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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
Study period:
From March 31, 1981 to April 14, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A study was conducted with the test substance following application of single dose to one of the eyes of the experimental animal and the untreated eye serves as the control. The degree of eye irritation/corrosion was evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals. Other effects in the eye and adverse systemic effects were also described to provide a complete evaluation of the effects.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Protein hydrolyzates, keratin, reaction products with 3-chloro-2-hydroxypropyl-cocoalkyl-dimethylammonium chloride
Molecular formula:
Molecular formula of major active constituents: C22H45Cl1N2O5 (representative molecular formula for C12 alkyl chain quaternised glutamic acid) C20H43CL1N2O3 (representative molecular formula for C12 alkyl chain quaternised alanine) C25H50CL1N3O6 (representative molecular formula for C12 alkyl chain quaternised peptides of alanine and glutamic acid)
IUPAC Name:
Protein hydrolyzates, keratin, reaction products with 3-chloro-2-hydroxypropyl-cocoalkyl-dimethylammonium chloride
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
24, 48, and 72 h
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Procedure
This test was designed to determine the ocular irritation potential of the test substance in rabbits. The procedure followed was a modification of that described by J.H. Draize. Six (6) New Zealand White rabbits, weighing approximately 2 kg and about 3 months of age, Sex unspecified, were obtained from a suitably licensed dealer. Animals were checked carefully upon receipt for ocular defects, diarrhea and dehydration, respiratory difficulties, postural deficiencies and general condition. Animals were acclimated at least 3 d prior to test initiation. They were housed in galvanized or stainless steel cages and identified through individual markings on the outer ear of each animal, as well as a cage label. Diet consisted of a growth and maintenance ration from a commercial producer, as well as water, libitum. Immediately prior to test initiation, the animals were placed in wooden restrainers. A dose of 0.1 mL of the test substance was placed on one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The eyelids were gently held together for 1 second. The contralateral eye, remaining untreated, served as control. If any of the test substance remained in the eye at 24 h. the eye was washed out with lukewarm water after the 24 h reading. Observations of ocular irritation were recorded 24, 48 and 72 h following instillation of the test substance. Additional readings were made at 4 and 7 d after application if irritation persisted. An animal was considered as exhibiting a positive reaction if the test substance produced any of the following: ulceration of the cornea other than a fine stippling, opacity of the cornea other than a slight dulling of the normal luster, inflammation of the iris other than a slight deepening of the folds or slight circumcorneal injection of the blood vessels, obvious conjunctival swelling with partial eversion of the lids or a diffuse crimson-red with individual vessels not discernible. If two (2) or more animals exhibited a positive reaction, the test substance was considered an ocular irritant (Unless the test was repeated with another six animals without positive reactions).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No adverse effect reported
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: No adverse effected reported
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: No swelling observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
20
Reversibility:
other: No adverse effects observed
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Summary of eye irritation

Rabbit

Day

Cornea (A*B*5) +

Iris (A*5) +

Conjunctivae (A+B+C)*2 -

 

 

Total score*

Opacity (A)

Area of cornea involved (B)

Values (A)

Redness (A)

Chemosis (B)

Discharge ©

1

1

0

0

0

0

0

0

0

 

2

0

0

0

0

0

0

0

 

3

0

0

0

0

0

0

0

 

4

-

-

-

-

-

-

-

 

7

-

-

-

-

-

-

-

2

1

0

0

0

0

0

0

0

 

2

0

0

0

0

0

0

0

 

3

0

0

0

0

0

0

0

 

4

-

-

-

-

-

-

-

 

7

-

-

-

-

-

-

-

3

1

0

0

0

0

0

0

0

 

2

0

0

0

0

0

0

0

 

3

0

0

0

0

0

0

0

 

4

-

-

-

-

-

-

-

 

7

-

-

-

-

-

-

-

4

1

0

0

0

0

0

0

0

 

2

0

0

0

0

0

0

0

 

3

0

0

0

0

0

0

0

 

4

-

-

-

-

-

-

-

 

7

-

-

-

-

-

-

-

5

1

0

0

0

0

0

0

0

 

2

0

0

0

0

0

0

0

 

3

0

0

0

0

0

0

0

 

4

-

-

-

-

-

-

-

 

7

-

-

-

-

-

-

-

6

1

0

0

0

0

0

0

0

 

2

0

0

0

0

0

0

0

 

3

0

0

0

0

0

0

0

 

4

-

-

-

-

-

-

-

 

7

-

-

-

-

-

-

-

Average

1

 

 

 

 

 

 

0

 

2

 

 

 

 

 

 

0

 

3

 

 

 

 

 

 

0

 

4

 

 

 

 

 

 

-

 

7

 

 

 

 

 

 

-

*Total score possible/animal/observation interval = 110

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
(no concentration specified)
Conclusions:
Under the study conditions, the test substance was determined to be non irritating to the eyes.
Executive summary:

A study was conducted to determine the eye irritation potential of the test substance, 'Cocodimonium hydroxypropyl hydrolysed keratin' (active: not specified) according to the Draize method, in compliance with GLP. Six (6) New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of 0.1 mL of the test substance in one eye. The contralateral eye, remaining untreated, served as a control. The test substance was used as received (pH - 6.3). The eyes of all animals remained unwashed for 24 h. Observations of corneal opacity, iritis, and conjunctivitis were recorded 24, 48 and 72 h after treatment, and at 4 and 7 d, if irritation persisted. No irritation effects were observed in all animals. The overall, Draize score was determined to 0. Under the study conditions, the test substance was determined to be non irritating to the eyes (CPT, 1981).