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EC number: 940-678-3 | CAS number: -
The bacterial reverse mutation assay and the in vitro mammalian cell mutation assay showed clear negative results. Both of the studies identify the substance as non mutagenic.
The in vitro mammalian chromosome aberration test showed that the substance induced structural chromosomal aberrations in the V79 Chinese hamster cell line in the presence of the metabolic system.
The test item, however, should be considered as non mutagenic because doses tested in the experiment were modified in order to take into account that test item is produced and exist as 50% or less in water in all his life-cycle . Therefore a factor of 2 was applied in the calculation of the purity of the substance, in order to test it at 100%, and, as a consequence, concentrations where doubled. The increase of the aberration observed at concentrations of 750 µg/mL or greater should be divided by a factor of 2, in order to evaluate the effective mutagenicity potential of the substance, as produced and utilized in all its life-cycle. Concentrations at which clastogenic activity was observed, are therefore very high and well above the historical control data of the negative control for this reason. Effective doses, instead, resulted within the control range.
In literature, long chain aliphatic alcohols do not contain structural elements of concern for potential interaction with DNA and have been shown to be without mutagenic activity, primarily on the basis of Ames assays and mouse micronucleus assays.
Reference: OECD SIDS Long chain alcohols, April 18-21, 2006
Basing on the results of the reported studies and taking into account the literature, the test item "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" does not require classification:
Classification: not required
Signal word: none
Hazard statement: none
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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