2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate

EC Number:

222-813-1

EC Name:

2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate

Cas Number:

3618-72-2

Molecular formula:

C23H25BrN6O10

IUPAC Name:

2-{[2-(acetyloxy)ethyl]({4-[ (E)-2-(2-bromo-4,6-dinitrophenyl)diazen-1-yl]-5acetamido-2-methoxyphenyl})amino}ethyl acetate

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three New Zealand white strain rabbits were supplied by Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
At the start of the study the animals weighed 2.37 - 2.66 kg and were approximately twelve to sixteen weeks old.
After a minimum acclimatisation period of five days each animal was given a number unique within the study written on the inner surface of the ear and on a cage label using a black indelible marker pen.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (Rabbit Diet, Special Diet Services Limited, l.litham, Essex, U.K. ) was allowed throughout the study.
The animal room was maintaÍned at a temperature of 19 - 22 °C and relative humidity of 50 - 55 %. The rate of air exchange was approximately 15 changes per hour and the Iigthing was controlled by a time switch to give 12 hours light and 12 hours darkness.

Test system

Controls:

other: untreated left eye served as control

Amount / concentration applied:

0.1 ml (48 mg)

Number of animals or in vitro replicates:

3 females

Details on study design:

Within 24 hours of commencement of the test both eyes of each rabbit provisionally selected, were exami ed for evidence of ocular irritation or defect using an ophthalmoscope. Animals showing evidence of ocular Ie sions were rejected and replaced.
0n the day of the test each rabbit was held firmly but gently until quiet. A volume of 0.1 ml of the test material which was found to weigh 48 mg was placed into the right eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test material was
dropped. The upper and lower eyelids were held together for about one second immediately after application to prevent loss of the test material from the eye. The left eye remained untreated and was used for control purposes.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Iridial inflammation and a dulling of the normal lustre of the cornea were noted in all treated eyes one hour after treatment. The corneas and iris of all animals appeared normal at subsequent observations.
Conjunctivis identified by redeness and swelling was apparent in all treated eyes at the on-hour observation. The irritation regressed and minimal conjunctivis persisted at the 24 h observation. All treated eyes appeared normal 48 h after treatment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance was tested for eye irritation following OECD 405. Under the experimental conditions the substance did not show any eye irritation potetial

Executive summary:

A study was conducted to determine the eye irritation potential of the test substance (97.4% purity) according to OECD Guideline 405. Three New-Zealand white rabbits received 48 mg (100 µL) of test substance in the conjunctival sac of one eye. The other eye remained untreated and served as negative control. Effects on iris, cornea and conjunctiva were evaluated after 1, 7, 24 and 48 h. Iridal inflammation and a dulling of the normal lustre of the cornea were noted in all treated eyes 1 h after treatment. The corneas and iris of all animals appeared normal at subsequent observations. Conjunctivitis, identified by redness and swelling, was apparent in all treated eyes at the 1 h observation. The irritation regressed and minimal conjunctivitis persisted at the 24 h time point. All treated eyes appeared normal after 48 h. Under the study conditions, the test substance was therefore not considered to be irritating to rabbit eyes (Archroma, 1986).