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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Remarks:
in vitro
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
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). This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

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:
The test substance was applied to the eyes of the rabbits, the eyes were not washed.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
An eye irritation test was conducted on 6 albino rabbits. 100 mg undiluted test substance was applied to the eyes of the rabbits. The test substance was not washed from the eyes. Observations were made at 1, 24, 48 and 72 hours, and 7 days post application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
9
Max. score:
110
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
4.5
Max. score:
110
Reversibility:
fully reversible within: 48 hrs
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.
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
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.