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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted according to GLP. However, purity of test article is unknown.

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:

(1981)

Deviations:

yes

Remarks:

Semi-occlusive dressing is recommended by guideline. However, occlusive dressing was used (worst case).

GLP compliance:

yes

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
- Lot/batch No.: Op. 11006
- Expiration date of the lot/batch: 1995-12-31
- Stability of test article: stable
- Stability under test conditions: stable for at least 2 h.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Strain as stated in the report: KFM-Han. Wistar (outbred, SPF)
- Source: Kleintierfarm Madoerin AG CH-4414 Fuellinsdorf / Switzerland
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 228 - 256 g (males), 197 - 211 g (females)
- Housing: individually in Makrolon type-2 cages
- Diet (ad libitum): pelleted standar Kliba 343, rat maintenance diet
- Water (ad libitum): tap water
- Acclimation period: 1 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 of animals
- % coverage: 10 % of total body surface
- Type of wrap: Occlusive dressing fixed with elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Skin was washed with lukewarm tap water
- Time after start of exposure: 24 h

TEST MATERIAL
- Application Volume/kg bw: 4 ml, corresponding to 2000 mg/kg bw.
- For solids, paste formed: Yes, test article was homogenised in PEG 400.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10 animals (5 males, 5 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations for mortality and clinical symptoms: 4-times at day one, afterwards daily.
- Frequency of weighing: Weights of animals were assessed on day 1, 8 and 15.
- Necropsy of survivors performed: Yes, all animals were sacrificed and subjected to gross pathology.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: None of the treated animals died.

Mortality:

No animal died.

Clinical signs:

other: After treatment a reddish skin discoloration was observed in all rats during the observation period. No other signs of local or systemic toxicity were observed.

Gross pathology:

No macroscopic findings were observed at necropsy.

Any other information on results incl. tables

Table 1: Mean body weights in grams (Dose level: 2000 mg/kg bw)

Test day	1*	8	15
Male	240 +/- 10	255 +/- 11	275 +/- 14
Female	206 +/- 5.4	211 +/- 8	219 +/- 8.7

body weights on day 1 were assessed before application of 2000 mg/kg bw.