Registration Dossier

Administrative data

Description of key information

NOAEL, Rat, Oral (Gavage), 5 Weeks = 1000 mg/kg bw/day

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
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.

No clinical signs of toxicity were observed, and no animals died during the administration period. No changes in bodyweight gains, food consumption, haematology, clinical chemistry, organ weights, macropathology or hisopathology were observed which could be attributed to treatment with the test compound.

It was conclued that Fe3P was well tolerated and that no signs of systemic toxicity had been seen in rats when administered up to 1000 mg/kg bodyweight/day for up to 5 weeks. On this basis, the No Observed Adverse Effect Level (NOAEL) in rats is 1000 mg/kg/day.

Justification for classification or non-classification

In the above-mentioned subacute study (Huntingdon Life Sciences, 2012), no signs of systemic toxicity were observed following repeat oral administration of Fe3P to rats for up to 5 weeks; there is therefore no basis on which to classify Fe3P for Specific Target Organ Toxicity (repeated exposure).

No data are available regarding repeated exposure to Fe3P by dermal or inhaled routes.