Registration Dossier
Registration Dossier
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EC number: 290-844-8 | CAS number: 90268-43-2
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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