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EC number: 204-889-8 | CAS number: 128-49-4
- 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
Endpoint summary
Administrative data
Description of key information
Both for the skin and eye irritation, in vivo key studies according to OECD 404 and 405 were available, demonstrating that the test substance is highly irritating to skin and resulting in irreversible eye damage. The overall irritation scores were 7.8 of max. 8 (1- 72 h) in the key study for skin irritation and 47 of max. 110 (1-72 h) in the key study for eye irritation. This information in combination with supporting studies resulted in skin irritation EU GHS category 2 and eye damage EU GHS category 1.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
A key study for skin irritation was performed in rats according to OECD 404 test guideline, which was considered to be reliable, adequate and relevant (Elementis, Mürmann 1988). A volume of 0.5 mL Docusate sodium (70% solution in ethanol/methanol and water) was applied on 6 cm2 shaved skin of 3 male rabbits by occlusive application. After this period, the skin area was washed with warm water and observed after 1, 24, 48, 72 hours and 6, 8, 10 and 14 days. The results showed that there was an irritation index of 7.8/8 over the 1 -72 hour period and some effects were still visible at 14 days.
A support study was conducted by application of 0.5 mL Docusate sodium 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 (Cytec, McGinty 1977a). 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. There was one other exploratory study in 2 rabbits which were exposed for 24 hours and evaluated after 24 and 72 hours, also showing eye irritating up to 72 hours (Dow, Rohm & Haas1974). As the latter study was exploratory, this was disregarded for the safety evaluation.
A key study for eye irritation was conducted with Docusate sodium according to OECD 405 test guideline, which was considered to be reliable, adequate and relevant (Elementis, Mürmann 1988). A volume of 0.1 mL Docusate sodium (mixture of 70% docusate sodium, ethanol in methanol, water) was applied to the eyes of 3 male rabbits. After 72 hours, fluorescein solution was applied for cornea evaluation and rinsing was performed with warm physiological solution. Evaluation after 1, 24, 48 and 72 hours and 6, 8, 10, 13, 17 and 21 days after application showed irreversible damage (including turbidity of the cornea). The mean overall irritation score for 1 -72 hours was 46,67/110.
A support study was conducted by application of a volume of 0.1 mL (0.1g) Docusate sodium to the eyes of 6 rabbits according to FHSA (Federal Hazard Substance Act) and CFR 1500.41 method. 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 (Cytec, McGinty 1977a). There was one other exploratory study in 2 rabbits which were evaluated after 24, 48 and 72 hours, also showing eye irritating up to 72 hours (Dow, Rohm & Haas1974). As the latter study was exploratory, this was disregarded for the safety evaluation.
In summary, both skin and eye irritation studies were available showing that Docusate sodium is irritating to skin and resulting in irreversible eye damage, resulting in the need for classification and labeling.
Effects on skin irritation/corrosion: highly irritating
Effects on eye irritation: corrosive
Justification for classification or non-classification
Based on the strong skin irritation (EU GHS category 2) and irreversible eye damage (EU GHS category 1), classification is warranted.
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