Barbituric acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20.09.1978 - 05.10.1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

according to OECD 410, but limited documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Barbituric acid, sodium salt

EC Number:

245-979-7

EC Name:

Barbituric acid, sodium salt

Cas Number:

24012-01-9

Molecular formula:

C4H4N2O3.xNa

IUPAC Name:

sodium 2,4,6-trioxotetrahydro-2H-pyrimidin-1-ide

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Fasting period before study: 15-20 h before administration
- Weight at study initiation: 210 - 300 g (males); 180 - 200 g (females)

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% suspension

Details on oral exposure:

- Concentration in vehicle: 10 and 50 % (w/v)
- Diet (e.g. ad libitum): Herlian MRH-Haltung, Eggersmann KG

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

1000 and 5000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: obwervations: 1 h, 1, 2, 7, 14 days; weighing: at the beginning of the study, after 2 to 4, 7 and 14 days
- Necropsy of survivors performed: yes/
- Other examinations performed: clinical signs, body weight, organs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no mortalities

Clinical signs:

other: orange staining of the urine (high dose level) and diarrhea (both dose levels)

Gross pathology:

Necropsy revealed no findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Regulation (EC) 1272/2008

Conclusions:

Single application of 5 000 mg test item per kg bw did not cause lethality in male and female rats during the 14 days observation period, resulting in a LD50 > 5 000 mg/kg bw.

Executive summary:

Male and Female rats were subjected to test acute oral toxicity according to OECD TG 401. The test item was administered at dose levels of 1 000 and 5 000 mg/kg bw to 5 male and 5 female rats respectively. During the 14 days observation period no animals died and there were no abnormalities found in necropsy, thus leading to an LD50 > 5 000 mg/kg bw.