[[4-[[4-(anilino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]benzenesulphonic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from to February 15, 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline test with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pigment Blue 61

IUPAC Name:

Pigment Blue 61

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Pigment Blue 61 (61DT6100), Batch# 9241902
Supplied by:Flint Group
Date Received:10/11/10
Storage:Room temperature and humidity
Description:Blue Powder
Sample Preparation:The test article was used as received.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

New Zealand White rabbits were received from Myrtle's Rabbitry, inc., Thompsons Station TN on 10/07/10 and acclimated for at least five days. Only animals in apparent good health were made available for study assignment. Prior to being selected for this study, both eyes of each animat were examined according to the Draize technique for any evidence of irritation or abnormalities of the cornea, iris and/or conjunctiva. A Mini-Maglite® flashlight equipped with a high intensity bulb was used to aid in the examination. Three rabbits (1 male - 2 females), free from evidence of ocular irritation or abnormalities, were assigned to this study without conscious bias.
The animals were born on 06/28/10. The pretest body weight range was 2.7 - 2.9 kg. The animals were identified by cage notation and a uniquely numbered metal eartag. The animals were housed 1/cage in suspended cages. Paper bedding was placed beneath the cages and changed at least three times/week. Fresh PMI Rabbit Chow (Diet #5321) was provided daily. Water was available ad libitum. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12-hour light/dark cycle and was kept clean and vermin free.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral eye

Amount / concentration applied:

The test article (0.1 ml equivalent (23.4 mg)) was placed by syringe-type applicator into the conjunctival sac that was formed by gently pulling the lower eyelid away from the eye. After insWlation, the lids were held together for approximately one second to insure adequate distribution of the test article.

Duration of treatment / exposure:

approximately one second

Observation period (in vivo):

at 1, 24, 48 and 72 hours and again on day 7 postdose

Number of animals or in vitro replicates:

1 male and 2 females

Details on study design:

Dosing
The test article (0.1 ml equivalent (23.4 mg)) was placed by syringe-type applicator into the conjunctival sac that was formed by gently pulling the lower eyelid away from the eye. After insWlation, the lids were held together for approximately one second to insure adequate distribution of the test article. One eye of each rabbit was dosed. The contralateral eye served as a control.
Type and Frequency of Observations
Using a Mini-Magiite® flashlight equipped with a high intensity bulb, the treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours and again on day 7 postdose. The control eyes were observed at the same time periods. Sodium fluorescein dye procedures were used at the 24-hour observation interval. The eye was examined with the aid of an ultraviolet light source. Ocular reactions were graded according to the numerical Draize technique. Additional signs were described.
Body weights were recorded pretest and at termination.
Observations for toxicity and pharmacological effects were recorded at each ocular observation period and mortality observations were performed daily. All animals were humanely sacrificed using C02 following study termination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 48hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 48hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 72hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24hours

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 72hours

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 48hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72hours

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48hours

Irritant / corrosive response data:

There was no cornea! opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared in one eye by 48 hours, in one eye by 72 hours and in one eye by day 7.
The control eyes appeared normal at all observation periods.

Other effects:

There were no abnormal physical signs noted during the observation period.
Body weights increased in two animals and stayed the same in one animal.

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions, test article caused mildly irritating to rabbit's eyes.

Executive summary:

This study was performed to investigate the irritant or corrosive effects of test article when applied to the eyes of a rabbit. This study was designed to comply with GLP regulations and OECD guideline 405. Three healthy New Zealand White rabbits(1 male, 2 females) were dosed with test article. Test article(0.1 ml equivalent 23.4 mg) was placed into the conjunctival sac of one eye of each rabbit for 4 hours. The eyes were examined pretest and scored by the Draize technique at 1,24, 48 and 72 hours and again on day 7 postdose. The contral eyes were observed at the same time periods. Animals were also observed for toxicological effects at each dermal observation period and observed for mortality daily.There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared in one eye by 48 hours, in one eye by 72 hours and in one eye by day 7.

The control eyes appeared normal at all observation periods.There were no abnormal physical signs noted during the observation period.

Therefore, test article is considered to be only mildly irritating to rabbit's eyes as the mean scores of conjunctival irritation < 2 (following grading at 24, 48 and 72 hours after installation of the test material), and which fully reverses within an observation period of 7 days.