Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

An oral subacute study with 1,3-dioxepane in rats is available (28-day feeding). No signs of general systemic or local toxicity were observed at the highest tested dose level (limit dose of 1000 mg/kg bw/day). In particular no effects on reproductive organs were identified.

Effects on developmental toxicity

Description of key information
In a prenatal developmental toxicity study the test substance 1,3-dioxepane was not teratogenic. 
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
3 000 mg/m³
Study duration:
subacute
Species:
rat
Additional information

In a prenatal developmental toxicity study the test substance 1,3-dioxepane was administered to pregnant Wistar rats via inhalation (whole-body exposure) from implantation to one day prior to the expected day of parturition (GD 6-19) at target concentrations of 1000, 3000 and 10000 mg/m³ to evaluate its potential maternal and prenatal developmental toxicity.

Evidence of maternal toxicity were described at a concentration of 10000 mg/m³, such as consistently reduced food consumption, reduced gross and corrected (net) body weight gain, decreased eosinophil counts and thymus weights. In conclusion, the no observed adverse effect concentration (NOAEC) for maternal toxicity is 3000 mg/m³. There were minor adverse fetal findings evident at a concentration of 10000 mg/m³, such as high rates of supernumerary thoracic vertebrae and 14th ribs. Although their toxicological significance is considered to be rather low, the no observed adverse effect concentration (NOAEC) for prenatal developmental toxicity is 3000 mg/m³. Reduced fetal body weights and a temporary delay of prenatal development of offspring were associated with congenerous effects in their mothers and thus not considered as an independent effect. The test substance is not teratogenic in rats.

Justification for classification or non-classification

In an OECD 414 developmental toxicity study in rats, no indications for developmental toxicity were identified therefore no classification is warranted.