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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The bacterial reverse mutation assay carried out n the substance and the in vitro mammalian cell mutation assay, carried out on similar substance, showed clear negative results. Both of the studies identify the substance as non mutagenic.

The in vitro mammalian chromosome aberration test. carried out on similar substance and used as read across reference, 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, as part of AlkylPolyGlucoside esters, 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 750μg/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

Justification for classification or non-classification

Basing on the results of the reported studies and taking into account the literature, the substance " Sodium salt of esterification products of C10-C16 (even numbered) alkylpolyglycosides with citric acid" does not require classification:

Classification: not required

Signal word: none

Hazard statement: none