5-(Acetyl-(3-(acetyl-(3,5-bis(2,3-dihydroxypropylcarbamoyl)-2,4,6-triiodophenyl)amino)-2- hydroxypropyl)amino)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide; 5,5'-((2-Hydroxytrimethylene)bis(acetylimino))bis(N,N'-bis(2,3-dihydroxypropyl)-2,4,6- triiodoisophthalamide);

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February-June 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was conducted in accordance with Good Laboratory Practices.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize, J.H. (1965), The appraisal of the safety of chemicals in food, drugs and cosmetics-dermal toxicity, Assoc. of Food and Drug Officials of the United States, Topeka, Kansas, pp.46-48.

Principles of method if other than guideline:

The study following Draize's technique in New Zealand White Rabbits ((Draize, J.H. (1965), The appraisal of the safety of chemicals in food, drugs and cosmetics-dermal toxicity, Assoc. of Food and Drug Officials of the United States, Topeka, Kansas, pp.46-48).

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

other: water and buffer ingredients

Remarks:

water and buffer ingredients

Controls:

yes

Amount / concentration applied:

0.5 ml aliquots of test substance.

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours

Number of animals:

6 exposed to test substance and 6 animals recieving only vehicle solution (control).

Details on study design:

See method

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

0.2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Test Article: Vehicle Formulation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

0.2

Reversibility:

fully reversible within: 72

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No irritant.

Other effects:

No other effects seen.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Iodixanol was considered nonirritating

Executive summary:

Iodixanol (NaCl formulation) was tested for acute skin irritation in rabbits in a "Draize test". Four test areas were clipped free of hair on the back of each of 6 New Zealand White rabbits (3 males, 3 females) and 2 of the areas on each animal were abraded with a skin abrader. Iodixanol (0.5 ml of a 320 mgI/ml solution) or placebo were applied to unabraded and abraded skin. Examination of the 6 unabraded and 6 abraded skin sites of the rabbits treated for 24 hours showed barely perceptible skin irritation at 3/6 abraded sites treated with iodixanol, and 2/6 abraded sites treated with with placebo. The irritation resolved within 72 hours.