Benzoic acid, 3-amino-5-[[[2,3-bis(acetyloxy)propyl]amino]carbonyl]-2,4,6-triiodo-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

rac-5-Amino-N-(2,3-diacetoxypropyl)-2,4,6-triiodoisophthalamic acid

EC Number:

602-891-7

Cas Number:

122731-59-3

Molecular formula:

C15 H15 I3 N2 O7

IUPAC Name:

rac-5-Amino-N-(2,3-diacetoxypropyl)-2,4,6-triiodoisophthalamic acid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Schriever
- Weight at study initiation: 3.5 -4.1 kg
- Housing: individually under conventional conditions in metal cages
- Diet (e.g. ad libitum): ad libitum: pell. AItromin® K
- Water (e.g. ad libitum): ad libitum: demineralized water
- Acclimation period: > 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 70-74
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

test substance remained in eye and was not flushed out

Observation period (in vivo):

72h

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: According to the score system in the "|llustrated Guide for Grading Eye Irritation by Hazardous Substances", U.S. Department of Health, Education and Welfare, Food and Drug Administration, Washington D.C. 20204, USA. The score system can also be found in the Annex to EEC Directive 92/69/EWG, dated 31. Jul. 1992, for the 17th adaption of the EEC Directive 67/548/EWG.

TOOL USED TO ASSESS SCORE: not specified

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

3

Reversibility:

fully reversible within: 2 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

Slight to moderate transient irritation on the rabbit conjuctiva mainly on application day. All animals were without any symptoms from day 2 or 3 onwards

Any other information on results incl. tables

 

Animal No. and sex	Location	Finding	Right eye 100 mg test item, hours after application			results	left eye control untreated, hours after application			results
			24	48	72		24	48	72
	Cornea		0	0	0	negative	0	0	0	negative
	Iris		0	0	0		0	0	0
	Conjunctiva	Reddening	1	0	0		0	0	0
		swelling	0	0	0		0	0	0
	Cornea		0	0	0	negative	0	0	0	negative
	Iris		0	0	0		0	0	0
	Conjunctiva	Reddening	1	0	0		0	0	0
		swelling	0	0	0		0	0	0
	Cornea		0	0	0	negative	0	0	0	negative
	Iris		0	0	0		0	0	0
	Conjunctiva	Reddening	1	0	0		0	0	0
		swelling	0	0	0		0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is non-eye irritant, classification is not required

Executive summary:

The single administration of Tamip diacetate to the right eye of female rabbits in the doses of 100 mg/kg results in slight to moderate transient irritation on the rabbit conjuctiva mainly on application day. All animals were without any symptoms from day 2 or 3 onwards. The test substance is non-eye irritant.