Registration Dossier

Administrative data

Description of key information

Rat, oral, combined rep. dose/developmental screening study (BASF, 2013, OECD 422, GLP): NOAEL systemic > 250mg/kg, local irritation occured in 7/10 males at 250mg/kg

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

(5-ethyl-1,3-dioxan-5-yl)methyl acrylate was administered orally by gavage to groups of 10 male and 10 female Wistar rats at dose levels of 0 mg/kg body weight/day, 40mg/kg bw/d, 100mg/kg bw/d, and 250mg/kg bw/d in corn oil, adjusted to the purity of the substance (78.1g/100g). The doses were selected based on a 14day test study in female rats. During this study, one female receiving 1000mg/kg b.w. died on day 13 due to severe irritation in the digestive system. Ulcerations / erosions and dicolored jejunal content were also seen in the surviving 3 females. Ulceration in one female of the mid dose receiving 500mg/kg b.w. was also judged as severe enough, that it would lead to the death of this animal throughout a longer treatment period. Thus the low dose of 250mg/kg, where slight ulcerations were also observed in one animal, was set as the high dose for the main study.

The duration of treatment in the main study covered 31days for males and 52 days for females. A detailed clinical observation was performed in all animals before initial test substance administration and at weekly intervals thereafter. Food consumption and body weight of the animals were determined in app. weekly intervals. Towards the end of the administration period a functional observational battery was performed and motor activity was measured in 5 animals per sex and test group. Clinicochemical and hematological examinations as well as urinalyses were also performed towards the end of the administration period in 5 animals per sex and test group. All animals were sacrificed by decapitation, under isoflurane anesthesia, and were assessed by gross pathology. Weights of selected organs were recorded and a histopathological examination was performed. Aside from hyperkeratosis in 7 out of 10 males in the high dose group, which is seen as a sign of local irritation and not systemic toxicity, no test substance related effects were observed. Thus, the NOAELs for systemic toxicity was set to 250mg/kg b.w., the highest dose tested.

Justification for classification or non-classification

No systemic toxicity has been observed, thus (5-ethyl-1,3-dioxan-5-yl)methyl acrylate does not have to be classified according to 67/548/EEC or CLP/EU-GHS.