5-methyl-1,3-oxazolidin-2-one

Endpoint summary

Description of key information

LD50 (oral, rat): > 2000 mg/kg bw (BASF SE, 2015)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: young adult animals (approx. 10 weeks)
- Weight at study initiation: animals of comparable weight (+/- 20% of the mean weight)
- Housing: single housing, Makrolon cage, type III
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight,pathology

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in the first and second test group.

Clinical signs:

In only one animal of the first test group impaired general state and piloerection were observed from hour 2 until hour 5 after administration.

Body weight:

The mean body weight increased within the normal range throughout the study period.

Gross pathology:

There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period.

Mortality
Dose (mg/kg bw):	2000	2000
Sex:	Female	Female
Administration:	1	2
No. of animals	3	3
Mortality (animals):	No mortality	No mortality

Under the conditions of this study the median lethal dose of 5-methyl oxazolidin-2-one after oral administration was found to be greater than 2000 mg/kg bw in rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP guideline study

Additional information

In an acute oral toxicity study performed according to the Acute Toxic Class method (OECD 423), 2000 mg/kg bw of the undiluted test item 5-methyl oxazolidin-2-one were administered by gavage to two test groups of three fasted Wistar rats each. Clinical signs occurred within the first 5 hours after administration: 2000 mg/kg (first and second test group): impaired general state in one animal and piloerection in one animal. No mortality occurred in the first and second test group.

The mean body weight increased within the normal range throughout the study period. There were no macroscopic pathological findings at the end of the observation period. The acute oral LD50 was calculated to be > 2000 mg/kg bw (BASF SE, 2015).

Justification for selection of acute toxicity – oral endpoint
only available study

Justification for classification or non-classification

Based on the results, the test item was not classified and labelled according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).