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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
Study precedes the development of Good Laboratory Practices

Test material

Constituent 1
Chemical structure
Reference substance name:
Triisononyl benzene-1,2,4-tricarboxylate
EC Number:
258-847-9
EC Name:
Triisononyl benzene-1,2,4-tricarboxylate
Cas Number:
53894-23-8
Molecular formula:
C36H60O6
IUPAC Name:
1,2,4-tris(7-methyloctyl) benzene-1,2,4-tricarboxylate
Test material form:
liquid
Details on test material:
Production sample
Specific details on test material used for the study:
Described as a clear yellow, slightly viscous liquid with a faint odor

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Groups of six adult male and female albino rabbits of the New Zealand White variety provided Purina Rabbit Chow and water available ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Treated eyes were held closed for one second following application. No rinsing was described in the study report.
Observation period (in vivo):
Seven days
Number of animals or in vitro replicates:
Six rabbits
Details on study design:
The test substance was administered as a single application of 0.1 ml into the conjunctival sac of the left eye of each of six rabbits. Untreated right eyes served as controls.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
80
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
10
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
20
Reversibility:
fully reversible within: 48 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
80
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
10
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
80
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
10
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
80
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
10
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.3
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
80
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
10
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
80
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
10
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.7
Max. score:
20
Reversibility:
fully reversible within: 48 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Slight conjunctival erythema (moderate in one animal at four hours) subsided by 72 hours. Slight discharge was noted at one hour only. On Day 7, negative fluorescein examination confirmed the absence of corneal damage in all eyes
Other effects:
Blinking and preening noted immediately after instillation of compound.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance produced only slight conjunctival irritation consisting of slight erythema and discharge which completely subsided by 72 hours. The substance does not meet criteria for classification.
Executive summary:

Potential for eye irritation was assessed in a group of six male and female New Zealand White rabbits. Each rabbit received a single instillation of 0.1 mL test substance in the conjunctival sac of one eye (with the other eye consider the control) without subsequent irrigation and were observed for eye irritation for up to seven days. The iris and corneas irritation scores consistently showed no signs of irritation during the observation period. Minor conjunctival indications of irritation (redness) were observed in four of six rabbits at 24 or 48 hours, but resolved by 72 hours in all cases. The substance does not meet criteria for classificaiton as an eye irritant.