Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Toxicity to reproduction

The Prussian blue has very low order of toxicity.It is likely to given by oral route .It has high molecular weight i.e 877.381g/mole and limited absorption from gut,99% of the administered Prussian blue dose was excreted unchanged in faeces,(HSDB) andhence this end point is considered for waiver.

Link to relevant study records
Reference
Endpoint:
reproductive toxicity, other
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because (i) the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), (ii) it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and (iii) there is no or no significant human exposure
other:
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Quality of whole database:
Waiver
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Toxicity to reproduction

The Prussian blue has very low order of toxicity.It is likely to given by oral route .It has high molecular weight i.e 877.381g/mole andlimited absorption from gut,99% of the administered Prussian blue dose was excreted unchanged in faeces,(HSDB) andhence this end point is considered for waiver.

Effects on developmental toxicity

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

Toxicity to reproduction

The Prussian blue has very low order of toxicity.It is likely to given by oral route .It has high molecular weight i.e 877.381g/mole andlimited absorption from gut,99% of the administered Prussian blue dose was excreted unchanged in faeces,(HSDB) andhence this end point is considered for waiver.