Registration Dossier
Registration Dossier
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EC number: 202-829-5 | CAS number: 100-20-9
Eye irritation
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:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Terephthalic acid
- EC Number:
- 202-830-0
- EC Name:
- Terephthalic acid
- Cas Number:
- 100-21-0
- Molecular formula:
- C8H6O4
- IUPAC Name:
- Terephthalic acid
- Details on test material:
- Terephthalic acid TA-12, Lot no. DDN-55.
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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