Barbituric acid

Endpoint summary

Description of key information

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.

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

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

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)

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

reliable with restrictions (sodium salt tested instead of acid)

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available