Isophthalic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-11-05 to 1984-11-19

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Proprietary study: equivalent to OECD guideline 405.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Isophthalic acid

EC Number:

204-506-4

EC Name:

Isophthalic acid

Cas Number:

121-91-5

Molecular formula:

C8H6O4

IUPAC Name:

isophthalic acid

Details on test material:

- Name of test material (as cited in study report): IPA-99
- Physical state: White Powder

- Storage condition of test material: Stored at room temperature at approxiametely 22 °C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
New Zealand albino rabbits were purchased from Hazleton Dutchland Laboratories for use in this study. Upon arrival (10/23/1984), the rabbits were held in quarantine for approximately two weeks and examined carefully to ensure their health and suitability as test subjects. Rabbits selected for the study were identified by a unique numbered metal tag inserted through the pinna of the right ear and by a cage number. Purina Lab Rabbit Chow HF #5326 and water supplied from a reverse osmosis purifier by an automatic watering system were available ad libitum. The rabbits were housed individually in stainless steel cages measuring 61.0 x 45.5 x 41.0 cm. Poly pads were placed in the pan below the stainless steel mesh floor of each animal cage to adsorb liquids.

ENVIRONMENTAL CONDITIONS
Air conditioned animal rooms were maintained at approximately 22 °C and 40 % relative humidity. Fluorescent lighting was provided for 12 hours followed by 12 hours of darkness.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
0.1 g of the undiluted test article was placed into the everted lower lid of the right eye of each rabbit. The lids were held closed for approximately two seconds following test article administration. The other eye was left untreated.


VEHICLE
No vehicle used

Duration of treatment / exposure:

IPA-99 was placed into the everted lower lid of the right eye of each rabbit. The lids were held closed for approximately two seconds following test article administration.

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

Rabbits used on test were selected at random and assigned to a single group of three males and three females.
The treated eye of each rabbit was scored for irritation at 1, 2, 3, 4, 7 and 14 days following test article administration. The right eye remained untreated and was used for control comparison.

The eyes were examined and scored by the method of Draize (Draize, J.H., Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Assoc. Food & drug Officials of the U.S., Austin TX, 1959). A rabbit was considered to exhibit a positive reaction if, at any observation period, the test article produced ulceration or opacity of the cornea (any cornea score greater than 0), inflammation or slight circumcorneal injection of blood vessels of the iris (any iris score greater than 0), any obvious conjunctival swelling with partial eversion of the lids (a chemosis score of 2 or greater) with individual vessels not easily discernable (“methods of Testing Primary Irritant Substances”, - Federal Register, 38, No. 187, p.27019, September 1973).

After the final observation, the rabbits were sacrificed, necropsies were not performed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72h

Score:

0

Max. score:

0

Remarks on result:

other: No reactions

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72h

Score:

0

Max. score:

0

Remarks on result:

other: No reactions

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72h

Score:

0.72

Max. score:

2

Reversibility:

fully reversible within: 96h

Remarks on result:

other: Erythema

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 96h

Irritant / corrosive response data:

No irritation of the cornea or iris was observed in any rabbit during the study. Conjunctival irritation (i.e. erythema, chemosis and/or discharge) was observed in all rabbits 1 day following test article administration. Complete recovery from these 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 evaluation.

Other effects:

None

Any other information on results incl. tables

Eye irritation scores:

Observation		24h	48h	72h	Mean (24-72h)	96h	7d	14d
Cornea	Opacity	0,0,0,0,0,0	0,0,0,0,0,0	0,0,0,0,0,0	0.00	0,0,0,0,0,0	0,0,0,0,0,0	0,0,0,0,0,0
Iris	Lesion	0,0,0,0,0,0	0,0,0,0,0,0	0,0,0,0,0,0	0.00	0,0,0,0,0,0	0,0,0,0,0,0	0,0,0,0,0,0
Conjunctivae	Erythema	1,1,1,1,2,2	1,0,0,0,1,1	0,0,0,1,1,0	0.72	0,0,0,0,0,0	1,0,0,0,0,0	0,0,0,0,0,0
	Chemosis	2,1,1,0,2,1	1,0,1,0,0,1	0,0,0,0,1,1	0.67	0,0,0,0,0,1	0,0,0,0,0,0	0,0,0,0,0,0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Isophthalic acid (IPA) was administered undiluted into one eye of each of six rabbits. 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. Therefore, IPA was not considered to be irritating.

Executive summary:

Isophthalic acid (IPA) was administered undiluted at a dose of 0.1 g 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. 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.