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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Feb - 20 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-(phenylmethylidene)imidazolidine-2,4-dione

EC Number:

700-728-5

Cas Number:

74805-60-0

Molecular formula:

C10H8N2O2

IUPAC Name:

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

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Crj: CD(SD)

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 197-205 g, females 179-196 g
- Fasting period before study: approx. 16 hours before administration
- Housing: 2-3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 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 test item/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

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 after administration; at 5, 15, 20 and 60 min, as well as at 3, 6 and 24 hours after administration and once a day for a period of 14 days
- Observations on mortality were made at least once daily to minimize loss of animals during the study. The time of death was recorded as precisely as possible.
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy

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:

No mortality occurred throughout this study.

Clinical signs:

other: Slightly reduced motility, slight ataxia and slight dyspnoea.

Body weight:

other body weight observations

Remarks:

The animals gained the expected weight throughout the whole study period.

Gross pathology:

No macroscopical findings were noted at autopsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this acute oral toxicity study the LD50 in male and female rats was determined to be >2000 mg/kg bw.