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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from Octobor 26, 2010 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:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

61DT6100

IUPAC Name:

61DT6100

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 individually weighed and moistened with 0.5 ml of distilled water to form a paste.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals were received from Myrtle's Rabbitry Inc., Thompsons Station, TN on 10/07/10. Following an acclimation period of at least five days, three healthy New Zealand White rabbits (1 male -2 females) were selected from a larger group 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 and individually housed 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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

0.5 g/site and moistened with 0.5 ml of distilled water to form a pasty consistency.

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after applying

Number of animals:

1 male, 2 females

Details on study design:

Site Preparation
The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. Each dose site was approximately 10x10 cm.
Dosing
The test article was individually weighed, 0.5 g/site and moistened with 0.5 ml of distilled water to form a pasty consistency. The test article was applied under a 2.5 x 2.5 cm gauze patch. Gentle pressure was applied to aid in the distribution of the test article over the prepared site. The patch was secured with non- irritating tape. The torso was covered with a piece of porous dressing (semi-occlusive) large enough to cover all dose sites with at least 5 cm square to spare on all sides of the gauze patch. Porous, non- irritating tape was used to encircle the trunk of the animal. The test article was kept in contact with the skin for 4 hours at which time the wrappings and patches were removed. Distilled water was used to gently wash the dose sites at the end of the exposure period, prior to scoring for dermal reactions. However, staining was noted at 60 minutes, and at 24 and 48 hours.
Type and Frequency of Observations
The test sites were scored for dermal irritation at 60 minutes and at 24, 48 and 72 hours following patch removal. Erythema and edema were scored according to the numerical Draize technique below. The skin was also evaluated for uiceration and necrosis or any evidence of tissue destruction. Additional signs were described.Body weights were recorded pretest and at termination.
Animals were observed for toxicological and pharmacological effects at each dermal observation period and observed for mortality daily. All animals were humanely sacrificed using C02 following study termination.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24-72hours

Score:

0

Max. score:

4

Reversibility:

no data

Remarks on result:

other: Staining was noted at 60 minutes, and at 24 and 48 hours. A numerical score could not be assigned at 60 minutes for all animals and in one animal at 24 hours following the 4 hour exposure due to the staining of the test article obscuring the dose site.

Irritant / corrosive response data:

There was no erythema or edema noted at any observation period.
Staining was noted at 60 minutes, and at 24 and 48 hours. A numerical score could not be assigned at 60 minutes for all animals and in one animal at 24 hours following the 4 hour exposure due to the staining of the test article obscuring the dose site.

Other effects:

here were no abnormal physical signs noted during the observation period.
All body weight changes were normal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results in this study, it can be concluded that test article is not irritant to the skin of rabbits.

Executive summary:

This study was performed to investigate the irritant or corrosive effects of test article when applied to the skin of a rabbit. This study was designed to comply with GLP regulations and OECD guideline 404. Three healthy New Zealand White rabbits(1 male, 2 females) were dosed dermally with test article, which applied to one intact site and wrapped with a semi-occlusive dressing for 4 hours. The wrapping were removed after applying 4 hours. Erythema and edema were scored at 1, 24, 48 and 72 hours following patch removal. Animals were also observed for toxicological effects at each dermal observation period and observed for mortality daily.There were no erythema or edema noted at any observation period. There were no abnormal physical signs noted during the observation period. All body weight changes were normal.

Therefore, it can be concluded that test article was not a dermal irritant.