3-(3-hydroxypropyl)oxazolidin-2-one

Endpoint summary

Description of key information

Oral: subacute NOAEL: 285 mg/kg bw/day (OECD guideline 407, BASF AG 2004)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

285 mg/kg bw/day

Study duration:

subacute

Species:

rat

Additional information

3-(3-Hydroxypropyl)-oxazolidin-2-on was administered to male and female Wistar rats via the diet at dose levels of 0, 750 (group 1), 3,000 (group 2) and 12,000 (group 3) ppm for 4 weeks in a GLP study performed according to OECD guideline 407 (BASF AG, 2004). Control and high dose groups consisted of each 10 animals per sex, whereas low and mid dose groups consisted of each 5 animals per sex. After 4 weeks of treatment 5 animals per sex of all dose groups were sacrificed (main group). The remaining 5 animals per sex of control and high dose groups were maintained for another 14 days without administration of the test substance (recovery groups). Food consumption and body weight were determined weekly. The animals were examined for signs of toxicity or mortality at least once a day. Detailed clinical examinations in an open field were conducted prior to the start of the administration period and weekly thereafter. Functional observational battery (FOB) as well as measurement of motor activity (MA) were carried out after 4 weeks of treatment. Clinicochemical, hematological examinations and urinalyses were performed towards the end of the administration period. Moreover, at the end of the recovery period only hematological parameters in females and urea in males were examined. All animals were assessed by gross pathology, followed by histopathological examinations.

At 12,000 ppm (1149.7 mg/kg bw/day in males, 1171.3 mg/kg bw/day in females), during the administration period, decreased urea in both sexes and increased red blood cells and hematocrit in females were observed. During the recovery period, no substance-related findings were observed. At 3,000 ppm (285.2 mg/kg bw/dayinmales, 295.3 mg/kg bw/day in females) and 750 ppm (69.7 mg/kg bw/day in males, 74.9 mg/kg bw/day in females), also no substance-related findings were observed.

In conclusion, only mild signs of toxicity were obtained at the top dose of 12,000 ppm which is equivalent tothe limit dose of 1000 mg/kg bw/day. All findings were reversible after cessation of the test substance administration. Under the conditions of the present study, the NOAEL was 3,000 ppm (285.2 mg/kg bw/day in males, 295.3 mg/kg bw/day in females) in both sexes.

Justification for classification or non-classification

Based on the results of the oral subacute toxicity study, the substance does not need to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.