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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conducted according to sound scientific principles, similar to OECD TG 405. GLP

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Reference Type:
publication
Title:
TRIS(2-ETHYLHEXYL)BENZENE-1,2,4-TRICARBOXYLATE
Author:
OECD SIDS
Year:
2002
Bibliographic source:
SIDS Initial Assessment Report for Siam 14: TRIS(2-ETHYLHEXYL)BENZENE-1,2,4-TRICARBOXYLATE

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
Source: Nouplaz TOTM(Tenneco Chemicals, Inc.)
Purity: 98.95%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Temperature - 70 ± 2 degree 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 - Techbord
Shepherd Products Company
Kalamazoo, Michigan 49005

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye was not treated
Amount / concentration applied:
0.1 mL test material, 100% w/w%
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
0.1 mL of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to severe as controls. The treated eyes were examined at one, two, three, four and seven days following instillation of the test materials into the eyes.

Evaluation : Interpretation of the results was made in accordance with the Draize Scale of Scoring Ocular Lesions.

Note: Under the DSD, CLP, and GHS, classification is based on the time points 24, 48, 72 hours AFTER the test material exposure has ended. In this experiment, the observation time points that correlate to these time points are 48 h (Day 2), 72 h (Day 3), and 96 h (Day 4).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: conjunctivae + chemosis score combined
Basis:
mean
Time point:
other: 48, 72, 96 h average
Score:
0.57
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Time points used for classification according to DSD, CLP, and GHS
Irritation parameter:
other: conjunctivae + chemosis score combined
Basis:
mean
Time point:
other: 24 hours after installation (Day 1)
Score:
2.3
Max. score:
4
Reversibility:
fully reversible
Remarks:
by day 3
Irritation parameter:
other: conjunctivae + chemosis score combined
Basis:
mean
Time point:
other: 48 hours after installation (Day 2)
Score:
1.7
Max. score:
2
Reversibility:
fully reversible
Remarks:
by day 3
Irritation parameter:
other: conjunctivae + chemosis score combined
Basis:
mean
Time point:
other: 72 hours after installation (Day 3)
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
other: conjunctivae + chemosis score combined
Basis:
mean
Time point:
other: 96 hours after installation (Day 4)
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
other: conjunctivae + chemosis score combined
Basis:
mean
Time point:
other: Day 7
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Day 1 through Day 7
Score:
0
Max. score:
0
Remarks on result:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Day 1 through Day 7
Score:
0
Max. score:
0
Remarks on result:
other: no effects observed
Irritant / corrosive response data:
see Table 1 for individual animal data

Any other information on results incl. tables

Table 1 - Individual Rabbit Scores

 

Tissue Score - day 1 day 2 day 3 day 4 day 7

 

Rabbit #1         

(1) Cornea total- 0 0 0 0 0

(2) Iris total - 0 0 0 0 0

(3) Conjunctivae total - 2 2 0 0 0

Total Ocular Irritation Score - 2 2 0 0 0

 

Rabbit #2         

(1) Cornea total 0 0 0 0 0

(2) Iris total 0 0 0 0 0

(3) Conjunctivae total 4 2 0 0 0

Total Ocular Irritation Score 4 2 0 0 0

 

Rabbit #3         

(1) Cornea total 0 0 0 0 0

(2) Iris total 0 0 0 0 0

(3) Conjunctivae total 2 2 0 0 0

Total Ocular Irritation Score 2 2 0 0 0

 

Rabbit #4         

(1) Cornea total 0 0 0 0 0

(2) Iris total 0 0 0 0 0

(3) Conjunctivae total 2 2 0 0 0

Total Ocular Irritation Score 2 2 0 0 0

 

Rabbit #5         

(1) Cornea total 0 0 0 0 0

(2) Iris total 0 0 0 0 0

(3) Conjunctivae total 2 2 0 0 0

Total Ocular Irritation Score 2 2 0 0 0

 

Rabbit #6         

(1) Cornea total 0 0 0 0 0

(2) Iris total 0 0 0 0 0

(3) Conjunctivae total 2 0 0 0 0

Total Ocular Irritation Score 2 0 0 0 0

 

Average Ocular Irritation Score

Day 1 - 2.3

Day 2 - 1.7

Day 3 - 0.0

Day 4 - 0.0

Day 7 - 0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The average erythema and edema score used for classification was calculated to be 0.57. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

0.1 mL of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to severe as controls. The treated eyes were examined at one, two, three, four and seven days following instillation of the test materials into the eyes.

The average erythema and edema score used for classification was calculated to be 0.57. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/548/EEC for dangerous substances and Directive 1999/45/EC for preparations.