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:

other: GLP and OECD testing guideline compliant study with well characterized test material.

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

Details on test material:

- 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 cm2 (5x5 cm) for males and 18 cm2 (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:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

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:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU