disodium 4-amino-6-((4-((4-(2,4-diaminophenyl)azo)phenylsulfamoyl)phenyl)azo)-5-hydroxy-3-((4-nitrophenyl)azo)naphthalene-2,7-disulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

421-880-6

EC Name:

-

Cas Number:

201792-73-6

Molecular formula:

C34H25N11Na2O11S3

IUPAC Name:

disodium 4-amino-6-{2-[4-({4-[2-(2,4-diaminophenyl)diazen-1-yl]phenyl}sulfamoyl)phenyl]diazen-1-yl}-5-hydroxy-3-[2-(4-nitrophenyl)diazen-1-yl]naphthalene-2,7-disulfonate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species: Rabbit
Strain: New Zealand White albino
Source: Charles River UK Limited, Manston Road, Margate, Kent, UK
Sex:female
Specification: Young adults
The three animals weighed 2885g, 2210g and 2470g at the beginning ofthe study.

The rabbits were housed individually in aluminium sheet cages in racks suitable for animals of this strain and the weight range expected during the course ofthe study. The rabbits were transferred to clean cages and racks, as necessary, during the study.
The animai room was designed to give the environmental conditions shown as follows:

Temperature: 17±2°C
Relative humidity: 40-70%
Air:Approximately 25 changes/hour
Light cycle:Artificial giving 12 hours light, 12 hours dark

Both temperature and relative humidity were monitored continuously using an automated system which triggers an alarm if values are outside specified ranges. In generai, the recorded values were within the specified ranges and any deviations that were observed are considered not to have affected the integrity of the study.
Diet (ST ANRAB SQC) Standard Diet Services Limited, Stepfield, Witham, Essex, UK and mains water, supplied by an automatic system were available ad libitum.
Each batch of diet is routinely analysed for composition and for the presence of contaminants.
Water is also periodically analysed for the presence of contaminants. No contaminants were found to be present in the diet or water at levels considered to be capable of interfering with the purpose or outcome of the study.

The animals were housed under the experimental conditions for at least 5 days prior to the start of the study.

Animals were individually identified with a number, unique within the study, which was written on the inner side of one ear, using a black, waterproof, marker-pen.
On the front of each cage was a card identifying the contained animal by procedure code, test substance, date of administration, dose level, individuai number, sex and study

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

The test sample (approximately 500mg) was moistened with a small amount (0.5ml) of deionised water

Duration of treatment / exposure:

four hours of application

Observation period:

10 days

Number of animals:

3 females

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Irritant / corrosive response data:

Very slight erythema had completely regressed 2 days after application

Any other information on results incl. tables

Prior to the start of the study, all rabbits were examined to ensure that they were physically normal and exhibited normal activity. Throughout the study, the animals were observed daily.

A small area on the application site of two animals was stained purple by the test sample, but this did not prevent the assessment of irritation.

Very slight erythema was observed in all three animals for 1 day after application, but had completely regressed 2 days after application. Very slight oedema was observed in one animai approximately 30 minutes after decontamination, but had completely regressed 1 day later.

There were no additional signs of irritation

Applicant's summary and conclusion

Interpretation of results:

other: not irritant

Conclusions:

The tested substance is non-irritant to rabbit skin following a single 4-hour application.

Executive summary:

A group of 3 female rabbits received a single four-hour application of tested Substance to the shorn flank. The animals were assessed for up to 10 days for any signs of skin irritation. Very slight erythema had completely regressed 2 days after application.

The tested substance is non-irritant to rabbit skin following a single 4-hour application.