Registration Dossier
Registration Dossier
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EC number: 242-354-0 | CAS number: 18472-51-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- 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:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Grading of ocular lesions was done according to a modified grading system, which is not described in the current OECD guideline 405. This is not considered a major drawback because this also an established and much-used method for the scoring of eye irritation.
- GLP compliance:
- no
Test material
- Reference substance name:
- D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)
- EC Number:
- 242-354-0
- EC Name:
- D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)
- Cas Number:
- 18472-51-0
- Molecular formula:
- C22H30Cl2N10.2C6H12O7
- IUPAC Name:
- N',N'''''-hexane-1,6-diylbis[N-(4-chlorophenyl)(imidodicarbonimidic diamide)] - D-gluconic acid (1:2)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
-Age at study initiation: no data
-Weight at study initiation: 3 - 3.5 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- not rinsed: no data
rinsed: 5 sec (followed by 2 min wash with distilled water) - Observation period (in vivo):
- Up to 7 days after instillation
- Number of animals or in vitro replicates:
- 6 (not rinsed)
3 (rinsed) - Details on study design:
- SCORING SYSTEM: According to Draize
Scores 0 - 15: non-irritating; 15.1 - 25: slightly irritating; 25.1 - 50 : moderately irritating; 50.1 - 110: severely irritating (corrosive)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 12.8
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 4.5
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 9.3
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- other: Mean total score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 17.5
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: eyes were not rinsed
- Irritation parameter:
- other: Mean total score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: eyes were rinsed
Applicant's summary and conclusion
- Interpretation of results:
- other: irritating
- Conclusions:
- The test substance is irritating to the eyes of rabbits.
- Executive summary:
Under the conditions of the assay, the instillation of 0.1 mL of 5 % chlorhexidine gluconate into the eyes of rabbits caused irritation of the cornea, iris and conjunctiva. The test compound was severely irritating in non-rinsed eyes and mildly irritating in rinsed eyes. The irritating effect was reversible (rinsed).
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