Registration Dossier
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EC number: 290-844-8 | CAS number: 90268-43-2
- 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
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- Nanomaterial photocatalytic activity
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
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- 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
Sensitization: No primary irritant, no allergenic
Developmental toxicity: no developmental toxicant
Additional information
Sulfosuccinate of Lanoline Alcohol is a complex substance, and for sensitization the Lanoline alcohol part of the molecule was considered.
Different studies on sensitization were performed on humans, in order to assess the allergenic potential of Lanoline Alcohol. For this scope various products based on lanolin alcohol were tested. A repeated insult patch test and a prophetic patch test were performed in order to evaluate erythema (intensity and area involved) and edema (elevation of the skin with respect to the control of the unaffected normal skin), primary irritation, "fatiguing” (not considered incidents of sensitization) and sensitization.
Most of the test materials based on lanoline alcohol did not produce primary irritation, fatiguing and only some of them produced mild or severe primary irritation and fatiguing.
Another test had the objective to determine if extracted or modified Lanolin products would produce positive patch test reactions on patients who had previously given positive patch test reactions to Lanolin. The interim conclusion is that the Lanolin sensitive patients did not react to all of the tested Lanolin Alcohols fractions, therefore products based on Lanoline Alcohols could not be considered a primary irritant or an allergen.
For Developmental toxicity data were available for the Sulfosuccinic part (represented by Dioctyil Sodium Sulfosuccinate DSS)
The authors of the study determined the prevalence of certain major congenital disorders among live-born infants of 6509 mothers in a prepaid health plan for the 30-month period between January 1, 1980 to June 30, 1982 who used a wide variety of drugs during the first trimester of pregnancy. One drug tested was the Dioctyl Sodium Sulfocuccinate (Colace).
No strong associations between any of the commonly used drugs (DSS included) and the congenital disorders studied were present.
Although the data presented on most of the drugs in this study are insufficient to rule out a modest association, they do rule out a strong association with many commonly used drugs and the generally serious congenital defects included in this evaluation.
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