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
non skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The study was performed on Sulfosuccinate of Lanoline Alcohol substance.
The results obtained in this study indicate that the test item may elicit a mild sensitisation response in mice following dermal exposure.
Since the substance is a surfactant, the LLNA (officially recommended) is not giving enough reliable results. A number of false positive have in fact been recorded on this substance family.
However many repeated skin sensitization test on humans are available for Lanolin Alcohol that is considered the most sensitizer portion of the whole molecule.
At this point all of the studies on humans did not define Lanoline Alcohol as a sensitizer substance, also in sensitive patients (for detail see section 7.10.4).
Justification for selection of skin sensitisation endpoint:
A LLNA study was performed on Sulfosuccinate of Lanoline Alcohol substance with positive results. However many repeated skin sensitization test on humans are available (Section 7.10.4) and the experience of many year in production and use of the substance demonstrated that the substance can be considered not sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) the criteria for the classification of skin sensitizer are:
Category 1:
(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or
(b) if there are positive results from an appropriate animal test
Sub-category 1A: substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.
Sub-category 1B: substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce.
The results of the test performed on Sulfosuccinate of lanolin alcohol would indicate the following classification: Category 1, with the signal word warning and hazard statement H317: May cause an allergic skin reaction.
However, considering the criteria a) and available test on humans (section 7.10.4), the substance Sulfosuccinate of lanolin Alcohol cannot be considered classified under the Regulation 1272/2008 because the important portion of the molecule is not able to cause primary irritation, or allergic reactions on humans.
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