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Description of key information

In a 28 day oral study in rats no treatment related effects were observed up to the limit dose of 1000mg/kg bw. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEC
3 000 mg/m³
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEC
3 000 mg/m³
Study duration:
subchronic
Species:
rat

Additional information

oral:

A 28-day oral study was performed according to OECD Guideline 407 and GLP. In brief 1,3-dioxepane dissolved in drinking water was gavaged to groups of 5 male and 5 female Wistar rats at dose levels of 100, 300 and 1000 mg/kg bw/day over a period of 4 weeks.

A NOAEL > 1000 mg/kg bw/day was identified since no relevant signs of general systemic or local toxicity were observed at the highest tested dose level.

inhalation:

In a subchronic inhalation study 10 male and 10 female Wistar rats per test group, were whole-body exposed to 1,3- dioxepane vapor for 6 hours per day, on 5 consecutive days per week (65 exposures). The study was performed in accordance to the OECD guideline 413 including functional observation battery and motor activity tests. The target concentrations were 1000, 3000 and 10000 mg/m3, a concurrent control group was exposed to air.

No treatment-related, adverse effects were identified in the test group 2 (3000 mg/m3) and test group 1 (1000 mg/m3).

Transient apathy, salivation, nose and eye discharge were observed in the high concentration group (10000 mg/m³). Moreover, at this concentration inorganic phosphate and chloride in serum were changed in both sexes and urea concentrations in females were increased whereas trigyceride levels in males were decreased. Based on this data it is not possible to unequivocally validate the adverse character of these effects. Therefore the NO(A)ECs for both systemic and local effects was 3000 mg/m3 under the current test conditions.

dermal:

no data available

Justification for classification or non-classification

In a 28 day oral study in rats no treatment related effects were observed up to the limit dose of 1000 mg/kg bw. Therefore no classification is warranted.

In a subchronic inhalation study in rats a NOAEC of 3000 mg/m3 was identified based on treatment-related findings in clinical pathology and local effects at the respiratory tract. Therefore, no classification is warranted in accordance to the guidance values of GHS chapter 3.9.2.9.