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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted equivlent to international guidelines, but predates GLP conditions. The study was conducted in a renomated laboratory and to the standards possible at the time of testing.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to internationally accepted guidelines, but predates GLP conditions. The study was conducted in a renomated laboratory and to the highest standards possible at the time of testing.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- males only
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Route of administration:
- oral: unspecified
- Doses:
- 25.2mL/kg, 22.4 mL/kg, 17.8 mL/kg and 14.1 mL/kg ; mixed with water to give a 20% solution
- No. of animals per sex per dose:
- 6 males
- Control animals:
- no
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 200 mg/kg bw
- Clinical signs:
- other: Animals became prostrate and lethargic.
- Gross pathology:
- Yellow fluid was observed through the gastrointestinal tract of those found dead.
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- A mortality of 5/5 at 5.0 g/kg bw, 3/5 at 4.5 mg/kg bw and 1/5 at 3.5 g/kg bw (and 0/5 at 2.8 g/kg bw) resulted in an oral LD50 of 4.2 g/kg bw. Animals became prostrate and lethargic; at necropsy, yellow fluid was obsrved through the gastrointestinal tract of those found dead.
- Executive summary:
In the current study, 20% dosusate solutions were given of 25.2, 22.4, 17.8 and 14.1 mL/kg bw, corresonding with approximate doses of 5.0, 4.5, 3.5 and 2.8 g/kg bw. A mortality of 5/5 at 5.0 g/kg bw, 3/5 at 4.5 mg/kg bw and 1/5 at 3.5 g/kg bw (and 0/5 at 2.8 g/kg bw) resulted in an oral LD50 of 4.2 g/kg bw. Animals became prostrate and lethargic; at necropsy, yellow fluid was observed through the gastrointestinal tract of those found dead.
Table1.Single oral dose in male Sprague-Dawley albino Rats
Conditions: fasted overnight ; mixed with water to give a 20% solution.
Dosage mL/kg |
Onset of (S) Signs, (D) Death, Hours and Days |
Died/ Dosed |
Mean Wt. |
Time of( R) Recovery , Days |
|||||||||||||||
0-6 |
6-24 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
I |
T |
1 |
2 |
3 |
4 |
5 |
6 |
7-14 |
||
25.2 |
|
4D |
1D |
|
|
|
|
|
|
5/5 |
147 |
- |
|
|
|
|
|
|
|
22.4 |
|
3D |
|
|
|
|
|
|
|
3/5 |
147 |
218 |
|
2R |
|
|
|
|
|
17.8 |
|
1D |
|
|
|
|
|
|
|
1/5 |
152 |
229 |
|
4R |
|
|
|
|
|
14.1 |
|
|
|
|
|
|
|
|
|
0/5 |
145 |
232 |
|
|
|
|
|
|
|
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted equivalent to international guidelines, however no reversibility was tested. The study was conducted in a renomated laboratory and to the standards at the time of testing.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.41
- Principles of method if other than guideline:
- FHSA procedure: Federal Hazardous Substance Act (6 animals instead of 3)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL of Aerosol OT-100 under covered patch
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- primary irritation score
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 3.83
- Max. score:
- 4
- Reversibility:
- no data
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Criteria used for interpretation of results: other: EU GHS
- Conclusions:
- Primary Irritation Score of 0.5 ml Aerosol OT-100 is 3.83.
- Executive summary:
A volume of 0.5 mL Docusate sodium was applied to intact and abraded skin of 6 male rabbits according to FHSA (Federal Hazard Act Substance) and CFR 1500.41 method for 24 hours under occlusive dressing. The reactions were evaluated after 24 and 72 hours and the substance was strongly irritating as indicated by a mean primary irritation score of 3.83/4.
Table1. Rabbit skin irritation
Conditions: 0.5mL Aerosol OT-100 under covered patch (FHSA Procedure)
Time, Hours |
Reaction |
Rabbit Number, Value |
Mean Value |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||
|
Erythema |
|
|
|||||
24 |
Intact |
3 |
3 |
2 |
1 |
3 |
2 |
2.33 |
72 |
Intact |
0 |
1 |
1 |
4 |
4 |
0 |
1.66 |
24 |
Abraded |
3 |
3 |
3 |
1 |
3 |
2 |
2.50 |
72 |
Abraded |
0 |
1 |
1 |
4 |
4 |
0 |
1.66 |
|
Edema |
|
|
|||||
24 |
Intact |
3 |
3 |
3 |
2 |
2 |
2 |
2.50 |
72 |
Intact |
1 |
0 |
2 |
2 |
1 |
0 |
1.0 |
24 |
Abraded |
3 |
3 |
3 |
2 |
2 |
2 |
2.50 |
72 |
Abraded |
1 |
0 |
2 |
2 |
1 |
1 |
1.16 |
Structure of tissue at the site of contact was not destroyed or changed irreversibly in 24 hours.
