Registration Dossier
Registration Dossier
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EC number: 701-366-0 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In order to evaluate the genotoxic properties of F- DIOX potassium salt it was deemed appropriate to use the Read Across approach based on the experimental studies performed on cC6O4 ammonium salt by virtue of similarity of chemical structure between F- DIOX potassium salt and cC6O4 ammonium salt (CAS no: 1190931-27-1).
F-DIOX potassium salt and cC6O4 ammonium salt are two salts of the same carboxylic acid, they differ only for the cationic part (K+ in F-DIOX potassium salt and NH4+ in cC6O4 ammonium salt) and therefore, considering the similarity of chemical structure, a similar biological behaviour is expected.
The evaluation of the potential mutagenicity of C6O4 ammonium salt is based on four different experimental studies.
In order to gain an understanding of the potential mutagenicity of the test item cC6O4 Ammomium Salt, an in vitro test battery was implemented:
- A bacterial reverse mutation assay, according to OECD 471
- AnIn vitromammalian cell gene mutation test, according to OECD 476
- AnIn vitromammalian chromosome aberration test, according to OECD 473
All studies were performed under GLP and all of them included a preliminary study on citoxicity of the test item under the specific experimental test condition.
The bacterial reverse mutation assay and thein vitromammalian cell mutation assay showed clear negative results. Both of the studies identify the substance as non mutagenic.
Thein vitromammalian chromosome aberration test, during the second experiment of the study, showed a positive result at the highest dose level in presence of metabolic activation. Consequently, the substance was identified as mutagenic under that experimental test condition.
In order to assess the relevance of this positive finding, considering that at the highest dose level signs of toxicity occurred, and considering that metabolic pathways cannot be simulated adequately in vitro,it was deemed appropriate to conduct anin vivostudy for chromosome aberration.
Thein vivomammalian bone marrow chromosome aberration test according to OECD 475 guideline was performed on the test item. This study showed a clear negative result since no statistically significant increase in the frequency of aberrant cells occurred at any dose level.
Considering that the results of in vivo test have an higher reliability in respect to the in vitro test, and considering that the positive findings in thein vitrostudy occurred only at the highest dose in presence of toxicity signs, it can be concluded that the test item cC6O4 Ammonium salt does not show potential to induce chromosome aberration on mammalian.
Therefore, on the grount of the entire genotoxicity assessment, it can be concluded that cC6O4 ammonium salt is not characterized by genotoxic properties.
Considering the similarity of chemical structure between F- DIOX potassium salt and cC6O4 ammonium salt, the same conclusion can be applied to F-DIOX potassium salt.
Impurities present in F-DIOX potassium salt are considered not to be able to affect the genotoxic properties of the substance.
Short description of key information:
The evaluation of genotoxic properties of F-Diox potassium salt is
based on the Read Across with cC6O4 ammonium salt by virtue of
similarity of chemical structure between F- Diox potassium salt and
cC6O4 ammonium salt (CAS no: 1190931-27-1).
The evaluation of the potential mutagenicity of C6O4 ammonium salt is
based on four different experimental studies.
Basing on the results of the studies, it was concluded that the test
item cC6O4 ammonium salt does not show genotoxic hazard.
Therefore, according to the criteria reported in the
Regulation1272/2008, the test item cC6O4 ammonium salt would indicate
the following:
Classification: not required
Signal word: none indicated
Hazard statement: none indicated
The same classification would be applied at F- Diox potassium salt.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Basing on the read across with cC6O4 ammonium salt above discussed and on consideration that impurities present in F-DIOX potassium salt are considered to be not able to affect the genotoxic properties of the substance, according to the criteria reported in the REGULATION (EC) No 1272/2008 (EU Regulation on Classification, Labeling and Packaging of substances and mixtures), F-DIOX potassium salt would indicate the following:
Classification: not required
Signal word: none indicated
Hazard statement: none indicated
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