Cetrimonium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From February, 1986 to June, 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Certificate of analysis of test substance not included in report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Cetrimonium chloride

EC Number:

203-928-6

EC Name:

Cetrimonium chloride

Cas Number:

112-02-7

Molecular formula:

C19H42N.Cl

IUPAC Name:

hexadecyltrimethylazanium chloride

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleinrusse Chbb: HM/Fa. Thomae

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2197 - 2317 g

Test system

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): 2%

Duration of treatment / exposure:

Solution was applied at test start and no rinsing was conducted.

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

4 males

Details on study design:

SCORING SYSTEM: According to Draize JH, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Ass. of Food and Drug Officials of the US, pp 49-52 (1959) at 1, 6, 24, 48, 72 and 96 h, as well 8, 11 and 14 days post-application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

4 animals

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

4 animals

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

4 animals

Time point:

24/48/72 h

Score:

ca. 2.67

Max. score:

4

Reversibility:

fully reversible within: 11 d

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

4 animals

Time point:

24/48/72 h

Score:

ca. 1.08

Max. score:

4

Reversibility:

fully reversible within: 11 d

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Remarks:

(exudation)

Basis:

mean

Remarks:

4 animals

Time point:

24/48/72 h

Score:

ca. 2.75

Max. score:

4

Reversibility:

fully reversible within: 11 d

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

overall irritation score

Remarks on result:

not measured/tested

Results 7

Irritation parameter:

maximum mean total score (MMTS)

Remarks on result:

not measured/tested

Any other information on results incl. tables

The effects noted in the study are summarised in the following table:

Endpoint	1hour	6 hours	24 hours	48 hours	72 hours	96 hours	8 d	11 d	14 d
Opacity grade	0	0.5	0.5	0.25	0.25	0.25	0.25	0.25	0
Opacity surface	0	0.5	0.5	1.0	0.5	0.5	0.25	0.25	0
Redness	1.5	2.0	2.25	3.0	2.75	1.75	0.25	0	-
Chemosis	1.75	2.0	1.5	1.0	0.75	0.25	0	0	-
Exsudation	2.75	3.0	3.0	2.75	2.50	1.50	0	0	-

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (irritant)

Remarks:

based on CLP criteria

Conclusions:

Under the study conditions, the test substance was considered to be highly irritating to the eyes.

Executive summary:

A study was performed to assess the eye irritation potential of test substance, C16 TMAC (2% active in water) in rabbits, according to OECD Guideline 405, in compliance with GLP. 0.1 mL of the test substance (diluted at 2%) was placed in the conjunctival sac of the right eye of four rabbits. The other eye of each rabbit remained untreated and served as a control. Ocular lesions were evaluated at 1, 6, 24, 48, 72 and 96 h as well 8, 11 and 14 days post-application according to the Draize (1959) method. In two rabbits, a slight corneal reaction was observed 2 days after the start of the study but there were no effects on the iris in any of the animals. Moderate to severe effects were however noted on the conjunctiva of the rabbits, with full recovery at 11 days. Under the study conditions, the test substance was considered to be highly irritating to the eyes (Kastner, 1986).