4,4-dimethyloxazolidine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Only 10 days observation period applied.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

Remarks:

only male rats were tested, observation period only 10 days

Principles of method if other than guideline:

No information on guideline followed.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4,4-dimethyloxazolidine

EC Number:

257-048-2

EC Name:

4,4-dimethyloxazolidine

Cas Number:

51200-87-4

Molecular formula:

C5H11NO

IUPAC Name:

4,4-dimethyl-1,3-oxazolidine

Test material form:

liquid

Specific details on test material used for the study:

- Test material name: Oxazolidine-A
- Lot No. of test material: 575916
- Purity: 87.4%

Test animals

Species:

rat

Strain:

other: Holtzman

Remarks:

albino rats

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified; young adults
- Weight at study initiation: 150-180 grams
- Fasting period before study: overnight
- Food and water ad libitum
- Acclimation period: not specified


ENVIRONMENTAL CONDITIONS
- not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: Dosage volume was 0.04 mL/g body weight.

Doses:

400, 630, 1000,1600, and 2500 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 10 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes, gross necropsies were performed after the observation period

Results and discussion

Preliminary study:

Preliminary examination indicated a LD50 of between 800 and 2000 mg/kg.

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

956 mg/kg bw

Based on:

test mat.

Remarks:

diluted with distilled water

Remarks on result:

other: determined by Spearman Karber method

Mortality:

Numbers of dead rats per dose:
400 mg/kg: 0; 630 mg/kg: 0; 1000 mg/kg: 3; 1600 mg/kg: 5; 2500 mg/kg: 5
The times of death of animals receiving the 1600 and 2500 mg/kg doses were within 2 minutes at the higher dose and approx. 5 minutes for the lower dose. Animals which had received the 1000 mg/kg dose died as follows: one dead within 24 hours after administration; one dead within 48 hours; one dead within 96 hours.

Gross pathology:

Necropsy findings: animals which died acutely where in rigor; hearts arrested in systole. Livers engorged with blood. No remarcable findings at necropsy of animal which died during or after the observation period.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The oral LD50 in rats was determined to be 956 mg/kg for the test item (CAS: 51200-87-4).

Executive summary:

The oral LD50 in rats was determined by gavage to male rats to be 956 mg/kg for the test item (CAS: 51200-87-4).