4,5-dihydroxy-1,3-dimethylimidazolidin-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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EEC Directive 92/69, 1992

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,5-dihydroxy-1,3-dimethylimidazolidin-2-one

EC Number:

223-496-2

EC Name:

4,5-dihydroxy-1,3-dimethylimidazolidin-2-one

Cas Number:

3923-79-3

Molecular formula:

C5H10N2O3

IUPAC Name:

4,5-dihydroxy-1,3-dimethylimidazolidin-2-one

Test material form:

liquid

Details on test material:

Name of the test substance used in the study report: Fixapret NF

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult male and female animals were used with a comparable body weight at the start of the study (150 g - 300 g). The animals were identified using cage cards and group identification was done by tail marking. The animals were housed in fully air-conditioned rooms with a central air-conditioning of 20 - 24°C for temperature and a relative humidity between 30 - 70%. The day/night rhythm was 12 h dark and 12 h light. Animals were housed single in stainless steel wire mesh cages with no bedding in the cages (sawdust in the waste trays). A standard laboratory diet was used and tap water was available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Aqueous formulation corresponds to the physiological medium.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Single oral administration by gavage (solution).
Observation period: 14 days
Acclimatization period of the animals: at least 1 week. The animals were given no feed at least 16 hours before administration, but water was available ad libitum.
Individually body weight determination shortly before application, weekly thereafter and at the end of the study (before fasting period).
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for general observations and mortality was made twice each workday and once on weekends and on public holidays for general observations and for any dead or moribund animals.
Necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy with gross-pathology examination. Necropsy of all animals that died before as soon as possible.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

none

Clinical signs:

other: none

Gross pathology:

no abnormalities