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EC number: 204-889-8 | CAS number: 128-49-4
- 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
No data are available for the registered substance, however data are available for the corresponding sodium salt of the substance, docusate sodium (CAS 577-11-7). These data are used for read-across to the registered substance calcium docusate (CAS 128-49-4). The presence of either of the counterions sodium or calcium is not considered to have an impact on the toxicity. It is therefore considered justified to use the data of the sodium salt for read across to the calcium salt of docusate.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A key sensitisation study for docusate sodium was conducted according to the modified Draize-Shelanski Repeat Insult Patch Test with approximately 300 mg docusate sodium applied to patch sites on the backs or volar forearms of 100 human subjects for ten alternate-days during 24 hour periods under occlusion (Cytec, Kligman 1977). Following a seven-day rest period, challenge patches of the material were applied in the same manner to fresh sites on the backs or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter. Although some subjects had mild irritation during induction, there was no sensitisation after challenge.
Sensitisation assays were also available from category members as supporting information.
· For a formulated product containing 44-46% CAS No. 127-39-9 (sodium di-iso-butyl sulfosuccinate), there were no instances of irritation or sensitization (Cytec, Kligman 1977).
· For a formulated product containing 78-80% CAS No. 2373-38-8 (sodium dihexylsulfosuccinate), there were no instances of irritation or sensitization. (Cytec, Kligman 1976a).
· For a formulated product containing approximately 70% CAS No. 2763 -22 -5 (bis (tridecyl) sodium sulfosuccinate), there were no instances of irritation or sensitization (Cytec, Kligman 1976b).
· For a test substance with >97% CAS No. 922-80-5 (sodium diamylsulfosuccinate), there were no instances of irritation or sensitization (Cytec, Kligman 1976c).
In summary, no skin sensitization was observed with docusate sodium and structural similar chemicals, hence it is unlikely that docusate sodium has sensitization potential. Further testing is not recommended/proposed based on this information.
Migrated from Short description of key information:
Sensitisation studies according to the modified Draize-Shelanski Repeat Insult Patch Test were negative for skin sensitisation for docusate sodium and for various category members as supporting information. Therefore it is unlikely that docusate sodium has sensitization potential for the skin.
Justification for classification or non-classification
As there was no skin sensitisation observed for the read-across analogue docusate sodium, there is no indication for classification of docusate calcium.
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