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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 231-308-5 | CAS number: 7491-09-0
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to internationally accepted test guidelines and is considered relevant, adequate and reliable.
- Justification for type of information:
- Data has been read across from a structurally similar substance in a category approach. See further discussion in the read across justification attached.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- minor deviation in treatment volume
- Principles of method if other than guideline:
- The use of acetone as a solvent for this study necessitated a reduction in the treatment volume from 0.1 ml to 0.05 mL ( to avoid toxic effects of the solvent). A corresponding reduction was therefore made for positive control treatments. In order to achieve the same final concentration of positive control per plate, the stock positive control solution concentrations specified in the protocol were doubled.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
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
- Details on test material:
- - Name of test material (as cited in study report): Sodium dioctyl sulphosuccinate , Aerosol OT-100
- Physical state: White, waxy solid
- Analytical purity: >97%
- Lot/batch No.: HJ2601
- Storage condition of test material: in the dark at room temperature
Constituent 1
Method
- Target gene:
- histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98,TA100, TA1535, TA1537, TA102
- Additional strain / cell type characteristics:
- other: histidine -requiring
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 (mammalian liver post-mitochondrial fraction) used for metabollic activation was prepared from male Sprague-Dawley rats induced with Aroclor 1254 and obtained from Molecular Toxicology Inc., Annapolis, Maryland, USA.
- Test concentrations with justification for top dose:
- Toxicity Range-finder Experiment: 8, 40, 200, 1000, 5000 µg/plate
Mutation Experiment 1 (-S9): 1.6, 8.0, 40, 200, 1000 µg/plate
Mutation Experiment 1 (+S9): 4, 20, 100, 500, 2500 µg/plate
Mutation Experiment 2 (-S9): 62.5, 125, 250, 500, 1000 µg/plate
Mutation Experiment 2 (+S9): 156.25, 312.50, 625.00, 1250.0, 2500.0 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: The use of acetone as a solvent for this study
necessitated a reduction in the treatment volume from 0.1 ml to 0.05 ml (to avoid toxic effects of
the solvent). A corresponding reduction was therefore made for positive control treatments. In
order to achieve the same final concentration of positive control per plate, the stock positive control
solution concentrations specified in the protocol were doubled.
Controls
- Untreated negative controls:
- yes
- Remarks:
- treatments with the solvent: acetone
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-nitrofluorene (2NF), Sodium azide (NaN3), 9-aminoacridine (AAC), Glutaraldehyde (GLU), 2-aminoanthracene (AAN)
- Remarks:
- With the exception of NAN3 and GLU, which were prepared in water, all stock solutions were prepared in sterile anhydrous analytical grade dimethyl sulphoxide (DMSO), and stored in aliquots at 0-5°C in the dark.
- Details on test system and experimental conditions:
- Experiment 1: plate incorporation
Experiment 2(+S-9): pre-incubation than plate incorporation
Experiment 2 (-S-9): plate incorparation
DURATION
- Pre-incubation period: 1 hour at 37°C (in Experiment 2 and +S-9)
- Exposure duration:
Incubation time in Toxicity range-finder Experiment= 3 days
Incubation time in Mutagenicity Experiment 1: 3days
Experiment 2+S-9 has a pre-incubation step of 1 hour
Incubation time in Mutagenicity Experiment 2= 3 days
- Expression time (cells in growth medium):
- Fixation time (start of exposure up to fixation or harvest of cells):
NUMBER OF REPLICATIONS:
Mutation Experiment 1, 2(-S-9): 5+3+3+3+3+3+3 (TA98, TA100, TA 1535, TA1537, TA102)
Mutation Experiment 1, 2 (+S-9): 5+3+3+3+3+3+3 (TA98, TA100)
Mutation Experiment 1, 2 (+S-9): 5+3+3+3+3+3 (TA 1535, TA1537, TA102) – no positive controls
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: colony counting
OTHER EXAMINATIONS:
- Other: m-statistic, Dunnett’s test, linear regression analysis
OTHER: - Evaluation criteria:
- A test compound was considered to be mutagenic if:
i) the assay was valid ( see 2.4.2.)
ii) Dunnett’s test gave significant response (p≤ 0.01) , and the data set showed a significant dose-correlation
iii) The positive responses described in (ii) were reproducible. - Statistics:
- For evaluation of test chemical and positive control data there are many statistical methods in use, and several are acceptable (7,8). The m-statistic was first calculated to check that the data were Poisson-distributed (8), and then Dunnett’s test was used to compare the counts of each dose with the control. The presence or otherwise of a dose-response was then examined using linear regression analysis (8).
Results and discussion
Test results
- Species / strain:
- other: TA98,TA100, TA1535, TA1537, TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: some thinning of the background lawn at 1000 µg/plate
- Other confounding effects: no
RANGE-FINDING/SCREENING STUDIES:
An initial toxicity range-finder experiment was carried out in
TA100 only, using final concentrations of sodium dioctyl sulphosuccinate at 8, 40, 200, 1000 and
5000 µg/plate plus a solvent and positive control. In the absence S-9, complete killing of the test
bacteria was observed at the highest concentration of 5000µg/plate. In addition, a thinning of the
background lawn at the second highest concentration (1000µg/plate) also indicated toxicity. In the
presence of S-9, toxicity was only observed at the highest dose. In view of these results , maximum
test concentrations of 1000 and 2500µg/plate were chosen for Experiment 1 treatments, in absence
and presence of S-9 respectively.
COMPARISON WITH HISTORICAL CONTROL DATA:
Individual plate counts from both experiments were recorded separately and the mean and
standard deviation of the plate counts for each treatment were determined. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
It is concluded that docusate sodium failed to induce mutation in 5 strains of Salmonella thyphimurium, when tested up to concentrations close to or within the toxic range, in the absence and presence of a rat liver metabolic activation system. - Executive summary:
An initial toxicity range-finder experiment was carried out in TA100 only, with docusate sodium concentrations of 8, 40, 200, 1000 and 5000 µg/plate plus a solvent and positive control. In the absence S-9, cytotoxicity was observed at the highest concentration of 5000µg/plate. In addition, a thinning of the background lawn at the second highest concentration (1000µg/plate) also indicated toxicity. In the presence of S9, toxicity was only observed at the highest dose. In view of these results, maximum test concentrations of 1000 and 2500 µg/plate were chosen for the main experiment 1, in absence and presence of S9 respectively. In experiment 1, concentrations were close to the limit of toxicity, therefore for experiment 2, concentrations for all strains were maximally 2000 µg/plate without S9 and 2500 µg/plate with S9. In both experiments, docusate sodium did not result in statistically significant increases in revertant number of colonies, both with and without S9.
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.