Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No studies were identified with a form of iron oxides on reproduction toxicity - fertility. However, it should be considered that adverse effects on fertility largely depend upon systemic exposure. Systemic exposure of iron oxides can be ruled out, owing to the negligible solubility of the substances in aqueous and organic solvents. See also read-across statement attached to the overall summary of Chapter 7.


Short description of key information:
Due to the lack of systemic exposure, effects of iron oxides on reproductive organs are not expected. The requirement is waived for this reason.

Effects on developmental toxicity

Description of key information
Owing to the lack of systemic exposure, effects of iron oxides on development are not expected and the requirement in question can thus be waived.
Additional information

No studies were identified with a form of iron oxides examining any developmental or/and teratogenic effects. However, it should be considered that developmental toxicity and teratogenicity can only occur in case of systemic exposure. Systemic exposure of iron oxides can be ruled out, due to the negligible solubility of the substances in aqueous and organic solvents. See also read-across statement attached to the overall summary of Chapter 7.

Justification for classification or non-classification

No classification needed, because possible endpoints require systemic exposure, which will be negligible after oral, inhalation or dermal exposure to iron oxides.