2,4-Imidazolidinedione, 5-(2-methylpropylidene)-, (5Z)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Feb - 24 Jun 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(5Z)-5-(2-methylpropylidene)imidazolidine-2,4-dione

EC Number:

700-726-4

Cas Number:

1369499-44-4

Molecular formula:

C7H10N2O2

IUPAC Name:

(5Z)-5-(2-methylpropylidene)imidazolidine-2,4-dione

Test animals

Species:

rat

Strain:

other: CD / Crl: CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: males approx. 6 weeks, females approx. 7 weeks
- Weight at study initiation: males 192-201 g, females 180-188 g
- Fasting period before study: feeding was discontinued approx. 16 hours before administration
- Housing: 2-3 animals/cage
- Diet: ad libitum (ssniff® R/M-H V1530, ssniff Spezialdiäten GmbH, D-59494 Soest, Germany)
- Water: ad libitum (tap water)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17.03.2003 To: 10.04.2003

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.8% aqueous hydroxypropylmethylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL in 0.8% aqueous hydroxypropylmethylcellulose gel

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg b.w.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: before and immediately, at 5, 15, 30 and 60 min, as well as at 3, 6 and 24 hours and 14 days after administration
- Observations on mortality were made at least once daily; the time of death was recorded as precisely as possible
- Observations on clinical signs: changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system, somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Individual body weights were recorded before administration of the substance and thereafter in weekly intervals up to the end of the study, and at death; changes in weight were calculated and recorded
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy ; all gross pathological changes were recorded; no histopathology was carried out as no macroscopical findings were noted at autopsy; autopsy and macroscopic inspection of animals which died prematurely were carried out as soon as possible after exitus

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

1 of 3 male and 1 of 3 female animals died prematurely within 24 hours after dosing.

Clinical signs:

other: Slightly to moderately reduced motility, slight to moderate ataxia, slight to moderate dyspnoea, ptosis.

Gross pathology:

No macroscopical findings were noted at autopsy.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The oral LD50 value of the test material in male and female rats was determined to be >2000 mg/kg bw. One male and one female animals died prematurely within 24 hours after dosing.