Dioctadecyl ether

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Additional information

Results from a developmental toxicity study and a subchronic toxicity study did not reveal any reason of concern for offspring and for parent animals with respect to developmental toxicity or fertility. Since significant scientific evidence for a lack of reprotoxic effects of the substance is drawn from these results and an additional two generation study is not expected to add any further relevant knowledge on this endpoint. Due to animal welfare aspects and/or laws, an additional study is therefore not warranted.

Short description of key information:
no study is available; no effects are expected from results obtained in a 90 day study and in a developmental study

Effects on developmental toxicity

Description of key information

developmental toxicity (rat): NOAEL > 1000 mg/kg bw

Effect on developmental toxicity: via oral route

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Additional information

In the prenatal developmental toxicity study, the homolog dioctylether was administered to female rats at dose levels of 100, 300 and 1000 mg/kg bw orally, by gavage from the 6th to 19th day of pregnancy. Under the present test conditions, the no-observed-effect level (NOEL) was above 1000 mg/kg bw for the dams. The NOEL for the fetuses was also above 1000 mg/kg bw. No test item-related malformations or variations were noted during external/internal examination of the fetuses or soft tissue examination (according to Wilson); skeletal examination (according to Dawson) revealed no test item-related malformations, variations or retardations.

In conclusion, the test substance possessed no teratogenic properties. No test item-related increase was noted in the incidence of malformations, variations and retardation tested until the dose of 1000 mg/kg bw.

Dioctylether is used as a read-across substance for distearylether. The only difference is the longer alkyl chain. Dioctylether is regarded as a worst case in this respect because of the higher bioavailability due to the lower molecular weight. Furthermore, the possible meatbolite stearyl alcohol does not present a teratogenic compound. Therefore, it is unlikely that the ether of stearyl alcohol which might also build in the human body is a teratogenic compound.

Based on the reliability and relevance, this study has been used as key study.

Justification for classification or non-classification

Based on results of the key study the substance does not need to be classified according to GHS (Regulation (EU) 1272/2008) and also does not need to be classified according to DPD (67/548/EEC).