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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:
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

Constituent 1
Chemical structure
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
Chemical structure
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

Resultsopen allclose all
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
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
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
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
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
Irritation parameter:
overall irritation score
Remarks on result:
not measured/tested
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).