C.I. Solvent Blue 43

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09/09/2012

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 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The Solvent blue-43 was tested for its dermal irritation potential in New Zealand White Rabbits at the Institute for Industrial Research & Toxicology following Good Laboratory practice. The study was conducted according to OECD guideline 404.

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:

Initial test (using one animal):
In the initial test one healthy rabbit of body weight 1.80kg±200gm selected for study after acclimatization. The test compound in the amount of 0.5 gm was applied at the different sites on the shaven back skin of animal. The hairs of back sides were removed (approximately 6 cm2) one day earlier before the treatment.

The site of application was covered with impervious dressing secured in position with adhesive tape. The first patch was applied on the shaven back skin of rabbit and removed after three minutes. No serious reaction was observed at the site of application. The second patch was applied on the different shaven back side and removed after one hour. There were no signs of skin reaction observed at this site of application. Finally, a third patch was applied at a different site and was removed after four hour. There were no signs of skin reaction observed at the site of application. Finally, the animal was observed for 14 days, for any irritation and corrosion.

The test compound solvent blue-43 did not produce any irritation or corrosive effect.

Confirmatory test (with addition animals):
Because there was no corrosive effect observed in the initial test, a confirmatory test was done using two additional animals following same procedure.

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

maximum 4 hour

Observation period:

14 days

Number of animals:

No. of animals : Three

Preparation of Animals
The animals were prepared 24 hrs prior to application of test product. The furs from the dorsal area of trunk of animals were removed with electric clippers exposing an area measuring approximately 6 cm2 of body surface area of animal. The care was taken such that abrasion penetrated the Stratum corneum only and not dermis.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hrs

Score:

0

Max. score:

0

Reversibility:

other: no irritation effect

Other effects:

The test compound Solvent blue-43 (CAS NO 61813-75-0) applied on the shaven back skin of rabbit did not produce any clinical signs of toxicity throughout the examination period of 14 days.

The site of application was observed for skin reaction if any. The intact skin site of application of each animal was observed for signs of erythema and oedema and the responses were scored following Draize’s method at 60 min., 24, 48 and 72 hours after application.

Any other information on results incl. tables

Skin reaction 

The results obtained from present study reveal that Solvent blue-43 (CAS NO 61813-75-0) when applied to shaven back skin of rabbits in the amount of 0.5 gm did not show any clinical signs of skin irritation reaction throughout the observation period. These responses were graded according to Draize’s Scoring method.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test compound solvent blue-43 applied on the shaven area of skin of New Zealand white rabbits in the amount of 0.5 gm did not showed any clinical signs of skin irritation.

Executive summary:

The test compound solvent blue-43 applied on the shaven area of skin of New Zealand white rabbits in the amount of 0.5 gm did not showed any clinical signs of skin irritation. Finally, the results obtained from present investigation concluded that the Solvent blue-43 is nonirritant to skin in New Zealand white rabbit. So, it can be concluded that the test compound solvent blue-43 did not produce any irritation or corrosive effect.