C.I. Solvent Blue 43

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12/09/2012

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

One healthy rabbits of body weight 1.60kg±200g was selected for study after acclimatization. Rabbit was examined for any abnormal discharge such as eye irritation, ocular defects or pre-existing corneal injury from eye 24 hours prior to application of test compound.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

disodium 4-{[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium 3-{[ethyl({4-[(4-{ethyl[(3-sulfonatophenyl)methyl]amino}cyclohexa-2,5-dien-1-ylidene)(2-sulfonatophenyl)methyl]phenyl})amino]methyl}benzene-1-sulfonate

Cas Number:

61813-75-0

Molecular formula:

C61H70N6S3O9

IUPAC Name:

disodium 4-{[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium 3-{[ethyl({4-[(4-{ethyl[(3-sulfonatophenyl)methyl]amino}cyclohexa-2,5-dien-1-ylidene)(2-sulfonatophenyl)methyl]phenyl})amino]methyl}benzene-1-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

The test compound was applied in the conjunctival sac of rabbit after gently pulling the lower eye lid away from the eyeball at the dose rate of 0.1gm. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weight before and during the study was observed.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hrs

Score:

1

Max. score:

1

Reversibility:

other: no iritation

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

From the results obtained from present study, it can be concludes as the test compound Solvent blue-43 (CAS NO 61813-75-0) supplied is practically non irritant to the eyes of New Zealand white rabbit under present test condition.

Executive summary:

Irritation Scoring

The test compound Solvent blue-43 (CAS NO 61813-75-0)when applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm did not produced any lesions such as pannus, staining throughout the observation period of 72 hours.

Clinical Signs

The test compound Solvent blue-43 (CAS NO 61813-75-0) applied in conjunctival sac of rabbits did not show any observable clinical signs throughout the observation period of 21 days.