Benzonitrile, 3,3'-(2,3,5,6-tetrahydro-3,6-dioxopyrrolo[3,4-c]pyrrole-1,4-diyl)bis-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-06-24 to 1993-03-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

adopted Sep. 19, 1984

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

412-640-1

EC Name:

-

Cas Number:

84632-50-8

Molecular formula:

C20 H10 N4 O2

IUPAC Name:

3-[4-(3-cyanophenyl)-3,6-dioxo-2H,3H,5H,6H-pyrrolo[3,4-c]pyrrol-1-yl]benzonitrile

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Appearance: orange powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: four to seven weeks
- Weight at study initiation: 110 to 120 g
- Fasting period before study: yes
- Housing: in groups of five according to sex in metal cages with wire mesh floors
- Diet: standard laboratory rodent diet (Biosure LAD 1) ad libitum
- Water: drinking water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 22°C
- Humidity: 49% (daily mean)
- Air changes: approximately 10 - 15 per hour
- Photoperiod: 12 hours artificial light (0700 - 1900 hours) in each 24-hour period

IN-LIFE DATES: From: 1993-01-19 To: 1993-02-04

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

PREPARATION OF DOSING SOLUTIONS:
A 25% w/v suspension of test item was prepared on the day of dosing in 1 % w/v aqueous methylcellulose.

VEHICLE
- Concentration in vehicle: 1 %
- Amount of vehicle: 20 mL / kg bw / day

Doses:

2.5 g / kg bw (preliminary study)
5 g / kg bw (main study)

No. of animals per sex per dose:

2 males and 2 females (preliminary study)
5 males and 5 females (main study)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Cage side observations: at least twice daily
- Clincal signs: soon after dosing and at frequent intervals for a period of 7 hours. On subsequent days once in the morning and at the end of the experimental day.
- Body weight: on Days 1 (prior to dosing), 8 and 15

- Necropsy of survivors performed: yes

Statistics:

No

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths following a single oral dose of test item.

Clinical signs:

other: Pilo-erection was observed in all rats within four minutes of dosing and throughout the remainder of Day 1. Recovery of all rats, as judged by external appearance and behaviour, was complete by Day 2. Orange/brown faeces were observed on Day 2 only.

Gross pathology:

No macroscopic abnormalities were observed for animals killed on Day 15.

Any other information on results incl. tables

Results of preliminary study:

The acute lethal oral dose of the test item to male and female rats was greater than 2.5 g/kg bodyweight.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU