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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
genetic toxicity in vitro
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read -across method was used for assessment of genetic toxicity. Read-across method was used in accordance with requirements REACH.

Data source

Reference
Reference Type:
other: read-across from similar substances
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Guideline:
other: no guideline required
GLP compliance:
no
Type of assay:
other: read-across

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Test results
Species / strain:
not specified
Metabolic activation:
not applicable
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
not specified

Any other information on results incl. tables

see attached document

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Read across the result is derived that Ashes (residues) – Biomass Combustion is 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.
Executive summary:

Similarity based upon:

The substances in question are UVCB substances for which similarity based upon the structural similarity may not be used, however, the substances have similar production technology, similar usage and composition. Moreover, for all other properties, except estimated mutagenicity for Ashes (residues) – Biomass Combustion, tests were determined with identical or highly similar results.

Therefore, the possibility of mutagenic properties estimation is based upon the similarity of substances (composition), test results (matching), identical classification and the same production technology and consecutive usage.

Conclusion:

Read across the result is derived that Ashes (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.