Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
100 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The study is well reported and it has been performed in GLP.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

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

Toxicity to reproduction: other studies

Additional information

The reproductive/developmental toxicity screening test permit to assign the NOAEL values for maternal and developmental toxicity.

The NOAEL for maternal toxicity was set at 300 mg/kg bw/day, on the basis of the observed clinical signs.

The NOAEL for developmental toxicity was set at 100 mg/kg bw/day, basing on the increased percentage of post-implantation loss.

Justification for classification or non-classification

Basing on the available data, no classification for reproductive and developmental toxicity was deemed necessary, according to Regulation 1272/2008/EC.