1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-10-27 to 1989-12-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted February 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

March, 1984

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione

EC Number:

229-175-3

EC Name:

1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione

Cas Number:

6422-83-9

Molecular formula:

C15H10N2O4

IUPAC Name:

1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: males: 14 weeks, females: 15 weeks
- Weight at study initiation: males: 2.9 kg, females: 2.4-2.6 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen).
- Diet (e.g. ad libitum): ad libitum, Pelleted standard Kliba 341, Batch 48/89 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Four days under test conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

bi-distilled

Amount / concentration applied:

Amount(s) applied: 0.5 g / animal

Duration of treatment / exposure:

4 h

Observation period:

72 h, reading intervals: 1, 24, 48 and 72 h

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm² intact shaved skin
- % coverage: 3.0 x 3.0 cm
- Type of wrap if used: A patch of surgical gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure the skin was flushed with lukewarm tap water.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48, 72 h

SCORING SYSTEM: according to OECD guideline
- Method of calculation: To classify the irritating property of the test article, the mean values of erythema/eschar as well as of edema formation were calculated for each individual, using the scores between 24 and 72 hours (EEC Council Directive 83/467/EEC, July 1983, Brussels/Belgium).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study conducted according to OECD guideline 404, the test item caused no skin irritating/corrosive reactions. The individual mean values for both erythema and edema from gradings at 24, 48 and 72 h were 0 in all three animals. Therefore, the test item does not fulfil the criteria for classification according to Regulation (EC) 1272/2008 (CLP) and the Globally Harmonized system of Classification and Lablelling of Chemical (GHS), and is thus considered to be not skin irritating.