The scoring system used herein for skin and eye irritation reactions was that of Draize, J.H., Woodward, G., and Calvery, H.O., J. Pharmacol.Exptl.Therap., 82 :377, 1944. The maximum score value for a skin reaction (excluding necrosis) is 4. The “primary irritation score” was the sum of the mean values divided by 4.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted equivalent to international guidelines, however no reversibility was tested. The study was conducted in a renomated laboratory and to the highest standards possible at the time of testing.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- Principles of method if other than guideline:
- FHSA procedure: Federal Hazardous Substance Act (6 instead of 3 animals)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 g of Aerosol OT-100
- Duration of treatment / exposure:
- Not provided (evalutation at 24, 48 and 72 hours)
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 14.9
- Max. score:
- 110
- Reversibility:
- not specified
- Irritant / corrosive response data:
- See Table 1.
- Interpretation of results:
- moderately irritating
- Remarks:
- alike Category 2 Criteria used for interpretation of results: other: A procedure: 16 CFR 1500.42 and FHSA
- Conclusions:
- Not provided, but changes were seen up to 72h.
- Executive summary:
A volume of 0.1 mL (0.1g) Docusate sodium was applied in the eyes of 6 rabbits according to CFR and FHSA (Federal Hazard Substance Act). Evaluation after 24, 48 and 72 hours showed that the substance was irritating as indicated by changes of the cornea, iris and conjunctiva up to 72 hour.
Table1. Rabbit eye irritation
Conditions : 0.1 gm of Aerosol OT-100 (FHSA Procedure)
Time, Hours |
Reaction |
Rabbit Number, Value |
Mean Value |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||
24 |
Cornea |
5 |
10 |
5 |
40 |
0 |
10 |
11.66 |
Iris |
0 |
0 |
0 |
5 |
0 |
5 |
1.66 |
|
Conjunctivae |
0 |
4 |
2 |
10 |
0 |
16 |
5.33 |
|
48 |
Cornea |
0 |
5 |
0 |
30 |
0 |
40 |
12.50 |
Iris |
0 |
0 |
0 |
5 |
0 |
5 |
1.66 |
|
Conjunctivae |
0 |
4 |
0 |
8 |
2 |
12 |
4.33 |
|
72 |
Cornea |
0 |
0 |
0 |
10 |
0 |
15 |
4.16 |
Iris |
0 |
0 |
0 |
5 |
0 |
5 |
1.66 |
|
Conjunctivae |
0 |
0 |
0 |
2 |
0 |
8 |
1.66 |
Maximum score are: 80 for cornea, 10 for IRIS and 20 for conjunctiva.
At any of the readings made at 24, 48 and 72 hours, there was
-no discernible opacity or ulceration of the cornea other than a slight dulling of the normal luster.
-no inflammation of the iris other than slight deepening of the folds, or slight circumcorneal injection.
-no diffuse, deep-crimson red appearance of the conjunctivae, with individual vessels not easily discernible.
- no obvious swelling of the conjunctivae, excluding cornea and iris, with partial eversion of the lids.
- no destruction or irreversible change of any tissue in 24 hours or less.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- male animals only
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
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): Aerosol® OT-100, Sodium Dioctyl Sulfosuccinate
- Physical state: white, waxy solid
- Analytical purity: >97%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
Administration / exposure
- Type of coverage:
- other: covered
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Dermal application to clipped unabraded skin
- Duration of exposure:
- 24 hours
- Doses:
- 10 mL/kg bw; equivalent to 10000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no
- Clinical signs:
- other: Signs of intoxication: none noted. Skin iritation: fissuring, desquamation, coriaceousness was noted. Rabbits noted pulling fur out.
- Gross pathology:
- No gross pathology was observed
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- LD50 >10000 mg/kg, dosed as received.
- Executive summary:
Docusate sodium dosed dermally in male rabbits at 10000 mg/kg bw did not lead to mortality. Clinical observations included some skin iritation (fissuring, desquamation, coriaceousness, pulling fur out), however no signs of intoxication or gross pathological findings were noted .
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