Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No information: study reported in 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Proprietary study, guideline-comparable and well reported

Data source

Reference
Reference Type:
other company data
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)
Principles of method if other than guideline:
Eye irritation test in rabbits
GLP compliance:
not specified
Remarks:
: older study, pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Terephthalic acid TA-12, Lot no. DDN-55. The purity was not stated. However, terephthalic acid is a monomer used in the production of saturated polyesters, and a purified (> 99.9% w/w) feedstock (free of production-process impurities) is essential for this purpose. The batch of terephthalic acid used in this study is considered to have been representative of commercial production and to have been at least 99% pure.

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 was applied
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:
cornea opacity score
Basis:
mean
Time point:
other: 24-72h
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: effect seen in 1/6 animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects seen
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72h
Score:
0.17
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
other: effects seen in 6/6 animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: effects seen in 6/6 animals
Irritant / corrosive response data:
All irritant effects had disappeared by the 48 hour observation
Other effects:
Conjunctival discharge was additionally noted in 1 rabbit at 24 hours only

Any other information on results incl. tables

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

Mean eye irritation scores

Observation

Timepoint

1h

24h

48h

72h

Mean (24-72h)

7d

Cornea

Opacity

0.00

0.17

0.00

0.00

0.06

0.00

Iris

Lesion

0.00

0.00

0.00

0.00

0.00

0.00

Conjunctivae

Erythema

1.00

0.50

0.00

0.00

0.17

0.00

Chemosis

1.00

0.33

0.00

0.00

0.11

0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is a mild eye irritant and does not require labelling as an eye irritant under CLP.
Executive summary:

100 mg undiluted terephthalic acid was instilled into one eye of six albino rabbits and ocular reactions assessd for up to 7 days.

Effects were limited to Grade 1 conjunctival erythema and chemosis in all rabbit, with Grade 1 corneal opacity also apparent in one rabbit at 24 hours only. Conjunctival discharge was addtionally noted in 1 rabit at 24 hours only. The substance is a mild eye irritant and does not require labelling as an eye irritant under CLP.