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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
Carcinogenicity
Administrative data
Description of key information
Docusate sodium was tested up to 1% dietary concentrations in standard rats for 2 years and in a special rat model for colorectal carcinogenesis for 20 weeks . Both models did not result in increased tumour findings Docusate sodium was tested up to 1% dietary concentrations in standard rats for 2 years and in a special rat model for colorectal carcinogenesis for 20 weeks . Both models did not result in increased tumor findings up to at a slight toxic dose level of 1% showing decreased body weight. NOAEL for toxicity was 0.5% dietary concentration (250 mg/kg bw/day) and NOAEL for tumorigenicity was 1% in the diet (500 mg/kg bw/day).
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- other: publication
- Adequacy of study:
- supporting study
- Study period:
- 1948
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Limited information on materials & methods available.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation:21 days
- Housing: individual cages
- Diet (e.g. ad libitum): Ground commercial rat biscuits with 1 % added codliver oil ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
controlled temperature and humidity - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: rotary batch mixer
DIET PREPARATION
- Mixing appropriate amounts with (Type of food): Ground commercial rat biscuits with 1% added codliver oil - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Two-year experiment: 2 year
- Frequency of treatment:
- daily
- Dose / conc.:
- 0.25 other: % nominal in diet
- Dose / conc.:
- 0.5 other: % nominal in diet
- Dose / conc.:
- 1 other: % nominal in diet
- No. of animals per sex per dose:
- 2-year experiment: 12 males per dose +12 males as control
- Control animals:
- yes, concurrent no treatment
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION :
- Food consumption for each animal determined : Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, all but a few
HISTOPATHOLOGY: Yes, not all - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- During the fast growing period of the first 12 weeks of the experiment the growth rates of the group of rats on diets containg 1% sodium dioctyl sulfosuccinate were slightly less than that of the control group.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No dislike for the food containing sodium dioctyl sulfosuccinate was evidenced by a decreased food intake in any group of animals.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No gross pathological changes attributable to treatment
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No microscopic pathological changes attributable to treatment
- Histopathological findings: neoplastic:
- no effects observed
- Dose descriptor:
- NOAEL
- Remarks:
- carcinogenicity
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Dose descriptor:
- NOAEL
- Remarks:
- toxicity
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Conclusions:
- Effects on growth and mortality: no effects on mortality, there was a highly significant (p<0.001) difference in body weight gain between the control group and the 1% dose group .
Pathology: there were no changes whatever attributable to treatment. - Executive summary:
Docusate sodium was administered for 2 years to rats at concentrations of 0.25, 0.5 and 1% in the diet. At 1%, there were no effects on mortality, bu there was a significant (p<0.001) decrease in body weight gain between the control group. No effects were observed at the 0.25 and 0.5% dose level, corresponding with 125 and 250 mg/kg bw/day. There were no dose related changes in tumour incidences up to 1%, corresponding with at least 500 mg/kg bw/day .
- Endpoint:
- carcinogenicity: oral
- Type of information:
- other: publication
- Adequacy of study:
- supporting study
- Study period:
- 1948
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Limited information on materials & methods available.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Fischer 344
- Details on test animals or test system and environmental conditions:
- Inbred male F344 rats were divided into two groups of 84 each and fed the following diets: ground chow and 5% corn oil (control group) and ground chow, 5% corn oil, and 1% DSS (experimental group). All rats received high-dose DMH base (1,2-dimethylhydrazine ), 20 mg/kg/week sc for 20 weeks. Twenty rats per group were killed after 3, 4, 5, and 6 months. Duodenum, small intestine, colon, and rectum were dissected out. Each tumor was measured for size and location and evaluated histologically.
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 20 weeks
- Frequency of treatment:
- daily
- Dose / conc.:
- 1 other: % nominal in diet
- No. of animals per sex per dose:
- 20 rats/period
- Control animals:
- yes, concurrent vehicle
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- decrease in tumors
- Details on results:
- The percentage of rats bearing tumors in the control and experimental groups did not differ significantly. In each rat there were fewer gastrointestinal tumors in the DSS-fed group of all histologic types combined, at all organ sites, at 5 and 6 months. This difference between the control and DSS-fed rats reached the level of statistical significance for tumors of the duodenum, colon, and rectum and for total gastrointestinal tumors at the 5th month.
