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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information
Short description of key information:
Studies on the effects of metallic iron on fertility are waived on the ground that these effects depend entirely on systemic exposure. Systemic exposure of iron can be ruled out, owing to the negligible solubility of the substances in aqueous and organic solvents. There is no significant systemic exposure after inhalation or dermal contact, the relevant exposure routes in the present context. Oral exposure is restricted to food fortification, supplementation and medicinal use. The strict regulation of iron absorption and storage in healthy humans will also prevent the systemic occurrence of free iron ions.

Effects on developmental toxicity

Description of key information
Studies on the developmental/teratogenic effects of metallic iron are waived on the ground that these effects depend entirely on systemic exposure. Systemic exposure of iron can be ruled out, owing to the negligible solubility of the substances in aqueous and organic solvents. There is no significant systemic exposure after inhalation or dermal contact. . Oral exposure is restricted to food fortification, supplementation, and medicinal use. The strict regulation of iron absorption and storage in healthy humans will also prevent the systemic occurrence of free iron ions
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification justified, because possible endpoints require systemic exposure, which will be negligible after inhalation or dermal exposure. Oral exposure only occurs on purpose by food fortification/supplementation and in a medicinal context. Moreover, the strict regulation of iron absorption and storage in healthy humans will also prevent the systemic occurrence of free iron ions and thereby effects on relevant endpoints.

Additional information

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