Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis([1,1'-biphenyl]-4-yl)-2,5-dihydro-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

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: 235 to 287 g, females: 181 to 213 g
- Fasting period before study: overnight
- Housing: individual
- 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: 1993-01-14 To: 1993-01-28

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: on the back of the animal
- coverage: 25 cm^2 (5x5 cm) for males and 18 cm^2 (3.5x5 cm) for females
- Amount(s) applied (volume or weight with unit): 10 ml/kg body weight
- Type of wrap if used: application on a gauze patch fixed successively to aluminium foil and flexible bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): substance was removed with tissue moistened with tap-water
- Time after start of exposure: 24h

TEST MATERIAL
- Concentration (if solution): 10 ml/kg body weight
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

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:

No mortality occured.

Clinical signs:

other: No clinical signs of ill health or behavioural changes were observed during the study period.

Gross pathology:

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

Other findings:

The treated skin area of all animals was discoloured red by the test substance during the study period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

A GLP conform study was performed with the test substance (purity 97.5%) to assess the acute dermal toxicity in rats according to OECD guideline 402. The test substance dissolved in polyethylene glycol was administered to the skin of five Wistar rats of each sex by semi-occlusive application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. Red staining of the treated skin and/or head, noted among all animals, were considered to be related to staining properties of the test substance. Therefore, the dermal LD50 value of the test substance in Wistar rats of either sex was established as exceeding 2000 mg/kg body weight.