Isophthaloyl dichloride

Eye irritation

Administrative data

Endpoint:

eye irritation

Remarks:

in vitro

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

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). This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

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

Test material information

Constituent 1

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.

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:

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

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 hour

Score:

9

Max. score:

110

Reversibility:

fully reversible within: 48 hrs

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hours

Score:

4.5

Max. score:

110

Reversibility:

fully reversible within: 48 hrs

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.

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:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
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.