Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A data waiver for reproductive toxicity studies according to OECD TG 421/422 and 443 is claimed.

Effects on developmental toxicity

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
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

A developmental toxicity study according to OECD TG 414 study revealed no treatment related effects for appearance, behaviour, mortality, absolute and corrected body weight gains, food intake, water intake, and fecal and urinary excretions up to and including 1000 mg/kg bw. No treatment related gross pathological findings occurred at dose levels up to and including 1000 mg/kg. The gestation rate, appearance and weights of placentas, postimplantation loss and correspondingly the number of fetuses, fetal sex distribution and fetal weights were unaffected by treatment at dose levels up to and including 1000 mg/kg. A treatment related effect on malformations, external, visceral and skeletal (including cartilage) deviations was not evident at dose levels up to and including 1000 mg/kg.

Summarizing and evaluating all data investigated revealed a NOAEL of 1000 mg/kg bw for each maternal and developmental toxicity.

Justification for classification or non-classification

No classification required for toxicity to reproduction according to Regulation (EC) No 1272/2008, Annex I.