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EC number: 221-424-4 | CAS number: 3089-17-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6 October 1998 to 13 November 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with OECD Guideline 405 and EU Method B.5
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5,12-dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione
- EC Number:
- 213-561-3
- EC Name:
- 5,12-dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione
- Cas Number:
- 980-26-7
- Molecular formula:
- C22H16N2O2
- IUPAC Name:
- 2,9-dimethyl-5,12-dihydroquino[2,3-b]acridine-7,14-dione
- Test material form:
- solid: nanoform
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Weight at study initiation: 3.51-3.91 kg
- Housing: separate cages arranged in a battery in fully air-conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- 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): 100 mg - Duration of treatment / exposure:
- One administration (for times of removal of the test substance see below)
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Application of the substance to the conjunctival sac of the left eye of each animal
REMOVAL OF TEST SUBSTANCE
- Washing: Washing with isotonic saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24 and 72 h after administration) took place
- Time after start of exposure: see above
TOOL USED TO ASSESS SCORE: fluorescein-sodium, under UV light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: effects observed at 1 hour, but reversible by 24 hour observation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effects
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Animal no. -- observation time -- cornea opacity -- cornea area -- iris -- conjunctiva redness -- conjunctiva chemosis -- conjunctiva discharge
311 -- 1 hour ---- 0 -- 0 -- 0 -- 2 -- 1 -- 1
311 -- 24 hours -- 0 -- 0 -- 0 -- 1 -- 0 -- 0
311 -- 48 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0
311 -- 72 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0
314 -- 1 hour -- --0 -- 0 -- 0 -- 1 -- 0 -- 0
314 -- 24 hours -- 0 -- 0 -- 0 -- 1 -- 0 -- 0
314 -- 48 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0
314 -- 72 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0
315 -- 1 hour ---- 0 -- 0 -- 0 -- 1 -- 0 -- 0
315 -- 24 hours -- 0 -- 0 -- 0 -- 1 -- 0 -- 0
315 -- 48 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0
315 -- 72 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0
Mean individual scores after 24, 48 and 72 hours for animal no. -- corneal opacity -- iris -- conjunctivae redness -- conjunctivae chemosis
311 -- 0.0 -- 0.0 -- 0.3 -- 0.0
314 -- 0.0 -- 0.0 -- 0.3 -- 0.0
315 -- 0.0 -- 0.0 -- 0.3 -- 0.0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions.
- Executive summary:
A study according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the rabbit eye.
One and 24 hours after treatment the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse crimson red colour. Additionally, a very slight swelling and slight from substance coloured eye discharge were observed in one animal one hour after treatment. Fourty-eight hours after treatment all signs of irritation were reversible.
As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.
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