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EC number: 204-526-3 | CAS number: 122-18-9
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:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Reduction of quaternary ammonium-induced ocular surface toxicity by emulsions: an in vivo study in rabbits
- Author:
- H. Liang, F. Brignole-Baudouin, L. Rabinovich-Guilatt, Z. Mao, L. Riancho, M.O. Faure, J.M. Warnet, G. Lambert, C. Baudouin
- Year:
- 2 008
- Bibliographic source:
- Molecular Vision, 2008; 14:204-216
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize test
- Principles of method if other than guideline:
- Draize test was performed to assess the extent of ocular damage caused to rabbits eyes when exposed to the test chemical
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cetalkonium chloride
- EC Number:
- 204-526-3
- EC Name:
- Cetalkonium chloride
- Cas Number:
- 122-18-9
- Molecular formula:
- C25H46ClN
- IUPAC Name:
- cetalkonium chloride
- Test material form:
- solid
- Details on test material:
- - Name of test material: Cetalkonium chloride
- IUPAC name: CETYL DIMETHYL BENZYL AMMONIUM CHLORIDE
- Molecular formula: C25H46ClN
- Molecular weight: 396.098 g/mole
- Smiles : c1(C[N+](CCCCCCCCCCCCCCCC)(C)C)ccccc1.[ClH-]
- Inchl: 1S/C25H46N.ClH/c1-4-5-6-7-8-9-10-11-12-13-14-15-16-20-23-26(2,3)24-25-21-18-17-19-22-25;/h17-19,21-22H,4-16,20,23-24H2,1-3H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid (white)
- Purity: 99.7%
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Cetalkonium chloride
- Molecular formula : C25H46ClN
- Molecular weight : 396.098 g/mole
- Substance type: Organic
- Physical state: Solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: Male
- Weight at study initiation: 2-3 kgs
Test system
- Vehicle:
- other: PBS
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 50 microliters of PBS containing 0.002% Solution
- Duration of treatment / exposure:
- 15 times at 5 minute intervals
- Observation period (in vivo):
- 4 hours, 1 day and 4 days
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- seven rabbits – 5 for study and 2 were sacrificed on day 1 for immunohistopathological observations
- Details on study design:
- Scoring: The maximum possible total score was 110 (conjunctiva=20, cornea=80, iris=10).
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Four hours after instillation of the test chemical, mild conjunctival hyperemia. At day 1, eyes treated with Cetalkonium chloride all returned to normal aspects without significant differences.
Mild conjunctival irritation was observed in all rabbits
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Four hours after instillation of the test chemical, mild conjunctival hyperemia. At day 1, eyes treated with the test chemical all returned to normal aspects without significant differences.
The Draize scores after 4 hours of instillation were 3±0.6.
Based on the scores and observations, 0.002% test chemical solution was considered to be irritating to rabbit eyes. - Executive summary:
Draize test was performed to assess the extent of ocular damage caused to rabbits eyes when exposed to the test chemical.
50 microliters of PBS containing 0.002% test chemical Solution was applied to the eyes of seven male New Zealand White rabbits15 times at 5-min intervals.The first instillation was chosen as time zero (T0). During the instillations, the time when conjunctival redness appeared was recorded. At H4, D1, and D4, the eyes were examined using slit lamp microscopy for ocular irritation and scored according to a weighted scale for grading the severity of ocular lesions modified from the Draize Test. The degree of redness, swelling (chemosis), and tearing of the conjunctiva; the degree and area of cornea opacity; and the increased.The maximum possible total score was 110 (conjunctiva=20, cornea=80, iris=10).
Four hours after instillation of the test chemical, mild conjunctival hyperemia. At day 1, eyes treated with test chemical all returned to normal aspects without significant differences.
The Draize scores after 4 hours of instillation were3±0.6.
Based on the scores and observations, 0.002% test chemical solution was considered to be irritating to rabbit eyes.
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