Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Species:
rabbit
Quality of whole database:
In-house toxicological report
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Naproxen given orally up to 60 mg/kg/day to pregnant rabbits did not affect fertility, gestation or number of live fetuses.


Short description of key information:
In-house toxicological report

Effects on developmental toxicity

Description of key information
In-house toxicological report
Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Species:
rat
Quality of whole database:
In-house toxicological report
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

Naproxen given orally to pregnant rats up to 20 mg/kg/day did not result in adverse effects in viability of pups, lactation index, sex ratio, or weight gain of offspring; however, slight increases in gestation length and significant increases in stillbirths was seen at > 10 mg/kg. Fetal deaths seen in naproxen-treated rats were apparently related to dystocia rather than to a direct toxic effect of the drug, as similar effects were observed with other commonly used nonsteroidal anti-infiammatory agents in the rat.

Justification for classification or non-classification