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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981-09-07 - 1981-09-15
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:
equivalent or similar to guideline
Guideline:
other: Federal Substances Act as described in the Federal Register, Section 1500.41 Federal Hazardous Substances Act Regulations - 16 CFR P 125
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
EC Number:
222-020-0
EC Name:
Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
Cas Number:
3319-31-1
Molecular formula:
C33H54O6
IUPAC Name:
tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
Details on test material:
Tris(2-ethoxyhexyl)trimellitate (CAS 3319-31-1): 98.95 %
2-Ethylhexanol: 0.5 %
Miescellaneous Esters: 1.00 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Husbandry Conditions:
Temperature: 70°F + /-2°F
Relative Humidity: 45% +/- 5%
Light: 12 hour light/dark cycle
Diet: Wayne 15% Rabbit Ration and tap water are provided ad libitum. Based on our current knowledge no contaminants are known to be in this diet or water that might be expected to interfere with the objectives of the study.
Caging: Stainless steel with elevated wire mesh flooring 1 rabbit/cage
Bedding: Techboard Shepherd Products Company Kalamazoo, Michigan 49005

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
7 days (single application but no washing)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
Six healthy young adult: New Zealand White rabbits were used in this study. 0.1 ml of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test material was not washed from the eyes.
The treated eyes were examined at one, two, three, four and seven days following instillation of the test material into the eyes. Interpretation of the results was made in accordance with the Draize Scale of Scoring Ocular Lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 2, 3, 4, 7 days
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 2, 3, 4, 7 days
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 3 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 3 d
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Score:
2.3
Reversibility:
fully reversible within: 3 d
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
48 h
Score:
1.7
Reversibility:
fully reversible within: 3 d
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible within: 3 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible within: 3 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible within: 3 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible within: 3 d
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible within: 3 d
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 4, 7 days
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 4, 7 days
Score:
0
Irritant / corrosive response data:
minimal conjunctival irritation with a score of 14 out of a possible 110 after 24 hours
minimal conjuctival irritation with a score of 10 out of a possible 110 after 48 hours
fully reversible after 3 days

Any other information on results incl. tables

Table with results is shown in attached file (Eye irritation - rabbits_tables.pdf) on page 2 -3.

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS (CLP) criteria not met
Conclusions:
Based on the accompanying table, the subject material is not a primary ocular irritant, all observed effects are fully reversible within 3 days.
Executive summary:

In vivo acute eye irritation has been assessed in the rabbit according to Federal Substances Act as described in the Federal Register, Section 1500.41 Federal Hazardous Substances Act Regulations - 16 CFR P 125 and in compliance with GLP criteria.

Six healthy young adult New Zealand White rabbits were used in this study. 0.1 ml of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test material was not washed from the eyes. The treated eyes were examined at one, two, three, four and seven days following instillation of the test material into the eyes. Interpretation of the results was made in accordance with the Draize Scale of Scoring Ocular Lesions

Based on the accompanying table, the subject material is not a primary ocular irritant, all observed effects are fully reversible within 3 days.