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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Additional information

Ames tests are available for Fe2O3, Fe3O4, ZnFe2O4 and (Fe, Mn)2O3/(Fe, Mn)3O4. The results of all available Ames tests were negative. A study on clastogenicity in mammalian cells in vitro according OECD 473 as well as a study on gene mutation in mammalian cells (V79/HPRT test according OECD 476) with Fe3O4 as a representative for the whole group were also negative.

In very limited additional in vitro studies not conducted according to GLP or accepted scientific protocols (no OECD TG followed) no coherent picture was observed. Some in vitro assays revealed inconclusive or positive results, whereas other assays concerning the same endpoint showed negative results. Due to methodological deficiencies and insufficient reporting of the physical state of the test compounds and insufficient documentation of key parameters, these tests have limited reliability at best and cannot be used for risk assessment.


Justification for selection of genetic toxicity endpoint
Key studies (Ames test, chromosome aberration test and HPRT test) are used

Short description of key information:
Several Ames tests, a study on clastogenicity in mammalian cells in vitro and a gene mutation assay in mammalian cells are available for iron oxides (powder). Additional genotoxicity assays were conducted with Fe3O4 nano-sized materials.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Due to the results of the available in vitro tests, a classification is not justified.