EC number: 278-562-3 | CAS number: 76836-02-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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 vitro
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- QSAR was 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. - Qualifier:
- according to guideline
- Guideline:
- other: DEREK NEXUS version 5.0.2
- GLP compliance:
- yes
- Interpretation of results:
- other: no alerts for skin sensitisation
- Executive summary:
According to DEREK NEXUS version 5.0.2, 1,4 piperazinediethanesulfonic acid disodium salt is predicted to be not sensitizing to the skin
- 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:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes
- Type of study:
- direct peptide reactivity assay (DPRA)
- 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 - 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.
- 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
- 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
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes
- Type of study:
- activation of keratinocytes
- 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 - Details on the study design:
- A valid KeratinoSensTM assay was performed according to OECD 442D and GLP. For the KeratinoSensTM assay, 1,4 piperazinediethanesulfonic acid disodium salt was dissolved in dimethyl sulfoxide to a final concentration of 200 mM. The final test concentrations in DMEM were 0.98 – 2000 µM and 1.0 – 2104 µM in experiment 1 and 2, respectively (2-fold dilution series). No precipitate was observed at any dose level tested. Two independent experiments were performed.
- Run / experiment:
- other: Experiment 1
- Parameter:
- other: Release of pro-inflammatory cytokines and induction of cyto-protective pathways in keratinocytes
- Value:
- 1.04
- Vehicle controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Run / experiment:
- other: Experiment 2
- Parameter:
- other: Release of pro-inflammatory cytokines and induction of cyto-protective pathways in keratinocytes
- Value:
- 1.15
- Vehicle controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is classified as negative in the KeratinoSensTM assay since negative results (<1.5-fold induction) were observed at test concentrations with a cell viability of >70% compared to the vehicle control.
- Executive summary:
A valid KeratinoSensTM assay was performed according to OECD 442D and GLP. For the KeratinoSensTM assay, 1,4 piperazinediethanesulfonic acid disodium salt was dissolved in dimethyl sulfoxide to a final concentration of 200 mM. The final test concentrations in DMEM were 0.98 – 2000 µM and 1.0 – 2104 µM in experiment 1 and 2, respectively (2-fold dilution series). No precipitate was observed at any dose level tested. Two independent experiments were performed. The test item showedno toxicity (no IC30 and IC50 value) and no biologically relevant induction of the luciferase activity (no EC1.5 value) was measured at any of the test concentrations in both experiments. The maximum luciferase activity induction (Imax) was 1.04-fold and 1.15-fold in experiment 1 and 2, respectively. The test item is classified as negative in the KeratinoSensTM assay since negative results.
Referenceopen allclose all
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.
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
The objective of this study was to reach an overall conclusion on the endpoint skin sensitization based on all available relevant information, includingin silico/in chemico/in vitrodata.
A DEREK assessment, DPRA assay and KeratinoSensTMassay were performed in accordance withSection 8.3 of Annex VII of Regulation (EC) No 1907/2006 as amended in Commission Regulation (EU) 2016/1688 of 20 September 2016 andthe strategy presented in ECHA Guidance on information requirements and chemical safety assessment Chapter R.7a.
According to DEREK NEXUS version 5.0.2, 1,4 piperazinediethanesulfonic acid disodium salt is predicted to be not sensitizing to the skin.
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. Furthermore, 1,4 piperazinediethanesulfonic acid disodium salt is found not to activate the antioxidant/electrophile responsive element (ARE)-dependent pathway in keratinocytes according to the results of a KeratinoSensTMassay.
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.
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.
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