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EC number: 245-629-3 | CAS number: 23386-52-9
- 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

Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Birth Defects and Drugs in Pregnancy
- Author:
- Heinonen OP, Slone D, Shapiro S
- Year:
- 1 977
- Bibliographic source:
- Publishing Sciences Group, Inc., Littleton 1977 , pp 385 & 442
- Reference Type:
- review article or handbook
- Title:
- Toxicity profile Dioctyl Sodium Sulphosuccinate
- Author:
- Bibra Information Department, Woodmansterne Road Carshalton Surrey SM5 4DS Great Britain
- Year:
- 1 989
- Reference Type:
- review article or handbook
- Title:
- Treating constipation during pregnancy
- Author:
- Trottier M, Erebara A, Bozzo P
- Year:
- 2 012
- Bibliographic source:
- Can Fam Physician. 2012 Aug;58(8):836-8.
Materials and methods
- Study type:
- other: prospective study
- Endpoint addressed:
- developmental toxicity / teratogenicity
Test material
- Reference substance name:
- Docusate sodium
- EC Number:
- 209-406-4
- EC Name:
- Docusate sodium
- Cas Number:
- 577-11-7
- Molecular formula:
- C20H38O7S.Na
- IUPAC Name:
- sodium 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxobutane-2-sulfonate
Constituent 1
Results and discussion
Any other information on results incl. tables
Table 1. Children (3,248) With Any Malformation in Relation to Exposure to Drugs Used for Gastrointestinal Disturbances During Lunar Months 1-4 Among 50,282 Mother-Child Pairs
|
No. of Mother- Chlld Pairs Exposed |
No. of Malformed Children |
Crude Relative Risk |
Hospital Standardized Relative Risk1
|
Survival and Race Standardized Relative Risk1 |
Dioctyl sodium sulfosuccinate |
30 |
3 |
1.55 |
1.33 |
1.32 |
1Estimated by the Mantel-Haenszel procedure
Table 2. Children (2,277) With Malformations Showing Uniform Rates by Hospital in Relation to Exposure to Drugs Used for Gastrointestinal Disturbances During Lunar Months 1-4 Among 50,282 Mother-Child Pairs
|
No. of Mother- Chlld Pairs Exposed |
No. of Malformed Children |
Crude Relative Risk |
Hospital Standardized Relative Risk1
|
Survival and Race Standardized Relative Risk1 |
Dioctyl sodium sulfosuccinate |
30 |
2 |
1.47 |
1.34 |
1.11 |
Table 3. Standardized Relative Risks (SAR) and Their 95% Confidence Intervals (Cl95) for Anytime Malformations Showing Uniform Rates by Hospital in Relation to Drugs Taken for Gastrointestinal Disturbances Used Anytime During Pregnancy (Based on Multiple Logistic Risk Function Analysis)
Drugs taken for GI disturbances |
No. of Users |
No. of Malformed Children |
SRR |
Cl95of RSS |
|
Observed |
Expected |
||||
Dioctyl sodium sulfosuccinate |
116 |
3 |
2.23 |
1.35 |
0.28-3.84 |
Applicant's summary and conclusion
- Conclusions:
- From 30 females who were exposed to Dioctyl sodium sulfosuccinate in months 1-4 of pregnancy, 3 gave birth to malformed children.
From 116 females who were exposed to Dioctyl sodium sulfosuccinate any time during pregnancy, 3 gave birth to malformed children.
There was no evidence to suggest that exposure to drugs taken for gastrointestinal disturbances (440 mother-child pairs) increases the risk of malformations. However, numbers were small and associations between specific drugs and various malformations could not be ruled out.
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