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

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 study was conducted to determine the prenatal developmental toxicity of the test substance, according to OECD Guideline 414, in compliance with GLP. Twenty two time-mated female Wistar Han rats per group were treated with test substance, from Day 6 to 20 post-coitum, by daily oral gavage at dose levels of 100, 300 and 1000 mg/kg/day. The rats of the control group received the vehicle, water, alone. The dose levels in this study were selected to be 0, 100, 300, 1000 mg/kg/day, based on the results of the dose range finder study.Test formulations prepared were considered homogeneous at the concentrations tested and analysis of the accuracy revealed acceptable levels.Chemical analyses of formulations were conducted once during the study to assess accuracy and homogeneity. The following parameters and end points were evaluated. Maternal toxicity (F0 -generation), mortality/morbidity, clinical signs, body weights, food consumption, gross necropsy findings, and number of corpora lutea, (gravid) uterine weight and uterine contents. In addition, the following parameters were determined for the Fetal (F1 -generation) the number of fetuses, early and late resorptions, total implantations, fetal body weights, sex ratio, externa, visceral and skeletal malformations and developmental variations. No mortalit and no treatment-related changes were noted in any of the maternal parameters investigated in this study (i.e. clinical appearance, body weight, food consumption, macroscopic examination) at any dose level. No treatment-related changes were noted in any of the developmental parameters investigated in the study (i.e. the number of fetuses, early and late resorptions, total implantations, fetal body weights, sex ratio, external, visceral and skeletal malformations and developmental variations) at any dose level.Under the study conditions, the NOAEL for developmental toxicity was determined to be >1000 mg/kg/day (Van de Ven, 2018).

Justification for classification or non-classification

Based on the pre-natal developmental toxicity study on the substance, no classification is warranted according to EU CLP (1272/2008) criteria.