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Repeated dose toxicity: oral

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Administrative data

repeated dose toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Mill scale is mainly and primarily composed of high-purity iron oxides (on average above 65%, i.e. FeO, Fe2O3, Fe3O4). Besides, other metal oxides and spinels, elements, and trace compounds such as oil residues <1% for all the uses except for batteries and Melting charge for which <3% can be found in the mill scale. More information on the justification of read across can be found in the attached document in the endpoint summarie of section 7.

Data source

Materials and methods

Test material

Constituent 1
Reference substance name:
Iron oxides
Iron oxides

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

No studies on repeated dose toxicity via the oral route with iron oxides were indentified in the literature. However, based on the physicochemical properties of iron oxides, it is not expected that they will dissolve in the weak acidic environment of the stomach to any significant extent. Hence, it is not likely that absorption by the gastrointestinal tract will occur that results in any substantial bioavailability after oral exposure. If any effects occur they will be local. Nonetheless, this route is not relevant for the substance of the present dossier. Since, according to REACH requirements, information on the repeated dose toxicity has only to be provided for the most relevant exposure route, being inhalation at this case, oral exposure can be excluded.