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

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

810-292-9

Cas Number:

1072-70-4

Molecular formula:

C4H7NO2

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): 5-methyl oxyzolidin-2-one
- Physical state: liquid, colorless, clear
- Analytical purity: 98.0 area-%
- Lot/batch No.: EWALD-00441

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels

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.

Any other information on results incl. tables

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.