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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from authoritative database and safety assessment report

Data source

Referenceopen allclose all

Reference Type:
other: authoritative database
Title:
Eye irritation study of isophthalic acid (CAS No: 121-91-5)
Author:
IFA GESTIS
Year:
2017
Bibliographic source:
GESTIS SUBSTANCE Database (information system in hazardous substance of the Berufsgenossenscheftn)
Reference Type:
secondary source
Title:
IUCLID Dataset for CAS 121-91-5
Author:
EUROPEAN COMMISSION – European Chemicals Bureau
Year:
2000
Bibliographic source:
IUCLID Dataset; EUROPEAN COMMISSION – European Chemicals Bureau; 18–FEB–2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
An eye irritation study of isophthalic acid (CAS No: 121-91-5) was conducted on six rabbits to assess the adverse effects caused by the chemical
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Isophthalic acid
EC Number:
204-506-4
EC Name:
Isophthalic acid
Cas Number:
121-91-5
Molecular formula:
C8H6O4
IUPAC Name:
1,3-benzenedicarboxylic acid
Test material form:
solid
Details on test material:
Name of the test chemical: Isophthtalic acid
Molecular Formula:C8H6O4
Molecular Weight: 166.1314 g/mol
InChI: 1S/C8H6O4/c9-7(10)5-2-1-3-6(4-5)8(11)12/h1-4H,(H,9,10)(H,11,12)
Substance Type: Organic
Physical State: Solid
Specific details on test material used for the study:
Name of the test chemical: Isophthtalic acid
Molecular Formula:C8H6O4
Molecular Weight: 166.1314 g/mol
InChI: 1S/C8H6O4/c9-7(10)5-2-1-3-6(4-5)8(11)12/h1-4H,(H,9,10)(H,11,12)
Substance Type: Organic
Physical State: Solid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
100% (100mg)
Duration of treatment / exposure:
14 days
Observation period (in vivo):
at 1, 2, 3, 4, 7, and 14 days following test article administration
Number of animals or in vitro replicates:
6
Details on study design:
- Area of exposure: one eye of each rabbit

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour
Score:
5.3
Max. score:
100
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
14 d
Score:
0
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The maximum irritation score of 5.3/110.0 was obtained 1 day after administration of the test article. Ocular Irritation was seen in all rabbits during the study, but only three rabbits exhibited positive reactions. Complete recovery from all signs of ocular irritation was evident in two rabbits by the 2nd day, in five rabbits by the 4th day, and in all rabbits by the final scoring interval.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The test material isophthalic acid (CAS No: 121-91-5) was considered to be not irritating to the rabbits’ eye.
Executive summary:

An eye irritation study ofisophthalic acid (CAS No:121-91-5)was conducted on six rabbits to assess the adverse effects caused by the chemical.

 

Isophthalic acid was administered undiluted at a dose of 0.1 gram into one eye of each of six rabbits, with the other eye serving as an untreated control. The treated eye of each rabbit was scored for irritation at 1, 2, 3, 4, 7, and 14 days following test article administration. The control eye was used for comparison.

 

The maximum irritation score of 5.3/110.0 was obtained 1 day after administration of the test article. Ocular Irritation was seen in all rabbits during the study, but only three rabbits exhibited positive reactions. Complete recovery from all signs of ocular irritation was evident in two rabbits by the 2nd day, in five rabbits by the 4th day, and in all rabbits by the final scoring interval.

 

Since all the ocular lesions cleared upto 14 days, the chemical isophthalic acid (CAS No:121-91-5) was considered to be not irritating to the rabbits’ eye.