- Dose descriptor:
- NOAEL
- Remarks:
- carcinogenicity
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Conclusions:
- Effects on growth and mortality: no effects on mortality, there was a highly significant (p<0.001) difference in body weight gain between the control group and the 1% dose group .
Pathology: there were no changes whatever attributable to treatment. - Executive summary:
The 1,2-dimethylhydrazine (DMH) rodent model for colorectal carcinogenesis was used to explore the effect of dietary Docusate sodium on carcinogenesis. Inbred male F344 rats were divided into two groups of 84 each and fed the following diets: ground chow and 5% corn oil (control group) and ground chow, 5% corn oil, and 1% DSS (experimental group). All rats received high-dose DMH base, 20 mg/kg/week sc for 20 weeks. Twenty rats per group were killed after 3, 4, 5, and 6 months. Duodenum, small intestine, colon, and rectum were dissected out. Each tumor was measured for size and location and evaluated histologically. The percentage of rats bearing tumors in the control and experimental groups did not differ significantly. In each rat there were fewer gastrointestinal tumors in the DSS-fed group of all histologic types combined, at all organ sites, at 5 and 6 months. This difference between the control and DSS-fed rats reached the level of statistical significance for tumors of the duodenum, colon, and rectum and for total gastrointestinal tumors at the 5th month.
Referenceopen allclose all
Table 1. Mean gain in weight of male rats given sodium dioctyl sulfosuccinate in their diet for a year
Dosage, % |
No. of animals |
Mean Gain in Weight, g |
Standard Error of Mean, g |
0.25 |
10 |
436.0 |
± 15.5 |
0.5 |
10 |
441.3 |
± 14.5 |
1 |
10 |
395.8 |
± 11.6 p<0.001 |
Control: 0 |
11 |
471.9 |
± 13.2 |
Table 1. Mean gain in weight of male rats given sodium dioctyl sulfosuccinate in their diet for a year
Dosage, % |
No. of animals |
Mean Gain in Weight, g |
Standard Error of Mean, g |
0.25 |
10 |
436.0 |
± 15.5 |
0.5 |
10 |
441.3 |
± 14.5 |
1 |
10 |
395.8 |
± 11.6 p<0.001 |
Control: 0 |
11 |
471.9 |
± 13.2 |
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
Justification for classification or non-classification
As there were no tumours observed, classification is not warranted.
Additional information
A literature study was available, where Docusate sodium was tested for 2 years in rats at concentrations of 0.25, 0.5 and 1% in the diet (Literature: Fitzhugh and Nelson, 1948). At 1%, there were no effects on mortality, but there was a significant (p<0.001) difference in body weight gain between the control group and the 1% dose group. No effects were observed at the 0.5% dose level, corresponding with 250 mg/kg bw/day. There were no dose related changes in tumour incidences up to 1%, corresponding with at least 500 mg/kg bw/day.
Secondly, a review also mentioned a study of Docusate sodium (DSS) in the 1,2-dimethylhydrazine (DMH) rodent model for colorectal carcinogenesis to explore the effect of on carcinogenesis. Inbred male F344 rats were divided into two groups of 84 each and fed the following diets: ground chow and 5% corn oil (control group) and ground chow, 5% corn oil, and 1% DSS (experimental group). All rats received high-dose DMH base, 20 mg/kg/week sc for 20 weeks. Twenty rats per group were killed after 3, 4, 5, and 6 months. Duodenum, small intestine, colon, and rectum were dissected out. Each tumor was measured for size and location and evaluated histologically. The percentage of rats bearing tumors in the control and experimental groups did not differ significantly. In each rat there were fewer gastrointestinal tumors in the DSS-fed group of all histologic types combined, at all organ sites, at 5 and 6 months. This difference between the control and DSS-fed rats reached the level of statistical significance for tumors of the duodenum, colon, and rectum and for total gastrointestinal tumors at the 5th month.
In summary, Docusate sodium was tested up to 1% dietary concentrations in standard rats for 2 years and in a special rat model for colorectal carcinogenesis for 20 weeks. Both models did not result in increased tumor findings up to at a slight toxic dose level of 1% showing decreased body weight. NOAEL for toxicity was 0.5% dietary concentration (250 mg/kg bw/day) and NOAEL for tumorigenicity was 1% in the diet (500 mg/kg bw/day). The absence of tumorigenicity confirmed the negative genetic toxicity potential of Docusate sodium described in section 7.6.
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