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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
poor documentation

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-cyclohexylaminopropylamine
EC Number:
222-001-7
EC Name:
3-cyclohexylaminopropylamine
Cas Number:
3312-60-5
Molecular formula:
C9H20N2
IUPAC Name:
N1-cyclohexylpropane-1,3-diamine
Test material form:
liquid
Details on test material:
3-Cyclohexylaminopropylamine from Performance Chemicals, lot number: 68-219-BC

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 ml of test compound
Duration of treatment / exposure:
One application
Observation period (in vivo):
24 h
Number of animals or in vitro replicates:
6 albino rabbits
Details on study design:
Six adult albino rabbits were each treated by instilling into one eye 0.1 ml of the test compound. The opposite eye served as controlin each case and treatment was alternated, right to left, among the animals.
Eye damage was evaluated by the scoring system of Draize as described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics pp.51 (published by the association of Food and Drug Officials of the United States). Observations were made at 2 to 4 and at 24 hours, when these animals were sacrified.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
mean of all animals
Time point:
other: 2-4- hours
Score:
80
Max. score:
80
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
Animal 1 and 2
Time point:
other: 2-4 hours
Score:
12
Max. score:
20
Reversibility:
not specified
Remarks on result:
probability of severe irritation
Irritant / corrosive response data:
All six rabbits screamed in pain upon instillation of the test compound. By two hours it was apparent that the eyes were permanently damaged, with the adjacent membranes and tissues severely burned. At 24 hours it was decided to sacrifice these rabbits since all were obviously permanently blinded and in great pain.

Any other information on results incl. tables

Rabbit Eye Irritation test Results

Cornea Iris  Conjunctivae     
Rabbit No Body weight initial [kg] Observation time  Opacity Area of involvement Score Iritis Score Erythema Edema Discharge Score Total score Autopsy
1 2.4 2 - 4 h 4 4 80     3 2 1 12 92 Lids blackened, Permanent damage
24h
48h
72h
5 days
    7 days                    
2 2.3 2 - 4 h 4 4 80     3 2 1 12 92 Lids blackened, permanent damage
24h
48h
72h
5 days
    7 days                    
3 2.1 2 - 4 h 4 4 80     3       80 Permanent damage
24h
48h
72h
5 days
    7 days                    
4 2.3 2 - 4 h 4 4 80     3       80 Permanent damage
24h
48h
72h
5 days
    7 days                    
5 2.4 2 - 4 h 4 4 80     3       80 Permanent damage
24h
48h
72h
5 days
    7 days                    
6 2.3 2 - 4 h 4 4 80     3       80 Permanent damage
24h
48h
72h
5 days
    7 days                    

Applicant's summary and conclusion

Conclusions:
The test compound must be considered to be a very severe eye corrosive substance, and small amounts in the eye may cause permanent blindness.
Executive summary:

Six adult albino rabbits were each treated by instilling into one eye 0.1 ml of the test compound. The opposite eye served as control in each case and treatment was alternated, right to left, among the animals.

Eye damage was evaluated by the scoring system of Draize. All six rabbits screamed in pain upon instillation of the test compound. By two hours it was apparent that the eyes were permanently damaged, with the adjacent membranes and tissues severely burned. At 24 hours it was decided to sacrifice these rabbits since all were obviously permanently blinded and in great pain. The test compound must be considered a very severe eye irritant, and small amounts in the eye may cause permanent blindness.