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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

There are no data available for filter cake from enzyme fermentation, consisting of fungal biomass and inorganic filtration aid. However, data on genetic toxicity are available for vinasses, residue of fermentation. Since all types of vinasses share a common origin and are therefore constituted of the same components determining their toxicological properties, read-across is performed (a detailed justification is attached in IUCLID section 13).

In vitro

- Gene mutation in bacteria

A bacterial gene mutation assay (Ames test) was conducted with vinasses, residue of fermentation following a protocol compliant with OECD guideline 471 and under GLP conditions (Molinier, 1992). Two test series were performed. In the first series, the direct plate incorporation procedure was performed with Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537 at concentrations up to 5000 µg/plate in the absence and in the presence of a metabolic activation (Aroclor 1254-induced rat liver S9-mix). The second test series were analogue, with the exception that the preincubation method was applied in the presence of metabolic activation. No cytotoxic effects were observed up to the highest concentration both in a preliminary cytotoxicity test with S. typhimurium TA 100 and in the main study. Vinasses, residue of fermentation did not induce mutations in the bacterial mutation tests in the absence and presence of metabolic activation in any of the strains tested. The positive and negative controls included in the experiments showed the expected results.

Negative results were also obtained in further tests performed with Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538 or E. Coli WPS2 uvrA at concentrations up to 5000 µg/plate with and without metabolic activation. In both studies, no cytotoxic effects were observed (Weill, 1990; Krul, 2002).


Short description of key information:
The available data indicate that the substance is not genotoxic.
In vitro:
Negative Ames tests with S. typhimurium TA 1535, TA 1537, , TA 1538, TA 98, TA 100 and TA 102, and E. coli WP2 uvr A, with and without metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available data on genetic toxicity of the substance are conclusive but not sufficient for classification according to the DSD (67/548/EEC) and CLP (1272/2008/EC) criteria.