5-amino-2,4,6-triiodoisophthalic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: We extrapolated the results with the read-across approach about eye irritation of Iodoftaluro in the rabbit. Iodoftaluro (5-amino-2,4,6-triiodo-1,3-benzenedicarbonyl dichloride) is a compound of Iodoftal and two molecules of chlorine.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

37441-29-5

EC Number:

609-431-4

Cas Number:

37441-29-5

IUPAC Name:

37441-29-5

Details on test material:

The test substance is Iodoftaluro (5-amino-2,4,6-triiodo-1,3-benzene-dicarbonyl dichloride).
CAS number: 37441-29-5
Physical state: powder
pH (10% in water): 2,9
Test substances were stored at room temperature in the dark in a closed cabinet.

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino rabbit

Details on test animals or tissues and environmental conditions:

3 males were used

Test system

Vehicle:

water

Controls:

other: the right eye of each animal was used as control

Amount / concentration applied:

A volume of about 0,1 ml with a maximum weight of 100 mg was used.

Duration of treatment / exposure:

The test substance was placed in the fornix conjunctivae of the left eye of the rabbit then the eyelids were maintained closed for one second to avoid a loss of substance.

Observation period (in vivo):

Animals were examined for signs of eye irritation and the response scored at 1 hour, 24 hours, 48 hours and 72 hours after application according to the grades given in the OECD guideline.

Number of animals or in vitro replicates:

There was one rabbit per product for the first run, then two complementary rabbits when the test substance was not found to be irritative.

Details on study design:

The eyes were not rinsed during the 24 hours following the application of the test substance. When necessary a rinse was made at the 24th hour.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

animal: #1,2 and 3

Time point:

other: 1, 24, 48, 72 h

Score:

< 0.3

Max. score:

0.06

Reversibility:

fully reversible

Remarks on result:

other: 0.06 is the average score

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test substance is not irritative for the rabbit eye.