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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
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:
2008
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

Constituent 1
Chemical structure
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%
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.