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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A combined repeat dose toxicity study and reproductive / developmental toxicity screening study in rats was conducted (Huntingdon Life Sciences, 2012) to assess the effect of Fe3P on rats following repeated oral administration. The study was conducted according to OECD test guideline 422, and in compliance with GLP.

Male and female rats were administered Fe3P by oral gavage for five weeks (males, and toxicity phase females), or for two weeks before mating, during mating and gestation, and until day six of lactation (main phase females). The dose groups were 100, 300, and 1000 mg/kg/day, and a concurrent control group was administered with untreated vehicle.

Reproductive performance was not affected by treatment with test material; the assessed factors included mating performance, fertility and offspring survival. No adverse effects were seen on offspring development up to Day 7 of age.

On the basis of this study, the No Observed Adverse Effect Level for reproductive and developmental toxicity is considered to be 1000 mg/kg/day.


Short description of key information:
NOAEL, rat, oral exposure = 1000 mg/kg/day

Effects on developmental toxicity

Description of key information
NOAEL, rat, oral exposure = 1000 mg/kg/day
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
Additional information

Refer to fertility discussion for details.

Justification for classification or non-classification

In the above reproductive / developmental toxicity screening study, no effects whatsoever were observed on the reproduction of rats following repeated exposure to Fe3P, and no adverse effects were seen on the development of offspring. Therefore, Fe3P does not require classification for reproductive or developmental toxicity.