Registration Dossier

Diss Factsheets

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
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

The lowest NOAEL available for the selected study is 100 mg/kg bw/day based on clinical findings in males of P generation.


Justification for selection of Effect on fertility via oral route:
The selected study is the only experimental study available.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
10 mg/kg bw/day
Species:
rat
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

The lowest NOAEL available for the selected study is 10 mg/kg bw/day based on maternal toxicity.


Justification for selection of Effect on developmental toxicity: via oral route:
The selected study is the only experimental study available.

Toxicity to reproduction: other studies

Additional information

The findings of the reproductive/developmental toxicity studies reported effects, mainly in presence of maternal toxicity, for which a hazard classification is not foreseen.

Justification for classification or non-classification

The substance is not classified for reproductive toxicity according to Regulation 1272/2008/EC.

Additional information

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