Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Four indicator Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and one indicator Escherichia coliWP2 uvrA strain were used. The test substance was suspended in water for injections and assayed in doses of 50-5000 mg which were applied to plates in volume of 0.1 mL.

Two series of experiments were performed with each strain - without metabolic activation and with a supernatant of rat liver and a mixture of cofactors.

In the arrangement given above, the test substance Ashes (residues) - Biomass Combustion was nonmutagenic for all the used bacterial strains with as well as without metabolic activation.

Read-across:

Read-across the result is derived thatAshes (residues) – Biomass Combustionis not mutagenic in the bacterial reverse mutation assay, in the mouse lymphoma assay and in the in vitro micronucleus assay in the presence and absence of metabolic activation up to the tested concentrations.

Mutagenic properties of Ashes (residues) – Biomass Combustion were derived by the read across method upon the similarity of Ashes (residues) and FBC Ash. The possibility of mutagenic properties estimation was based upon the similarity of substances (composition), test results (matching), identical classification and the same production technology.

Ashes (residues) – Biomass Combustion does not have to be classified for mutagenicity according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) because no mutagenic properties were derived for Ashes (residues) – Biomass Combustion by the read across method.


Short description of key information:
Bacterial Reverse Mutation Test was performed according to EU method B.13/14 Mutagenicity – Reverse mutation test using bacteria, which is analogous to the OECD Test Guideline No. 471
GLP study

Read-across on the basis of two similar substances was performed instead of in-vitro micronucleus test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The Ames screening test usually is not sufficient to assessment mutagenicity. In this case the results of Ames test are supplied by read-across method. The conclusions both of the methods are negative therefore the test substance may be considered as non-mutagenic.