Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 682-239-6 | CAS number: 1190931-41-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In order to evaluate the genotoxic properties of F- DIOX acid 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 acid and cC6O4 ammonium salt (CAS no: 1190931-27-1).
C6O4 ammonium salt is the carboxylic acid derivative of F-DIOX acid and therefore C6O4 ammonium salt differs from F-DIOX acid only for the presence of the cationic part NH4+.
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, anin vitrotest 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 adequatelyin 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 ofin vivotest have an higher reliability in respect to thein vitrotest, 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 grounds 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 acid and cC6O4 ammonium salt, the same conclusion can be applied to F-DIOX acid.
Short description of key information:
The evaluation of genotoxic properties of F-DIOX acid is based on the Read Across with cC6O4 ammonium salt by virtue of similarity of chemical structure between F- DIOX acid 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.
Considering the similarity of chemical structure between F-DIOX acid and cC6O4 ammonium salt, the same conclusion can be applied to F-DIOX acid.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Basing on the read across with cC6O4 ammonium salt above discussed, according to the criteria reported in the REGULATION (EC) No 1272/2008 (EURegulation onClassification, Labeling and Packaging of substances and mixtures), F-DIOX acid would indicate the following:
Classification: not required
Signal word: none indicated
Hazard statement: none indicated
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
