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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-05-13 - 1993-06-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 404) performed under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted on 17 July 1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

416-250-2

EC Name:

-

Cas Number:

84632-59-7

Molecular formula:

C26 H28 N2 O2

IUPAC Name:

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

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, Biberach/Riss, Germany
- Age at study initiation: No data
- Weight at study initiation: 2300 - 2870 g
- Housing: Individually in metal cages.
- Diet: standard rabbit pellet – Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: No data
- Photoperiod: 12 hours light cycle day

IN-LIFE DATES: From: 1993-05-18 To: 1993-05-21

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g, moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours after patch removal (assessment of skin reactions at 1, 24, 48 and 72 hour(s) after patch removal)

Number of animals:

3 males

Details on study design:

TEST ITEM PREPARATION
- 0.5 g (per animal) of the test item was moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80 before application.

TEST SITE
- 24 hours before treatment, both flanks were shaved
- Area of exposure: at least 36 cm² on the right flank
- Coverage: 6 cm² of the intact skin
- Type of wrap: Moistened surgical gauze patch (ca. 12– 16 cm²) with the test item - applied to approximately 6 cm² of the intact skin of the clipped area - covered with an occlusive dressing, dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- No washing performed

SCORING SYSTEM: OECD scoring system

OBSERVATIONS
- Viability/Mortality: Daily
- Clinical signs: Daily
- Body weights: recorded at start and on day 3 of the test
- Necropsy: no

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24

Score:

0

Max. score:

4

Remarks on result:

other: No scoring possible in the 2 remaining rabbits at 24 h.

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48, 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

IRRITATION:
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The mean values from 24 to 72 hours were therefore 0 for erythema and 0 for oedema.

CORROSION:
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

COLORATION
One hour after patch removal in all animals and 24 hours after patch removal in two animals a possible erythema reaction could not be evaluated because of test item-related orange staining.

Any other information on results incl. tables

VIABILITY/MORTALITY/CLINICAL SIGNS

No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

 

BODY WEIGHTS

The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information