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Registration Dossier
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EC number: 700-776-7 | CAS number: -
Toxicological information
Eye irritation
Administrative data
- Endpoint:
- eye 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 OECD guideline, 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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- Wistar
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 11-12 weeks
- Housing: single
- Diet d libitum
- Water d libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Observation period (in vivo):
- Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
SCORING SYSTEM: according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- and #2
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: opacitiy, due to staining by the test item
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Irritant / corrosive response data:
- The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the iris of any animal at any of the examinations. The slight opacity of the whole corneal area at the 1-hour reading was provoked by the test item staining. No corrosion was observed at any of the measuring intervals.
No corrosion of the cornea was observed at any of the reading times. - Other effects:
- Slight staining of the treated eyes produced by the test item was observed in all animals at the 1-hour reading and in two animals at the 24-hour reading. Red test item remnants were evident in all animals at the 1-hour reading.
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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