Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 209-406-4 | CAS number: 577-11-7
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 1991
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Referenceopen allclose all
- Reference Type:
- other: Submission of unpublished data by CTFA, 200 pp. Available for review from Director, Cosmetic Ingredient Review, 1101 17th Street, NW, Suite 310, Washington, DC 20036, USA.
- Title:
- Acute oral, ocular, primary dermal irritation, 21-day dermal irritation, photocontact allergenicity, 6 RIPTs, 13-week subchronic dermal, 13-week subchronic inhalation, four 4-day mini-cumulative irritation. Submission of unpublished data by CTFA, 200 pp.
- Author:
- Cosmetic, Toiletry, and Fragrance Association (CTFA).
- Year:
- 1 991
- Bibliographic source:
- CIR 1998, 2013 and 2016
- Reference Type:
- review article or handbook
- Title:
- Amended Final Report on the Safety Assessment of Dioctyl sodium sulfosuccinate.
- Author:
- CIR (Cosmetic Ingredient Review)
- Year:
- 1 998
- Bibliographic source:
- International Journal of Toxicology, 147(Suppl. 4):1-20,1998.
- Reference Type:
- review article or handbook
- Title:
- Re-review: Safety Assessment of Alkyl Sulfosuccinate Salts as Used in Cosmetics.
- Author:
- CIR Expert Panel
- Year:
- 2 013
- Bibliographic source:
- CIR Expert Panel Meeting June 10-11, 2013. Release Date: May 17, 2013.
- Reference Type:
- review article or handbook
- Title:
- Safety Assessment of Dialkyl Sulfosuccinate Salts as Used in Cosmetics. Tentative Amended Report for Public Comment.
- Author:
- CIR (Cosmetic Ingredient Review)
- Year:
- 2 013
- Bibliographic source:
- Tentative Amended Report for Public Comment. Release Date: June 20, 2013. Panel Meeting Date: September 9-10, 2013.
- Reference Type:
- publication
- Title:
- Safety Assessment of Dialkyl Sulfosuccinate Salts as Used in Cosmetics.
- Author:
- Cosmetic lngredient Review (CIR) Expert Panel: Monice M. Fiume , Bart Heldreth, Wilma F. Bergfeld, Donald V. Belsito, Ronald A. Hill, Curtis D. Klaassen, Daniel C. Liebler, James G. Marks Jr, Ronald C. Shank, Thomas J. Slaga, Paul W. Snyder, and F. Alan Andersen.
- Year:
- 2 016
- Bibliographic source:
- International Joumal of Toxicology 2016, Vol. 35(Supplement 3) 34S-46S. DOi: 10.1177/1091581816673808
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Sprague-Dawley rats, 12 male and 12 female, were exposed to an aerosol of a product containing an effective Dioctyl Sodium Sulfosuccinate concentration of 0.21%. The concentration of exposure was 4.2 mg/m3, and lasted 4 hours a day, 5 days a week, for 13 weeks. An equal number of rats were kept in a control chamber during this time.
During week 7, two rats from each group were killed and necropsied. At the end of the 13 weeks, the remainder of the animals were killed and necropsied. - GLP compliance:
- not specified
- Limit test:
- no
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
- Specific details on test material used for the study:
- aerosol of a product containing an effective diethylhexyl sodium sulfosuccinate concentration of 0.21% at an exposure concentration of 4.2 mg/m3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 4 h/day, 5 days/wk
Doses / concentrations
- Dose / conc.:
- 4.2 other: mg/m3
- Remarks:
- a product containing an effective diethylhexyl sodium sulfosuccinate concentration of 0.21% at an exposure concentration of 4.2 mg/m3
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- During week 7, two rats from each group were killed and necropsied. At the end of the 13 weeks, the remainder of the animals were killed and necropsied.
Results and discussion
Results of examinations
- Details on results:
- There were no statistically significant differences in dosed and control groups, attributable to Dioctyl Sodium Sulfosuccinate, for the following parameters: mean body weight gain, survival, appearance and behavior, urinalysis values, and microscopic lesions. The following significant differences were noted in hematologic parameters in treated rats as compared to control rats: elevated erythrocytic values in male rats at 7 weeks and depressed mean corpuscular hemoglobin concentration values in male rats at 13 weeks. Significant differences between dosed and treated rats in clinical chemistry parameters included: elevated serum glutamic pyruvic transaminase (SGPT) values in males at 13 weeks, depressed SGPT values in females at 7 weeks, depressed serum alkaline phosphatase (SAP) values in females at 13 weeks, and elevated glucose values in both the 7- and 13-week females. For the male rats, there was a significant difference in relative brain, liver, and testis weights. In females, there was a significant difference in the absolute, but not relative, heart weight. At 7 weeks, the lungs of animals necropsied were examined and stained with Oil Red O. One dosed male rat had some scattered foci of neutrophils along with an increase in the number of free alveolar macrophages.
Applicant's summary and conclusion
- Conclusions:
- Rats exposed to an aerosol of a product containing an effective diethylhexyl sodium sulfosuccinate concentration of 0.21% at an exposure concentration of 4.2 mg/m3, 4 h/day, 5 days/wk, for 13 wks, had significant changes in hematology and clinical chemistry parameters as compared to controls.
- Executive summary:
Sprague-Dawley rats, 12 male and 12 female, were exposed to an aerosol of a product containing an effective Dioctyl Sodium Sulfosuccinate concentration of 0.21% (CTFA 1991). The concentration of exposure was 4.2 mg/m3, and lasted 4 hours a day, 5 days a week, for 13 weeks. An equal number of rats were kept in a control chamber during this time.
During week 7, two rats from each group were killed and necropsied. At the end of the 13 weeks, the remainder of the animals were killed and necropsied. There were no statistically significant differences in dosed and control groups, attributable to Dioctyl Sodium Sulfosuccinate, for the following parameters: mean body weight gain, survival, appearance and behavior, urinalysis values, and microscopic lesions. The following significant differences were noted in hematologic parameters in treated rats as compared to control rats: elevated erythrocytic values in male rats at 7 weeks and depressed mean corpuscular hemoglobin concentration values in male rats at 13 weeks. Significant differences between dosed and treated rats in clinical chemistry parameters included: elevated serum glutamic pyruvic transaminase (SGPT) values in males at 13 weeks, depressed SGPT values in females at 7 weeks, depressed serum alkaline phosphatase (SAP) values in females at 13 weeks, and elevated glucose values in both the 7- and 13-week females. For the male rats, there was a significant difference in relative brain, liver, and testis weights. In females, there was a significant difference in the absolute, but not relative, heart weight. At 7 weeks, the lungs of animals necropsied were examined and stained with Oil Red O. One dosed male rat had some scattered foci of neutrophils along with an increase in the number of free alveolar macrophages.
Reference:
Cosmetic, Toiletry, and Fragrance Association (CTFA). 1991. Acute oral, ocular, primary dermal irritation, 21-day dermal irritation, photocontact allergenicity, 6 RIPTs, 13-week subchronic dermal, 13-week subchronic inhalation, four 4-day mini-cumulative irritation. Submission of unpublished data by CTFA, 200 pp. Available for review from Director, Cosmetic Ingredient Review, 1101 17th Street, NW, Suite 310, Washington, DC 20036, USA.
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.