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in vitro gene mutation study in bacteria
Data waiving:
study technically not feasible
Justification for data waiving:
Justification for type of information:
REACH Annex XI, Section 2 states that testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance.

Evaluation of the OECD 471 Guideline for the In vitro gene mutation study in bacteria, paragraph 6 states as follows:

6. The bacterial reverse mutation test may not be appropriate for the evaluation of certain classes of chemicals, for example highly bactericidal compounds (e.g. certain antibiotics) and those which are thought (or known) to interfere specifically with the mammalian cell replication system (e.g. some topoisomerase inhibitors and some nucleoside analogues). In such cases, mammalian mutation tests may be more appropriate.

It should be noted that the substance for assessment, as detailed within the route of manufacture, is manufactured by extraction and further purification of hibiscus seed kernel flour with solvent.

All flours contain a microbial population. This population varies greatly in numbers, but the flora is rather constant in the types of microorganisms present. Microbiological organisms include bacteria, yeasts and moulds. These organisms are almost universally present in the environment. The microbiological content of a flour is a reflection of the product from which it was milled. The starting material is naturally exposed to microbial organisms as it grows in the field and as it is stored and transported.

An In vitro gene mutation study in bacteria assay was started. However, due to contamination of the test substance with such microbial populations, even after sterilisation, the test substance is not suitable for the bacterial reverse mutation assay. Due to the contamination of the test substance observed in the 1st Experiment an evaluation of the experiment was not possible. Different attempts were performed to sterilize the test substance (e.g. use of UV light and/or sterilization in 70% ethanol). However, none of the tested possibilities were successful. Therefore, the test substance is not suitable for the bacterial reverse mutation assay.

The study report is appended below as justification of the fact that the substance cannot be evaluated for this endpoint for the reasons cited above.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion