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

Effects on developmental toxicity

Description of key information

Key study. Method according to OECD 414, GLP study. The test item was found to have a NOAEL for maternal and developmental toxicity in rats of 3300 mg/kg bw/d.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
3 300 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The available study has a Klimisch score of 2.
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

Key study. A study was conducted to assess the embryotoxic, fetotoxic, and teratogenic potential of the oral administration of the test item in rats by a method according to OECD 414 (GLP study). Starting from day 0 of gestation, 28 mated female Wistar Crl:(WI)WU BR rats per group received experimental diets containing the analogue substance at levels of 0 (control), 1.25, 2.5, and 5%. The top dose was selected on the basis of previous studies conducted. Maternal examinations performed included detailed clinical observations, body weights, food consumption and compound intake, gross necropsy, and organ weights. The fetuses were removed from the uterus, dried of amniotic fluid, weighed, sexed by observing the anogenital distance, and examined for gross abnormalities. The placentas of the live fetuses were weighed and examined for macroscopic abnormalities. Early and late resorptions and dead fetuses were counted. Half of the fetuses randomly selected from each litter were eviscerated, partly skinned, fixed in 70% ethanol, cleared in potassium hydroxide, and stained with Alizarin Red S for examination of the skeleton. The remaining fetuses were fixed in Bouins fluid for subsequent visceral examination. All examinations for fetal abnormalities were performed microscopically. Skeletal and visceral examinations were conducted on fetuses of the control and high-dose group only. Based on the test results, the test item, at a dietary level of up to 5% (corresponding to an intake of about 3.3 g/kg bw/day) did not exhibit any maternal toxicity, fetotoxicity, embryotoxicity, or teratogenicity in Wistar Crl:(WI)WU BR rats. Therefore, the NOAEL of the test item in rats was set at 3300 mg/kg bw/d.

Justification for classification or non-classification

Based on the available information, the substance is not classified for toxicity to reproduction in accordance with CLP Regulation (EC) No. 1272/2008.