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EC number: 229-175-3 | CAS number: 6422-83-9
Toxicological information
Skin irritation / corrosion
Currently viewing:
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:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- 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
- 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
Constituent 1
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
Resultsopen allclose all
- 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
- 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.
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