Registration Dossier
Registration Dossier
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EC number: 700-776-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according GLP and OECDguideline, well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of mono-[(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl]-5,12-dihydroquino[2,3-b]acridine-7,14-dione and di-[(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl]-5,12-dihydroquino[2,3-b]acridine-7,14-dione and 5,12-dihydroquino[2,3-b]acridine-7,14-dione
- EC Number:
- 700-776-7
- Molecular formula:
- C29H17O4N3 (unspecified isomers) / C38H22O6N4 (unspecified isomers) / C20H12O2N2
- IUPAC Name:
- Reaction mass of mono-[(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl]-5,12-dihydroquino[2,3-b]acridine-7,14-dione and di-[(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl]-5,12-dihydroquino[2,3-b]acridine-7,14-dione and 5,12-dihydroquino[2,3-b]acridine-7,14-dione
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 10 weeks
- Housing: single
- Diet ad libitum
- Water ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30- 70
- air changes: 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- moistened with approximately 0.1 ml of purified water before application - Duration of treatment / exposure:
- 4h
- Observation period:
- scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left flank
- 100 cm2
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water to clean the application site
SCORING SYSTEM: numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- 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 individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
The body weights of all rabbits were considered to be within the normal range of variability.
The application of the test item onto the skin resulted in light red staining of the treated skin throughout the whole study in one animal, up to the 72 hours or 7 day observation in the two remaining animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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