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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study conducted in accordance 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 401 (Acute Oral Toxicity)

Version / remarks:

(1981)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

401-540-3

EC Name:

-

Cas Number:

84632-65-5

Molecular formula:

C18H10Cl2N2O2

IUPAC Name:

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

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain of animals as stated in the report: KFM-Han. Wistar (outbred, SPF-Quality)
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf / Switzerland
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 214 - 237 g (males), 172 - 200 g (females)
- Housing: groups of 5 in Makrolon type-3 cages
- Diet: pelleted standard Kliba 343, rat maintenance diet, ad libitum
- Water: tap water, ad libitum
- 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

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

The test article was suspended in the vehicle (weight by volume). Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer. The preparation was made immediately prior to dosing.

MAXIMUM DOSE VOLUME APPLIED: no data available

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 animals (5 females, 5 males)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations on mortality and viability and clinical signs: 4-times during test day 1, daily during days 2 - 15
- Frequency of weighing: body weight was assessed on day 1, 8 and 15.
- Necropsy of survivors performed: yes, all animals were sacrifieced and subjected to gross pathology.

Statistics:

No statistics were performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: None of the animals died after treatment.

Mortality:

No mortality occured.

Clinical signs:

other: After administration of 5000 mg/kg bw sedation, dyspnea, hunched body position and ruffled fur were observed in animals of both sexes. Additionally rales were observed in males. All rats recovered after 24 h. In addition to the above symptoms the extremit

Gross pathology:

No macroscopic findings were observed at necropsy.

Other findings:

No other findings

Any other information on results incl. tables

Table 1 Mean body weights in grams (Dose level: 5000 mg/kg bw)

Test day	1 *	8	15
Male	224 +/- 8.5	264 +/- 10	289 +/- 12
Female	187 +/- 11	211 +/- 11	217 +/- 12

* body weights on day 1 were assessed before application of 5000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a GLP-study according to OECD TG 401 using the limit test dose of 5000 mg/kg bw, the LD50 oral of the substance was determined to be > 5000 mg/kg bw in both females and males.

Executive summary:

The acute oral toxicity of the substance was inevstigated in a GLP-compliant staudy according to OECD Test Guideline 401 (version 1981). Suspended in polyethylene glycol, 5000 mg/kg bw of the substance were given to 5 male and 5 female Wistar rats by gavage. The rats were observed for clinical signs and body weight change for 15 days. After sacrifice, the rats were subjected to gross pathology. Besides some clinical effect in the first 24 hours, no effects of the substance, especially mortality and on body weight, were observed. Therefore, the LD 50 was > 5000 mg/kg bw for both sexes.