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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:
2003-05-29 to 2003-06-01
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Colourless liquid
Details on test material:
Bernel Ester TCC (Tricapryl Citrate), Lot #P1585
Colourless lliquid stored at room temperature
100%. Test substance was expected to be stable for the duration of testing

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
New Zealand Albino, three male young adults. They were housed singly. Temperature 18-22 C with 12/12 hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL was instilled into the conjunctival sac of the right eye of 3 healthy rabbits by pulling the lower lid way from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimise loss of the test subtsance. The left eye remained untreated and served as a control.
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Ocular irritation was evaluated using a high-intensity white ligh in accordance with Draize et al. at 1, 24, 48 and 72 hours post-installation. The time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #1
Time point:
72 h
Score:
13.3
Max. score:
110
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of mild irritation
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #2
Time point:
72 h
Score:
13.3
Max. score:
110
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of mild irritation
Irritation parameter:
maximum mean total score (MMTS)
Basis:
animal #3
Time point:
72 h
Score:
13.3
Max. score:
110
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of mild irritation

Any other information on results incl. tables

   
   
   
   
   
  Incidence of Irritation
 Time Post Instillation (Hours)  Corneal Opacity  Iritis  Conjunctivitis
 1  0/3  0/3  3/3
 24  0/3  0/3  3/3
 48  0/3  0/3  3/3
 72  0/3  0/3  0/3

 Time Post Instillation (Hours)  Severity of Irritation - Mean Score
 1  13.3
 24  10.0
 48  4.0
 72  0.0
 

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Executive summary:

0.1 mL of the test substance was instilled into the right eye of 3 healthy rabbits by pulling the lower lid way from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimise loss of the test subtsance. The left eye served as a control. Occular irritation was evaluated by the Draize et al. method. Ocular irritation was evaluated using a high-intensity white ligh in accordance with Draize et al. at 1, 24, 48 and 72 hours post-installation. The time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra.

All animals appeared active and healthy. Apart from the eye irritation described below, there were no signs of gross toxicity, adverse phamacologic effects or abnormal behaviour.

No corneal opacity ot iritis was noted for any treated eye during the study. One hour after test substance installation, all three treated eyes exhibited conjunctivitis. The overall severity of irritation decreased with time. All animals were free of occular irritiation within 72 hours.

The Maximum Mean Total Score was 13.3 and is therefore classified as mildly irritating to the eye under these study conditions.