Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis([1,1'-biphenyl]-4-yl)-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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

413-920-6

EC Name:

-

Cas Number:

88949-33-1

Molecular formula:

C30 H20 N2 O2

IUPAC Name:

3,6-bis({[1,1'-biphenyl]-4-yl})-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Substance type: Organic
- Physical state: Solid
- Lot/batch No.: Z-2281/1,2,4,5
- Expiration date of the lot/batch: April 01, 1997
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: Approx. 9 weeks
- Weight at study initiation: males: 222 - 243 g, females: 166 - 182 g
- Fasting period before study: overnight
- Housing: 5 animals per sex per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1993-01-13 To: 1993-01-27

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight.

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: Twice daily (mortality, viability), once daily (weighing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (daily)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality observed.

Mortality:

none

Clinical signs:

other: No clinical signs were observed during the study period. However, red discolouration of skin, tail and faeces were noted from day 3 onward.

Gross pathology:

Macroscopic post mortem examination of the surviving animals at termination did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of the test substance in Wistar rats of either sex was established as exceeding 2000 mg/kg body weight.

Executive summary:

The acute oral toxicity of the test substance (purity 97.5%) was examined in a reliable study according to OECD Guideline 401 and GLP. The test substance dissolved in polyethylene glycol was administered by single oral gavage to five Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality or clinical signs were observed during the study period. However, red discolouration of skin, tail and faeces were noted from day 3 onward. The mean body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post-mortem examination of the animals. Therefore, the oral LD50 was established to exceed 2000 mg/kg body weight.