Reaction product of Saccharose, Glycerine, biodiesel propoxylated

Endpoint summary

Additional information

The test substance Reaction product of Saccharose, Glycerine, biodiesel propoxylated was tested for its mutagenic potential in a bacterial reverse mutation assay according to OECD guideline 471 and for potential chromosome-damaging effects in a chromosome aberration assay according to OECD guideline 473. In the Ames test, the substance was tested at dose ranges of 33 μg - 5 000 μg/plate in Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli WP2 uvrA with and without metabolic activation (S9 mix). A biologically relevant increase in the number of his+ or trp+ revertants was not observed either without S9 mix or after the addition of a metabolizing system.

In the chromosome aberration assay, the substance was tested at concentrations up to 300 μg/mL in V79 cells. A sample of 100 metaphases for each culture treated with the test substance was analyzed for chromosomal aberrations. In all experimental parts scored for cytogenetic damage, the vehicle controls gave frequencies of aberrations within the range expected for the V79 cell line. Both positive control substances, EMS and cyclophosphamide, led to the expected increase in the number of cells containing structural chromosome aberrations. The test substance did not cause any biologically relevant increase in the number of structurally aberrant metaphases incl. and excl. gaps at both sampling times either without S9 mix or after adding a metabolizing system. No relevant increase in the frequency of cells containing numerical chromosome aberrations was demonstrated either.

The results from a mammalian point mutation assay have been 'read across' from 2, 2', 2''-nitrilotriethanol, propoxylated (ISOPA 2009). They are negative. The read across, as permitted by Annex XI paragraph 1.5, is based on the justification in the report by Paul Illing Consultancy Services Ltd and Marlin Consultancy (Illing and Barratt, 2007). The report identifies that 2, 2', 2''-nitrilotriethanol, propoxylated is the most bioavailable of the evaluated NLP polyols linked by an ether group.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Under the experimental conditions of the Ames test, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.

Under the experimental conditions described, the test substance is considered not to have a chromosome-damaging (clastogenic) effect under in vitro conditions in V79 cells in the absence and the presence of metabolic activation.

Read across to 2, 2', 2''-nitrilotriethanol, propoxylated indicates that the test substance is non-mutagenic in mammalian cells.

Classification according to Regulation (EC) 1272/2008 (CLP) is not warranted.