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EC number: 224-152-4 | CAS number: 4216-02-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register Vol 38, no 187, S. 27019, 1973
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- pre-guideline study
Test material
- Reference substance name:
- Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione
- EC Number:
- 224-152-4
- EC Name:
- Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione
- Cas Number:
- 4216-02-8
- Molecular formula:
- C26H12N4O2
- IUPAC Name:
- bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione
- Test material form:
- solid: nanoform
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- SPF-Albino-Himalayan
- Source: Hoechst AG, breeding colony
- Weight at study initiation: 1,5 - 2,0 kg
- Housing: single caged
- Diet: standard diet ERKA 8300 ad libitum
- Water: tap water ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye remained untreated and served as control respectively
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 100 mg
- Duration of treatment / exposure:
- 24 h, rinsing with physiol. saline 24 h after instillation
- Observation period (in vivo):
- examinations at 1, 7, 24, 48, 72 h after instillation
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Application of the substance to the conjunctival sac of the left eye of each animal, the right eye served as control respectively
- Instillation: 100 mg of the undiluted substance
- Washing: Washing with physiological saline 24 h after administration
- Tool to assess score after 48 and 72 h: 0.01 % solution of fluorescein sodium, under UV light
The eyes are examined and the grade of ocular reaction is recorded at 1, 7, 24, 48, and 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 1-6 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: initial slight signs of irritation (cornea) in 2 animals were fully reversible within 24 h
- Irritation parameter:
- iris score
- Basis:
- animal: # 1-6 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 1 - 6 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: the shortened observation period of 72 h
- Remarks on result:
- other: considered to be fully reversible within a prolonged observation period
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 1, 2, 4, 5 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: the shortened observation period of 72 h
- Remarks on result:
- other: considered to be fully reversible within a prolonged observation period
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- discharge in all animals until 24 h and still existing in 2 animals at the end of the observation period after 72h.
- Other effects:
- no other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- the slight effect does not result in a classification of the test item according to the classification criteria of Regulation (EC) No 1272/2008
- Conclusions:
- The test material is slightly irritating to the eyes under the test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. All animals showed a conjunctiva redness score of one until the end of the 72 h observation period. Conjunctiva chemosis score was fully reversible within 72 h for all animals except one.
Based on the slightness of the observed conjunctival effects and because of their proceeding recovery full reversibility is expected in the course of a prolonged recovery period in all animals.
Therefore, the slight effect does not result in a classification of the test item according to the classification criteria of Regulation (EC) No 1272/2008. - Executive summary:
Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. Different effects could be observed. Conjunctiva redness score of 1 in all animals at all reading time points, which was not fully reversible within 72 h. Conjunctiva chemosis score of 1 was not fully reversible after 72 h in 1 animal. Slight discharge was still existent in 2 animals after 72 h.
Based on the slightness of the observed conjunctival effects and because of their proceeding recovery full reversibility is expected in the course of a prolonged recovery period in all animals.
No effects on cornea and iris were observed at reading time points 24, 48 and 72 h.
Therefore, the test item has not to be classified for eye irritation according to Regulation (EC) No 1272/2008.
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