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Toxicological information

Eye irritation

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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:
1998
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

Constituent 1
Chemical structure
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

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.