Barbital sodium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

This method has a similar structure to the acute toxic class method (OECD 423), which was adopted years later in 1996.

Principles of method if other than guideline:

The development of a method for the investigation of the acute toxicity of an unknown chemical substance, with an estimation on the LD50, is described. This method has a similar structure to the acute toxic class method (OECD 423), which was adopted years later in 1996.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Barbital sodium

EC Number:

205-613-9

EC Name:

Barbital sodium

Cas Number:

144-02-5

Molecular formula:

C8H11N2O3.Na

IUPAC Name:

sodium 5,5-diethyl-4,6-dioxo-1,4,5,6-tetrahydropyrimidin-2-olate

Test material form:

not specified

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

Animals were treated with substances after at least 5 days of adaptation.

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

In the initial investigations the range of doses producing the toxic effects is established. Based on these results, further specific doses are administered to calculate an LD50.

Doses:

first part of investigation: 10/100/1000 mg/kg bw, second part of investigation: 100/140/225/370/600/1000 mg/kg bw.

No. of animals per sex per dose:

first part of investigation: 3 animals per dose; second part of investigation: each of the proposed doses was given to groups consisting of one animal, two animals, three animals and five animals.

Control animals:

not specified

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

600 mg/kg bw

Based on:

test mat.

Remarks on result:

other: dose group consisting of 5 animals

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

650 mg/kg bw

Based on:

test mat.

Remarks on result:

other: dose group consisting of 3 animals

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

600 mg/kg bw

Based on:

test mat.

Remarks on result:

other: dose group consisting of 2 animals

Effect levels 4

Sex:

male

Dose descriptor:

LD50

Effect level:

770 mg/kg bw

Based on:

test mat.

Remarks on result:

other: dose group consisting of 1 animal

Applicant's summary and conclusion

Conclusions:

Classification category 4 based on GHS criteria.

Executive summary:

A method for the investigation of the acute toxicity of chemical substances, with an estimation on the LD50, is described.

This approach is a stepwise procedure with the use of 3 male rats in the first step and 1/2/3/5 male rats in the second step. Mortality and/or the moribund status of the animals was observed. This method has a similar structure to the acute toxic class method (OECD 423), which was adopted years later in 1996. The acute toxicity oral in rats was reported as LD50 600 mg/kg bw in male rats.