Registration Dossier
Registration Dossier
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EC number: 233-701-7 | CAS number: 10319-14-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione
- EC Number:
- 233-701-7
- EC Name:
- 2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione
- Cas Number:
- 10319-14-9
- Molecular formula:
- C18H10BrNO3
- IUPAC Name:
- 2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Observation period (in vivo):
- 1, 2, 3, 7 day
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- 78 mg of the tested substance was instilled into one eye of each animal, the other eye remaining untreated, served as control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2-6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3-4
- Time point:
- 24/48/72 h
- Score:
- ca. 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 5-6
- Time point:
- 24/48/72 h
- Score:
- ca. 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1-4-5-6
- Time point:
- 24/48/72 h
- Score:
- ca. 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Other effects:
- Temporary dulling of the normal lustre of the cornea was seen in one animal.
A diffuse crimson red colouration of the conjunctivae and considerable swelling with partial eversion of the eyelids in five animals.
Mild conjuncitval reactions were observed in the remaining animal.
The eyes of four animals were normal on day seven.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritant according ot CLP regulation (EU 1272/2008)
- Conclusions:
- not eye-irritant
- Executive summary:
The substance was tested for eye irritation potential according to the technique described in the consumer product safety commission of the U.S.A. in the code of federal regulations, title 16, section 1500.42.
78 mg of test substance was instilled into one eye of each animal, the other eye remaining untreated, served as control.
Eye reactions were scored at 1 d, 2 d, 3 d, and 7 d after exposure.
In two animals at day 7 slight effect on redness was still present.
The mean irritation indexes (at 1, 2 and 3 d) were the following:
Corneal score: (5/6)=0; 1/6 =1
iris score (6/6) = 0.
conjunctivae score (6/6) <2
chemosis (6/6) < 2
Therefore, the test substance is a non-eye irritant.
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