Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 September to 23 September 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to acceptable standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
Deviations:
yes
Principles of method if other than guideline:
The test was carried out in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name: triisodecyl benzene-1,2,4-tricarboxylate
Appearance: Pale, yellow liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals
Healthy New Zealand White rabbits were used. These were aged 12-14 weeks with average body weights of 2.19 kgs (2 females) and 2.15 kgs. (2 males) and were obtained from a commercial supplier (Hacking and Churchill). Six rabbits (3 males and 3 females) were acclimatized in the test area for one week prior to the start of the trial.

Husbandry
The rabbits were caged singly in an experimental room maintained at a temperature of l6°C (± 1°)and a relative humidity of 50 - 70%. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. A commercial diet (Labsure, Christopher Hill. Group)was fed ad lib. Filtered water acidified to approximately pH3 was available at all times.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other:
Amount / concentration applied:
0.1 ml of the test compound were instilled into the conjunctival sac of the left eye.
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Six rabbits
Details on study design:
The eyes of the experimental animals were examined and found normal prior to the test. 0.1 ml of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 200 ml. of warm water.

The rabbits were examined 1, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary. The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A. Fluorescein (Fluorets -Smith and Nephew Pharmaceuticals Limited)was used as an aid in assessing corneal damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: At 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: At 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: At 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: At 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: At 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: At 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: At 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: At 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
for all 6 animals
Time point:
other: At 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Irritant / corrosive response data:
Conjunctiva

A very slight reaction was seen 2/3 washed and 3/3 unwashed eyes in 1 hour after compound application.

3/3 washed and 1/3 unwashed eyes were normal at 24 hours. The remaining 2/3 unwashed eyes were normal at 48 hours.

The reactions seen in unwashed eyes were similar to those in washed eyes.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these results, the substance is not classified as an eye irritant.
Executive summary:

Based on these results, the substance is not classified as an eye irritant.