Pyrrolo[3,4-c]pyrrole-1,4-dione, 2,5-dihydro-3,6-diphenyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant OECD Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted May 12, 1981

GLP compliance:

yes

Remarks:

Research & Consulting Company AG, Switzerland

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Physical state: solid
- Analytical purity: commercial grade
- Stability under test conditions: stable for at least 2 hours

Test animals

Species:

rat

Strain:

other: KFM-Han. Wistar (outbred, SPF-Quality)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: males: 234 - 277 g, females: 201 - 215 g
- Fasting period before study: no
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 ± 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: about 10%
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with luke warm tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg

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: Four times during test day 1, and daily during days 2 - 15; weighing: Test day 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The LOGIT-Model could not be applied to the observed rates of death. The toxicity mas estimated mithout use of a statistical model.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths observed

Clinical signs:

other: A reddish discoloration of the treated skin was observed in all rats during the observation period. No other signs of local or systemic toxicity was observed in the treated animals.

Gross pathology:

No macroscopic organ changes were observed