Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

OECD 422: 50 mg/Kg bw/day was determined to be the NOAEL (No Observed Adverse Effect Level) for systemic and developmental toxicity in rats.

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
50 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
One key Guideline (OECD 422) combined repeated dose, reproductive developmental toxicity screening study in rats available for assessment.
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

Description of key information

Dose range-finding pre-natal developmental toxicity: The test material exhibited maternal toxicity when administered at 1000 mg/Kg/day while it was well tolerated when administered to pregnant rats for 14 days (Days 6-19 post coitum), up to the dose level of 100 mg/Kg/day.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
One key pre-natal developmental toxicity dose range-finding study in rats available for assessment.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information derived from the experimantal study conducteed on the substance. No classification is warranted according to the CLP Regulation (EC n. 1272/2008).