Benzoyl chloride, 3-[[[2,3-bis(acetyloxy)propyl]amino]carbonyl]-2,4,6-triiodo-5-[(2-methoxyacetyl)amino]-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-04-22 to 1994-11-20

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Directive 92/69/EWG, dated 31. Jul. 1992, for the 17th adaption of the EEC Directive 67/548/EWG.

Version / remarks:

1992

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

rac-3-(2,3-Diacetoxypropylcarbamoyl)-2,4,6-triiodo-5-methoxyacetylaminobenzoyl chloride

EC Number:

604-759-4

Cas Number:

150928-21-5

Molecular formula:

C18 H18 Cl I3 N2 O8

IUPAC Name:

rac-3-(2,3-Diacetoxypropylcarbamoyl)-2,4,6-triiodo-5-methoxyacetylaminobenzoyl chloride

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: 3.8 -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:

Amount / concentration applied:

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

Duration of treatment / exposure:

single application, observation for at least 72h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

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:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Findings	Right eye 100 mg TIP-Dimidchlorid/eye
	A	x-y
Outer eyelids
- Slight secretion with wetting of surrounding fur	9/3	1-2
- slight swelling of the margin eyelids	2/1	1-1
- Incomplete eyelid closure	1/1	1-1
Conjunctiva palpebrae
- slight reddening	1/1	1-1
- slight injection of blood vessels	3/1	1-1
Membrana nicitans
- slight reddening	3/1	1-1
- slight injection of blood vessels	6/3	1-1
Conjunctiva sclerae
- slight reddening	3/1	1-1
- slight injection of blood vessels	7/3	1-1
A = summation of positive findings/number of animals concerned x-y = first – last days of occurrence of a finding

 

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	0	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	0	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	0	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:

According to the score system in the "lllustrated Guide for Grading Eye Irritation by hazardous Substances" animals reacted negatively. The substance is not considered to be irritating to the eyes.

Executive summary:

In a primary eye irritation study according to  EEC Directive 92/69/EWG, dated 31. Jul. 1992, for the 17th adaption of the EEC Directive 67/548/EWG., 100 mg of TIP-Diamidchlorid (100 % a.i.) was instilled into the conjunctival sac of the right eye of young adult New Zealand rabbits (3 females). Animals then were observed for 3 days.  Irritation was scored by the method of 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.

In this study, TIP-Diamidchlorid is not an eye irritant based on the absence of any severe damages, i.e. reddening/swelling of conjunctivae, chemosis or corneal opacity.