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

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
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

No data on developmental toxicity are available for dihexyl ether. A prenatal developmental toxicity study is available for he structurally-related dioctyl ether. Based on the close structural similarity the results of this study can be cross-read to dihexyl ether.

In the prenatal developmental toxicity study, the test substance 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.

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).