Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

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


Short description of key information:
In order to test the genetic toxicity "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" the Ames test, the Chromosomal aberration study and the Mouse lymphoma test were considered.
The Ames test was performed on Eucarol AGE SS (D-Glucopyranose, oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1- (coco alkyl) ethers, sodium salts) was old name for EUCAROL AGE SS/ND before REACH regulatory - new nomenclature.
The substance was identified with:
CAS: 151911-53-4
EC: 500-331-5

The chromosomal aberration test was performed on "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" according the OECD 473, the EU Method B.13/14 and EPA OPPTS 870.5375.
The mouse lymphoma test was performed on "Sulfonation products of (esterification products of C9-11 (branched anwas performed on "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" according the OECD 476, the EU Method B.17 and EPA OPPTS 870.5300.
Eucarol AGE 91/S ( Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite ) was used as supporting substance due to the structural analogy.
It can be expected a similar structural features.
All studies were performed under GLP conditions.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

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