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EC number: 202-830-0 | CAS number: 100-21-0
Eye irritation
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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other company data
- 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)
- 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 substance name:
- Terephthalic acid
- EC Number:
- 202-830-0
- EC Name:
- Terephthalic acid
- Cas Number:
- 100-21-0
- Molecular formula:
- C8H6O4
- IUPAC Name:
- benzene-1,4-dicarboxylic acid
- 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.
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 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:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No data reported on individual animals
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No data reported on individual animals
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No data reported on individual animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No data reported on individual animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No data reported on individual animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No data reported on individual animals
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No data reported on individual animals
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No data reported on individual animals
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No data reported on individual animals
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No data reported on individual animals
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No data reported on individual animals
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No data reported on individual animals
- 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 informationCriteria 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.
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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