Registration Dossier
Registration Dossier
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EC number: 232-340-2 | CAS number: 8005-56-9 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 71110.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study meets the requirements of OECD Guideline 404 and EU Method B.4 (84/449/EEC)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bisbenzimidazobenzo[lmn][3,8]phenanthrolinedione
- EC Number:
- 232-340-2
- EC Name:
- Bisbenzimidazobenzo[lmn][3,8]phenanthrolinedione
- Cas Number:
- 8005-56-9
- Molecular formula:
- C26H12N4O2
- IUPAC Name:
- bisbenzimidazobenzo[lmn][3,8]phenanthrolinedione
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Animal specifics: Chbb: NZW (SPF)
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, 88400 Biberach
- Age at study initiation: 3 months to 5 months
- Weight at study initiation: 2.4 kg to 2.6 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2123) ad libitum, appr. 15 g hay daily
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18° ± 3°C (air-condition)
- Humidity (%): 55 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Polyethyleneglycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g; pasted with 0.9 ml Polyethyleneglycol
VEHICLE
- Amount(s) applied (volume or weight with unit):1.0 ml to moisten the test item
- Lot/batch no. (if required): Ch-B 2322 , Riedel de Haen AG - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch (Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
as in EU Method B.4, assessed approximately 30 - 60 min, 24, 48, and 72 h after the romoval of the test item
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritant / corrosive response data:
- No signs of irritations were observed during the whole observation period
- Other effects:
- Staining produced by the test item was present at all reading time points.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- The test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
- Conclusions:
- The test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
- Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g, pasted with polyethyleneglycol to the intact flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal. No signs of irritation were observed during the whole observation period. Staining produced by the test item was present at all reading time points.
No skin reactions were observed. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
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