Cetalkonium chloride

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:

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

Test material information

Constituent 1

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.