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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
This study is used for read-across and therefore has been assigned a reliability of 2 (reliable with restrictions). The study, if used in support of terephthalic acid, has a reliability of 1 (reliable without restriction).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Terephthalic acid TA-12, Lot no. DDN-55.

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Albino rabbits

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100 mg undiluted test substance
Duration of treatment / exposure:
Single dose
Observation period (in vivo):
Observations were made at 1, 24, 48 and 72 hours, and 7 days post application.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
6
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
48 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: all animals
Time point:
24/48/72 h
Remarks on result:
other: not reported
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
10
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
5
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
All irritant effects had disappeared by the 48 hour observation. One rabbit was assigned a score of 10 for corneal irritation at the 24 hour time point, but returned to normal by the 48 hour observation. No other corneal effects were observed. Individual animal data are presented in Table 1. The average irritation score 1 hour after application was 9.0 (out of a possible 110), and at 24 hours was 4.5 (out of a possible 110).
Other effects:
not reported.

Any other information on results incl. tables

Table 1. Individual rabbit data showing eye irritation scores. The scores given at the 48 and 72 hour and 7 day time points were the same, hence these scores have been given in one column.

Tissue

Rabbit No.

1 hour

24 hours

48 hours, 72 hours, 7 days

Cornea

1

0

0

0

Iris

5

0

0

Conjunctiva

4

0

0

Total

9

0

0

 

Cornea

2

0

0

0

Iris

5

0

0

Conjunctiva

4

0

0

Total

9

0

0

 

Cornea

3

0

10

0

Iris

5

5

0

Conjunctiva

4

6

0

Total

9

21

0

 

Cornea

4

0

0

0

Iris

5

0

0

Conjunctiva

4

0

0

Total

9

0

0

 

Cornea

5

0

0

0

Iris

5

0

0

Conjunctiva

4

2

0

Total

9

2

0

 

Cornea

6

0

0

0

Iris

5

0

0

Conjunctiva

4

4

0

Total

9

4

0

 

Averages

 

 

 

 

Cornea

0.0

1.7

0

Iris

5.0

0.8

0

Conjunctiva

4.0

2.0

0

Total

9.0

4.5

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The author classified the test substance not irritating to the eyes of rabbits
Executive summary:

Limited information is available regarding this study. 100 mg undiluted test substance was applied to the eyes of albino rabbits. One rabbit showed a stronger reaction than the others, but in all cases eyes had returned to normal within 48 hours. The average irritation score 1 hour after application was 9.0 (out of 110), and at 24 hours was 4.5 (out of 110). The author classified the test substance as non-irritating to rabbit eyes.