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Diss Factsheets
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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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 416.82 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 8.4
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 11 901 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Key 90-day oral toxicity study available; no repeated dose inhalation toxicity study available.
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested in the various studies, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Extrapolation from subchronic to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already applied in route-to-route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodyanmic differences between speices; see justification attached.
- AF for intraspecies differences:
- 2.4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies). While the DNEL is based on a read across substance as the only difference is the sodium rather than the calcium salt both will be dissociated in the physiological environment. Therefore a factor of 1 was used.
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 200.89 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 33.6
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Key 90-day oral toxicity study available; no repeated dose dermal toxicity study available.
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested in the various studies, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Extrapolation from subchronic to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodyanmic differences between speices; see justification attached.
- AF for intraspecies differences:
- 2.4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies). While the DNEL is based on a read across substance as the only difference is the sodium rather than the calcium salt both will be dissociated in the physiological environment. Therefore a factor of 1 was used.
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
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.
Repeated dose toxicity was tested in various species, including rats, dogs, rabbits and monkeys. The NOAEL of 750 mg/kg bw/day obtained in the key study in rats was confirmed to be consistent with data from docusate sodium and category members in supporting studies in rats; other data from other species were of limited reliability and relevance and therefore not taken into account.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 419.25 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature.
- Overall assessment factor (AF):
- 14
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 5 870 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Key 90-day oral toxicity study available; no repeated dose inhalation toxicity study available.
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested in the various studies, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Extrapolation from subchronic to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already applied in route-to-route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- NNo toxicodyanmic differences between speices; see justification attached.
- AF for intraspecies differences:
- 4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies). While the DNEL is based on a read across substance as the only difference is the sodium rather than the calcium salt both will be dissociated in the physiological environment. Therefore a factor of 1 was used.
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 120.54 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 56
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Key 90-day oral toxicity study available; no repeated dose dermal toxicity study available.
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested in the various studies, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Extrapolation from subchronic to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodyanmic differences between speices; see justification attached.
- AF for intraspecies differences:
- 4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies). While the DNEL is based on a read across substance as the only difference is the sodium rather than the calcium salt both will be dissociated in the physiological environment. Therefore a factor of 1 was used
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.39 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA factors in combination with recent scientific literature
- Overall assessment factor (AF):
- 56
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Not applicable
- AF for dose response relationship:
- 1
- Justification:
- Different doses were tested in the various studies, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1.4
- Justification:
- Extrapolation from subchronic to chronic; see justification attached.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- No toxicodyanmic differences between speices; see justification attached.
- AF for intraspecies differences:
- 4
- Justification:
- Refined assessment of population differences; see justification attached.
- AF for the quality of the whole database:
- 1
- Justification:
- Results were based on key Klimisch 1-2 studies (and possible supporting studies). While the DNEL is based on a read across substance as the only difference is the sodium rather than the calcium salt both will be dissociated in the physiological environment. Therefore a factor of 1 was used
- AF for remaining uncertainties:
- 2.5
- Justification:
- For remaining uncertainties that would result from the above assessment factors.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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.
Repeated dose toxicity was tested in various species, including rats, dogs, rabbits and monkeys. The NOAEL of 750 mg/kg bw/day obtained in the key study in rats was confirmed to be consistent with data from docusate sodium and category members in supporting studies in rats; other data from other species were of limited reliability and relevance and therefore not taken into account.
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.