Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis[4-(1,1-dimethylethyl)phenyl]-2,5-dihydro-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-05-13 - 1993-06-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 401) performed under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted on 24th February 1987

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:

416-250-2

EC Name:

-

Cas Number:

84632-59-7

Molecular formula:

C26 H28 N2 O2

IUPAC Name:

3,6-bis(4-tert-butylphenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione

Test animals

Species:

rat

Strain:

other: albino (Tif: RAI f (SPF))

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production, 4332 Stein, Switzerland
- Age at study initiation: young adult animals
- Weight at study initiation: 172 to 220 g
- Housing: 5 animals/sex housed in Macrolon cagestype 4, with standardized soft wood bedding
- Diet: Rat diet ad libitum, prior to dosing, the animals were fasted overnight
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 55 +/- 10 °C
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: From: 1993-06-01 To: 1993-06-22

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Details on oral exposure:

VEHICLE:
- Concentration in vehicle: 200 mg/mL, based on dose volume
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle: to make dosing by gavage possible
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED:
- 2000 mg/kg bw (males and females)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- once daily for 14 days for clinical signs and mortality
- Body weights were recorded immediately before administration and on days 7 and 14,
- Necropsy of survivors performed: yes

Statistics:

No statistical testing was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred in this study.

Clinical signs:

other: Piloerection, hunched posture, and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 4 to 5 days.

Gross pathology:

At necropsy, spotted lungs were found in one female. No deviations from normal morphology were found in the remaining animals.