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
Skin irritation/corrosion: not irritating
Eye irritation: not irritating
Respiratory irritation: no study available
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The potential of Sulfosuccinate of Lanolin Alcohol solid to be irritant to the skin was investigated through an in vitro skin irritation study using a commercial reconstructed human epidermis (RhE) model named EPISKINTM
The test item did not induce cell death, and good homogeneity was observed between replicates.
According to the established criteria (cell viability less than 50%), the test item is considered to have no irritant effect on the skin under the reported experimental conditions.
Based on several results, also Lanoline Alcohol portion is not considered a primary dermal irritant.
The potential of Solfosuccinate of Lanolin Alcohol to cause corrosion/severe irritation by using the Bovine Corneal Opacity and Permeability (BCOP) assay, was examined in agreement with OECD Guideline no. 437 (adopted on September 2009) and OECD Supplement to Test Guidelines nos. 437 and 438.
The results obtained indicate that the test item induces slight changes in cornea opacity under the reported experimental conditions, but according to the OECD Guideline no. 437, the test item is not to be classified as corrosive or severely irritant to the eye. However, according to the criteria stated in the OECD Supplement to Test Guidelines nos. 437 and 438, there is an indication of a mild irritant effect to the eye.
Several results also on Lanoline Alcohol portion confirm that the substance can not be considered an ocular irritant.
Justification for selection of skin irritation / corrosion endpoint:
Sulfosuccinate of Lanoline Alcohol is chemically a complex substance, composed by a Lanoline Alcohol and a Sulfosuccinic part.
The test has been selected because it was performed on the registering substance.
Justification for selection of eye irritation endpoint:
Sulfosuccinate of Lanoline Alcohol is chemically a complex substance, composed by Lanoline Alcohol part and a Sulfosuccinic part.
The test has been selected because it was performed on the registering substance.
Justification for classification or non-classification
Skin irritation/corrosion:
The substance Sulfosuccinate of Lanolin Alcohol is not classified a skin irritant because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.
Eye irritation:
The substance Sulfosuccinate of Lanolin Alcohol is not classified an eye irritant because in the selected test it doesn't meet the classification criteria of the CLP regulation n. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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